This report contains 250 citations. These are the input citations, used to train MScanner.

Warning: page scripts have not run - all things clickable will not function until they do. If the page is taking a while to load, consider downloading the zip file of results instead. If your browser is saying that there is blocked content, click the alert and "Allow blocked content".

Extra features: it is possible to save/load manual classifications (assigned by clicking in the "C" column) to file. To use this feature, save a local copy of this file (e.g. using "Save As" or from the zip archive) and open it in Mozilla Firefox or Internet Explorer 7. To use another feature where later results pages can be appended to the table, open the file in Mozilla Firefox.

Title contains
Title/abstract contains
Title/abstract does not contain
Medline record date between and
Abbreviated journal contains
Author list contains
Score is at least
Order by

     

Filter visible hides any currently visible rows that do not match the filter criteria. Show all citations unhides all hidden rows. Invert selection makes the visible rows hidden and the hidden rows visible.

The Medline record date is not the date of publication: it is the date on which the completed Medline citation record became available, so that recently added citations can be filtered for.

The title and abstract filters are case-insensitive regular expressions. They match substrings, but have many additional features. For example, "rat" matches both "rat" and "aberration", but "\brat\b" will only match "rat" ("\b" means "word boundary"). To search for both "rat" and "human", first filter for "rat", then filter for "human".

   

Opens PubMed in a new window, for the citations that are visible below. The second button instead opens those citations which have been marked relevant by clicking once in "C" column (colours changes to red ...)).

Clicking a second time explicitly marks the citation as irrelevant (...). Grey citations ( ...) are not manually classified".

   

These buttons will save or load classifications (the marks in the "C" column as to whether a citation is relevant or irrelevant) to a file called inputs_53.csv.

  Next up is: . 

Append citations from later results files to the bottom of this one.

Table of citations (250 visible)

CRScorePMIDDateAuAbTitleJournal
1300168.39160426962005.09.20++Sildenafil therapy in patients with sickle cell disease and pulmonary hypertension.Br J Haematol
RF Machado, S Martyr, GJ Kato, RJ Barst, A Anthi, MR Robinson, L Hunter, W Coles, J Nichols, C Hunter, V Sachdev, O Castro, MT Gladwin,
Pulmonary hypertension is a frequent complication of sickle cell disease that is associated with haemolysis, impaired nitric oxide bioavailability and high mortality. We sought to evaluate the safety and efficacy of selective pulmonary vasodilators and antiproliferative agents in this at-risk population. After optimising sickle cell disease therapy to stabilise haemoglobin and fetal haemoglobin levels, we evaluated the safety and efficacy of sildenafil in 12 patients with sickle cell disease and pulmonary hypertension. Sildenafil therapy (mean duration 6 +/- 1 months) decreased the estimated pulmonary artery systolic pressure [50 +/- 4 to 41 +/- 3 mmHg; difference 9 mmHg, 95% confidence interval (CI): 0.3-17, P = 0.043] and increased the 6-min walk distance (384 +/- 30 to 462 +/- 28 m; difference 78 m, 95% CI: 40-117, P = 0.0012). Transient headaches occurred in two patients and transient eye-lid oedema in four patients. No episodes of priapism occurred in the three men in the study; two of them were on chronic exchange transfusions and one had erectile dysfunction. In conclusion: (1) sickle cell disease patients with anaemia and pulmonary hypertension have significant exercise limitation; (2) the 6-min walk distance may be a valid endpoint in this population; (3) therapy with sildenafil appears safe and improves pulmonary hypertension and exercise capacity. Additional phase I studies in males with sickle cell disease followed by phase II/III placebo controlled trials evaluating the safety and efficacy of sildenafil therapy in sickle cell disease patients with pulmonary hypertension are warranted.
1300268.3985537951996.02.22++Chronic intrathecal baclofen in severely disabling spasticity: selection, clinical assessment and long-term benefit.Acta Neurol Belg
B Pirotte, A Heilporn, A Joffroy, D Zegers de Beyl, P Wesel, J Brotchi, M Levivier,
Flexor and extensor spasms associated with severe spasticity frequently cause pain and suffering in neurologically impaired patients, and greatly interfere with comfort and activities. When high doses of oral medications are necessary to keep the symptoms under control and are poorly tolerated, the long-term spinal-selective intrathecal infusion of baclofen by means of implanted drug pump and catheter is a safe, efficient and reversible alternative to destructive surgical procedures. Between September 1991 and March 1995, intrathecal baclofen was infused in 18 selected patients out of a series of 42 severely disabled spastic cases. We report here our preliminary experience with the criteria of selection, the initial intrathecal bolus test and the long-term benefit of the selected patients. Our results confirm the dramatic immediate and long-term benefit reported in other series. After a period of treatment of 1 to 42 months, 13 patients had a complete disappearance of their spastic symptoms without any oral treatment, one patient kept unchanged clonus despite the use of low-dose oral treatment and another one a severe, not improved dysuria although in both of them hypertonia and spasms were abolished. Finally, 2 patients had important joint stiffness slightly impairing the benefit from the treatment. None of the 18 patients had central side-effects related to baclofen. With time, a slight increase in daily dose (inferior to 10%) was necessary in most patients.
1300368.395544461981.03.24++A controlled double-blind study of haloperidol versus thioridazine in the treatment of restless mentally subnormal patients. Serum levels and clinical effects.Acta Psychiatr Belg
K Väisänen, R Rimón, P Räisänen, M Viukari,
A randomized cross-over trial was conducted in 30 restless mentally subnormal patients by increasing the dosage of haloperidol from 10 to 60 mg and of thioridazine from 100 to 600 mg daily. The effects of drug holidays and serum drug levels were also examined. Mesoridazine had 5-6 times higher serum levels than the parent compound and relatively high serum levels are achieved already with moderate doses. The observed differences between haloperidol and thioridazine treatment were surprisingly few. Serum cholesterol was higher (P < 0.05) at the end of the thioridazine administration. Drug holidays may benefit may patients.
1300468.3974165961980.11.25++Effects of long-term inhaled salbutamol therapy on the provocation of asthma by histamine.Am Rev Respir Dis
ET Peel, GJ Gibson,
Eight patients with asthma in remission were treated for 4 wk with a regular beta 2 stimulant. (salbutamol, 200 microgram) given 4 times/day by aerosol. Histamine provocation tests were performed at the beginning and at the end of the treatment period, and again 2 wk after cessation of treatment. Throughout the 6-wk period, the patients recorded peak expiratory flow (PEF) at home twice daily before and after inhaling 200 microgram of salbutamol. No significant differences were seen in the average PEF values or in the bronchodilator responses. There were no changes in the bronchial sensitivity to histamine during the study, and the protective effect of inhaled salbutamol against histamine provocation was preserved after the period of regular therapy. The results suggested that the regular use of a selective beta2 stimulant by inhalation in conventional therapeutic amounts in patients with asthma is unlikely to produce clinically important tolerance or increased susceptibility to an asthma-provoking stimulus.
1300568.3828025491989.11.13++Single-dose cefuroxime axetil versus multiple-dose cefaclor in the treatment of acute urinary tract infections.Antimicrob Agents Chemother
A Iravani, GA Richard,
Eighty-nine college women with acute urinary tract infections were treated orally with either 1,000 mg of cefuroxime axetil in a single dose (n = 59) or 250 mg of cefaclor three times a day for 7 days (n = 30). At 1 week posttherapy, 88% of the patients in the cefuroxime axetil group and 97% in the cefaclor group were clinically and bacteriologically cured (P greater than 0.10). There was no statistically significant difference between the cure rates of the two treatment groups. However, this study has only a 50% power to detect a 10% difference. Therefore, there is a substantial possibility of a type II error, i.e., failing to find a difference that is actually present. At 4 weeks posttherapy, 78% of the patients in the cefuroxime group and 80% in the cefaclor group remained cured. By 36 weeks posttherapy, the cumulative rate of recurrence in both treatment groups was 60%. Of the patients with a positive antibody-coated bacteria test, fewer achieved a short-term cure after single-dose treatment with cefuroxime axetil than those with a negative antibody-coated bacteria test (67 versus 96%; P less than 0.01).
1300668.3822761071991.03.06++Effect of two oral care protocols on the incidence of stomatitis in hematology patients.Cancer Nurs
SA Kenny,
Research-based oral care protocols for the control and treatment of stomatitis secondary to cytotoxic therapy are scarce in the nursing literature. The purpose of this pilot study was to determine the efficacy of two different oral care protocols in decreasing the incidence of stomatitis in patients with hematologic malignancies receiving chemotherapy and radiation therapy. It was hypothesized that patients with hematologic malignancies using oral care protocol A would have a lower incidence of treatment-induced stomatitis than patients using oral care protocol B. Eighteen subjects with hematologic malignancies treated with high doses of chemotherapy alone or in combination with radiation therapy were randomly assigned to one of two specific oral care protocols. Protocols differed in the type of lip lubricant, toothette, and mouthwash used. The Oral Assessment Guide (21) was used to assess oral status five times a week for the duration of each subject's hospitalization. A t test for independent samples was used to determine if the difference in the condition of the oral cavity was related to the different oral care treatments. A statistically significant difference was not found between the mean oral assessment scores of the two groups. A trend emerged, however, of a lower incidence of stomatitis in the subjects using the experimental oral care protocol. A serendipitous finding was that reinforcement of oral care instructions and nursing assessments of the oral cavity seemed to promote patient compliance with the oral care regime. A supplementary analysis revealed a statistically significant (r = -0.7177) negative correlation between the degree of stomatitis and the peripheral white blood cell count.
1300768.38124523972002.12.13++Rabeprazole improves health-related quality of life in patients with erosive gastroesophageal reflux disease.Dig Dis Sci
JF Johanson, R Siddique, AM Damiano, L Jokubaitis, A Murthy, A Bhattacharjya,
The purpose of this study was to assess the effect of rabeprazole 20 mg once a day on patient-reported health-related quality of life in routine clinical practice. Patients with erosive gastroesophageal reflux disease participating in an open-label, 8-week study completed the SF-36 Health Survey before and after treatment with rabeprazole. For all SF-36 scales, there was a statistically significant (p < or = 0.007) improvement in mean scores from baseline to week 8. Improvements in each of the subscales, except for physical functioning, general health, and mental health, were at least 5% in magnitude, a level considered clinically meaningful. Furthermore, while baseline scores were significantly poorer than general United States population scores, follow-up scores for four of the subscales (role limitations due to physical problems, social functioning, role limitations due to emotional problems, and mental health) were comparable to general population scores. In conclusion, rabeprazole significantly improved health-related quality of life in erosive gastroesophageal reflux disease patients and restored social functioning and emotional well-being to levels comparable to those observed in the United States general population.
1300868.3795462991998.06.26++Effectiveness of a home program intervention for young children with autism.J Autism Dev Disord
S Ozonoff, K Cathcart,
This project evaluated the effectiveness of a TEACCH-based home program intervention for young children with autism. Parents were taught how to work with their preschool autistic child in the home setting, focusing on cognitive, academic, and prevocational skills essential to later school success. To evaluate the efficacy of the program, two matched groups of children were compared, a treatment group and a no-treatment control group, each consisting of 11 subjects. The treatment group was provided with approximately 4 months of home programming and was tested before and after the intervention with the Psychoeducational Profile-Revised (PEP-R). The control group did not receive the treatment but was tested at the same 4-month interval. The groups were matched on age, pretest PEP-R scores, severity of autism, and time to follow-up. Results demonstrated that children in the treatment group improved significantly more than those in the control group on the PEP-R subtests of imitation, fine motor, gross motor, and nonverbal conceptual skills, as well as in overall PEP-R scores. Progress in the treatment group was three to four times greater than that in the control group on all outcome tests. This suggests that the home program intervention was effective in enhancing development in young children with autism.
1300968.37108384602000.08.03++Growth in human milk-Fed very low birth weight infants receiving a new human milk fortifier.Ann Nutr Metab
P Porcelli, R Schanler, F Greer, G Chan, S Gross, N Mehta, M Spear, J Kerner, AR Euler,
BACKGROUND/AIMS: Human milk fortification has been advocated to enhance premature infants' growth. We, therefore, undertook this study of a new human milk fortifier containing more protein than a reference one. METHODS: Open, randomized, controlled, multiclinic trial, with weekly growth parameters and safety evaluations in premature infants <1,500 g. RESULTS: The 2 groups did not differ in demographic and baseline characteristics. The adjusted daily milk intake was significantly higher in the infants fed reference human milk fortifier (n = 29; 154.2 +/- 2.1 vs. 144.4 +/- 2.5 ml/kg/day, mean +/- SE; p < 0.05). Both human milk fortifiers produced increases over baseline in weight, length, and head circumference, with greater gains observed in the new human milk fortifier-fed infants for the former two parameters (weight gain 26.8 +/- 1.3 and 20.4 +/- 1.2 g/day, p < 0.05; head circumference 1.0 +/- 0.1 and 0.8 +/- 0.1 cm/week; length 0.9 +/- 0.1 and 0.8 +/- 0.1 cm/week, respectively). Serum chemistries were normal and acceptable for age. Study events were typical for premature infants and similar in both groups. CONCLUSIONS: This new human milk fortifier had comparable safety to the reference human milk fortifier and promoted faster weight gain and head circumference growth.
1301068.37155316792004.12.07++Zinc plus beta-carotene supplementation of pregnant women is superior to beta-carotene supplementation alone in improving vitamin A status in both mothers and infants.Am J Clin Nutr
MA Dijkhuizen, FT Wieringa, CE West, Muhilal,
BACKGROUND: Deficiencies of vitamin A, iron, and zinc are prevalent in women and infants in developing countries. Supplementation during pregnancy can benefit mother and infant. OBJECTIVE: We examined whether supplementation during pregnancy with iron and folic acid plus beta-carotene or zinc or both improves the micronutrient status of mothers and infants postpartum. DESIGN: Pregnant women (n = 170) were supplemented daily only during pregnancy with beta-carotene (4.5 mg), zinc (30 mg), or both or placebo plus iron (30 mg) and folic acid (0.4 mg) in a randomized, double-blind, placebo-controlled trial. Micronutrient status was assessed 1 and 6 mo postpartum. RESULTS: Six months postpartum, plasma retinol concentrations were higher in the women who received zinc during pregnancy than in women who did not. Infants born to mothers supplemented with beta-carotene + zinc had higher plasma retinol concentrations, with the frequency of vitamin A deficiency reduced by >30% compared with the other 3 groups. Breast-milk beta-carotene concentrations were higher in all women supplemented with beta-carotene, but breast-milk retinol concentrations were higher only in women who received beta-carotene + zinc. Zinc concentrations did not differ among groups in mothers and infants. CONCLUSIONS: Zinc supplementation during pregnancy improved the vitamin A status of mothers and infants postpartum, which indicates a specific role of zinc in vitamin A metabolism. Addition of both beta-carotene and zinc to iron supplements during pregnancy could be effective in improving the vitamin A status of mothers and infants.
1301168.373701711979.05.16++A randomised controlled trial of the effect on middle-aged men of advice to stop smoking.J Epidemiol Community Health
G Rose, PJ Hamilton,
A randomised controlled trial of smoking cessation is reported in 1445 male smokers aged 40-59 at high risk of cardiorespiratory disease. The 714 men in the intervention group were recalled for a series of personal interviews with a doctor. After one year, 51% of the intervention group reported that they were not smoking any cigarettes, and most of the others reported a reduction. Compared with the "normal care" group, the men in the intervention group showed a decline in the prevalence of sputum production and dyspnoea; ventilatory function did not improve but its rate of decline was significantly slowed. There were no evident effects on blood pressure levels, nor on electrocardiographic findings over three years, nor on sickness absence over one year. Mortality follow-up has continued for an average of 7.9 years; 98 (13.7%) of the intervention group have died, compared with 94 (12.9%) of the "normal care" group. The 95% confidence limits on mortality range from 2.63% in favour of intervention to 4.37% in favour of normal care. The power of the trial has been reduced by smoking cessation in the "normal care" group. It is concluded that smoking cessation in these middle-aged men improved the symptoms and progress of chronic bronchitis; but the reversibility of the risk of cigarettes to the smoker's life may have been overestimated in observational studies.
1301268.36154650932005.01.10++Feasibility of combining multi-channel functional neuromuscular stimulation with weight-supported treadmill training.J Neurol Sci
JJ Daly, RL Ruff,
More than 3 million stroke survivors live with residual disabilities and mobility deficits even after rehabilitation. Therefore, it is important to develop new, more effective, gait training methods. The purpose of this study was twofold: (1) testing the feasibility of combining multi-channel functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes and body weight supported treadmill training (BWSTT) for gait training; and (2) documenting the potential gait practice advantages afforded by combining FNS-IM and BWSTT. Eight subjects with gait deficits in the chronic phase (>12 months) were enrolled. Intramuscular electrodes were placed in the paretic hip abductors, knee flexors and extensors, and ankle dorsiflexors, plantarflexors, and evertors. Subjects were treated with exercise and gait training using the combined technologies 1 1/2 h/week, four times/week, for 12 weeks. Feasibility was tested according to performance of the technologies, clinician skill factors, and subject satisfaction. Impairment, function, and quality of life were measured. Provision of practice for eight gait characteristics was catalogued. We found the following results for the combined technologies: (1) the combined technologies were safe and feasible; (2) clinicians required five training sessions to reach proficiency; (3) subjects were satisfied; (4) there were significant gains in impairment and functional measures; (5) a greater number of gait practice characteristics were provided with the combined technologies than with either alone.
1301368.36113158322001.08.02++Comprehensive evaluation of community-based diabetic patients: effect of feedback to patients and their physicians: a randomized controlled trial.Diabetes Care
RG Hiss, ML Gillard, BA Armbruster, LA McClure,
OBJECTIVE: To demonstrate improvements in diabetes care stimulated by comprehensive evaluation of community-based diabetic patients with feedback to the patients and their physicians. RESEARCH DESIGN AND METHODS: A comprehensive evaluation of community-based diabetic patients with annotated reporting of results to both patients and their physicians (universal intervention) was followed by random assignment of 50% of patients to individual counseling (randomized intervention). In four communities, two large and two small, 55 type 1 and 376 type 2 diabetic patients were recruited, evaluated, and reassessed at 1 year. Outcome measures were HbA1c, serum cholesterol, and systolic and diastolic blood pressure. RESULTS: There were significant improvements in all outcome measures for type 2 diabetic patients randomized to individual counseling (P = 0.03; follow-up rate 84%) and significant improvements in all outcome measures for all high-risk type 2 patients (highest P value = 0.004; follow-up rate 85%). CONCLUSIONS: Comprehensive evaluation of diabetic patients at the community level with annotated reporting of results to the patients and their physicians was associated with improvement of mean HbA1c, cholesterol, and systolic and diastolic blood pressure, particularly in patients in high-risk status for these outcome variables. Individual counseling of 50% of patients, randomly selected, enhanced these results.
1301468.3529735711988.12.29++Mechanisms of bronchial hyperreactivity in cystic fibrosis.Pediatr Pulmonol
PP Van Asperen, P Manglick, H Allen,
We studied 14 patients with cystic fibrosis (CF) who had evidence of bronchial hyperreactivity on a standardized histamine challenge. Patients had a histamine challenge on the first day. Then they were pretreated with either 0.25 mg ipratropium bromide or 0.5 mg fenoterol hydrobromide on 2 separate days, and the histamine challenge was repeated. Baseline forced expiratory volume in 1 sec was similar on the 3 days; however, there was a small but significant (P less than 0.05) improvement after fenoterol. Mean PC20 on the control day was 1.50 mg/ml, which increased significantly after pretreatment with ipratropium (2.88 mg/ml, P less than 0.01) and fenoterol (3.64 mg/ml, P less than 0.005), indicating protection against histamine-induced bronchial hyperreactivity. The six CF patients with "coexistent asthma," as defined by recurrent episodes of wheezing responsive clinically to bronchodilator therapy, had no significant protection from ipratropium, whereas the eight "nonasthmatic" CF patients were protected by both ipratropium and fenoterol. We postulate that at least two mechanisms contribute to histamine-induced bronchial hyperreactivity in patients with CF, one related to vagally mediated reflex bronchoconstriction and another that acts independently of this mechanism.
1301568.35115810532001.10.18++Delayed suprachoroidal hemorrhage after glaucoma filtration procedures.Ophthalmology
SS Tuli, D WuDunn, TA Ciulla, LB Cantor,
OBJECTIVES: To determine the incidence of, risk factors for, and outcomes of delayed suprachoroidal hemorrhage (DSCH) after glaucoma filtration surgery. DESIGN: Retrospective case-control study. PARTICIPANTS: All patients undergoing glaucoma filtration procedures between 1986 and 2000 at Indiana University who were diagnosed postoperatively with suprachoroidal hemorrhage. A total of 66 patients with DSCH were identified. These were compared with a randomly selected group of patients who underwent similar procedures but did not have suprachoroidal hemorrhage. METHODS: Total cases of DSCH were initially compared with the total number of glaucoma surgeries to determine the overall incidence and the incidence in the different procedures. Subsequently, a case-control study was performed comparing the group with hemorrhage to the control group to identify risk factors. Finally, outcomes and prognostic factors were determined by comparing vision preoperatively and postoperatively and parameters of patients with good and poor outcomes. MAIN OUTCOME MEASURES: Incidence of DSCH, risk factors associated with its occurrence, visual outcomes, and factors important for prognosis. RESULTS: Of a total of 2285 glaucoma filtration procedures, 66 (2.9%) cases of DSCH were identified. It developed in 9 of 615 (1.5%) trabeculectomies without antimetabolite, 30 of 1248 (2.4%) trabeculectomies with antimetabolite, 2 of 72 (2.8%) valved tube shunt implantations, and 25 of 350 (7.1%) nonvalved tube shunt implantations. The increased incidence of DSCH after tube shunts compared with trabeculectomy-associated DSCH was significant (P < 0.0001) with an odds ratio of 3.2. The risk factors for DSCH after glaucoma surgery include white race (P = 0.012), anticoagulation (P = 0.034), severe postoperative hypotony (P = 0.033), and aphakia/anterior chamber intraocular lens (P = 0.002). The visual outcomes of patients with hemorrhage were poor, with a decrease in logarithm of the minimum angle of resolution visual acuity from 0.72 to 1.36, which was statistically significant compared with the controls (P < 0.009). CONCLUSIONS: Delayed suprachoroidal hemorrhage occurs more frequently after tube shunt implantation than after trabeculectomy. Caution should be exercised when operating on patients with known risk factors, because the visual outcomes after DSCH are poor.
1301668.34114523342001.08.30++Fenoldopam infusion associated with preserving renal function after aortic cross-clamping for aneurysm repair.J Cardiovasc Pharmacol Ther
TB Gilbert, JU Hasnain, WR Flinn, MP Lilly, ME Benjamin,
BACKGROUND: Cross-clamping of the descending aorta during operative repairs causes sudden, significant reductions in renal function that may persist well beyond arterial clamp release. Commonly used agents, such as dopamine and mannitol, have not consistently affected renal outcome in these high-risk patients. Fenoldopam mesylate is a novel, highly selective dopamine type-1 agonist that preferentially dilates the renal and splanchnic vasculature, but has not been investigated in patients undergoing prolonged aortic clamping for whom adverse renal outcomes should be more likely. METHODS AND RESULTS: Twenty-two adult patients without significant pre-existing renal dysfunction and presenting for elective repairs of abdominal aortic aneurysms were studied. Fenoldopain mesylate was infused after obtaining baseline values ranging from 0.1 to 1.0 microg/kg/min for the first 24 hours postoperatively to maintain mean arterial pressure +/-25% baseline. Serial renal function indices, including creatinine clearance and electrolyte fractional excretions, were measured at baseline, at aortic clamping and unclamping, and post-clamp release, and were estimated through hospital discharge. Creatinine clearance fell during abdominal exploration and clamping, reaching a nadir with clamp removal. Partial recovery occurred by 2 hours after clamp removal, and returned to baseline values by postoperative day 1 and thereafter. Fractional excretions rose rapidly throughout the operative phase. Total fenoldopam dose was directly related to the baseline creatinine clearance; after clamp removal, creatinine clearance was directly related to the mean arterial pressure at the lowest dose of fenoldopam, and inversely related to the mean arterial pressure at clamp release. CONCLUSIONS: In elderly patients with severe vascular disease undergoing aneurysmal repairs, the use of a fenoldopam infusion in this open-label, uncontrolled trial was associated with a relatively rapid return of renal function to baseline values, despite profound decreases during aortic cross-clamping. Further studies will be necessary to investigate how fenoldopam infusions compare with traditional therapies.
1301768.3478826601995.04.13++Evaluation of a continuing education intervention "Periodontics in General Practice".Community Dent Oral Epidemiol
LF Brown, PA Keily, AJ Spencer,
Evidence exists that some dentists may be failing to perform adequate periodontal diagnostic and preventive care for their patients. Continuing education (CE) is an avenue that is frequently employed as a strategy to alter the style of practice. This paper presents an evaluation of a year-long continuing education intervention "Periodontics in General Practice", conducted among randomly selected private general dental practices in Adelaide, South Australia. The CE intervention featured a 1-day seminar, bi-monthly newsletters, individualised 3-monthly comparative feedback, and technical assistance. The study employed a longitudinal quasi-experimental design, which allowed for evaluation of the effectiveness of the intervention among practices employing hygienists (n = 12) and not employing dental hygienists (n = 12), taking into account the covariates of baseline level of provision of periodontal services, the practice's level of participation in the intervention and attendance at other CE courses in periodontics over the year. A comparison group of practice (n = 12) did not participate in the intervention over the year. Patient record audits, conducted at baseline and at 12 months, provided data for the evaluation of the effect of the intervention on the recording of periodontal diagnostic, preventive and treatment items. Practices participating in the intervention showed increases in the percentage of records containing at least one periodontal diagnostic notation, and those practices employing hygienists showed an increase in the percentage of records with at least one preventive notation and one treatment item.(ABSTRACT TRUNCATED AT 250 WORDS)
1301868.34161895182005.11.21++Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in advanced head and neck cancer.Br J Cancer
M Tsukuda, A Kida, M Fujii, N Kono, T Yoshihara, Y Hasegawa, M Sugita,
The purpose of this study was to determine the feasible adjuvant therapy administration schedule of S-1 for locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients receiving definitive treatments were randomly assigned to either arm A (51 cases) receiving oral S-1 of 2-week administration followed by 1-week rest for 6 months, or arm B receiving S-1 of 4-week administration followed by 2-week rest for 6 months. Planned treatment was given in 40% of patients in arm A and 29% in arm B. The cumulative rates of the relative total administration dose of S-1 at 100% were 54.9% (95% CI: 40.1-69.7%) in arm A and 34.3% (95% CI: 21.1-47.4%) in arm B, respectively (P=0.054). Adverse events were recorded in 41 patients (82.0%) in arm A and 48 patients (94.1%) in arm B (P=0.060). The incidences of diarrhoea (10 vs 28%; P<0.05) and skin toxicities (18 vs 37%; P<0.05) were significantly higher in arm B. One-year disease-free survival was similar in both arms: arm A 81.2% (95% CI: 70.0-92.4%); arm B 77.0% (95% CI: 65.0-89.0%). The schedule of 2-week administration followed by 1-week rest seems to be more feasible for oral 6-month administration of S-1 in adjuvant chemotherapy of locoregionally advanced SCCHN.
1301968.337902871977.01.03++The paradoxical effect of adrenergic and methylxanthine drugs in cystic fibrosis.Pediatrics
GG Shapiro, J Bamman, P Kanarek, CW Bierman,
This study examined the effect of aerosolized isoproterenol and oral theophylline on pulmonary function in cystic fibrosis (CF) to determine how often these drugs are beneficial and whether there is a correlation between response to isoproterenol and response to oral theophylline. After obtaining baseline pulmonary function tests before and after isoproterenol aerosol, 12 patients with CF were put on a double-blind trial of high-dosage theophylline (10 mg/kg three times per day) or placebo for four weeks and were then switched to the alternate regimen for the next four weeks. Patients had weekly evaluations of pulmonary function and plasma theophylline determinations. Gastrointestinal side effects were common with theophylline. The responses to aerosolized bronchodilators were inconsistent from week to week. After aerosolized bronchodilator, five of 12 patients had an average increase of 10% or more in FEF45%-55% and FEF70%-80%. While taking oral theophylline, five patients had a 10% or more decrease in FEF 45%-55% and six patients had a decrease in FEF70%-80%. We conclude that there was no concordance between response to isoproterenol and theophylline, and that adrenergic and methylxanthine drugs must be used with caution in patients with CF.
1302068.3397641321998.10.16++Early intervention, untreated psychosis and the course of early schizophrenia.Br J Psychiatry Suppl
D Linszen, M Lenior, L De Haan, P Dingemans, B Gersons,
BACKGROUND: Studies have proved that early intervention can delay psychotic relapses, and prevent psychosocial deterioration in people with schizophrenia and related disorders. METHOD: Our study with young people with recent onset schizophrenia has shown that an intensive intervention programme had a beneficial effect on the occurrence of psychotic relapse and the course of psychotic syndromes. This effect lasted until the end of the 15-month intervention. No significant effect of the two different intervention conditions became apparent. RESULTS: The results of a follow-up study showed that this beneficial effect did not last. Fifteen per cent of the people had a psychotic relapse during the intervention, whereas 64% relapsed during follow-up. CONCLUSIONS: These results show that referral to other mental health agencies after intervention is not sufficient and that more support is required to continue disease management, medication compliance and stress management.
1302168.3328647931985.11.15++A double-blind group comparison of mianserin and clomipramine in the treatment of mildly depressed psychiatric out-patients.Acta Psychiatr Scand Suppl
GC Dunbar, M Naarala, H Hiltunen,
The effects of mianserin 30-60 mg and clomipramine 75-150 mg were compared in a randomized double-blind study of 62 mildly depressed out-patients. Treatment was continued for three to four weeks, after which approximately 50% of patients left the study clinically much improved. Significant benefits for mianserin were apparent at days 7 and 21 on the Hamilton Depression Rating Scale (HDRS) total score and at day 7 on the HDRS anxiety-somatization factor score. No difference in overall antidepressant activity was found in those patients treated for four weeks. There was a significantly greater number of side-effects in the clomipramine treated group. It is suggested that mianserin is a more rational treatment than clomipramine in this group of patients because of a greater anxiolytic action and a lower incidence of side-effects.
1302268.3368755301983.09.09++Life skills training for chronic schizophrenics.J Nerv Ment Dis
MA Brown, AM Munford,
This research evaluates the effectiveness of training chronic schizophrenic patients in interpersonal and instrumental skills for coping adequately in community living situations. The subjects were male, chronic schizophrenic inpatients with histories of multiple rehospitalizations. Twenty-eight volunteers were randomly assigned to either the life skills training or to a traditional Veterans Administration rehabilitation program. The life skills program included 7 weeks of training in interpersonal and instrumental skills considered important for community tenure: interpersonal communication skills, nutrition, health, finance, time management, and utilization of community resources. Acquisition of skills was assessed by means of a Life Skills Inventory (LSI) and five attitudinal and affective measures pretreatment and post-treatment. The results of the comparison of outcome measures showed the treatment group superior to the control in interpersonal skills, finance, health, use of community resources, and total LSI score. They also showed greater improvement on most of the attitudinal and affective measures. Patients are being followed to measure duration of community placement and maintenance of skills.
1302368.3294721451998.03.24++Cariostatic effect of glass ionomer retained orthodontic appliances. An in vivo study.Swed Dent J
S Twetman, JS McWilliam, A Hallgren, A Oliveby,
The cariostatic effect of a fluoride releasing bonding agent was investigated and compared with a conventional composite based material in connection with bonding of orthodontic brackets in 22 homologous pairs of premolars. All subjects had malocclusions requiring orthodontic treatment with fixed appliances and extraction of at least two premolars. 6-13 weeks prior to extraction, orthodontic brackets were bonded to the labial surfaces of the extraction teeth with either a glass ionomer cement or a bis-GMA resin. Initially, the children were instructed in tooth brushing and the regular use of fluoride. After extraction, the bonded teeth were stained and evaluated in a stereo-microscope regarding the incidence and extension of initial enamel demineralisation. The zone of intact enamel adjacent to the bracket base and bonding material was measured in a stereo-microscope at four predetermined locations with the aid of an electronic ruler and scored according to four categories. The incidence of enamel demineralisation adjacent to glass ionomer bonded and composite bonded brackets was 68% and 77% respectively. In 12 pairs of premolars however, the demineralisation appeared to a lesser extent on the enamel around the brackets was generally wider when glass ionomer cement was used compared to the composite resin. These differences were statistically significant (p < 0.05) mesially and distally, but non-significant cervically and incisally. The results indicate that bonding with glass ionomer cement may have a local cariostatic effect in children requiring fixed orthodontic appliances.
1302468.32116416702001.12.04++Rectal misoprostol versus intravenous oxytocin for the prevention of postpartum hemorrhage after vaginal delivery.Am J Obstet Gynecol
TS Gerstenfeld, DA Wing,
OBJECTIVE: To compare rectally administered misoprostol to intravenously administered oxytocin for the management of third-stage labor. STUDY DESIGN: Subjects were randomized to receive two, 200-microg misoprostol tablets rectally (study medication) plus 2 mL saline in Ringer's lactate intravenously or two lactose tablets rectally plus 20 units oxytocin in Ringer's lactate intravenously (control medication). Blood loss was determined by estimation, measurement, and change in hematocrit values from admission to postpartum day 1. Subjects were excluded if cesarean delivery was required. RESULTS: A total of 325 women underwent analysis. By estimation, 21% of subjects and 15% of controls had postpartum hemorrhage (P =.17). By using measured blood loss, we determined that 70 of 154 (46%) study subjects and 61 of 161 (38%) control subjects had postpartum hemorrhage (P =.17). For 36 (23%) misoprostol subjects and 18 (11%) oxytocin subjects at least one additional agent was required to control bleeding (P =.004). CONCLUSION: Rectal misoprostol (400 microg) was no more effective than intravenous oxytocin in preventing postpartum hemorrhage.
1302568.32110286552001.02.08++Hypomagnesaemia in chronic, stable asthmatics: prevalence, correlation with severity and hospitalization.Eur Respir J
OS Alamoudi,
Magnesium (Mg) deficiency is associated with airway hyperreactivity, wheeze and impairment of lung function. The prevalence of hypomagnesaemia, and its effect on asthma is unclear. Therefore, this prospective study was undertaken to evaluate the prevalence of low serum Mg level, to correlate whether hypomagnesaemia (serum Mg level <0.74 mmol x L(-1)) is associated with severity of asthma and increased frequency of hospitalizations in chronic, stable asthmatics. Ninety-three chronic stable asthmatics, who were on regular follow-up in an asthma clinic, were studied. On attendance to the asthma clinic, each subject was interviewed and clinically evaluated. The serum Mg level (normal 0.74-1.2 mmol x L(-1)), as well as the severity of asthma was measured. The medications used were recorded. The total number of hospitalizations due to asthma exacerbation was scored for the last three months that preceded the date of measuring the serum Mg level. Twenty-five patients (27%) had a low Mg level with a mean+/-SD of 0.69+/-0.04 mmol x L(-1), while 68/93 (73%) had a normal Mg level (0.82+/-0.08 mmol x L(-1)). The number of hospitalizations in asthmatics with low Mg levels was 10/25 (40%), compared to 8/68 (12%) (p<0.01) in asthmatics with normal Mg levels. Multiple logistic regression analysis showed that severe asthma was the only factor associated significantly with hypomagnesaemia (p=0.04). No effect was observed for inhaled beta-agonist, inhaled steroid or theophylline therapy on serum Mg level. To conclude, hypomagnesaemia is common in chronic asthmatics. Chronic asthmatics with low Mg tend to have more hospitalizations than chronic asthmatics with normal Mg. Hypomagnesaemia was also associated with more severe asthma.
1302668.3211494841975.11.01++The use of povidone-iodine ('Betadine') pessaries in the treatment of candidal and trichomonal vaginitis.Curr Med Res Opin
JN Henderson, IB Tait,
One hundred and thirty-five women suffering from trichomonal, candidal, or both infections simultameously, were treated with povidone-iodine pessaries, 2 pessaries being inserted nightly. Ninety-nine women were given a 7-day course of treatment, but the results obtained were disappointing, and the authors do not recommend such a regime for routine treatment. Better results were obtained with the recommended 14-day course. A further 36 women suffering from chronic trichomonal and/or canidal infections which had previously resisted orthodox treatment were given a prolonged 28-day course of pessary treatment. The results obtained were very encouraging, 92% of the trichomonal and 96% of the canidal infections being cured. Furthermore, although povidone-iodine is slightly less effective in trichomoniasis, most patients suffering from a chronic infection (candidal, as well as trichomonal) were cured by the one preparation. Side-effects did occur, but were significant in only 3 patients. Subjective symptoms, especially any offensive odour, disappeared within 3 days of the start of the treatment. The authors recommend that the 28-day course of povidone-iodine pessaries is used in those cases where trichomoniasis or candidosis has been a therapeutic problem in the past, particularly if the patient is currently on the oral contraceptive pill.
1302768.3285880561996.03.22++Controlled comparison of the effects and abrupt discontinuation of buspirone and lorazepam.Prog Neuropsychopharmacol Biol Psychiatry
M Bourin, M Malinge,
1. The purpose of this study was to compare the effects and abrupt discontinuation of buspirone 15 or 20 mg tid and lorazepam 3 or 4 mg tid following 8 weeks of treatment. A total of 43 outpatients with generalized anxiety disorder were included in the study and 39 entered the withdrawal phase. 2. Clinical assessments were performed at baseline, 2, 4, 6 and 8 weeks (active phase) and after 9 and 10 weeks (withdrawal phase). These included the Hamilton anxiety scale, the visual analogue scale, the CHESS 84 (a check list for the evaluation of somatic symptoms) and the Lader tranquilizer withdrawal scale (translated in french). 3. Results show similar efficacy for lorazepam and buspirone during the active phase with a higher significant difference for buspirone on the CHESS 84 in relation with neurovegetatives symptoms: lorazepam D0 :16.30 +/- 3.14 D56: 5.10 +/- 0.93 (p < or = 0.01) buspirone D0 :18.82 +/- 3.4 D56: 4.73 +/- 1.18 (p < or = 0.001) No withdrawal phenomena was observed for both drugs using HAM-A lorazepam D63 :12.59 +/- 2.26 D70: 12.0 +/- 1.75 (p = ns) buspirone D63 :10.05 +/- 1.28 D70: 10.32 +/- 1.82 (p = ns) and the same significant difference using Lader scale: lorazepam D63 :4.44 +/- 0.89 D70: 6.96 +/- 1.28 (p < or = 0.05) buspirone D63 :2.95 +/- 0.66 D70: 4.15 +/- 0.92 (p < or = 0.05). 4. This study confirmed that buspirone was as effective as lorazepam at D56 in monitored outpatients with generalized anxiety disorder.(ABSTRACT TRUNCATED AT 250 WORDS)
1302868.3292479781997.09.23++Effect of neuroleptic treatment on depressive symptoms in acute schizophrenic episodes.Psychiatry Res
M Krakowski, P Czobor, J Volavka,
This study examined depressive symptoms in acute schizophrenic episodes and their relationship to neuroleptic treatment. Sixty-three depressed and 62 non-depressed acutely exacerbated schizophrenic patients were evaluated with the Brief Psychiatric Rating Scale, the Scale for the Assessment of Positive Symptoms, the Simpson-Angus Extrapyramidal Scale, and the Hamilton Rating Scale for Depression. Subjects were then randomly assigned to different haloperidol plasma levels and followed for 3 weeks. Overall, depression improved with treatment of the acute psychosis, but a positive association between extrapyramidal side effects and depressive symptoms emerged over time. Depressive symptoms tended to be positively related to haloperidol plasma levels. The results suggest that depressive symptoms in schizophrenia are heterogeneous in origin; while neuroleptics can ameliorate depressive symptoms inherent in the acute schizophrenic episode, they can also contribute to depression.
1302968.31171270832007.03.15++A painless method of ultrasonically assisted debridement of chronic leg ulcers: a pilot study.Eur J Vasc Endovasc Surg
J Tan, S Abisi, A Smith, KG Burnand,
OBJECTIVES: Devitalized tissue in a recalcitrant leg ulcer is common and may impede healing. The aim of this study was to evaluate the use of a non-invasive low frequency ultrasound device to debride chronic leg ulcers as an adjunct to compression bandages therapy. METHODS: 19 patients with leg ulceration of at least 6 months were recruited. Low frequency ultrasound at 25kHz was delivered by a portable Sonaca--180 via a handheld probe, using normal saline as the irrigation/coupling medium. The ultrasound was applied for 10-20 seconds per probe head area onto the ulcer. Each leg underwent treatment at an interval of 2-3 weeks with compression bandages reapplied at the end of the treatment. Serial colour photographs were taken to evaluate the response at each visit. RESULTS: Each patient received on average 5.7 treatments each ranged from 5-20 minutes depending on the ulcer size. Symptomatic relief (pain and odour reduction) was achieved in 6 patients. 7 patients achieved complete ulcer healing (mean ulcer size=4.72+/-SD 1.872cm(2)) but no response was observed in 8 patients. There were no major complications of the treatment which was relatively painless. CONCLUSIONS: The application of low frequency ultrasound debridement may heal some recalcitrant ulcers when standard compression regimens have failed. It is cheap and does not require admission. The role of simple wound cleansing requires further investigation.
1303068.30110693122000.12.20++Budesonide in the treatment of Crohn's disease: a meta-analysis.Aliment Pharmacol Ther
C Papi, R Luchetti, L Gili, S Montanti, M Koch, L Capurso,
AIM: To perform a meta-analysis to assess the effectiveness and safety of oral budesonide for inducing remission in active Crohn's disease and for preventing relapse in Crohn's disease with medically- or surgically-induced remission. METHODS: All randomized, double-blind controlled trials involving oral budesonide therapy in Crohn's disease were retrieved from a Medline search, reviews articles or their bibliographies. Of 83 articles retrieved, 12 met the inclusion criteria. Data extraction was performed by three independent observers and scoring disagreements were resolved by consensus. RESULTS: Six trials tested budesonide in active disease and six in quiescent disease. Budesonide was less effective than conventional corticosteroids for inducing remission of active Crohn's disease (pooled rate difference, RD -8.5%; 95% CI: -16.4 to -0.7%; P=0.02), but corticosteroid-related adverse events were reduced (RD -22.4%; 95% CI: -32 to -12.8%; P < 0.001). In quiescent Crohn's disease, budesonide was as effective as placebo for preventing relapse in medically induced remission (RD -0.8%; 95% CI: -9.9 to 8.3%; P=0.42) and endoscopic recurrence in surgically induced remission (RD -3.5%; 95% CI: -16.9 to 9.8%; P=0.30). In the long term treatment, budesonide had an occurrence rate of corticosteroid-related adverse effects similar to placebo (RD 5.3%; 95% CI: -3.9 to 14.5%; P=0.30). CONCLUSIONS: Budesonide is significantly less effective than conventional corticosteroids for inducing remission in active Crohn's disease, but the risk of corticosteroid-related adverse effects is significantly reduced. Budesonide is not effective in preventing relapse of Crohn's disease after medically- or surgically-induced remission.
1303168.29109015112000.10.18++Prospective study of early discharge after acute myocardial infarction (SHORT)Eur Heart J
MJ van der Vlugt, H Boersma, CM Leenders, GA Pop, MJ Veerhoek, ML Simoons, JW Deckers,
AIMS: To identify, without additional investigation, a large group of myocardial infarction patients at low risk who would qualify for early discharge. METHODS: The decision rule was developed in 647 unselected patients with consecutively admitted myocardial infarction, and validated in 825 others. Daily event-rates were calculated for major (death, ventricular fibrillation, recurrent infarction, heart failure, advanced AV-block) and minor (unstable angina and rhythm-abnormalities) cardiac complications. RESULTS: Patients free from major complications until day 7 (44% of all patients) were found to constitute a very low risk group and thus would qualify for discharge at day 7. Of the 39% of patients with an uncomplicated infarction (low risk) in the validation group, 31% were discharged at day 7, while 8% stayed longer because of non-cardiac co-morbidity, for social reasons or logistic problems. No major adverse event occurred within 7 days after hospital discharge and only 1.8% developed complications within 1 month. The median duration of hospital stay for all in-hospital survivors was 7 days compared to 10 days in the control group. CONCLUSION: Prospective application of the early discharge decision rule, based upon simple clinical variables and without the need for additional non-invasive and/or invasive tests, resulted in a significant reduction of hospital stay. The decision rule correctly classified patients into high and low risk groups and appeared feasible and safe. Its efficacy was demonstrated by its ability to identify a large group of post infarction survivors at low risk for complications during follow-up.
1303268.29118015872002.05.08++Liposomal amphotericin B versus conventional amphotericin B in the empirical treatment of persistently febrile neutropenic patients.J Antimicrob Chemother
PJ Cagnoni,
Liposomal amphotercin B was compared with conventional amphotericin B for empirical antifungal therapy in febrile neutropenic patients in a randomized, double-blind, multicentre trial. Using a composite end-point, the two drugs were equivalent in overall efficacy. However, the liposomal amphotericin B treatment group had fewer proven fungal infections, fewer infusion-related side effects and less nephrotoxicity. Patient data from that study were analysed to compare the pharmacoeconomics of liposomal versus conventional amphotericin B therapy. Itemized billing data from 414 patients were collected and analysed. Hospital costs from first dose were significantly higher for all patients who received liposomal amphotericin B ($48,962 versus $43,183, P = 0.02). However, hospital costs were very sensitive to the cost of the study medication ($39,648 versus $43,048, when acquisition costs are not included, P = 0.4). Using decision analysis models and sensitivity analyses to vary the cost of study medications and risk of nephrotoxicity, the break-even points for the cost of liposomal therapy were calculated to range from $72 to $87 per 50 mg for all patients, and $83 to $112 per 50 mg in allogeneic bone marrow transplant patients. Therefore, the drug acquisition costs and the risk of nephrotoxicity are important factors in determining the cost-effectiveness of liposomal amphotericin B as empirical therapy in persistently febrile neutropenic patients. In a recent randomized double-blind study comparing liposomal amphotericin B at 3 or 5 mg/kg/day with amphotericin B lipid complex (ABLC) 5 mg/kg/day as empirical antifungal treatment in patients with febrile neutropenia, liposomal amphotericin B was associated with less toxicity than ABLC, both in terms of infusion-related reactions and nephrotoxicity. The incidence of study drug discontinuation due to toxicity was: liposomal amphotericin B 3 mg/kg/day, 14%; liposomal amphotericin B 5 mg/kg/day, 15%; and ABLC, 42% (P < 0.001).
1303368.29152850052005.02.03++[Italian study on the treatment of anaemia in chronic dialysis patients switched over to less frequent doses of darbepoetin from human recombinant erythropoietin (rHuEPO)]G Ital Nefrol
L Del Vecchio, G Villa, G Carraro, M Morosetti, L Pedrini, M Adorati Menegato, M Amato, MM Mauro, P Borgatti, F Malberti, P Marai, F Locatelli,
BACKGROUND: Darbepoetin alpha is a novel erythropoiesis stimulating protein with unique properties as compared to recombinant human erythropoietin (rHuEPO), including a three-fold longer elimination half-life that allows for less frequent dosing. This study was aimed at testing the efficacy and safety of darbepoetin alpha in a large number of chronic dialysis patients switched from rHuEPO. METHODS: Nine hundred and fifty dialysis patients in stable treatment with rHuEPO were switched to darbepoetin alpha. Patients receiving rHuEPO 2 or 3 times weekly were switched to once weekly darbepoetin alpha and those receiving rHuEPO once weekly were switched to once every other week darbepoetin alpha. Patients received darbepoetin alpha by the same route of administration (SC or IV) as the one used for rHuEPO. The unit doses of darbepoetin alpha (10-150 microg) were titrated to maintain haemoglobin concentration within -1.0 and +1.5 g/dL of the individual mean baseline haemoglobin levels and between 10 and 13 g/dL for 24 weeks. RESULTS: The mean change in haemoglobin from baseline to the evaluation period (weeks 21-24) was statistically but not clinically significant [-0.10 g/dL (95% CI: -0.18, -0.02]. In general, the geometric mean weekly dose of study drug from screening/baseline to evaluation period remained substantially unmodified [(from 26.10 micro g/wk to 25.90 microg/wk; percentage change -0.40% (95% CI: -3.78, 3.10)]. Overall, darbepoetin alpha was well tolerated. CONCLUSIONS: The treatment of anaemia of a large dialysis patient population with unit dosing of darbepoetin alpha is effective and safe in maintaining target haemoglobin concentration at reduced dose frequency.
1303468.2981538031994.05.09++Objective assessment for exercise treatment on the B-200 isostation as part of work tolerance rehabilitation. A random prospective blind evaluation with comparison control population.Spine
BL Sachs, SS Ahmad, M LaCroix, D Olimpio, R Heath, JA David, AD Scala,
The purpose of this study was to assess repeated exercise on the B-200 Isostation as part of rehabilitation work tolerance for nonsurgical patients with lumbar spine disorders. For a consecutive 7-month period, treatment subjects were randomly assigned according to birth date for participation in two groups: a standard work tolerance program only or standard work tolerance program plus inclusion of exercise on the B-200 Isostation. Each patient had similar referral diagnosis requiring conservative treatment. Treatment groups were compared with a control population of volunteers who had neither back pain nor known underlying spinal pathology. All study patients had objective measurement of range of motion, isometric strength, and velocity of motion, on the B-200 Isostation before treatment and at follow-up 3 weeks after treatment. The data showed no significant difference of percent improvement when comparing patients in either of the randomized assigned treatment groups. There was a higher percentage of improvement for each treatment group as compared with the control individuals, however. Based on our study using the B-200 Isostation, there is little objective justification for including exercise on the B-200 dynametric Isostation as part of the rehabilitation routine for improvement of functional physical capacity.
1303568.2879176901994.11.01++Functional capacity before and after cardioversion of atrial fibrillation: a controlled study.Br Heart J
AT Gosselink, HJ Crijns, MP van den Berg, SA van den Broek, H Hillege, ML Landsman, KI Lie,
OBJECTIVE--To evaluate the effect of cardioversion on peak oxygen consumption (peak VO2) in patients with long-standing atrial fibrillation, to assess the importance of underlying heart disease with respect to the response to exercise, and to relate functional capacity to long-term arrhythmia outcome. DESIGN--Prospective controlled clinical trial. SETTING--Tertiary referral centre. PATIENTS--63 consecutive patients with chronic atrial fibrillation accepted for treatment with electrical cardioversion. Before cardioversion all patients were treated with digoxin, verapamil, or a combination of both to attain a resting heart rate < or = 100 beats per minute. INTERVENTIONS--Electrical cardioversion. MAIN OUTCOME MEASURES--Peak VO2 measured before and 1 month after electrical cardioversion to compare patients who were in sinus rhythm and those in atrial fibrillation at these times. Maintenance of sinus rhythm for a mean follow up of 19 (7) months. RESULTS--Mean (1SD) peak VO2 in patients in sinus rhythm after 1 month (n = 37) increased from 21.4 (5.8) to 23.7 (6.4) ml/min/kg (+11%, P < 0.05), whereas in patients with a recurrence of atrial fibrillation 1 month after cardioversion (n = 26) peak VO2 was unchanged. In patients who were in sinus rhythm both those with and without underlying heart disease improved, and improvement was not related to functional capacity or left ventricular function before cardioversion. Baseline peak VO2 was not a predictive factor for long-term arrhythmia outcome. CONCLUSION--Restoration of sinus rhythm improved peak VO2 in patients with atrial fibrillation, irrespective of the presence of underlying heart disease. Peak VO2 was not a predictive factor for long-term arrhythmia outcome after cardioversion of atrial fibrillation. These findings suggest that cardioversion is the best method of improving functional capacity in patients with atrial fibrillation, whether or not they have underlying heart disease and whatever their functional state.
1303668.2884491251993.04.15++Antioxidant vitamins or lactulose for the prevention of the recurrence of colorectal adenomas. Colorectal Cancer Study Group of the University of Modena and the Health Care District 16.Dis Colon Rectum
L Roncucci, P Di Donato, L Carati, A Ferrari, M Perini, G Bertoni, G Bedogni, B Paris, F Svanoni, M Girola,
Colonic adenomas represent the natural precursor lesions of most colorectal cancers. The treatment of choice is endoscopic polypectomy. However, after endoscopic removal, polyps recur in a large fraction of cases. Thus, we evaluated the effect of antioxidant vitamins or lactulose on the recurrence rate of adenomatous polyps. After polypectomy, 255 individuals were randomized into three groups. Group 1 was given vitamin A (30,000 IU/day), vitamin C (1 g/day), and vitamin E (70 mg/day); Group 2 was given lactulose (20 g/day); Group 3 received no treatment. Forty-six subjects had to be excluded because the histologic diagnosis was not consistent with adenoma. The remaining 209 individuals were included in the analysis according to the "intention to treat" criterion, though 34 did not adhere to the scheduled treatment or were lost during the follow-up. Subjects were followed at regular intervals for an average of 18 months. Polyps recurring before one year from index colonoscopy were considered missed by the endoscopist. In the 209 evaluable subjects, the percentages of recurrence of adenomas were 5.7 percent, 14.7 percent, and 35.9 percent in the vitamins, lactulose, and untreated groups, respectively. The fraction of subjects remaining free of adenomas, estimated by Kaplan-Meier survival curves, was significantly different among the three groups (log-rank chi-squared = 17.138; P < 0.001). Using Cox's regression analysis, treatment was the only variable that significantly contributed to the model (regression coefficient = 0.905; P < 0.001). In conclusion, either antioxidant vitamins or, to a lesser extent, lactulose lower the recurrence rate of adenomas of the large bowel and can be proposed as chemopreventive agents, at least in high-risk individuals.
1303768.2874711291981.05.28++A comparison of a three-day and seven-day clotrimazole regimen for vulvovaginal candidiasis.Clin Ther
TB Lebherz, LC Ford, V Kleinkopf,
Patients with mycologically proven symptomatic fungal infections of the vagina were treated ina double-blind trial with either one 100-mg clotrimazole vaginal tablet daily for seven days (group I) or two tablets daily for three days (group II). Patients were evaluated at one and four weeks after therapy. The investigator's evaluation of treatment efficacy showed 85% (22/26) success in group II compared with 75% (21/28) in group I (P = 0.46). Both groups had improvement itching, discharge, and vaginal and vulval irritation. No significant (P less than 0.10) differences were seen between groups after therapy. Only three side effects were seen. It is concluded that a three-day course of two clotrimazole vaginal tablet daily is as effective and safe as the previously recommended one tablet daily for seven days, and the shorter therapy is likely to improve patient compliance.
1303868.2789979291997.01.30++Health outcome improvements in patients with systemic lupus erythematosus using two telephone counseling interventions.Arthritis Care Res
JS Austin, RS Maisiak, DM Macrina, LW Heck,
OBJECTIVE: To examine the effectiveness of two telephone intervention strategies for improving the health outcomes of patients with systemic lupus erythematosus (SLE). METHODS: Fifty-eight SLE patients were randomly assigned to receive a 6-month telephone counseling intervention using either a treatment counseling (TC) or symptom monitoring (SM) strategy. Health outcomes were assessed using the Fatigue Severity Scale (FSS) and the Arthritis Impact Measurement Scales 2 (AIMS2). RESULTS: At the 6-month followup, the mean AIMS2 Physical Function scale and AIMS2 Social Support scale scores were significantly improved (P < 0.05) for the TC group compared to the SM groups. The mean FSS score, AIMS2 Affect score, and AIMS2 Pain score were significantly improved (P < 0.05) for both groups. CONCLUSIONS: Telephone interventions, especially using the TC approach, can be effective for improving the functional status of persons with SLE.
1303968.2735322421986.11.20++[Myocardial infarct promoting type A behavior--an attempt to modify stress-inducing behavior]Rehabilitation (Stuttg)
J Egger, R Schoberberger, E Schleicher,
To change some crucial elements of coronary-prone behaviour in cardiac patients is considered an important task of behaviour medicine, to reduce physico-chemical and, in particular, psychosocial "risk factors". The experimental study presented had examined whether the type A behaviour pattern, defined as the essential element of coronary-prone behaviour for its latent provocation of stress reactions, can be positively modified through behaviour therapy-focussed treatment within a clinical setting. A total of 91 persons, i.e. 49 recent-MI patients from an inpatient rehabilitation programme and 42 clients of a smoker counselling centre, were examined to identify type A or type B behaviour patterns (Rosenman u. Friedman, 1964). Of 39 type A post-MI patients, 13 (randomly selected) subjects were included in the "trial group" (VG), and participated, within a 4-8 week inpatient rehabilitation programme, in psychological training of stress management, relaxation, and self-control techniques; 3 patients denied participation; the remaining 23 type A post-MI patients, and the 20 type A smoker counselling clients, served as control group KG (A) and KG (B), who did not receive psychological training. Psychological and physiological parameters were assessed at the beginning (t1), the end (t2), as well as 3 and 6 months (t3 and t4) following completion of the psychological training. The results obtained confirm that the MI group includes significantly more type A persons (80 percent) than the cardiologically inconspicious control group of smokers (48 percent). Analysis of the data obtained at the various measurement points show that, as opposed to KG (A) and KG (B), significant improvements have in fact occurred in the trial group, such as reduced mental and psychovegetative stress reactions, which persisted even 3 months after programme completion.(ABSTRACT TRUNCATED AT 250 WORDS)
1304068.2661191681982.03.13++Oxatomide and exercise-induced asthma in children: the value of serial exercise tests.Clin Allergy
M Silverman, M Tooley,
Two groups of eight asthmatic children carried out serial treadmill exercise tests at 2-hourly intervals, after double-blind premedication with oxatomide (2 mg/kg by mouth), sodium cromoglycate powder (20 mg by inhalation) or matched placebo preparations. The drugs were studied in one group up to 6 hr and in the other group (omitting sodium cromoglycate) from 4 to 10 hr after administration. Peak expiratory flow rate was measured before and after exercise to give an index of exercise-induced asthma. Oxatomide had a slight but significant bronchodilator effect. After a lag period of up to 4 hours, oxatomide exerted a significant protective effect against exercise-induced asthma which lasted until at least 8 hr. At 10 hr after ingestion, the effect had gone. A mean maximum diminution of exercise-induced asthma of 49% was found, in comparison with placebo. Oral oxatomide after a lag period, exerts a significant protective effect against exercise-induced asthma. The relevance of these observations for the clinical management of asthma remains to be determined.
1304168.25149611552004.10.19++Efficacy of AT in pre-eclampsia: a case-control prospective trial.Thromb Haemost
DM Paternoster, S Fantinato, F Manganelli, M Milani, U Nicolini, A Girolami,
Pre-eclampsia is an extremely severe condition. It is associated with vasospasm, activation of the coagulation system and abnormal haemostasis. In pre-eclamptic patients increased plasmatic concentrations of fibronectin, laminin, von Willebrand factor (VWF) and endothelin are observed. Experimental studies on rats have also shown that the doses of antithrombin III (AT) needed to mediate anti-inflammatory processes are much higher than those required to obtain the anti-coagulant effect. The study aimed to evaluate the clinical efficacy of treatment with high AT doses (HD) in comparison with standard doses (SD). The primary endpoint was the prolongation of pregnancy defined as time (in days) from enrollment to delivery and to assess the maternal bleeding at and after delivery. The secondary endpoint was to demonstrate a role for AT in controlling haemostasis at conventional doses, and the inflammatory state at higher doses. The biochemical parameters assessed were: AT activity (%), Fibronectin (Fn), Fibrinogen, D-dimer, Uricemia, Proteinuria 24h, Protein C Reactive (PCR), Granulocyte Elastase and Endothelin. This study included 23 pre-eclamptic women. Patients were randomly subdivided into two groups: 10 patients ("cases") were treated with high doses of AT (6 vials: 3000 units) once daily for 5 days, or until delivery, while 13 women ("controls") were treated with doses of AT sufficient to maintain at least 80% of the activity. High-dose therapy was associated with prolongation of pregnancy by 2.5 days more when compared with controls (p = 0.03; Mann-Whitney test). The incidence of clinical significant bleeding was lower in cases than in controls (mean 550 mL vs. 650 mL, respectively). Preventive- and conservative-type treatment of moderate-severe pre-eclampsia, based on the administration high doses of AT, allows a significant prolongation of pregnancy, and thus a better neonatal outcome, as well as less maternal intra- and post-operative bleeding. Fn, PCR and elastase levels (markers of inflammation) decrease in the HD group in comparison with SD group. In the HD group, the AT plasma levels were obviously higher both at the end of the treatment (p < 0.0001) and after delivery (p = 0.03), in comparison with SD group. The fibrinogen and D-dimer levels were above the reference interval in both groups. TPA and PAI 1 were found to be significantly raised in the course of pre-eclampsia. In conclusion, the bio-chemical findings support a role for AT in controlling the haemostasis at conventional doses, and the inflammatory state at higher doses.
1304268.2582597491994.01.19++Management of prelabor rupture of membranes at term. A randomized study.Acta Obstet Gynecol Scand
LS Sperling, AL Schantz, A Wåhlin, S Duun, P Jaszczak, B Scherling, AA Carstensen, S Frese, E Hvilsom, B Ploug-Jensen,
OBJECTIVE. To compare the rate of obstetric interventions, length of labor, and maternal morbidity in pregnancies with prelabor rupture of membranes at term after either early or late induction of labor in both primiparous and pluriparous women. DESIGN. Prospective, randomized study. SUBJECTS. 362 women with singleton pregnancies, cephalic presentations, gestational age of 36 completed weeks or more were allocated at random to induction with oxytocin either 6 hours after PROM (n = 62) (early) or 24 hours (n = 62) (late). Those eligible, but not participating in the study, totalled 238 women. MAIN OBSTETRIC MEASURES. Time of spontaneous labor in the late induction group, length of labor, obstetric intervention rate, maternal morbidity, and the degree of histologic chorioamnionitis. RESULTS. The length of labor was longer in the late induction group than in the early induction group in both primiparous and pluriparous (p < 0.05). There were no overall differences in the rate of obstetric interventions or maternal morbidity, but there were marked differences between primiparous and pluriparous women. Increasing time span between the period from rupture of membranes to delivery increased the degree of histologic chorioamnionitis. CONCLUSION. If a woman wants a short labor, she will benefit from early induction. We did not find statistical differences in the rate of obstetric intervention or in the maternal morbidity, but there was a tendency towards adverse effects of late induction.
1304368.2540142151985.08.19++The Stanford Five-City Project: design and methods.Am J Epidemiol
JW Farquhar, SP Fortmann, N Maccoby, WL Haskell, PT Williams, JA Flora, CB Taylor, BW Brown, DS Solomon, SB Hulley,
The Stanford Five-City Project is a large experimental field study of community health education for the prevention of cardiovascular disease. It will provide data on fundamental questions in cardiovascular disease epidemiology, communication, health education, behavior change, and community organization, and will also test the ability of a potentially cost-effective program to prevent cardiovascular disease at the community level. This paper describes the purposes, hypotheses, design, and methods of the Five-City Project as a reference for future papers describing results. It is hypothesized that a 20% decrease in cardiovascular disease risk will lead to a significant decline in cardiovascular disease event rates in two treatment communities compared with three reference communities as a result of a six-year intervention program of community-wide health education and organization. Risk factor change will be assessed through four surveys of independent samples and in a repeatedly surveyed cohort. Cardiovascular disease event rates will be assessed through continuous community surveillance of fatal and nonfatal myocardial infarction and stroke.
1304468.2586733091996.08.09++Effect of extensive debridement and treatment on the healing of diabetic foot ulcers. Diabetic Ulcer Study Group.J Am Coll Surg
DL Steed, D Donohoe, MW Webster, L Lindsley,
BACKGROUND: There has been a broad interest in the use of growth factors to treat patients with chronic nonischemic diabetic ulcers. STUDY DESIGN: One hundred eighteen patients were studied in a randomized, prospective, double-blind, multicenter trial comparing treatment with topically applied recombinant human platelet-derived growth factor (rhPDGF) or placebo (vehicle) and were treated until completely healed or to 20 weeks. All patients had aggressive sharp debridement of their ulcers before randomization and repeat debridement of callus and necrotic tissue as needed. The influence of debridement was evaluated by reviewing the records of the office visits where debridement was performed. RESULTS: Forty-eight percent of patients treated with rhPDGF healed compared with 25 percent of patients who received placebo (p = 0.01). The mean percentage of office visits where debridement was performed was comparable for the two treatment groups: 46.8 percent (rhPDGF) and 48.0 percent (placebo). In general, a lower rate of healing was observed in those centers that performed less frequent debridement. The improved response rate observed with more frequent debridement was independent of the treatment group. However, for any given center, the percentage of patients who healed was greater with rhPDGF than placebo. CONCLUSIONS: Wound debridement is a vital adjunct in the care of patients with chronic diabetic foot ulcers.
1304568.25125275372003.04.23++Standard and enhanced cognitive-behavior therapy for late-life generalized anxiety disorder: two pilot investigations.Am J Geriatr Psychiatry
J Mohlman, EE Gorenstein, M Kleber, M de Jesus, JM Gorman, LA Papp,
OBJECTIVE: Although cognitive-behavior therapy (CBT) is an efficacious treatment for generalized anxiety disorder (GAD) in younger adults, little is known about its efficacy in older patients. Investigations to date have tested group-format or otherwise nonstandard versions of CBT. The studies described here are, to our knowledge, the first to test the efficacy of individual-format CBT administered in a mental health clinic for treatment of late-life GAD. METHODS: Study 1 tested a standard version, and Study 2 tested an enhanced version (ECBT) that included learning and memory aids designed to make the therapy more effective with elderly patients (e.g., homework reminder and troubleshooting calls, weekly review of all concepts and techniques). RESULTS: Study 1 CBT participants showed significant improvement on GAD severity ratings. Study 2 ECBT participants showed significant improvement on two self-report measures, rates of posttreatment GAD, and GAD severity ratings. ECBT resulted in improvement on more measures and yielded larger effect sizes than standard CBT, when each was compared against a wait-list control group. CONCLUSION: Results of these pilot studies suggest that standard individual-format CBT may not be optimally effective for treating late-life GAD; thus, ECBT should be tested further in randomized trials.
1304668.2435378231987.01.20++Towards a model stroke trial. The single-centre naftidrofuryl study.Neuroepidemiology
TJ Steiner, F Clifford Rose,
It has been questionable whether the lack of proven pharmacological treatments in acute cerebral infarction (ACI) reflects ineffective drugs or only inadequacies in their assessment. The difficulties in developing a rationale for drug therapy in this condition favoured the former, although the latter possibility was supported by re-evaluation of most published trials. In this paper, a plausible rationale, in terms of our current understanding of both the drug and the condition, is expounded for treatment of ACI with naftidrofuryl. Guidelines for the design and conduct of clinical trials in acute stroke are discussed in relation to the particular problems posed: need for early initiation of treatment; need for, and difficulties of, diagnostic confirmation; matching of treatment groups by prognostic indicators of uncertain significance, and requirements for large numbers of patients and long-term follow-up. The practical application of these guidelines is tested in a clinical trial of naftidrofuryl conducted in a single centre on 100 patients with proven diagnoses. Rigorous attention to all aspects of selection, treatment and follow-up, with an explanatory approach to the trial design, was predicted to produce a positive result if the drug was effective. The findings were that naftidrofuryl treatment was associated with no change in death rate but with clinically and statistically significant improvements in neurological recovery and bed-occupancy. Better functional recovery was also noted, so that the trial result was coherent. It was concluded that a beneficial effect had been recorded, and consistency of this outcome with those of previous studies is demonstrated. A case is made for further studies to define exactly the role of this drug in the management of ACI.
1304768.24151682892004.09.24++[Results of vacuum therapy (v.a.C.) of superficial and deep dermal burns]Zentralbl Chir
C Schrank, M Mayr, M Overesch, J Molnar, G Henkel V Donnersmarck, W Mühlbauer, M Ninkovic,
BASIS: This prospective multi-centre study in co-operation with the Wake Forrest University covered the area of applications for treatment of fresh, superficial and deep dermal burns and scalds (grade II a-b). The micro-circulation relationships, wound healing time, extent of germ settlement and the connective tissue edema were of particular interest (together with the increase or decrease in burn depth). Moreover, the economical aspects were compared with conservative therapy. MATERIAL AND METHODS: his study was carried out on our intensive care ward on 11 patients suffering from burn injuries and we took the healing process as the basis (2001-2003). Inclusion criteria for the study were burns on both hands, degree II a-b, occurring trauma less than 6 hours ago and a treatment period of minimum 48 hours. In any case the hands inflicted with deeper and extensive burns (assessment by 2 experienced, independent appraising plastic surgeons) were subject to V.A.C. therapy. The standard conventional, conservative therapy applied to the other hand was taken for comparison or control purposes to determine the success. Since October 2001 we use the IC-View perfusography with ICG colouring (ICG pulsion, PULSION Medical Systems AG, Munich, Germany) for objective findings both previously and during the course of treatment. A respective quantitative analysis and assessment of the recorded video sequences were made with the help of special software (IC-CALC, PULSION Medical Systems AG, Munich, Germany). Here too, the intensity of the fluorescence indicated the blood circulation through the connective tissue and is on the same level. Basis for this method of study was the work of Holm et al. in our department. RESULTS: Above all, the results of our study revealed a significant reduction or prophylaxis of the connective tissue edema. Due to improvement in the micro-circulation, also supported by dynamic IC-View laser-fluorescence videography it could be determined that the wound healing process was quicker and without complication in the majority of cases. This was all the more true, although even when the extent of the deep dermal hand burns treated by V.A.C. therapy was greater than on the hand taken for comparison. Extending the therapy applied to the hand to the entire extremity could contribute to avoiding operative stress (escharotomy) in selected cases. Troublesome supporting of the hands and the ergotherapeutic use of splints were not necessary because of the exact fixation of the extremities ensured by the vacuum method. The advantage became more obvious when both the cost factor and time expenditure were considered and compared with previous conservative therapy. CONCLUSIONS: In the near future the treatment of superficial and deep dermal burns/scalds by V.A.C. therapy can help in reducing the expenditure in time, material and personnel when treating large area wounds. A further advantage is not only to be seen in the optimised healing process in the case of superficial and deep dermal burn wounds but also in the reduction or even avoidance of extensive escharotomy with the accompanying operation trauma. In this respect close mesh control of the blood circulating conditions appeared to us to be important and as a result of our study V.A.C. therapy was approved in December 2002 for the treatment of superficial and deep dermal burns by FDA (Dept. of Health and Human Services).
1304868.24154943832005.01.31++Trivalent intranasal influenza vaccine, live.Ann Pharmacother
MW McCarthy, DR Kockler,
OBJECTIVE: To review human data on the efficacy, safety, and clinical use of trivalent intranasal influenza vaccine, live (TIIVL). DATA SOURCES: A MEDLINE search (1966-3rd week of January 2004) using the terms influenza vaccine, intranasal administration, and FluMist was conducted. References from pertinent articles were also reviewed. STUDY SELECTION AND DATA EXTRACTION: Studies conducted in humans and published in English were selected. Double-blind, controlled trials evaluating the efficacy and safety of TIIVL were evaluated. DATA SYNTHESIS: Administration of TIIVL results in mucosal and humoral immunity to influenza. Results of clinical trials in children and adults have demonstrated that TIIVL reduces the incidence of influenza. In children, TIIVL was also associated with a decrease in febrile illness and febrile otitis media. In adults, reductions in workday absences and medical visits due to febrile upper respiratory tract illness were also documented. TIIVL is well tolerated, with rhinorrhea or nasal congestion and sore throat occurring more frequently than with placebo. CONCLUSIONS: TIIVL is an alternative to intramuscular inactivated influenza vaccine in healthy individuals between 5 and 49 years of age. However, the vaccine is contraindicated in the majority of patient populations for whom annual influenza vaccination is recommended.
1304968.2436986551986.05.28++Evaluation of a vasoactive substance, naftidrofuryl, during the rehabilitation phase after an ischaemic insult.Curr Med Res Opin
H Ducarne,
Sixty-one patients who were undergoing an 8-week course of physical rehabilitation, which started on average 30 days after a cerebrovascular accident, were entered into a controlled double-blind, randomized study of 600 mg naftidrofuryl daily against identical placebo. The following parameters were measured before, and at 4 and 8 weeks after onset of treatment: neurological examinations by a weighted-assessment system, walking ability, and independence in activities of daily living. At the same time, the degree of cerebral lesion and brain atrophy were evaluated by CT scan and the size of the EEG deformations were estimated. During the first 4 weeks of rehabilitation, the placebo patients showed a significant improvement in the neurological symptoms which did not continue during the second period of treatment. On the contrary, the naftidrofuryl patients showed a continuous improvement in the neurological impairment during the whole period of treatment. Thus, at the end of treatment, there was a statistical difference between both groups. An explorative analysis of the most frequent symptoms showed a significant improvement in the naftidrofuryl group in independence in activities of daily living, walking, bladder control and sensory syndrome, whilst the changes in the placebo group were not statistically significant. Another significant change under treatment with naftidrofuryl was found in EEG evaluation which, at the end of the treatment period, showed less moderate and severe pathological alterations. Thus the value of naftidrofuryl treatment in patients with cerebral vascular accidents may be explained by an activation of cerebral metabolism in partially damaged regions of the brain, leading to an improvement in learning ability. In this way the recovery process that occurs during rehabilitation may be accelerated.
1305068.23106765982000.04.07++Five-year mortality in patients with acute chest pain in relation to smoking habits.Clin Cardiol
J Herlitz, BW Karlson, M Sjölin, J Lindqvist, T Karlsson, K Caidahl,
BACKGROUND: Smoking is one of the major risk indicators for development of coronary artery disease, and smokers develop acute myocardial infarction (AMI) approximately a decade earlier than nonsmokers. In smokers with established coronary artery disease, quitting smoking has been associated with a more favorable prognosis. However, most of these studies comprised younger patients, the majority of whom were males. HYPOTHESIS: The purpose of the study was to determine mortality, mode of death, and risk indicators of death in relation to smoking habits among consecutive patients admitted to the emergency department with acute chest pain. METHODS: In all, 4,553 patients admitted with acute chest pain to the emergency department at Sahlgrenska University Hospital during a period of 21 months were included in the analyses and were prospectively followed for 5 years. RESULTS: Of these patients, 36% admitted current smoking. They were younger and had a lower prevalence of previous cardiovascular diseases than did nonsmokers. The 5-year mortality was 19.4% among smokers and 24.9% among non-smokers (p < 0.0001). However, when adjusting for difference in age, smoking was associated with an increased risk [relative risk (RR) 1.51; 95% confidence interval (CI) 1.32-1.74; p < 0.0001]. Among patients presenting originally with chest pain, the increased mortality for smokers was more pronounced in patients with non-acute than acute myocardial infarction (AMI). Among patients who died, death in smokers was less frequently associated with new-onset myocardial infarction (MI) and congestive heart failure. Among those who smoked at onset of symptoms and were alive 1 year later, 25% had stopped smoking. Patients with a confirmed AMI who continued smoking 1 year after onset of symptoms had a higher mortality (28.4%) during the subsequent 4 years than patients who stopped smoking (15.2%; p = 0.049). CONCLUSION: In consecutive patients admitted to the emergency department with acute chest pain, current smoking was significantly associated with an increased risk of death during 5 years of follow-up. Among patients who died, death in smokers was less frequently associated with new-onset MI and congestive heart failure than was death in nonsmokers.
1305168.2396991921998.11.12++Preparation for menopause: prospective evaluation of a health education intervention for mid-aged women.Maturitas
KL Liao, MS Hunter,
Many women approach menopause with uncertainty about what will happen and how to deal with changes that occur. The current study aimed to evaluate the short-term outcome of a health education intervention devised to prepare 45-year old women in general practices. One hundred and seventy-eight 45-year old women registered at five general practices in south London were targeted for the research; 106 of the women responded and 86 of these women formed a usable pre-menopausal sample which was randomly allocated to the preparation intervention and control conditions. Preparation involved two health education sessions carried out in small groups and covering information and discussion of the normal menopause transition in the context of mid-life. The women completed pre- and post-intervention (3 and 15 months) questionnaires which assessed knowledge and beliefs about menopause and a number of health-related behaviours. Knowledge improved significantly at the follow-up assessments for the preparation group but not for the control group. On the whole, the prepared women's beliefs about menopause became less negative following the intervention, although there were also some changes reported by the control group. The proportion of smokers decreased from 25 to 20% for the prepared women although this did not reach statistical significance. There was no change in the prevalence of regular exercise. There was also a decrease in the intention to take hormonal treatments following the intervention. Suggestions for further development of health promotion services for mid-aged women and more holistic health care practices are proposed.
1305268.23110633362000.11.21++Long-term oral ganciclovir prophylaxis for prevention of cytomegalovirus infection and disease in cytomegalovirus high-risk renal transplant recipients.Transplantation
J Kletzmayr, E Kreuzwieser, T Watkins-Riedel, G Berlakovich, J Kovarik, R Klauser,
BACKGROUND: Although specific therapy is available with ganciclovir, cytomegalovirus (CMV) disease remains a major problem after renal transplantation especially in CMV seronegative recipients of organs of seropositive donors (D+R-). METHODS: In an open-labeled prospective controlled trial we evaluated the effect of long-term oral ganciclovir prophylaxis (3 g/day for 3 months posttransplantation) in a cohort of 31 CMV-high risk (D+R-) renal transplant recipients (GC) compared with a cohort of 28 high-risk patients with targeted CMV prophylaxis (CO) receiving i.v. ganciclovir during antirejection therapy. Primary end-points were CMV infection, diagnosed by pp65 antigenemia assay or serologic method, and CMV disease. Additionally severity of CMV disease quantified by a scoring system was evaluated. RESULTS: CMV prophylaxis significantly reduced the incidence of CMV infection (CO: 75%, GC: 45%; P<.05) and CMV disease (CO: 60%, GC: 29%; P<.05) without relevant side effects and without any clinical suspicion of ganciclovir resistance. Severity of CMV disease as quantified by a scoring system was reduced from 8.3+/-6.7 points in controls to 3.3+/-2.6 points in ganciclovir-treated patients (P<.05). Mortality did not differ significantly between the two groups (CO: n=3, GC: n=1; NS). However, there was one lethal CMV disease and a second death possibly attributable to CMV disease in the control group, whereas in ganciclovir-treated patients there was no CMV-associated fatal outcome. CONCLUSION: Long-term oral ganciclovir prophylaxis is effective and safe in CMV high-risk renal transplant recipients.
1305368.2367216681984.06.08++A comparative outcome study of individual, group, and conjoint psychotherapy.Arch Gen Psychiatry
PA Pilkonis, SD Imber, P Lewis, P Rubinsky,
Sixty-four outpatients were assigned to individual, group, or conjoint psychotherapy with experienced private clinicians. The length of the treatments ("cognitive insight" or "affective insight" therapies) averaged 26.8 sessions. To examine comparative outcomes, patients and significant others were assessed on both general outcome measures (eg, symptoms, target complaints) and mode-specific indexes (eg, private self-awareness, interpersonal functioning, and family environment). The most notable finding was the significant improvement of the sample as a whole at both termination and follow-up (average, 31 weeks). When differential outcomes did appear, they were more often attributable to differences among therapists and to interactive effects (ie, a particular fit between specific patient characteristics and a specific mode of therapy) than to main effects for any single therapy. The findings also demonstrated the importance of a systems approach to understanding fully the effects of psychotherapy because the patient's view of the family, the significant other's view of the patient, and the significant other's own adjustment tended to vary together, regardless of the mode of treatment.
1305468.23150073742004.07.16++Electromotive drug administration of lidocaine to anesthetize the bladder before botulinum-A toxin injections into the detrusor.Spinal Cord
B Schurch, A Reitz, G Tenti,
STUDY DESIGN: Prospective, open label, cross-over-designed clinical study. OBJECTIVE: To evaluate the effectiveness of an instillation of lidocaine into the bladder with versus without electromotive drug administration (EMDA) to anesthetize the bladder before botulinum-A toxin injections. SETTING: Neurourology, Swiss Paraplegic Center, Balgrist University Hospital, Zurich, Switzerland. METHODS: In all, 28 patients with severe neurogenic detrusor overactivity but preserved bladder sensibility were treated with botulinum-A toxin injections into the detrusor muscle. A measure of 300 u of botulinum-A toxin (Botox) was injected at 30 sites sparing the trigone. Prior to the injection, the bladder was anesthesized with conventional lidocaine instillation in a group of 10 patients and with lidocaine instillation enhanced by EMDA in 28 patients. The patients scored the injection pain on a 10-point rating scale. Pain rating scores with versus without EMDA enhancement of the lidocaine instillation were analyzed and the costs of the EMDA procedure were compared to general/spinal anesthesia. RESULTS: The mean pain score of the 10 patients who underwent the injections of Botox after conventional lidocaine instillation was 4.0 (SD 1.6). Following EMDA enhanced lidocaine instillation slight even or no pain occurred during the injections of Botox, and the mean pain score was 0.5 (SD 0.2). Compared to spinal or general anesthesia, the local anesthesia saved around 15% of the costs. CONCLUSIONS: EMDA enhanced instillation of lidocaine enables a sufficient anesthesia of the bladder wall that ensures a painless application of the botulinum-A toxin injections into the detrusor muscle. This method may avoid general or spinal anesthesia in patients with preserved bladder sensibility. It ensures considerable cost reduction, avoids anesthesia-related risks and complications and enables the procedure on an outpatient basis.
1305568.2281661881994.05.26++Bacterial vaginosis is associated with prematurity and vaginal fluid mucinase and sialidase: results of a controlled trial of topical clindamycin cream.Am J Obstet Gynecol
JA McGregor, JI French, W Jones, K Milligan, PJ McKinney, E Patterson, R Parker,
OBJECTIVE: The pathogenesis of preterm birth and other adverse pregnancy outcomes linked with reproductive tract infection remains poorly understood. Mucolytic enzymes, including mucinases and sialidases (neuraminidase), are recognized virulence factors among enteropathogens and bacteria that cause periodontal infection. Perturbation of maternal cervicovaginal mucosa membrane host defenses by such enzyme-producing microorganisms may increase the risk of subclinical intrauterine infection during pregnancy and thus increase risks of preterm birth. STUDY DESIGN: We prospectively evaluated vaginal fluid mucinase and sialidase and selected cervicovaginal bacteria along with pregnancy outcomes in 271 women. Within this study, women with bacterial vaginosis (16 to 27 week' gestation) were treated with 2% clinadmycin vaginal cream or placebo. Enzyme, microbial findings, treatment effects, and pregnancy outcomes were compared among drug- and placebo-treated women and control women without bacterial vaginosis. RESULTS: Presence of bacterial vaginosis at intake was associated with increased risk of preterm birth (relative risk 3.3, 95% confidence interval 1.2 to 9.1, p = 0.02), premature rupture of membranes (relative risk 3.8, 95% confidence interval 1.6 to 9.0, p = 0.002), and preterm premature rupture of membranes. Mucinase and sialidase activities were more commonly identified, and they occurred in higher concentrations, if present, in women with bacterial vaginosis (mucinase: 44.3% with bacterial vaginosis vs 27.4% without, p = 0.007; sialidase: 45% with bacterial vaginosis vs 12% without p < 0.001). Sialidase activity was associated with bacterial vaginosis-linked organisms (Gardnerella vaginalis, Mobiluncus spp, and Mycoplasma hominis) and Chlamydia trachomatis and yeast species; mucinase activity was associated only with bacterial vaginosis-linked microorganisms. Clindamycin, 2% cream, was effective treatment for bacterial vaginosis and temporarily reduced mucinase and sialidase activities. Topical treatment of bacterial vaginosis did not reduce risks of perinatal morbidity. Women with persistent or recurrent sialidase 8 weeks after treatment were at increased risk of preterm birth (15.6% vs 7.4%) premature rupture of membranes (30% vs 15%), and low birth weight (20% vs 3%, relative risk 6.8, 95% confidence interval 1.6 to 28.1). CONCLUSIONS: Persistence of sialidase-producing vaginal microorganisms in numbers sufficient to increase vaginal fluid sialidase activity may be a risk factor for possibly preventable subclinical intrauterine infection and preterm birth. This study confirms and further informs our understanding of the association of bacterial vaginosis and preterm birth; studies to evaluate whether systemic treatment for bacterial vaginosis can effectively reduce vaginal mucolytic enzymes and risks of prematurity and other morbid outcomes are continuing.
1305668.22169409722006.12.07++Fluconazole prophylaxis in extremely low birth weight infants: association with cholestasis.J Perinatol
ZH Aghai, M Mudduluru, TA Nakhla, B Amendolia, D Longo, N Kemble, S Kaki, R Sutsko, JG Saslow, GE Stahl,
BACKGROUND: Extremely low birth weight (ELBW) infants are at increased risk for invasive candidiasis and associated morbidity and mortality. The use of fluconazole prophylaxis in this population has raised a benefit versus risk concern among clinicians. OBJECTIVES: To evaluate the effectiveness and safety of fluconazole prophylaxis in ELBW infants. STUDY DESIGN: ELBW infants (BW<or=1,000 g) born during the pre-prophylaxis era (PPE, January 1998-February 2002) were compared with prophylaxis era (PE, March 2002-September 2005). Infants born during PE received fluconazole prophylaxis for 6 weeks, as long as they had intravenous access. Demographic and clinical data were collected. The two groups were compared for baseline demographics, risk factors for candidiasis, the incidence of invasive candidiasis, liver enzymes, alkaline phosphatase, and bilirubin (total and direct). RESULTS: Nine out of 137 infants (6.6%) developed invasive candidiasis during PPE compared to none of 140 (0%) during PE (P=0.006). During PE, 60/140 (42.9%) infants developed conjugated hyperbilirubinemia compared to 12/137 (8.8%) during PPE (P<0.001). CONCLUSION: Although a fluconazole prophylaxis regimen for ELBW infants was effective in preventing invasive candidiasis, an increase in the incidence of conjugated hyperbilirubinemia was observed. Further studies are needed to evaluate the safety of fluconazole prophylaxis in this population.
1305768.21121885912003.05.16++The addition of social support to a community-based large-group behavioral smoking cessation intervention: improved cessation rates and gender differences.Addict Behav
LE Carlson, E Goodey, MH Bennett, P Taenzer, J Koopmans,
OBJECTIVE: To determine the effects on cessation rates of adding a partner support group component to a large-group community-based behavioral smoking cessation program. METHODS: During the past eight smoking cessation programs at the Tom Baker Cancer Centre in Calgary, Alberta, Canada, separate support group sessions were offered for support persons of prospective quitters. Six hundred smokers brought 156 support people with them to the groups. Cessation rates were calculated at 3, 6, and 12 months postquit. RESULTS: Those smokers who had support people attending at least one of the support group sessions had higher cessation rates at 3, 6, and 12 months (56%, 46%, and 43%) compared to those without a support person in attendance (36%, 35%, 32%). This effect was especially strong for men, with 3-, 6-, and 12-month cessation rates for those with support of 58%, 54%, and 56%, compared to 52%, 41%, and 36% in the women with support. For men without a support person, the rates were 34%, 35%, and 33%, compared to 38%, 35%, and 31% in women without support. This indicates that although support was initially effective for women, it had no effect on sustained abstinence. CONCLUSIONS: The addition of a support person group to a large-group behavioral smoking cessation program was effective in improving 3-month cessation rates in both men and women, but over 1-year of follow-up support was only associated with greater sustained abstinence in men.
1305868.21112300312001.05.03++Psychological therapies for adults with anorexia nervosa: randomised controlled trial of out-patient treatments.Br J Psychiatry
C Dare, I Eisler, G Russell, J Treasure, L Dodge,
BACKGROUND: Currently, without systematic evidence, psychotherapy for anorexia nervosa in adults draws on psychodynamic, cognitive and systemic theories. AIMS: To assess effectiveness of specific psychotherapies in out-patient management of adult patients with anorexia nervosa. METHOD: Eighty-four patients were randomised to four treatments: three specific psychotherapies - (a) a year of focal psychoanalytic psychotherapy; (b) 7 months of cognitive-analytic therapy (CAT); (c) family therapy for 1 year - and (d) low contact, 'routine' treatment for 1 year (control). RESULTS: At 1 year, there was symptomatic improvement in the whole group of patients. This improvement was modest, several patients being significantly undernourished at follow-up. Psychoanalytic psychotherapy and family therapy were significantly superior to the control treatment; CAT tended to show benefits. CONCLUSIONS: Psychoanalytic and family therapy are of specific value in the out-patient treatment of adult patients with anorexia.
1305968.2118595181991.08.29++Analgesic potency of a new anticonvulsant drug versus acetylsalicylic acid via laser somatosensory evoked potentials. Randomized placebo-controlled double-blind (5-way) crossover study.Arzneimittelforschung
K Schaffler, CH Wauschkuhn, M Gierend,
A randomized, double-blind crossover study was performed with three different acute oral dosages of CM 40907 (3-(4-hydroxypiperidyl)-6-(2'-chlorophenyl)-pyridazine) (600, 900 and 1200 mg), a newly developed anticonvulsant drug, vs acetylsalicylic acid (ASA, 1000 mg) and placebo in 12 male healthy volunteers to check analgesic potency. Objective algesimetry was done by Laser Somatosensory Evoked Potentials (LSEP). Subjective pain intensities were measured by retrospective visual analog scale ratings (VAS). Effects on objective vigilance were checked by Auditory Evoked Potentials (AEP). For both types of evoked potentials there was a simultaneous control of alterations in vigilance by means of the adaptive pursuit tracking task (APTT). A vigilance-controlled EEG (V-EEG) and a resting (R-EEG), visual analog scales (VAS) on sedation, excitation and anxiety as well as vital parameters (blood pressure and heart rate under supine and upright conditions) and adverse event scales were included in this trial as well. CM 40907 showed distinct analgesic effects on objective and subjective algesimetric parameters, which for the highest dosage (1200 mg) were superior in ("central") P2-amplitude suppression of LSEPs to those of ASA in ("peripheral") N1-amplitudes suppression and ongoing for more than 6 h. Subjective sedation was decreased, however, AEP-findings indicated a decreased vigilance after CM 40907. Some EEG-patterns, specifically related with CM 40907--although being ambiguous in classification terms--resembled features of benzodiazepines. Blood pressure and heart rate were raised in a clinically irrelevant manner.
1306068.21111631232001.04.05++Multiple previous detoxifications are associated with less responsive treatment and heavier drinking during an index outpatient detoxification.Alcohol
R Malcolm, JS Roberts, W Wang, H Myrick, RF Anton,
Investigators have found a relationship between the number of previous alcohol withdrawals (AWs) and severity of withdrawal. We evaluated patients with multiple previous AWs, as compared to those with 0-1 previous withdrawals, in an outpatient detoxification trial comparing lorazepam (LZ) to carbamazepine (CBZ). A mixed model analysis of covariance was used to analyze Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) scores as a function of detoxification history (0-1 vs. 2 or more), drug group (CBZ vs. LZ), assessment day, and hours since last drink. The mixed model analysis of covariance (ANCOVA) indicated a significant detoxification history by assessment day interaction (P< or =.03). Least square means associated with this interaction suggested that the CIWA-Ar scores for the multiple detox patients declined more slowly than those with 0-1 previous detoxifications. Patients with multiple detoxes were 150% more likely to experience a heavy drinking day during treatment (P< or =.03). The multiple detox group drank more each drinking day (P=.001) and a greater proportion of this group had early heavy drinking (P=.0002). In the present study, intensity of AW symptoms and early heavy drinking were independent of treatment medications and were more common in patients who had previously undergone multiple treatments for AW.
1306168.2077026441994.03.23++Ambulatory pediatric tonsillectomy and the identification of high-risk subgroups.Otolaryngol Head Neck Surg
MA Rothschild, P Catalano, HF Biller,
Financial and utilization concerns have focused on reducing hospitalization costs for many procedures, including tonsillectomy. However, the safety of ambulatory tonsillectomy for all patients remains questionable. At our institution, tonsillectomy has essentially been an inpatient procedure by policy. We have reviewed the charts of 153 consecutive patients under 19 years of age who underwent this procedure between 1989 and 1990, in an attempt to identify "high-risk" subgroups. Variables examined were: indication for surgery, hours to adequate oral intake and to discharge, age, sex, surgeon status, underlying medical condition, complications, and concomitant procedures. Statistically significant differences (p < 0.05) were found in the time to adequate oral intake and discharge for children under 4 years of age as compared to older patients. Furthermore, 7% of patients with a preoperative diagnosis of obstructive sleep apnea showed clinical evidence of significant airway compromise postoperatively. No patient in the study group experienced postoperative bleeding before discharge. Our results have identified high-risk subgroups of children undergoing tonsillectomy who are at greater risk for these complications, and therefore may benefit from an inpatient setting.
1306268.20106614762000.02.18++Combination therapy using prednisolone and cyclophosphamide slows the progression of moderately advanced IgA nephropathy.Clin Nephrol
K Tsuruya, A Harada, H Hirakata, K Mitsuiki, T Johko, H Kondoh, S Takechi, M Fujishima,
AIM: We retrospectively examined the effect of combination therapy using prednisolone (PSL) and cyclophosphamide (CPA) on the progression of IgA nephropathy (IgAN) in 45 patients with moderate to severe histological changes. PATIENTS AND METHODS: Patients were recruited from 129 consecutive patients with IgAN seen over 10 years based on semiquantitative histological grading. They were divided into two groups: PSL+CPA group (n = 26, male/female = 11/15, age 40+/-3 years (SEM)) or control group undergone conventional therapy with or without antiplatelet agents (n = 19, male/female = 10/9, age 41+/-3). In PSL+CPA group, PSL and CPA treatment commenced using a dose of 30 and 50 mg/day, respectively. PSL was reduced by 5 mg every month. RESULTS: The clinical parameters at the start of treatment such as age, gender, histological score, blood pressure, urinary protein excretion and serum creatinine concentration (SCr) were not different between the groups. The mean observation period in PSL+CPA group (3.3+/-0.3 years) was not different from the control group (4.0+/-0.7 years). In PSL+CPA group, urinary protein excretion, defined as the ratio of urinary protein to creatinine concentration (UP/UCr), significantly decreased from 3.9+/-0.4 to 1.3 +/-0.2 (p<0.01), whereas it remained high in the control group (3.8+/-0.7 to 2.7+/-0.8). The progression rate (PR), which was determined by the slope of the correlation between time after renal biopsy and reciprocal SCr, was significantly lower in PSL+CPA (0.054+/-0.014) than in the control group (0.172+/-0.032 dl/mg/year, p<0.001). Our results indicated that PSL+CPA combination therapy was effective in slowing the progression of moderately advanced IgAN. CONCLUSION: We suggest that the immunosuppressive treatment with CPA is sometimes necessary to preserve renal function in patients with histologically advanced IgAN.
1306368.1917704721992.02.27++The impact of a patient education programme in the control of hypertension.J Hum Hypertens
A Roca-Cusachs, D Sort, J Altimira, R Bonet, E Guilera, J Monmany, J Nolla,
The value of patient education programmes in the control of hypertension is controversial. We have conducted a prospective study to investigate a patient education programme in our clinic. Every new patient was randomised into one of two different groups: a control group (CG, n = 149) and an intervention group (IG, n = 138); the latter group was invited to attend two educational talks and subsequently one tutorial meeting. Blood pressure, heart rate, Quetelet Index, attendance, knowledge level, analytical parameters and the prevalence of other risk factors were measured in both groups before and after 6 months follow-up. No significant differences were detected between the two groups initially. At 6 months, both groups significantly lowered their BP; the only differences observed between groups (IG vs. CG) were: the number of correct answers to the questionnaire (14.5 +/- 3.7 vs. 12.9 +/- 3.7, P less than 0.01), the rate of occasional therapeutic abandonment (10.3 vs. 25%, P less than 0.05), 24 h sodium excretion (97 +/- 45 vs. 127 +/- 68 mmol/l, P less than 0.01) and the number of withdrawals (39 vs. 25%, P less than 0.05). We conclude that in spite of increased knowledge, less frequent abandonment of drug treatment and better observance of a low salt diet, patients in the IG had an increase in the number of drop-outs. Our data suggest that education in hypertension clinics should play a supportive role rather than a primary one in the control of high blood pressure.
1306468.19172578662007.07.17++Predictive factors for the development of scoliosis in Duchenne muscular dystrophy.Eur J Paediatr Neurol
M Kinali, M Main, J Eliahoo, S Messina, RK Knight, J Lehovsky, G Edge, E Mercuri, AY Manzur, F Muntoni,
OBJECTIVE: Scoliosis is a frequent complication (68-90%) of Duchenne muscular dystrophy (DMD). Prevention of limb deformities, rehabilitation in knee-ankle-foot-orthoses (KAFOs) and glucocorticoids prolong walking and standing, and might reduce scoliosis. We evaluated possible predictive factors for scoliosis development in a large DMD population. METHODS: Case notes of 123 DMD boys, > or = 17 years, followed at our centre between 1992 and 2002 were reviewed. Univariate analysis was used to relate two outcome measures (age at onset of scoliosis and severity at 17 years) with (i) glucocorticoids treatment; (ii) ages at (a) loss of independent ambulation, (b) rehabilitation into KAFOs, (c) loss of standing, (iii) forced vital capacity (FVC) (%) between 11 and 12 years and (iv) lower limb contractures. RESULTS: In total, 37/123 boys (30%) received intermittent prednisolone (0.75 mg/kg/day, 10 day/month) for a median 1-year (2 months-9 years), starting between 7.7 and 12.4 years (mean 9.5). About 96/123 (78%) were rehabilitated into KAFOs at 10.2+/-1.6 years. Age at loss of ambulation in KAFOs was 12.3+/-1.9 years and at loss of standing 12.8+/-2.1 years. About 95/123 (77%) boys developed scoliosis (Cobb angle >30 degrees ). Mean age+/-S.D. at scoliosis onset was 12.7+/-1.6 years. Forty-three boys (35%) had scoliosis surgery by 15+/-1.2 years. Later age at loss of ambulation (p<0.0001) and longer duration of prednisolone treatment (p=0.01) related to later scoliosis onset. Ages at loss of ambulation and standing were inversely related to scoliosis severity at 17 years (p<0.005). Hip asymmetry and %FVC at 11-12 years were directly related to scoliosis severity (p=0.02). CONCLUSIONS: Our data indicate a significant association between prolonged ambulation and a reduced risk of scoliosis development. Glucocorticoid administration, in our series, appear to be associated with a later onset of scoliosis, but did not alter the severity at 17 years, probably reflecting the shorter overall glucocorticoid exposure in this population.
1306568.1813067351993.08.19++Prevention of local relapses and new localisations of oral leukoplakias with the synthetic retinoid fenretinide (4-HPR). Preliminary results.Eur J Cancer B Oral Oncol
F Chiesa, N Tradati, M Marazza, N Rossi, P Boracchi, L Mariani, M Clerici, F Formelli, L Barzan, A Carrassi,
This paper analyses preliminary results of a randomised chemoprevention trial in patients surgically treated for oral leukoplakia started in 1988 at the Istituto Nazionale Tumori of Milan with the synthetic retinoid N-(4-hydroxyphenyl)-retinamide (4-HPR). To date 115 patients have been randomised, after surgical excision of oral leukoplakia, to receive 200 mg 4-HPR daily for 52 weeks versus no intervention. 80 patients completed the 1-year intervention, 41 in the control group and 39 in the 4-HPR group. During this period 12 local relapses or new lesions occurred in the control group and three in the 4-HPR group. Only 5 patients interrupted the intervention because of toxicity. No impaired dark adaptation was observed. It is concluded that 4-HPR is well tolerated and seems efficacious in preventing relapses and new localisations during the treatment period. This promising trend needs further confirmation.
1306668.1792475031997.08.25++Primary pulmonary hypertension: improved long-term effects and survival with continuous intravenous epoprostenol infusion.J Am Coll Cardiol
SM Shapiro, RJ Oudiz, T Cao, MA Romano, XJ Beckmann, D Georgiou, S Mandayam, LE Ginzton, BH Brundage,
OBJECTIVES: This study sought to determine the long-term effects of continuous infusion of epoprostenol (epo) therapy on survival and pulmonary artery pressure in patients with primary pulmonary hypertension (PPH). BACKGROUND: PPH is a progressive disease for which there are few effective therapies. METHODS: Patients with PPH and New York Heart Association functional class III or IV symptoms of congestive heart failure underwent right heart catheterization and Doppler-echocardiography to measure the maximal systolic pressure gradient between the right ventricle and right atrium (delta P) and cardiac output (CO). Doppler-echocardiography and catheterization data were compared. Patients were followed up long term with Doppler-echocardiography. RESULTS: Of 69 patients who went on to receive epo, 18 were followed up for > 330 days (range 330 to 700). During long-term follow-up, there was a significant reduction in delta P, which decreased from 84.1 +/- 24.1 to 62.7 +/- 18.2 (mean +/- SD, p < 0.01). A Kaplan-Meier plot of survival of our study patients demonstrated improved survival compared with that of historical control subjects. The 1-, 2- and 3-year survival rates for our patients were 80% (n = 36), 76% (n = 22) and 49% (n = 6) compared with 10- (88%, n = 31), 20- (56%, n = 27) and 30-month (47%, n = 17) survival rates in historical control subjects. CONCLUSIONS: Patients receiving continuous infusion of epo for treatment of PPH experience a decrease in pulmonary artery pressure. Long-term follow-up of this single-center patient group demonstrated improved long-term survival during epo therapy compared with that in historical control subjects and confirms predicted improved outcomes based on shorter follow-up periods.
1306768.1770427991982.07.22++A double-blind, placebo-controlled trial of polymerized whole ragweed for immunotherapy of ragweed allergy.J Allergy Clin Immunol
LC Grammer, CR Zeiss, IM Suszko, MA Shaughnessy, R Patterson,
Immunotherapy with polymerized ragweed (PRW) has been demonstrated to be safe and effective when compared with monomeric ragweed or untreated controls. To further establish the efficacy of PRW, a trial was conducted comparing PRW, placebo, and no treatment in ragweed-sensitive individuals. In a double-blind manner, 21 patients were treated before the 1981 ragweed season with 15 weekly injections of PRW totaling about 50,000 PNU and 1200 microgram antigen E, while 19 patients were treated with 15 weekly injections of a caramelized glucose and histamine placebo. An additional control group received no injections. Blood was drawn for IgE against ragweed antigen E (IgE-a-AgE) and for blocking antibody against AgE before treatment, after treatment (before season), and after season. In the untreated patients, blood was drawn before season and after season. Daily symptom score sheets were completed by patients each day of the ragweed season. Blocking antibody rose more than 40-fold with treatment (p = 0.0001) in the PRW group but was unchanged in the placebo group with treatment. IgE-a-AgE rose with PRW therapy. Clinical efficacy of PRW was again confirmed in this study. Symptom score mean in the PRW group was statistically lower than the mean in the placebo group (p = 0.022) and in the untreated group (p = 0.018). There were no systemic reactions and only minor local reactions during treatment. In summary, PRW is an improved form of immunotherapy.
1306868.1764122711983.10.08++Sulpiride trial in chronic schizophrenia with comparison of two dosage regimens.Psychopharmacology (Berl)
DM Lewis, HR Bond, SH Curry,
In a study with both open and double-blind phases, a therapeutic response to sulpiride was first established in 18 chronic schizophrenic inpatients. Following this, two dosage regiments, a morning only dose, and the same daily total dose in two equal fractions at 8 a.m. and 4 p.m., were compared using a balanced design, crossover, placebo controlled study. Clinical effects were evaluated by means of the Brief Psychiatric Rating Scale (BPRS). There was a significant reduction in the mean BPRS score in all phases of the study. There was no significant difference between the mean BPRS scores resulting from the two dosage regimens. The study indicated that the two dosage regimens were equally efficacious.
1306968.1731266261988.04.21++Glibenclamide improves the response to insulin treatment in non-insulin-dependent diabetics with second failure to sulfonylurea therapy.Acta Med Scand
PE Lins, S Lundblad, E Persson-Trotzig, U Adamson,
The effect of combined insulin-glibenclamide therapy on glucose control was evaluated in a double-blind placebo controlled study of 20 patients with non-insulin-dependent diabetes mellitus (NIDDM) and second failure to oral antidiabetic therapy with glibenclamide or glipizide. After an observation period of 1-3 months, insulin treatment was initiated which resulted in rapid improvement of the glycemic control within 6 weeks. Thereafter glibenclamide or placebo was added to insulin for a further 12 weeks. Glibenclamide improved the glycemic control as expressed by a diminution of blood glucose and HbA1c. This was observed in spite of the fact that the daily insulin dose was reduced by approximately 30% in the glibenclamide-treated group of patients. It is concluded that in NIDDM patients with second failure to glibenclamide ot glipizide therapy, the responsiveness to glibenclamide may be at least partially restored by a short period of insulin treatment. It is suggested that therapy with insulin and glibenclamide is an appropriate treatment regimen for NIDDM patients with second failure to sulfonylurea therapy.
1307068.16151035442004.12.09++New strategies in anaemia management: ACORD (Anaemia CORrection in Diabetes) trial.Acta Diabetol
M Laville,
Anaemia is a key component of diabetic nephropathy, but its importance has only recently been recognised. Recombinant human erythropoietin (epoetin) is an established treatment for renal anaemia, and may help to reduce complications associated with diabetic nephropathy, such as cardiovascular disease. The limited experience with the use of epoetin in this patient group prompts the urgent need for clinical data on anaemia correction in early diabetic nephropathy, particularly with regard to benefits on cardiovascular risk reduction. The Anaemia CORrection in Diabetes (ACORD) study will investigate the effects of anaemia correction on cardiac structure and function in patients with early diabetic nephropathy. This 15-month multicentre study will recruit 160 adult patients with diabetes, mild or moderate chronic kidney disease (with creatinine clearance >or=30 ml/min at screening) and moderate anaemia (haemoglobin [Hb], 10.5-13.0 g/dl). Patients will be randomised to one of two groups: the early treatment group will receive subcutaneous epoetin beta (NeoRecormon) at study entry to maintain target Hb levels of 13-15 g/dl, while the control group will reflect current practice and will not receive epoetin therapy until Hb levels decline below 10.5 g/dl. The primary efficacy variable, change in left ventricular mass index, will be evaluated at 15 months following randomisation; secondary efficacy variables will include changes in cardiac structure and function over the study period. The ACORD study should provide valuable information on the benefits of anaemia correction in patients with early diabetic nephropathy. The study will also increase awareness of the importance of treating anaemia associated with diabetes.
1307168.1661380661983.12.17++Midazolam dosage studies in institutionalized geriatric patients.Br J Clin Pharmacol
H Beck, M Salom, J Holzer,
Three different dosage studies were carried out with midazolam in 47 institutionalized geriatric patients (17 males: mean age 82.9 years; 30 females: mean age 81.3 years) who were suffering from insomnia of long standing. Study I investigated the hypnotic efficacy of midazolam versus placebo in a double-blind, cross-over trial comparing the 7.5 and 15 mg doses of midazolam in 18 subjects. Both midazolam doses shortened sleep onset latency by 40 min (15 mg) and 31 min (7.5 mg). Both doses increased total sleep time compared with placebo. In study II, a comparative, cross-over trial in 10 subjects, an initial dose of 7.5 mg midazolam was sufficient to reduce the subjective appreciation of sleep onset time to less than 60 min on 66 of 70 study nights. Oxazepam (25 mg) had a comparable favourable effect but less frequently (53 of 70 nights). In study III, individual dose limits were investigated in 19 insomniac patients. The minimum effective dose was 7.5 mg. The maximum tolerated dose was in the range 15 to 52.5 mg according to the subjects' assessment. The most common optimum dose was 15 mg (10 of 19 patients). The higher doses prolonged sleep but midazolam appears to have a wide margin of safety as residual sedative effects appeared only after very high doses (four of 19 for 30 mg; eight of 19 for 37.5 mg). In some patients, 7.5 mg was the minimum dose that was effective in shortening sleep latency.(ABSTRACT TRUNCATED AT 250 WORDS)
1307268.1695713421998.06.16++Physical activity and NIDDM in African-Americans. The Pitt County Study.Diabetes Care
SA James, L Jamjoum, TE Raghunathan, DS Strogatz, ED Furth, PG Khazanie,
OBJECTIVE: Studies directly examining the association between physical activity and NIDDM in African-Americans are rare. Consequently, the strength of this association in this ethnic minority group remains unclear. The current study broadly characterizes the types of physical activity engaged in by a community sample of working-class African-Americans and then quantifies the association between physical activity and NIDDM risk in this population. RESEARCH DESIGN AND METHODS: During the 1993 reexamination of participants in the Pitt County Study in North Carolina, data on NIDDM history, current use of insulin or oral hypoglycemic drugs, and approximately 12-h overnight fasting blood glucose (FBG) were obtained from 598 women and 318 men, ages 30-55 years. The presence of NIDDM was determined by current insulin or medication use and FBG > or = 140 mg/dl. Study participants were assigned to one of four categories of physical activity: strenuous, moderate, low, or inactive. RESULTS: The weighted prevalence of NIDDM in the sample was 7.1%. After adjustment was made for age, sex, education, BMI, and waist-to-hip ratio, NIDDM risk for moderately active subjects was one-third that for the physically inactive subjects (odds ratio [OR], 0.35; 95% CI, 0.12-0.98). The ORs for low (OR, 0.51; 95% CI, 0.20-1.29) and strenuous (OR, 0.65; 95% CI, 0.26-1.63) activity also tended to be lower. A summary OR that contrasted any activity versus no activity was 0.51 (95% CI, 0.23-1.13). CONCLUSIONS: Moderate physical activity was strongly associated with reduced risk for NIDDM in this sample. While replication of these findings is needed, public health interventions designed to increase moderate (leisure-time) physical activity in black adults should be strongly encouraged.
1307368.16120399272002.06.20++Family history and prostate cancer screening with prostate-specific antigen.J Clin Oncol
T Mäkinen, TL Tammela, UH Stenman, L Määttänen, S Rannikko, J Aro, H Juusela, M Hakama, A Auvinen,
PURPOSE: Early detection of prostate cancer has been recommended for men with affected first-degree relatives despite the lack of evidence for mortality reduction. We therefore evaluated the impact of family history in the Finnish prostate cancer screening trial. PATIENTS AND METHODS: Approximately 80,000 men were identified from the population register for the first screening round. Of the 32,000 men randomized to the screening arm, 30,403 were eligible at the time of invitation. A blood sample was drawn from the participants (n = 20,716), and serum prostate-specific antigen (PSA) was determined. Men with a PSA level > or = 4.0 ng/mL were referred for prostate biopsy. Information on family history was obtained through a self-administered questionnaire at baseline. RESULTS: A total of 964 (5%) of the 20,716 screening participants had a positive family history, and 105 (11%) were screening-positive. Twenty-nine tumors were diagnosed, corresponding to a detection rate of 3.0% (29 of 964) and a positive predictive value of 28% (29 of 105). Of the 19,347 men without a family history, 1,487 (8%) had a PSA level > or = 4.0 ng/mL. The detection rate was 2.4% (462 of 19,347) and the positive predictive value was 31% (462 of 1,487). The risk associated with a positive family history was not substantially increased (rate ratio, 1.3; 95% confidence interval, 0.9 to 1.8). The results were not affected by the age of the screenee or age at diagnosis of the affected relative. The program sensitivity was 6% (29 of 491) (ie, selective screening policy would have missed 94% of cancers in the population). No differences were seen in the characteristics of screen-detected cancers by family history. CONCLUSION: Our findings provide no support for selective screening among men with affected relatives.
1307468.1623249211990.05.18++Analgesic efficacy of flurbiprofen as compared to acetaminophen and placebo after periodontal surgery.J Periodontol
F Gallardo, E Rossi,
The purpose of the present investigation was to compare the analgesic efficacy of flurbiprofen, a nonsteroidal anti-inflammatory drug, which is a phenyl propionic acid derivative, with acetaminophen and placebo in 63 adult outpatients with moderate to severe dental pain following periodontal surgery. After surgery was completed under local anesthesia, the patients received under double-blind conditions an envelope containing four tablets of either flurbiprofen 100 mg, acetaminophen 500 mg, or placebo and they were instructed to take one tablet every 6 hours when postoperative pain reached moderate to severe intensity. To determine analgesic efficacy and patients recorded pain intensity on a scale of 0 to 3. Patients were allowed to remedicate after 1 hour if pain was not reduced. Flurbiprofen was shown to possess an adequate analgesic effect superior to either placebo (P less than 0.005) or acetaminophen (P less than 0.01) in the parameters studied. Our results seem to further support earlier data obtained with the drug in dental patients with postoperative pain after the surgical removal of impacted third molars; therefore, it is concluded that flurbiprofen used as directed is a new alternative for the proper treatment of pain following periodontal surgery.
1307568.15111033752001.05.31++The effects of standard care counseling or telephone/in-person counseling on beliefs, knowledge, and behavior related to mammography screening.Oncol Nurs Forum
VL Champion, CS Skinner, JL Foster,
PURPOSE/OBJECTIVES: To determine the most effective methods of increasing mammography adherence while also considering ease of intervention delivery in evolving healthcare systems. DESIGN: Experimental. SETTING: Women from a health maintenance organization and a large general medicine practice. SAMPLE: Women 50-85 years of age who had not had breast cancer and did not have a mammogram within the last 15 months. METHODS: Once consent and baseline information were obtained, women were randomized to receive in-person, telephone, or no mammography counseling. MAIN RESEARCH VARIABLES: Mammography adherence, perception of susceptibility to breast cancer, and benefits, barriers to, and knowledge of mammography. FINDINGS: Compared to standard care, telephone counseling was more than twice as effective at increasing mammography adherence, whereas in-person counseling resulted in almost three times the mammography adherence postintervention. Both telephone and in-person counseling are successful in changing perceived susceptibility, knowledge, barriers, and benefits. CONCLUSION: Both telephone and in-person counseling interventions were successful in changing beliefs, which, in turn, increased mammography adherence. IMPLICATIONS FOR NURSING PRACTICE: Interventions based on altering beliefs are effective for increasing mammography adherence.
1307668.14151215532004.06.29++Resource use for total and supracervical hysterectomies: results of a randomized trial.Obstet Gynecol
J Showstack, M Kuppermann, F Lin, E Vittinghoff, RE Varner, RL Summitt, SG McNeeley, LA Learman, H Richter, S Hulley, AE Washington,
OBJECTIVE: Hysterectomy is the most common major surgical procedure performed in the United States for nonobstetric reasons. Although most hysterectomies include removal of the cervix, the rate of supracervical procedures has increased in recent years. To provide evidence about the outcomes of both types of hysterectomy, we conducted a randomized clinical trial of total (TAH) or supracervical (SCH) hysterectomy (the "TOSH" trial). We report here an analysis of 24-month resource use by patients in this trial. METHODS: A randomized controlled trial was performed at 3 clinical centers to compare resources used by 120 patients who received a total or supracervical abdominal hysterectomy. Service use during a 24-month follow-up period was identified from medical and billing records and patient reports. Each service used was assigned a relative value, which was then converted into 2002 U.S. dollars. RESULTS: Overall resource use was similar in the 2 study groups in the first 12 months after randomization (TAH 5,870 US dollars; SCH 6,018 US dollars; 95% confidence interval for difference -960 US dollars, 1,255 US dollars; P <.79) and for the full 24 months (TAH 6,448 US dollars; SCH 7,479 US dollars; 95% confidence interval for difference -533 US dollars, 2,616 US dollars; P <.20). In exploratory multivariable analyses, resource use was significantly associated with baseline body mass index greater than or equal to 35 kg/m(2) (8,440 US dollars versus 6,398 US dollars, P =.02) and heavy bleeding (7,550 US dollars versus 5,368 US dollars, P =.02). CONCLUSION: We conclude that the use of medical care resources over a 24-month period is comparable for total and supracervical hysterectomy. The association of a woman's weight and bleeding pattern with subsequent resource use requires further investigation.
1307768.14126142462003.03.25++A prospective and randomized study of primary hormonal therapy for patients with localized or locally advanced prostate cancer unsuitable for radical prostatectomy: results of the 5-year follow-up.BJU Int
H Akaza, Y Homma, K Okada, M Yokoyama, M Usami, Y Hirao, T Tsushima, Y Ohashi, Y Aso,
OBJECTIVE: To evaluate the effect of primary hormonal therapy for patients with localized and locally advanced prostate cancer. PATIENTS AND METHODS: Patients with stage T1b-T3 prostate cancer who were not scheduled for radical prostatectomy were allocated into two groups: group 1 (73 men) received luteinizing hormone-releasing hormone (LHRH) agonist monotherapy and group 2 (78 men) received LHRH agonist and chlormadinone acetate. Patients were followed using serum prostate specific antigen levels, prostate size and the detection of distant metastasis for 5 years. RESULTS: The median (range) follow-up was 78 (63-87) months. The 5-year progression-free survival rate was significantly higher in group 2 (68%) than in group 1 (47%). However, the overall and cause-specific survival rate at 5 years were similar in both groups, at 72% and 93% in group 1, and 64% and 89% in group 2, respectively. CONCLUSION: The overall survival rates of the both groups were no different from that of the normal Japanese population of the same age group. Although this study did not include an untreated group, i.e. watchful waiting, these results might indicate the usefulness of primary hormonal therapy in controlling localized and locally advanced prostate cancer. The 5-year observation period is still short and the study is continuing to determine the 10-year survival.
1307868.14129115852004.04.09++Incidence of cancer after a first episode of idiopathic venous thromboembolism treated with 3 months or 1 year of oral anticoagulation.J Thromb Haemost
MR Taliani, G Agnelli, P Prandoni, C Becattini, M Moia, M Bazzan, W Ageno, C Tomasi, G Guazzaloca, GB Ambrosio, A Bertoldi, R Salvi, R Poggio, M Silingardi,
BACKGROUND: A prolonged treatment with oral anticoagulants has been claimed to reduce the incidence of newly diagnosed cancer in the long-term follow-up of patients with venous thromboembolism. OBJECTIVES: In a multicenter prospective study we assessed the incidence of newly diagnosed clinically overt cancer in patients with a first episode of idiopathic venous thromboembolism (VTE) treated with oral anticoagulants for 3 months or 1 year. PATIENTS AND METHODS: Consecutive patients with an idiopathic venous thromboembolism who had completed 3 months of oral anticoagulant therapy without having a recurrence, bleeding or newly diagnosed cancer were randomized to discontinue oral anticoagulant therapy or to continue it for nine additional months. Idiopathic venous thromboembolism was defined as thrombosis occurring in the absence of known cancer, known thrombophilia, or temporary risk factors for venous thromboembolism. All patients were followed up for at least 1 year after randomization. RESULTS: A total of 429 patients, 265 patients with DVT and 164 with PE, were followed up for an average of 43.7 months after randomization. A newly diagnosed cancer occurred in 32 patients (7.5%), 13 (6.2%) of the 210 patients treated for 3 months and 19 (8.7%) of the 219 patients treated for 1 year (RR = 0.71, 95% confidence interval 0.36-1.41). CONCLUSIONS: The incidence of newly diagnosed clinically overt cancer is not reduced in patients with idiopathic venous thromboembolism treated with 1-year anticoagulant treatment compared with patients treated for 3 months.
1307968.13105294641999.12.07++Comparison of biochemical markers of bone remodelling in the assessment of the effects of alendronate on bone in postmenopausal osteoporosis.Clin Chim Acta
JJ Stĕpán, J Vokrouhlická,
The effects of alendronate treatment on biochemical markers of bone remodelling and bone mineral density (BMD) were studied in 30 Caucasian women (postmenopausal for at least 3 years, age 42-76 years, with BMD of the lumbar spine at least 2 S.D. below the mean for mature, premenopausal women). The patients were randomly assigned to receive alendronate (10 mg/day) or placebo for 12 months (double blind). The study was subsequently extended to a second year of open alendronate treatment. The treatment with alendronate resulted in a significant and progressive increase in BMD of the lumbar spine and femoral neck. Under the treatment, the maximal decrease of biochemical markers of bone remodelling (osteocalcin in plasma, bone-specific alkaline phosphatase, N-terminal propeptide of type I procollagen and C-terminal telopeptide of type I collagen in serum, and cross-linked amino-terminal N-telopeptide and total hydroxyproline in urine) was observed at 6 months with no further change during the 2-year period. There were no significant differences in discriminating between patients treated for 1 year with alendronate or placebo using either the percentage change in spine BMD at month 12, or a single measurement of the marker at month 6, or log (percent of baseline at month 6 of value of the marker). In this respect, the power of all the biochemical markers were comparable. The markers are a valuable adjunct to the measurements of BMD, especially in the patients not showing an increase of 3% or more at the lumbar spine BMD after 1 year of treatment.
1308068.1398194461998.11.19++Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group.N Engl J Med
JG McHutchison, SC Gordon, ER Schiff, ML Shiffman, WM Lee, VK Rustgi, ZD Goodman, MH Ling, S Cort, JK Albrecht,
BACKGROUND: Only 15 to 20 percent of patients with chronic hepatitis C have a sustained virologic response to interferon therapy. We compared the efficacy and safety of recombinant interferon alfa-2b alone with those of a combination of interferon alfa-2b and ribavirin for the initial treatment of patients with chronic hepatitis C. METHODS: We randomly assigned 912 patients with chronic hepatitis C to receive standard-dose interferon alfa-2b alone or in combination with ribavirin (1000 or 1200 mg orally per day, depending on body weight) for 24 or 48 weeks. Efficacy was assessed by measurements of serum hepatitis C virus (HCV) RNA and serum aminotransferases and by liver biopsy. RESULTS: The rate of sustained virologic response (defined as an undetectable serum HCV RNA level 24 weeks after treatment was completed) was higher among patients who received combination therapy for either 24 weeks (70 of 228 patients, 31 percent) or 48 weeks (87 of 228 patients, 38 percent) than among patients who received interferon alone for either 24 weeks (13 of 231 patients, 6 percent) or 48 weeks (29 of 225 patients, 13 percent) (P<0.001 for the comparison of interferon alone with both 24 weeks and 48 weeks of combination treatment). Among patients with HCV genotype 1 infection, the best response occurred in those who were treated for 48 weeks with interferon and ribavirin. Histologic improvement was more common in patients who were treated with combination therapy for either 24 weeks (57 percent) or 48 weeks (61 percent) than in those who were treated with interferon alone for either 24 weeks (44 percent) or 48 weeks (41 percent). The drug doses had to be reduced and treatment discontinued more often in patients who were treated with combination therapy. CONCLUSIONS: In patients with chronic hepatitis C, initial therapy with interferon and ribavirin was more effective than treatment with interferon alone.
1308168.1395092931998.05.05++Pamidronate. A review of its use in the management of osteolytic bone metastases, tumour-induced hypercalcaemia and Paget's disease of bone.Drugs Aging
AJ Coukell, A Markham,
Pamidronate (APD) is a potent inhibitor of bone resorption that is useful in the management of patients with osteolytic bone metastases from breast cancer or multiple myeloma, tumour-induced hypercalcaemia or Paget's disease of bone. After intravenous administration, the drug is extensively taken up in bone, where it binds with hydroxyapatite crystals in the bone matrix. Matrix-bound pamidronate inhibits osteoclast activity by a variety of mechanisms, the most important of which appears to be prevention of the attachment of osteoclast precursor cells to bone. In patients with osteolytic bone metastases associated with either breast cancer or multiple myeloma, administration of pamidronate together with systemic antitumour therapy reduces and delays skeletal events, including pathological fracture, hypercalcaemia and the requirement for radiation treatment or surgery to bone. Pamidronate generally improves pain control. Quality-of-life and performance status scores in pamidronate recipients were generally as good as, or better than, those in patients who did not receive the drug. Overall survival does not appear to be affected by pamidronate therapy. Tumour-induced hypercalcaemia also responds well to pamidronate therapy: 70 to 100% of patients achieve normocalcaemia, generally 3 to 5 days after treatment. Response durations vary, but are commonly 3 weeks or longer, In comparative studies, pamidronate produced higher rates of normocalcaemia and longer normocalcaemic durations than other available osteoclast inhibitors, including intravenous etidronate, clodronate and plicamycin (mithramycin). In most patients with Paget's disease of bone, intravenous pamidronate reduces bone pain and produces biochemical response. Serum alkaline phosphatase levels generally fall 50 to 70% from baseline 3 to 4 months after pamidronate treatment. Biochemical response may be prolonged. Pamidronate is well tolerated by most patients. Transient febrile reactions, sometimes accompanied by myalgias and lymphopenia, occur commonly after the first infusion of pamidronate. Other reported adverse events include transient neutropenia, mild thrombophlebitis, asymptomatic hypocalcaemia and, rarely, ocular complications (uveitis and scleritis). Pamidronate should be considered for routine use together with systemic hormonal or cytotoxic therapy in patients with breast cancer or multiple myeloma and osteolytic metastases. At present, pamidronate is the drug of choice for first-line use in the management of patients with tumour-induced hypercalcaemia. It is an effective treatment for Paget's disease and is the treatment of choice where oral bisphosphonates are not an option.
1308268.1387608501996.09.13++A clinical evaluation of the effectiveness of a fluoride-releasing visible light-activated bonding system to reduce demineralization around orthodontic brackets.Am J Orthod Dentofacial Orthop
LM Trimpeneers, LR Dermaut,
The presence of decalcification (white spots) after the removal of orthodontic appliances still remains a problem. A method to deliver fluoride to the area beneath and around the bonded attachments, independent of patient compliance, could be very helpful. Therefore special attention is being currently directed to the so-called "fluoride releasing bonding adhesives." A clinical trial was carried out to compare the effect of a visible light-cured fluoride-releasing (F-releasing) material with a chemically cured nonfluoride resin on white spot formation during fixed orthodontic therapy. Fifty patients entered the trial, and 762 brackets were bonded in a crossover design. Intraoral slides were taken before and after treatment and were evaluated for white spot formation. Statistical data analysis was carried out by means of a chi-square test. The results of this clinical study indicate that there was no significant difference between the decalcification rates for both types of adhesives. When the appearance of white spots was evaluated in an overall manner, there was significantly more upper than lower decalcification.
1308368.12452101981.01.29++Oxitropium bromide (Ba 253), an advance in the field of anticholinergic bronchodilating treatments. Preliminary results.Rev Inst Hyg Mines (Hasselt)
A Minette, M Marcq,
The changes in FEV1 and in specific conductance induced by 200 micrograms oxitropium bromide given as pressurized aerosol were measured at 8 time intervals during 7 hours after inhalation in a group of 19 patients with reversible broncho-obstruction. The working of the drug was compared to the functional values observed at the same time intervals after placebo, 40 micrograms ipratropium bromide and 400 micrograms fenoterol. Both oxitropium and ipratropium were definitely and significantly superior to placebo at all time intervals. Oxitropium was superior to ipratropium at the 7th hour. At this time interval the difference was significant At the 7th hour oxitropium gave higher mean results than fenoterol, but this difference was not significant. The drug was also compared to its competitors regarding its subjective and cardiovascular tolerance. No unfavourable side-effects were observed.
1308468.1294253851998.01.26++Efficacy of tepid sponging versus paracetamol in reducing temperature in febrile children.Ann Trop Paediatr
NB Agbolosu, LE Cuevas, P Milligan, RL Broadhead, D Brewster, SM Graham,
A block randomized clinical trial to compare the efficacy of tepid sponging with the use of paracetamol in febrile children was undertaken at the Queen Elizabeth Central Hospital, Blantyre. Eighty children aged between 6 and 54 months with axillary temperatures of between > or = 38.5 degrees C and < or = 40 degrees C and a clinical diagnosis consistent with upper respiratory tract infection and/or malaria were block randomized to receive either oral paracetamol (15 mg/kg) or tepid sponging. Children receiving tepid sponging were sponged from head to toe (except the scalp) by leaving a thin layer of water on the body. If the body became dry it was repeated and continued until the axillary temperature fell to < 38.5 degrees C. Axillary temperature and assessment of discomfort (convulsions, crying, irritability, vomiting and shivering) were recorded every 30 minutes for 2 hours. A significantly greater and more rapid reduction of fever was demonstrated with paracetamol than with tepid sponging. Tepid sponging without antipyretics is often used to reduce fever, but our results suggest that this is effective only during the 1st 30 minutes. Paracetamol is clearly more effective than tepid sponging in reducing body temperature in febrile children in a tropical climate.
1308568.1280537401994.09.06++A prospective randomized trial comparing R1 subtotal gastrectomy with R3 total gastrectomy for antral cancer.Ann Surg
CS Robertson, SC Chung, SD Woods, SM Griffin, SA Raimes, JT Lau, AK Li,
OBJECTIVE: The authors determined if more radical surgery with extended lymphadenectomy improves the results of gastrectomy in patients with adenocarcinoma of the gastric antrum. SUMMARY BACKGROUND DATA: The overall survival in patients with gastric cancer is disappointing. Improved survival has been reported by Japanese authors. Whether this is because of a higher number of early gastric cancers in the Japanese series, different biologic behavior in Asians, or the adoption of radical surgery with lymphadenectomy remains unclear. METHODS: R1 subtotal gastrectomy with omentectomy and R3 total gastrectomy (omentectomy, splenectomy, distal pancreatectomy, lymphatic clearance of the celiac axis, and skeletonization of vessels in the porta hepatis) were evaluated in a prospective, randomized comparison. RESULTS: Fifty-five patients were randomized--25 to the R1 group and 30 to the R3 group. The two groups were comparable for age, sex, tumor size, TNM stage, and length of follow-up. The R3 group had a longer operating time (140 vs. 260 min; p < 0.05), a greater transfusion requirement (0 vs. 2 units, p < 0.05) and a longer hospital stay (8 vs. 16 days; p < 0.05) (medians; Mann-Whitney U test). The only postoperative death was in the R3 group and was caused by intra-abdominal sepsis. Fourteen patients in the R3 group developed left subphrenic abscesses. There were no major complications in the R1 group. Overall survival was significantly better in the R1 group (median survival estimated by Kaplan-Meier method, 1511 vs. 922 days, p < 0.05, log-rank test). CONCLUSIONS: R3 total gastrectomy can be performed with a low mortality, but it has a high morbidity because of intra-abdominal sepsis. The data do not support the routine use of R3 total gastrectomy for treatment of patients with antral cancer.
1308668.12104477911999.09.02++Serum urate determines antioxidant capacity in middle-aged men - a controlled, randomized diet and exercise intervention study.J Intern Med
M Rosell, J Regnström, A Kallner, ML Hellénius,
OBJECTIVES: To study whether advice on diet and/or exercise, given in order to reduce cardiovascular risk factors in middle-aged men, affects the intake of antioxidants, urate concentration and the total antioxidant capacity in serum. DESIGN: A 6-month randomized controlled intervention study. SETTING: Primary Health Care in Sollentuna, Stockholm, and the Department of Medicine, Karolinska Hospital, Stockholm, Sweden. SUBJECTS: One hundred and fifty-eight healthy men (46.2 +/- 5.0 years) with moderately raised cardiovascular risk factors. INTERVENTIONS: Advice on diet (D, n = 40), exercise (E, n = 39), diet and exercise (DE, n = 39) and a control group (C, n = 39). MAIN OUTCOME MEASURES: Dietary intake, exercise habits, S-urate and the antioxidant capacity in serum (TAOC). RESULTS: After 6 months, changes in dietary and exercise habits were seen in all three intervention groups and favourable effects were seen on BMI, waist circumference, blood pressure, S-cholesterol and fasting insulin. The intake of alpha-tocopherol was decreased in groups D and E (P < 0.01) and beta-carotene was increased in groups D and DE (P < 0.01). In group DE, the intake of vitamin C was increased (P < 0.05). S-urate was reduced in group D from 345 to 325 micromol L-1 (P < 0.05). No significant changes in TAOC were seen in any group. S-urate and TAOC were correlated (r = 0. 58, P < 0.001) and S-urate was correlated to several parameters in the metabolic syndrome. CONCLUSION: Favourable changes in diet and exercise reduced several cardiovascular risk factors but did not affect the total antioxidant capacity in serum. S-urate was a strong determinant of the antioxidant capacity.
1308768.11111205502001.04.19++Breastfeeding training for health professionals and resultant changes in breastfeeding duration.Sao Paulo Med J
JA Taddei, MF Westphal, S Venancio, C Bogus, S Souza,
CONTEXT: Promotion of breastfeeding in Brazilian maternity hospitals. OBJECTIVE: To quantify changes in the breastfeeding duration among mothers served by hospitals exposed to the Wellstart-SLC course, comparing them with changes among mothers attended by institutions not exposed to this course. DESIGN: Randomized Institutional Trial. SETTING: The effects of training on breastfeeding duration was assessed in eight Brazilian hospitals assigned at random to either an exposed group (staff attending the Wellstart-SLC course) or a control group. SAMPLE: For each of the eight study hospitals, two cohorts of about 50 children were visited at home at one and six months after birth. The first cohort (n = 494) was composed of babies born in the month prior to exposure to the Wellstart-SLC course, and the second cohort (n = 476) was composed of babies born six months subsequent to this exposure. MAIN MEASUREMENTS: Kaplan-Meier curves were plotted to describe the weaning process and log-rank tests were used to assess statistical differences among survival curves. Hazard ratio (HR) estimates were calculated by fitting Cox proportional hazard regression models to the data. RESULTS: The increases in estimated, adjusted rates for children born in hospitals with trained personnel were 29% (HR = 0.71) and 20% (HR = 0.80) for exclusive and full breastfeeding, respectively. No changes were identified for total breastfeeding. CONCLUSION: This randomized trial supports a growing body of evidence that training hospital health professionals in breastfeeding promotion and protection results in an increase in breastfeeding duration.
1308868.1196761471998.08.13++Karaoke therapy in the rehabilitation of mental patients.Singapore Med J
CM Leung, G Lee, B Cheung, E Kwong, YK Wing, CS Kan, J Lau,
OBJECTIVES: To study the efficacy of karaoke singing and its implications in the rehabilitation of mental patients in Hong Kong Chinese. METHODS: A double blind controlled trial was conducted over six weeks in a small sample of chronic schizophrenic patients matched in age, sex and duration of illness. The index group practised karaoke and the controlled group practised simple singing. Subjects were assessed in changes in mood and social interaction. RESULTS: No significant difference was detectable within the 2 groups. However, significant differences of anxiety and social interaction at the end of the third and sixth weeks respectively, were detectable between the 2 groups. CONCLUSION: Karaoke therapy may be more effective than simple singing in improving social interaction. There is preliminary evidence that it may be anxiety-provoking for unstable schizophrenic patients. More research is required for further elucidation of the characteristics of favourable candidates, optimal schedule and active components of the therapy.
1308968.1180598161994.09.15++Laparoscopic adnexectomy: a comparison with laparotomy.Am J Obstet Gynecol
DE Pittaway, P Takacs, P Bauguess,
OBJECTIVE: Our purpose was to compare the newer technique of laparoscopic adnexal excision with conventional laparotomy. DESIGN: With the same entry criteria, a retrospective, consecutive series of 26 women who underwent adnexectomy by laparotomy was compared with a later prospective consecutive series of 64 women who had laparoscopic adnexectomy in a university referral practice. The two groups were similar in all characteristics examined. The ages of the women ranged from 18 to 70 years, but only two women were postmenopausal. Pelvic pain with or without an ovarian cystic mass was the surgical indication in 91% to 92% of the women. Seven women had a persistent adnexal cystic mass and one woman had a unilateral androgen-secreting ovary. Bipolar coagulation was the laparoscopic method used. RESULTS: Median operating time (88 vs 107 minutes), blood loss (72 vs 222 ml), days in the hospital (1 day vs 3 days), total costs ($4573 vs $6044), and recovery time (1 week vs 4 weeks) were significantly less with laparoscopic adnexectomy. There were no differences between the two techniques in major complications (one in each group), blood transfusions, adhesion formation, or the proportion of women noting improvement of pain symptoms. CONCLUSION: In this preliminary assessment of laparoscopic adnexectomy, this surgical procedure offers significant advantages to laparotomy in selected patients when performed by a laparoscopist experienced in advanced techniques.
1309068.10103153111983.04.15++The effect of home respiratory therapy on hospital readmission rates of patients with chronic obstructive pulmonary disease.Respir Care
S Roselle, FJ D'Amico,
The South Hills Health System Home Health Agency, Homestead, Pennsylvania, studied the effect of home respiratory therapy on hospital readmission rates in 418 patients with chronic obstructive pulmonary disease (COPD). Respiratory therapists evaluated and followed referred patients in their homes. Oxygen, breathing equipment, and supplies were provided, and patients were educated in use, cleaning, and maintenance of equipment. Data for the study were taken from hospital records, home assessments, and discharge summaries. All patients studied had been hospitalized in the year prior to receiving home respiratory therapy. After 12 months of follow-up, 64% had not been rehospitalized. In the year prior to home respiratory therapy, the average number of hospital admissions per patient had been 1.28, with the average length of hospital stay being 18.25 days. During the home respiratory therapy study period of 12 months, the average number of hospital admissions was 0.48, with the average length of hospital stay being 6.09 days. These results indicate that home care provided by respiratory therapists can significantly reduce the rehospitalization of COPD patients. Prevention of rehospitalization in the study group resulted in estimated average hospital costs of savings of $2,625 per per patient for the year. As a result of this study, two large local industrial employers, the Federal Black Lung program, and Blue Cross of Western Pennsylvania have added respiratory therapy to their home health benefits.
1309168.1064338401984.09.28 +[Multicenter study of 2 urokinase protocols in severe pulmonary embolism. Research Group on Urokinase and Pulmonary Embolism]Arch Mal Coeur Vaiss
The results of a multicentre trial (10 centres) of urokinase (UK) extracted from human urine in patients with recent massive pulmonary embolism (PE) are reported. The aim of this trial was to compare the efficacy of two protocols of UK therapy: low dose UK: 2 000 IU/kg/hour (UKl) associated with heparin, against high dose UK: 4 400 IU/kg/hour for 12 hours (UKh) followed by heparin. This randomised single blind trial included patients under 80 years of age. The clinical diagnosis of recent PE (less than 5 days) was confirmed by pulmonary angiography showing over 30% vascular obstruction (Miller index greater than 11). The efficacy of treatment was assessed by the degree of early revascularisation on pulmonary angiography 30 to 48 hours after the start of thrombolytic therapy, as analysed by 4 independent vascular radiologists. A total of 133 patients entered the trial between November 1978 and October 1981: 2 died before receiving treatment, 2 were excluded, 129 patients were retained (67 UKl and 62 UKh). The initial clinical, haemodynamic and angiographic parameters were comparable in the two groups: Miller index; 22.6 +/- 3.7 (UKl) and 22.6 +/- 3.4 (UKh), an average vascularisation defect of 66%. The efficacy of treatment was the same: 26% and 20% respectively. The incidence of haemorrhagic complications was the same in both groups: 24% and 29% respectively, but only 2% of patients had spontaneous severe bleeding.(ABSTRACT TRUNCATED AT 250 WORDS)
1309268.10149988462004.07.12++Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer.Ann Oncol
ME O'Brien, N Wigler, M Inbar, R Rosso, E Grischke, A Santoro, R Catane, DG Kieback, P Tomczak, SP Ackland, F Orlandi, L Mellars, L Alland, C Tendler,
BACKGROUND: This study was designed to demonstrate that efficacy [progression-free survival (PFS)] of CAELYX [pegylated liposomal doxorubicin HCl (PLD)] is non-inferior to doxorubicin with significantly less cardiotoxicity in first-line treatment of women with metastatic breast cancer (MBC). PATIENTS AND METHODS: Women (n=509) with MBC and normal cardiac function were randomized to receive either PLD 50 mg/m2 (every 4 weeks) or doxorubicin 60 mg/m2 (every 3 weeks). Cardiac event rates were based on reductions in left ventricular ejection fraction as a function of cumulative anthracycline dose. RESULTS: PLD and doxorubicin were comparable with respect to PFS [6.9 versus 7.8 months, respectively; hazard ratio (HR)=1.00; 95% confidence interval (CI) 0.82-1.22]. Subgroup results were consistent. Overall risk of cardiotoxicity was significantly higher with doxorubicin than PLD (HR=3.16; 95%CI 1.58-6.31; P<0.001). Overall survival was similar (21 and 22 months for PLD and doxorubicin, respectively; HR=0.94; 95%CI 0.74-1.19). Alopecia (overall, 66% versus 20%; pronounced, 54% versus 7%), nausea (53% versus 37%), vomiting (31% versus 19%) and neutropenia (10% versus 4%) were more often associated with doxorubicin than PLD. Palmar-plantar erythrodysesthesia (48% versus 2%), stomatitis (22% versus 15%) and mucositis (23% versus 13%) were more often associated with PLD than doxorubicin. CONCLUSIONS: In first-line therapy for MBC, PLD provides comparable efficacy to doxorubicin, with significantly reduced cardiotoxicity, myelosuppression, vomiting and alopecia.
1309368.10147636962004.02.24++Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients.Acta Orthop Scand
H Husted, L Blønd, S Sonne-Holm, G Holm, TW Jacobsen, P Gebuhr,
INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed. PATIENTS AND METHODS: 40 patients were randomized to tranexamic acid (10 mg/kg given as a bolus intravenous injection, followed by a continuous infusion of 1 mg/kg/hour for 10 hours) or placebo (20 mL saline given intravenously) 15 minutes before the incision. We recorded the peroperative and postoperative blood losses at removal of the drain 24 hours after the operation and the number of blood transfusions. RESULTS: Patients receiving tranexamic acid had a mean peroperative blood loss of 480 mL versus 622 mL in patients receiving placebo (p = 0.3), a postoperative blood loss of 334 mL versus 609 mL (p = 0.001), a total blood loss of 814 mL versus 1231 mL (p = 0.001) and a total need for 4 blood transfusions versus 25 (p = 0.04). No patient in either group had symptoms of deep venous thrombosis, pulmonary embolism or prolonged wound drainage. INTERPRETATION: Transemic acid is effective in reducing the postoperative blood loss, the total blood loss and the need for blood transfusion in primary total hip arthroplasty.
1309468.09169048592007.03.23++Evaluation of a visit preparation intervention implemented in two rural, underserved counties of Northern California.Patient Educ Couns
J Belkora, M Katapodi, D Moore, L Franklin, K Hopper, L Esserman,
OBJECTIVE: Evaluate satisfaction with visit preparation at three rural resource center sites. METHODS: The resource centers sent eight employees and two volunteers for training at UCSF in Consultation Planning (CP). CP is a service to help patients make a list of questions before seeing their doctors. Researchers used multivariate ordered logistic regression analysis to investigate the variation in satisfaction among 99 CP Clients served by the resource centers in 2003. RESULTS: Sixty-seven CP Clients who completed surveys were highly satisfied (mean=8.67, standard deviation (S.D.)=1.85, range=5-10). Variation in satisfaction was associated only with whether or not the CP Provider was a breast cancer survivor serving a breast patient (p=0.005). Satisfaction was not associated with CP Client demographics; type of upcoming medical visit; or CP Provider age, remuneration status, nursing background, and volume of CP Clients. CONCLUSION: Community-based resource centers have implemented CP to the satisfaction of their clients. Further research should expand the delivery of CP to more underserved members of the community and evaluate its acceptability and impact. There may be a therapeutic alliance formed when survivors provide CP to newly diagnosed patients. PRACTICE IMPLICATIONS: CP should be considered by patient support programs wishing to expand their client services to include visit preparation.
1309568.0961410901984.03.23++Treatment of premature labor contractions with combined ritodrine and indomethacine.Int J Gynaecol Obstet
Z Katz, M Lancet, M Yemini, BM Mogilner, A Feigl, H Ben Hur,
The results of combined ritodrine and indomethacine treatment (RI) in premature labor contractions were compared with ritodrine alone (R). One hundred and twenty patients with threatened premature labor in weeks 26-34 were studied. Sixty RI women received 100 mg ritodrine in infusion followed by 60 mg daily orally until 35 weeks and indomethacine 200 mg on the first day of treatment only. The R group included 60 women with identical tocolysis indices, age of pregnancy and anamnestic parameters who received ritodrine only. The mean prolongation index (PI) was 18.2 in the RI group, against 11.5 in the R patients (P less than 0.05). The mean prolongation of pregnancy was 5.6 weeks in the first and 3.6 in the control group (P less than 0.05). Birthweight and Apgar scores were similar in the two groups. In order to examine the possible early closure of the ductus arteriosus due to the indomethacin therapy, echocardiograms were done on all newborn in the RI group: the pre-ejection period and right ventricular ejection time ratio was 0.19-0.26 after delivery and 0.17-0.22 1 month later, which excludes pulmonary diastolic hypertension due to premature closure of the duct. The combined RI treatment is more effective that R alone and does not give rise to any complications in the mother or the fetus.
1309668.09120863532002.08.12++Heel ultrasonography in monitoring alendronate therapy: a four-year longitudinal study.Osteoporos Int
S Gonnelli, C Cepollaro, A Montagnani, S Martini, L Gennari, M Mangeri, C Gennari,
The possibility of using quantitative ultrasound (QUS) in monitoring the response to antiresorptive drugs has yet to be defined. The aim of the present study was to evaluate whether heel ultrasonography, considering its characteristics of long-term precision, is able to monitor osteoporotic patients treated with alendronate. We studied 150 postmenopausal osteoporotic women (age 59.6 +/- 5.3 years) treated with alendronate and calcium (n = 74) or with calcium alone (n = 76) for 4 years. At baseline and after 12, 24, 36 and 48 months, we measured bone mineral density (BMD) at the lumbar spine by dual-energy X-ray absorptiometry (DXA, Hologic 4500), and speed of sound (SOS), broadband ultrasound attenuation (BUA) and Stiffness at the calcaneus by Achilles plus. Moreover, the longitudinal precision of QUS parameters was assessed by measuring 10 subjects once a month for 1 year and, on the basis of the coefficients of variation we obtained, we calculated the Least Significant Change between two measurements. In the alendronate-treated patients, at year 1, BMD increased by 4.2%, SOS by 0.4%, BUA by 1.1% and Stiffness by 3.2%; at year 2, BMD increased by 5.0%, SOS by 0.7%, BUA by 1.4% and Stiffness by 5.7%. At year 3, BMD increased by 6.2%, SOS by 0.9%, BUA by 1.8% and Stiffness by 7.6%. At the end of the study period, BMD increased by 7.6%, SOS by 1.2%, BUA by 1.9% and Stiffness by 9.0%. The minimal significant difference between two measurements was 0.8% for SOS, 5.6% for BUA and 5.0% for Stiffness. Among the QUS parameters, Stiffness showed the greatest total treatment effect and a longitudinal sensitivity which was only slightly lower than BMD. The MTI, which represents the period between scans required to show that a 'true' change has occurred, was 1.8, 2.7, 11.9 and 2.2 years for BMD, SOS, BUA and Stiffness respectively. Therefore, although the spinal BMD remains the optimal method, QUS at the heel, and in particular Stiffness, seems to be a sensitive tool for monitoring the response to alendronate.
1309768.0988714161997.02.06++Behavior therapy and the transdermal nicotine patch: effects on cessation outcome, affect, and coping.J Consult Clin Psychol
PM Cinciripini, LG Cinciripini, A Wallfisch, W Haque, H Van Vunakis,
The process and outcome of a smoking cessation program using behavior therapy alone (BT) or behavior therapy plus the nicotine patch (BTP) was studied in 64 participants. Participants quit smoking on a target date after a period of ad libitum smoking, cognitive-behavior therapy preparing them for cessation, and behavioral rehearsal for high-risk situations, including stress management, and coping with negative affect. Abstinence was significantly higher for the BTP group versus the BT group from the end of behavioral treatment (79% vs. 63%) through the 3-month follow-up (p < .01), with the effects weakening at the 6- (p = .06) and 12-month marks (p = 38% vs. 22%). More general distress was observed among BT versus BTP participants (i.e., increased withdrawal, tension, fatigue, and coping frequency with decreased coping effort; coping-to-urge ratio). The coping behavior of the BTP group may have been more effective than that of the BT group, as indicated by their significantly higher level of self-efficacy.
1309868.0921863231990.06.14++Interventional antimicrobial strategy in febrile neutropenic patients. Results of a multicenter study in 1,260 patients with hematological malignancies. The Interventional Antimicrobial Strategy Study Group, Paul Ehrlich Society for Chemotherapy.Onkologie
G Maschmeyer, H Link, W Hiddemann, P Meyer, M Helmerking, D Adam,
In a prospective, randomized multicenter trial of the Paul Ehrlich society different concepts for sequential empirical antimicrobial strategy for the treatment of patients with neutropenia less than 1.0/nl and fever greater than 38.5 degrees C and/or documented infection were studied. In phase I, patients with unexplained fever (FUO) were randomized for the combination of acylaminopenicillin plus aminoglycoside or third-generation cephalosporin plus aminoglycoside or double beta lactam therapy. Non-responders received additional vancomycin or all three substances of phase I in phase II. In phase III, all patients with persistent fever were then treated with amphotericin B plus 5-flucytosine and rifampin and randomized for the continuation of the double beta lactam regimen or additional imipenem/cilastatin. 667 (52.9%) of 1260 evaluable patients had FUO during the whole study period, of which 62.5% could be cured in phase I, 43.2% of non-responders in phase II and 55% of persistently febrile patients in phase III. The overall rate of complete response was 79.5%. 2.8% were non-responders, 11.7% were not evaluable for response and 40 patients (6%) died during the study, 24 (60%) of whom due to the underlying disease or the toxicity of antileukemic therapy. A significant difference between the treatment groups could not be detected in either of the three study phases.
1309968.0917472681992.01.23++Patient education about cough: effect on the consulting behaviour of general practice patients.Br J Gen Pract
G Rutten, J Van Eijk, M Beek, H Van der Velden,
The aim of this general practice study was to examine how the consulting behaviour of patients with a cough was affected when the tasks and responsibilities of patients, practice nurses and general practitioners were reorganized. In four 'average' single-handed general practices the effects on the consulting behaviour of patients of a rational practice policy on cough and the provision of systematic patient education on cough were compared with patient behaviour in four matched control practices. Changes of behaviour were measured in 548 patients who consulted for cough at least twice, in two successive autumn-winter periods. Significantly more patients in the experimental practice changed their behaviour to follow the practice guidelines than did patients in the control practices (56% versus 30%, P less than 0.001). The proportion of patients who continued to consult in the approved manner was greater among patients receiving intervention (66% versus 29%, P less than 0.001). This was equally true for patients who had suffered less than four episodes of cough or more than four episodes. The more often the patients received the education, the more effective it was. All patients who consulted the general practitioner for cough during the first autumn-winter period filled in a cough diary during the second period. From this it appeared that the intervention did not result in patients delaying consultation when they had a cough lasting longer than three weeks or one with 'serious' symptoms. It would appear that a rational practice policy and the provision of patient education can stimulate patients to modify their consulting behaviour. This could result in a reduction in the costs of health care.
1310068.0883120321994.03.24++Effectiveness and cost of different strategies for information feedback in general practice.Br J Gen Pract
A Szczepura, J Wilmot, C Davies, J Fletcher,
AIM. The aim of this study was to determine the effectiveness and relative cost of three forms of information feedback to general practices--graphical, graphical plus a visit by a medical facilitator and tabular. METHOD. Routinely collected, centrally-held data were used where possible, analysed at practice level. Some non-routine practice data in the form of risk factor recording in medical notes, for example weight, smoking status, alcohol consumption and blood pressure, were also provided to those who requested it. The 52 participating practices were stratified and randomly allocated to one of the three feedback groups. The cost of providing each type of feedback was determined. The immediate response of practitioners to the form of feedback (acceptability), ease of understanding (intelligibility), and usefulness of regular feedback was recorded. Changes introduced as a result of feedback were assessed by questionnaire shortly after feedback, and 12 months later. Changes at the practice level in selected indicators were also assessed 12 and 24 months after initial feedback. RESULTS. The resulting cost per effect was calculated to be 46.10 pounds for both graphical and tabular feedback, 132.50 pounds for graphical feedback plus facilitator visit and 773.00 pounds for the manual audit of risk factors recorded in the practice notes. The three forms of feedback did not differ in intelligibility or usefulness, but feedback plus a medical facilitator visit was significantly less acceptable. There was a high level of self-reported organizational change following feedback, with 69% of practices reporting changes as a direct result; this was not significantly different for the three types of feedback. There were no significant changes in the selected indicators at 12 or 24 months following feedback. The practice characteristic most closely related to better indicators of preventive practice was practice size, smaller practices performing significantly better. Separate clinics were not associated with better preventive practice. CONCLUSION. It is concluded that feedback strategies using graphical and tabular comparative data are equally cost-effective in general practice with about two thirds of practices reporting organizational change as a consequence; feedback involving unsolicited medical facilitator visits is less cost-effective. The cost-effectiveness of manual risk factor audit is also called into question.
1310168.0878656431995.03.30++Bran supplementation in the treatment of irritable bowel syndrome.Aliment Pharmacol Ther
J Snook, HA Shepherd,
BACKGROUND: Irritable bowel syndrome remains the commonest reason for referral to a gastroenterology clinic. Patients with irritable bowel syndrome are frequently advised to increase their intake of bran fibre, despite inconclusive experimental evidence of benefit. METHODS: The effect of dietary supplementation with a bolus of bran fibre (12 g/day) was studied in a block-randomized, placebo-controlled, crossover study of 80 patients with irritable bowel syndrome referred to a District General Hospital outpatient clinic. Comparison of the benefits of bran and placebo was based upon personal assessment of individual and overall symptom profiles, determined from a simple daily symptom score and post-treatment interview. RESULTS: Overall symptomatic improvement was reported with bran by 52% and with placebo by 54% of patients. Bran supplementation was no more effective than placebo in improving individual symptoms of irritable bowel syndrome, and for wind-related symptoms it was significantly less effective (P < 0.001). CONCLUSION: Dietary supplementation with bran is of no value in the treatment of patients with irritable bowel syndrome referred to a hospital clinic.
1310268.0790240251997.03.04++Acupressure versus intravenous metoclopramide to prevent nausea and vomiting during spinal anesthesia for cesarean section.Anesth Analg
DJ Stein, DJ Birnbach, BI Danzer, MM Kuroda, A Grunebaum, DM Thys,
Nausea and vomiting occur frequently during cesarean section under spinal anesthesia. Metoclopramide reduces intraoperative nausea and vomiting, but not without potential side effects. Acupressure, a noninvasive variation of acupuncture that involves constant pressure on the wrist, has been suggested as an alternative method to prevent nausea and vomiting. The aim of this study was to compare acupressure and intravenous (IV) metoclopramide for the prevention of nausea and vomiting during elective cesarean section under spinal anesthesia. Seventy-five patients were studied in a randomized, prospective, double-blind comparative trial. Group I patients received acupressure bands + 2 mLIV saline, Group II patients received placebo wrist bands + 10 mg IV metoclopramide, and Group III patients received placebo wrist bands + 2 mL IV saline. Patients who received either acupressure or metoclopramide prior to initiation of spinal anesthesia for cesarean section had much less nausea than patients in the placebo group. Acupressure is an effective, non-pharmacologic method to reduce intraoperative nausea during elective cesarean section in the awake patient.
1310368.0761251851982.10.21++Assessment of beta-adrenoceptor antagonists in asthmatic patients.Br J Clin Pharmacol
RE Ruffin, EL McIntyre, KM Latimer, HE Ward, AJ Crockett, JH Alpers,
1 Bronchial smooth muscle, skeletal muscle and cardiac beta-adrenoceptor antagonism have been compared in twelve asthmatic patients after three beta-adrenoceptor antagonists at two dose levels. The non-selective antagonist propranolol (40 and 160 mg), the non-selective antagonist with partial agonist activity pindolol (5 and 20 mg) and the beta 1-selective antagonist atenolol (50 and 200 mg) were studied on separate occasions. 2 Six placebo days were used in this double-blind crossover study to allow interpretation of individual as well as group results. 3 Bronchial smooth muscle effects were assessed by resting spirometry, histamine inhalation test and spirometric response to inhaled fenoterol. Skeletal muscle effects were assessed by resting tremor and fenoterol induced tremor. 4 Cardiac beta-adrenoceptor antagonism was assessed by measuring the effect on resting heart rate and on maximum heart rate in a standard exercise test. 5 Pindolol tended to cause least change from placebo in resting spirometry, caused significant tremor response, inhibited the fenoterol airway response, and tended to protect against inhaled histamine. 6 Atenolol 60 mg was the only drug to allow a fenoterol airway response similar to placebo. Atenolol increased the inhaled histamine responsiveness. 7 Propranolol 160 mg caused the most reduction in spirometry but also tended to cause the maximum reduction in exercise heart rate. Propranolol caused increased inhaled histamine responsiveness. 8 Initial sensitivity to inhaled histamine did not necessarily predict significant reduction in an asthmatics' spirometry by a beta-adrenoceptor antagonist. The effect of a beta-adrenoceptor antagonist on histamine responsiveness does not correspond to its effect on inhaled beta 2-adrenoceptor agonist responsiveness.
1310468.0780193781994.08.02++Recruiting high risk women into a breast cancer health promotion trial.Cancer Epidemiol Biomarkers Prev
C Lerman, BK Rimer, M Daly, E Lustbader, C Sands, A Balshem, A Masny, P Engstrom,
This study sought to identify factors that facilitate or hinder participation in a breast cancer health promotion trial among high-risk women. The subjects were 271 women ages 35 years and older who had a family history of breast cancer in at least one first-degree relative. All subjects were eligible for participation in a randomized trial which compares breast cancer risk counseling with general health counseling. Structured telephone interviews evaluated demographic characteristics, risk factors, risk perceptions, breast cancer concerns, and past screening practices. The results showed that education level was a key determinant of the importance of these factors in participation. Logistic regression modeling indicated that women with a high school education or less were most likely to participate if: (a) their relatives' diagnoses had greatly increased their perceptions of their personal risks [OR (OR) = 4.1], particularly if they perceived that risk to be very high (OR for interaction = 6.4); and (b) if they were ages 40-49 years versus 35-39 or 50 + years (OR = 2.6). By contrast, among women with education beyond high school, participation was predicted by (a) marital status (OR = 2.6), (b) employment (OR = 0.03 for employed), (c) number of affected relatives (OR = 0.07 for 1 versus 2 first-degree relatives), and (d) previous biopsy (OR = 0.42). These findings suggest that recruitment strategies that tailor messages to women's educational levels might be most effective.
1310568.0783274181993.08.10++A randomized trial of the impact of risk assessment and feedback on participation in mammography screening.Prev Med
SJ Curry, SH Taplin, C Anderman, WE Barlow, C McBride,
BACKGROUND. Although rates of mammography screening among women in the general population have been increasing they still fall short of national goals. This study evaluated the effects on rates of participation in mammography screening of obtaining risk factor information and providing general or personalized risk information through direct mailed correspondence. METHODS. Women enrollees in a health maintenance organization (N = 2,076), age 50 and above, were randomized to one of the following four groups: (a) no risk factor questionnaire + generic invitation, (b) no risk factor questionnaire + general risk invitation, (c) risk factor questionnaire + general risk invitation, and (d) risk factor questionnaire + personal risk invitation. Computerized visit records were monitored for 12 months following a mailed invitation to assess whether a mammogram had been obtained. RESULTS. Overall participation was 37.5% and the rate of participation did not differ significantly across groups (P = 0.26). Participation was related to age (P < 0.02), with rates highest for women ages 60-69 years (42.7%) compared with those for women ages 50-59 (35.5%) and those age 70+ (33.7%). Among women with a family history of breast cancer, the personalized risk invitation was associated with significantly higher participation compared with general risk invitation (66.7 versus 42.9%, respectively; P < 0.003). CONCLUSIONS. Women with a family history of breast cancer are more likely to obtain a mammogram if that fact is reinforced as a risk factor. Research on environmental barriers to mammography screening may suggest alternative strategies for increasing participation.
1310668.07116915232001.12.05++The current practice of intra-aortic balloon counterpulsation: results from the Benchmark Registry.J Am Coll Cardiol
JJ Ferguson, M Cohen, RJ Freedman, GW Stone, MF Miller, DL Joseph, EM Ohman,
OBJECTIVES: This study presents clinical data from the first large registry of aortic counterpulsation, a computerized database that incorporates prospectively gathered data on indications for intra-aortic balloon counterpulsation (IABP) use, patient demographics, concomitant medication and in-hospital outcomes and complications. BACKGROUND: The intra-aortic balloon pump (IABP) is widely used to provide circulatory support for patients experiencing hemodynamic instability due to myocardial infarction, cardiogenic shock, or in very high risk patients undergoing angioplasty or coronary artery bypass grafting. METHODS: Between June 1996 and August 2000, 203 hospitals worldwide (90% U.S., 10% non-U.S.) collected 16,909 patient case records (68.8% men, 31.2% women; mean age 65.9 +/- 11.7 years). RESULTS: The most frequent indications for use of IABP were as follows: to provide hemodynamic support during or after cardiac catheterization (20.6%), cardiogenic shock (18.8%), weaning from cardiopulmonary bypass (16.1%), preoperative use in high risk patients (13.0%) and refractory unstable angina (12.3%). Major IABP complications (major limb ischemia, severe bleeding, balloon leak, death directly due to IABP insertion or failure) occurred in 2.6% of cases; in-hospital mortality was 21.2% (11.6% with the balloon in place). Female gender, high age and peripheral vascular disease were independent predictors of a serious complication. CONCLUSIONS: This registry provides a useful tool for monitoring the evolving practice of IABP. In the modern-day practice of IABP, complication rates are generally low, although in-hospital mortality remains high. There is an increased risk of major complications in women, older patients and patients with peripheral vascular disease.
1310768.06123629632002.10.24++The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial.J Consult Clin Psychol
P Bach, SC Hayes,
The present study examined the impact of a brief version of an acceptance-based treatment (acceptance and commitment therapy; ACT) that teaches patients to accept unavoidable private events; to identify and focus on actions directed toward valued goals; and to defuse from odd cognition, just noticing thoughts rather than treating them as either true or false. Eighty inpatient participants with positive psychotic symptoms were randomly assigned to treatment as usual (TAU) or to 4 sessions of ACT plus TAU. ACT participants showed significantly higher symptom reporting and lower symptom believability and a rate of rehospitalization half that of TAU participants over a 4-month follow-up period. The same basic pattern of results was seen with all participant subgroups except delusional participants who denied symptoms.
1310868.0678752641995.04.06++Determinants of response to immunosuppressive therapy in idiopathic pulmonary fibrosis.Eur Respir J
K van Oortegem, B Wallaert, CH Marquette, P Ramon, T Perez, JJ Lafitte, AB Tonnel,
Idiopathic pulmonary fibrosis (IPF) response to corticosteroids and cytotoxic medications appears to be the most important determinant of survival. The purpose of this retrospective study was to analyse the determinants of response to immunosuppressive therapy with prednisone alone, or prednisone and cyclophosphamide, in IPF. Twenty five consecutive patients were studied. Initial evaluation in untreated patients included clinical, biological and functional parameters. Sequential evaluation by pulmonary function tests (forced vital capacity (FVC) and transfer factor of the lungs for carbon monoxide (TLCO)) was performed at a 3 month interval. Response to therapy was defined as an improvement in FVC and/or TLCO of more than 10% after 12 months, with maintenance of this improvement for at least another 12 months. Twelve of the 25 patients were classified as responders. A symptomatic disease of less than 12 months duration before onset of therapy related to response. FVC was more impaired in the group of responders when the comparison was limited to patients with an FVC of less than 90%. Bronchoalveolar lavage cell counts were not significantly different between responders and non-responders. Assessment of pulmonary function after 3 months of treatment was predictive of maintenance of the response or of even further improvement. Patients with improved FVC after 3 months of therapy had a significantly shorter symptomatic disease before onset of treatment (7.6 +/- 7.1 vs 20.2 +/- 18.6 months). A beneficial effect of addition of cyclophosphamide was observed only in patients who demonstrated an early but short-lived improvement to steroids. Adverse reactions of immunosuppressive therapy were noticed in 10 patients, and required discontinuation of treatment in six of them.(ABSTRACT TRUNCATED AT 250 WORDS)
1310968.06120212272002.05.30++Oral sildenafil is an effective and specific pulmonary vasodilator in patients with pulmonary arterial hypertension: comparison with inhaled nitric oxide.Circulation
E Michelakis, W Tymchak, D Lien, L Webster, K Hashimoto, S Archer,
BACKGROUND: The prognosis of patients with severe pulmonary hypertension (PHT) is poor. To determine prognosis and guide therapy, an acute hemodynamic trial of selective pulmonary vasodilators, usually inhaled nitric oxide (iNO), was performed. We hypothesized that oral sildenafil, a phosphodiesterase-5 inhibitor, is a safe and effective alternative to iNO. METHODS AND RESULTS: We studied 13 consecutive patients (mean+/-SEM, 44+/-2 years of age; 9 women) referred for consideration of heart-lung transplantation or as a guide to medical therapy. All but one were functional class III or IV. Patients had primary PHT (n=9), pulmonary arterial hypertension (n=2), or secondary PHT (n=2). Hemodynamics and serum cyclic guanosine-monophosphate levels (cGMP) were measured at baseline and at peak effects of iNO (80 ppm), sildenafil (75 mg), and their combination. The decrease in pulmonary vascular resistance was similar with iNO (-19+/-5%) and sildenafil (-27+/-3%), whereas sildenafil+iNO was more effective than iNO alone (-32+/-5%, P<0.003). Sildenafil and sildenafil+iNO increased cardiac index (17+/-5% and 17+/-4%, respectively), whereas iNO did not (-0.2+/-2.0%, P<0.003). iNO increased, whereas sildenafil tended to decrease, pulmonary capillary wedge pressure (+15+/-6 versus -9+/-7%, P<0.0007). Systemic arterial pressure was similar among groups and did not decrease with treatment. cGMP levels increased similarly with iNO and sildenafil, and their combination synergistically elevated cGMP (P<0.0001). CONCLUSIONS: A single oral dose of sildenafil is as effective and selective a pulmonary vasodilator as iNO. Sildenafil may be superior to iNO in that it increases cardiac output and does not increase wedge pressure. Future studies are indicated to establish whether sildenafil could be effective over a longer duration.
1311068.0537223261986.08.14++Prevention and treatment of endemic iodine-deficiency goiter by iodination of a municipal water supply.J Clin Endocrinol Metab
S Squatrito, R Vigneri, F Runello, AM Ermans, RD Polley, SH Ingbar,
A recently described method for the prevention and treatment of endemic iodine deficiency and goiter, introduction of iodine into a public water supply, was tested in Troina, a town of about 13,000 inhabitants in northeast Sicily. There, before initiation of the program, a goiter endemic of moderate severity was present, as evidenced by goiter prevalence of 55% in school children. Iodine deficiency in nongoitrous adults was indicated by daily urinary iodine excretion of 40.7 +/- 2.6 micrograms (mean +/- SE) and 24-h thyroid radioiodine uptake of 50.8 +/- 2.4%. Iodination of the water supply was initiated in November 1979 using a stream-splitting device that diverts a controlled fraction of the total water flow to a canister containing iodine crystals, where the water becomes saturated with iodine (approximately 300 mg/liter) before returning to the main stream. Except for a 15-month interruption during which governmental authorization of the program was being reconfirmed, treatment of the water has continued to the present time, initially at a level of 81 +/- 25 micrograms/liter (mean +/- SD) and since resumption at a level of 46.5 +/- 5 micrograms/liter. Iodination of the water was followed by a prompt and marked reduction in goiter prevalence, and by improvement in biochemical indices of iodine deficiency. By April 1983, overall goiter frequency in school children had declined to 6.1%, and large goiters (WHO Grade 2) had virtually disappeared. By January 1984, daily urinary iodine excretion had increased to 85.6 +/- 6.5 (SEM) micrograms and radioiodine uptake had decreased to 40.7 +/- 4.7%. Serum thyroid-related hormone concentrations were as follows (pretreatment vs. November-December 1983): T4, 5.8 +/- 0.3 vs. 8.4 +/- 0.3 microgram/dl; T3, 1.6 +/- 0.05 vs. 1.2 +/- 0.06 ng/ml; TSH, 3.7 +/- 0.2 vs. 2.2 +/- 0.1 microU/ml; all changes being statistically significant. By late 1983, serum T4, T3, and TSH values in Troina were almost identical to those in Catania, a community in which iodine deficiency is not present (goiter prevalence in school children, 2.2%). In contrast, in Troina serum T4 concentrations were significantly higher and serum TSH concentrations were significantly lower than those in Maniaci, a iodine-deficient town near Troina, in which the water was not iodinated. Iodinated water was well tolerated by the population of Troina, and no adverse effects of water iodination, including any increase in the frequency of hyperthyroidism, was observed. At present prices, the cost of the water iodination program in Troina would be approximately 4 cents (U.S.) per person per year.(ABSTRACT TRUNCATED AT 400 WORDS)
1311168.0593839261998.01.12++Evaluation of a standard protocol for retentive encopresis: a replication.J Pediatr Psychol
LJ Stark, LC Opipari, DL Donaldson, MB Danovsky, DA Rasile, AF DelSanto,
Replicated the efficacy of a short-term, combined medical and behavioral intervention protocol for retentive encopresis. Fifty-nine children who had failed standard medical management for retentive encopresis and their parents participated in six 1-hour group treatment sessions. Treatment protocol combined the medical management strategies of enema clean out, increasing dietary fiber, and daily toilet sitting with the child behavior management strategies of differential attention, contingency management, and contracting. For the overall sample, the number of soiling incidents decreased 85%, the weekly frequency of independent bowel movements increased 15%, the weekly frequency of parent-prompted bowel movements increased 9%, and daily dietary fiber intake increased 121% pre- to posttreatment. The majority of the sample (86%) stopped soiling by the end of treatment and did not require further treatment. Results are discussed in terms of the comparability with previous findings and the utility of combined medical and psychological treatments for children with encopresis who have failed standard medical approaches.
1311268.0570465431982.08.07++Alternative modes of cyclophosphamide and azathioprine therapy in lupus nephritis.Ann Intern Med
HJ Dinant, JL Decker, JH Klippel, JE Balow, PH Plotz, AD Steinberg,
Forty-one patients with systemic lupus erythematosus and glomerulonephritis were studied in a randomized drug trial. Thirteen patients received prednisone only (Group 1), 16 received oral cyclophosphamide and oral azathioprine (1 mg/kg body weight . d of each initially) (Group 2), and 12 were given boluses of intravenous cyclophosphamide (0.5 to 1.0 g/m2 body surface area every 3 months) (Group 3). The mean observation period was 42 months (range 1 to 6.5 years). Renal function deteriorated in four of 12 patients in Group 1 and three of 27 patients in Groups 2 and 3 (p = 0.114). By life-table analysis, 86% of the entire group survived 5 years after entry to the study. Marked hypertension, fluctuating changes in serum creatinine, erratic changes in levels of antibody to DNA, reduced C3 levels, increasing proteinuria or sustained hematuria, and flares of extrarenal disease activity occurred more commonly in Group 1. Infectious complications were not commoner in Groups 2 and 3. We conclude that any marginal benefits produced by the programs tested cannot be shown in this class of patients without markedly increasing the sample size. Our current studies involve more vigorous treatment of patients with more acute disease and less treatment during prolonged periods of relatively good health.
1311368.0497362341998.12.22++Metabolic control in children with insulin-dependent diabetes mellitus 5 y after diagnosis. Early detection of patients at risk for poor metabolic control.Acta Paediatr
G Forsander, B Persson, J Sundelin, E Berglund, K Snellman, R Hellström,
Children (n = 38) aged 3-15 y were randomly chosen, at the time of diabetes diagnosis, for conventional management at a hospital ward, or for treatment partly in a training apartment where the family was offered problem-based education and special therapeutic support. HbA1c, blood glucose stability, urinary C-peptide excretions and incidence of hypoglycaemic attacks and diabetes ketoacidosis (DKA) were monitored and some standardized, self-estimated psychological tests were performed during the first 2 y after diagnosis. During the 3 y thereafter, HbA1c, presence of DKA, microalbuminuria, retinopathy and hypertension were monitored. None of the patients demonstrated signs of diabetes microangiopathy or DKA. The overall mean HbA1c level was 7.2% 5 y after diagnosis and 30% of the children had HbA1c values <6.3%. There were no differences in the HbA1c values for the patients treated by the different management regimens. Blood glucose variability (SD) was also similar, with 75% of the values in the range of 3-10 mmol/l. Patients with poor glycaemic control (mean HbA1c >8.3%) year 5 after diagnosis had already the second year after diagnosis significantly higher HbA1c values and blood glucose variability. The fathers of these patients demonstrated a higher degree of maladjustment. On the basis of increasing HbA1c values, high blood glucose variability and psychosocial risk factors such as their fathers' emotional responses, patients at risk for poor metabolic control in the future can be identified within 2 y after diagnosis. Efforts and resources can thus be focused at an early stage on this group.
1311468.04160148742005.10.26++Community case management for former jail inmates: its impacts on rearrest, drug use, and HIV risk.J Urban Health
K Needels, S James-Burdumy, J Burghardt,
Dramatically increasing incarceration rates in the United States have led to large concentrations of formerly imprisoned people in poverty-stricken urban areas. Therefore, identifying ways to help inmates who exhibit multiple, serious problems and who are at great risk of experiencing poor postrelease outcomes is especially important to urban communities, as well as to service providers and policymakers concerned about these communities. Our research provides evidence about the effectiveness of one strategy, called Health Link, which recruited adult women and adolescent men while they were incarcerated in a New York City jail and offered case management services during the especially challenging first year after release. About 1,400 participants who enrolled during a 3-year period were randomly assigned either to a group that was eligible for intensive discharge planning services and community-based case management services or to a group eligible for less-intensive discharge planning and no community-based services. We investigated whether the availability of these services reduced rates of drug use, HIV risk, and rearrest. Using data from interviews and hair analysis to measure impacts during a 1-year follow-up period after clients' release from jail, we detected increased participation in drug treatment programs and weak evidence for reduced drug use. However, we did not observe reductions in rearrest rates or in activities with high risk of HIV infection. We conclude that a well-executed case management program can make modest differences in a few short-term outcomes of former inmates. However, the intervention did not lead to the hoped-for changes across a range of outcomes that would clearly indicate greater success in community reintegration or improved health.
1311568.0415757871992.06.02++Reduction of joint pain in patients with knee osteoarthritis who have received monthly telephone calls from lay personnel and whose medical treatment regimens have remained stable.Arthritis Rheum
J René, M Weinberger, SA Mazzuca, KD Brandt, BP Katz,
OBJECTIVE. We previously reported that monthly telephone contact by lay personnel, to promote self-care for patients with osteoarthritis (OA), was associated with improved joint pain and physical function after 1 year of followup. The present study was a secondary analysis to determine whether improvement was contingent on intensified medical treatment. METHODS. We reanalyzed control/treatment group differences in all 40 subjects with radiographically confirmed knee OA who had had no changes in antirheumatic drug therapy or institution of physical therapy during the period of observation. RESULTS. Group differences in measured pain remained significant (effect size [ES] = 0.65 SD, P less than 0.01). The same trend was observed for physical function (ES = 0.53 SD, P not significant). CONCLUSION. The findings in this reanalysis suggest that periodic telephone support interventions are effective enough to be regarded as an adjunctive treatment for OA.
1311668.0289194441997.03.25++The efficacy of cryotherapy in the postoperative shoulder.J Shoulder Elbow Surg
KP Speer, RF Warren, L Horowitz,
We report the results of an outcome study that used visual analog scales to evaluate the efficacy of cryotherapy in the postoperative shoulder. This prospective study included 50 consecutive patients admitted to the hospital for at least one night after anterior shoulder stabilization, rotator cuff repair, or total shoulder replacement. The patients were randomized: 25 were fitted with a cryotherapy device in the operating room, and 25 were not. Otherwise, postoperative treatment was identical for the two groups, including types of analgesic agents given. Visual analog responses were converted to numeric values by simple measurement techniques. The scales assessed pain, comfort, sleep, analgesic use, and overall satisfaction. On the night of the operation the pain was less severe and occurred less often in the cryotherapy group. Those in the cryotherapy group slept better on the night of the operation and perceived the need to use pain medicine less often in comparison with those in the noncryotherapy group. By postoperative day 10 patients in the cryotherapy group reported their shoulders hurt less often and with less severity. Swelling was less, and shoulder movement hurt less during rehabilitation, enhancing the rehabilitative effort. Cryotherapy offers a number of benefits for care of patients in the immediate postoperative period.
1311768.02123807882003.02.14++Safety and efficacy of cefepime versus ceftazidime in the treatment of severe infections.J Microbiol Immunol Infect
CK Huang, YS Chen, SS Lee, WR Lin, HC Tsai, HH Lin, SR Wann, JY Chen, MY Yen, YC Liu,
An open-label, randomized study was conducted to evaluate the safety and efficacy of cefepime versus ceftazidime in the treatment of severe bacterial infections, including septicemia, urinary tract infection, bacterial bronchitis, bacterial pneumonia, and intraabdominal infection. Fifty-two patients with severe infections were eligible and prospectively randomized to receive cefepime (26 patients) or ceftazidime (26 patients) during a 15-month period. Forty-two patients were evaluable (24 in the cefepime group and 18 in the ceftazidime group). Most (86%) of the patients had urinary tract infections and the most commonly isolated pathogen was Escherichia coli (79%). Satisfactory clinical response rates of 71% and 61%, and bacteriological eradication rates of 87.5% and 89% were achieved for the cefepime and ceftazidime groups, respectively. Two patients treated with cefepime died, one from superinfection and one from suspected paraneoplastic syndrome. Cultures of the blood obtained at entry into the study were positive in 19 (45%) of the 42 evaluable cases. In the cefepime group, a patient with Salmonella paratyphi A septicemia was cured, which has not been previously reported. Adverse effects attributable to therapy were minimal in both groups of patients, and none required discontinuation or dose reduction. In conclusion, these results suggest that cefepime is as efficacious and well tolerated as ceftazidime in the treatment of severe bacterial infections, such as septicemia, urinary tract infection, bacterial bronchitis, bacterial pneumonia, and intraabdominal infection.
1311868.02109446472000.09.06++Preoperative radiotherapy for resectable rectal cancer: A meta-analysis.JAMA
C Cammà, M Giunta, F Fiorica, L Pagliaro, A Craxì, M Cottone,
CONTEXT: The benefit of adjuvant radiotherapy for resectable rectal cancer has been extensively studied, but data on survival are still equivocal despite a reduction in the rate of local recurrence. OBJECTIVE: To assess the effectiveness of preoperative radiotherapy followed by surgery in the reduction of overall and cancer-related mortality and in the prevention of local recurrence and distant metastases. DATA SOURCES: Computerized bibliographic searches of MEDLINE and CANCERLIT (1970 to December 1999), including non-English sources, were supplemented with hand searches of reference lists. The medical subject headings used were rectal cancer, radiotherapy, surgery, RCT, randomized, and clinical trial. STUDY SELECTION: Studies were included if they were randomized controlled trials (RCTs) comparing preoperative radiotherapy plus surgery with surgery alone and if they included patients with resectable histologically proven rectal adenocarcinoma, without metastatic disease. Fourteen RCTs were analyzed. DATA EXTRACTION: Data on population, intervention, and outcomes were extracted from each RCT according to the intention-to-treat method by 3 independent observers and combined using the DerSimonian and Laird method. DATA SYNTHESIS: Radiotherapy plus surgery compared with surgery alone significantly reduced the 5-year overall mortality rate (odds ratio [OR] 0.84; 95% confidence interval [CI], 0.72-0.98; P =.03), cancer-related mortality rate (OR, 0.71; 95% CI, 0.61-0.82; P<.001), and local recurrence rate (OR, 0.49; 95% CI, 0.38-0.62; P<.001). No reduction was observed in the occurrence of distant metastases (OR, 0.93; 95% CI, 0.73-1.18; P =.54). CONCLUSIONS: In patients with resectable rectal cancer, preoperative radiotherapy significantly improved overall and cancer-specific survival compared with surgery alone. The magnitude of the benefit is relatively small and criteria are needed to identify patients most likely to benefit from adjuvant radiotherapy. JAMA. 2000;284:1008-1015
1311968.0187517541996.09.30++Ovulation induction in clomiphene-resistant anovulatory women with normal dehydroepiandrosterone sulfate levels: beneficial effects of the addition of dexamethasone during the follicular phase.Fertil Steril
EA Trott, L Plouffe, K Hansen, R Hines, DW Brann, VB Mahesh,
OBJECTIVE: To evaluate the effect on ovulation of a 10-day course of dexamethasone (DEX) initiated concurrently with a 5-day course of clomiphene citrate (CC) in CC-resistant patients with normal DHEAS levels. DESIGN: Retrospective review. SETTINGS: Patients from the clinical practice of the authors at the Medical College of Georgia, Augusta, Georgia. PATIENTS: Thirteen oligomenorrheic women with normal DHEAS levels who failed to ovulate on a graduated regimen of CC up to a dose of 150 mg for 5 days. INTERVENTIONS: Ten-day course of DEX initiated concurrently with a 5-day course of CC; ovulation and pregnancy outcomes recorded. MAIN OUTCOME MEASURE: Pregnancy. RESULTS: Eleven of 13 women had evidence of ovulation. Five clinical pregnancies were achieved. CONCLUSION: These initial data support improvements in follicular development with an overlapping follicular phase regimen of CC and DEX in patients with normal DHEAS levels and a previous poor response.
1312068.01110508082000.11.07++[Amantadine for the treatment of levodopa dyskinesias in Parkinson's disease]Medicina (B Aires)
MG Cersósimo, MC Scorticati, FE Micheli,
The development of dyskinesias is a common side effect during chronic levodopa therapy in parkinsonian patients. Recent reports suggest that amantadine, a drug with well known antiparkinsonian activity, is effective in the treatment of this complication. In order to evaluate its usefulness we conducted an open label, prospective and longitudinal study in 26 patients with Parkinson's disease (PD) on chronic levodopa therapy who presented peaks of dose dyskinesias. After 3 weeks' treatment dyskinesia severity was reduced by 70% (p < 0.0001) on the I SAPD scale and by 68.8% (p < 0.0002) on the UPDRS IV subscale. Patients were later evaluated every 45 days showing persistent drug benefit during follow-up ranging from 2 to 11 months (mean 6.5 months). One third of our series presented unwanted effects which were only severe enough in 2 cases to discontinue treatment. In the others, side effects were transient or readily abated with amantadine dose reduction. Our findings support amantadine as a safe and useful drug to treat levodopa-induced dyskinesias which on occasion prove as disabling as PD itself. Treatment with amantadine should routinely be considered before indicating pallidotomy for levodopa-induced dyskinesias.
1312168.0116725471991.05.01++Discontinuation of neuroleptic medication in older, outpatient schizophrenics. A placebo-controlled, double-blind trial.J Nerv Ment Dis
PE Ruskin, G Nyman,
Thirty-five schizophrenic outpatients over the age of 52 who had been stable on neuroleptic medication were all switched to haloperidol. Ten patients were unable to tolerate the haloperidol and two dropped out of the study. The remaining 23 patients were randomly and blindly assigned to haloperidol or placebo and then followed for 6 months. Five patients did not complete the study due to medical or administrative reasons. Among the patients who completed the study, five of 10 randomized to placebo relapsed compared with only one of eight randomized to haloperidol. However, three of 10 patients randomized to placebo have remained stable without medication for 2.5 years.
1312268.01118584502002.04.02++A multimethod study of advanced practice nurse postdischarge care.Clin Excell Nurse Pract
CA Dellasega, TM Zerbe,
In the United States, increasing emphasis is being placed on understanding the roles and cost-effectiveness of advanced practice nurses (APNs). This study used both quantitative and qualitative strategies to explore the impact of APN intervention for frail rural elders being discharged from the hospital. For the quantitative component, analyses of specific postdischarge elder (n = 140) and caregiver (n = 65) outcomes were conducted using four groups receiving the following types of care: no nursing care, registered nurse (RN) care only, APN care only, and both RN and APN care. Outcomes assessed included elder cognitive functioning, self-rated health, informal services provided, and use of health care resources. Caregiver outcomes included physical, emotional, and depressive symptoms, as well as stress scores, physician visits, and missed work days. Elders in the APN-only group experienced fewer emergency room visits and hospital readmissions, although the difference was not significant. Caregivers receiving APN-only support reported significantly fewer work days missed. For the qualitative component, a focus group with four APNs who delivered the intervention was conducted to explore unique aspects of their roles and specific interventions they provided. A theme of these results was more comprehensive and autonomous delivery and management of care to both elders and their caregivers.
1312368.00107801382000.05.18++Telephone-administered cognitive-behavioral therapy for the treatment of depressive symptoms in multiple sclerosis.J Consult Clin Psychol
DC Mohr, W Likosky, A Bertagnolli, DE Goodkin, J Van Der Wende, P Dwyer, LP Dick,
This study examined the efficacy of an 8-week telephone-administered cognitive-behavioral therapy (CBT) for the treatment of depressive symptomatology in multiple sclerosis (MS) patients. The treatment, Coping with MS (CMS), included a patient workbook designed to structure the treatment, provide visual aids, and help with homework assignments. Thirty-two patients with MS, who scored at least 15 on the Profile of Mood States Depression-Dejection scale, were randomly assigned to either the telephone CMS or to a usual-care control (UCC) condition. Depressive symptomatology decreased significantly in the CMS condition compared with the UCC condition. Furthermore, adherence to interferon beta-1a, a disease-modifying medication for the treatment of MS, was significantly better at the 4-month follow-up among patients who received CMS as compared with those in the UCC condition.
1312467.99105885011999.12.09++A comparative evaluation of hemostatic agents in the management of soft tissue graft donor site bleeding.J Periodontol
JA Rossmann, TD Rees,
BACKGROUND: Periodontal plastic surgery has increased the use of palatal wounds for donor tissue, with the most common complication being excessive bleeding from the palate after harvesting tissue. This study was conducted to evaluate the efficacy of 3 methods for achieving hemostasis on the palate after harvesting donor tissue for autogenous soft tissue grafts. METHODS: Thirty sites were evaluated at surgery for hemostasis and followed over 21 days for healing and adverse events. Three treatment groups were randomly selected and patients received either a test product or control comprising: 1) oxidized regenerated cellulose; 2) absorbable gelatin sponge; or 3) sterile gauze with external pressure as the control. All patients received a surgical stent for the palate. RESULTS: The results were analyzed for smokers and non-smokers, and the median time to hemostasis was significantly shorter when a hemostatic agent was applied to the palatal wounds compared to controls in both groups. Pain assessment showed no differences across treatment groups. However, by 21 days, only the oxidized regenerated cellulose group had complete healing based on blinded clinical evaluation with all sites rated as normal to rapid healing, compared to the absorbable gelatin sponge group where 40% of the sites were rated as slow healing. Adverse events, primarily bleeding episodes during the first 7 days after surgery, were found in 40% of the oxidized regenerated cellulose and gauze control groups, while no sites in the absorbable gelatin sponge group had an adverse event. The patients were followed for an average of 10 months and demonstrated a mean shrinkage of their recipient grafts of 24% in total surface area. CONCLUSIONS: This study concluded that the use of hemostatic agents for palatal wounds is confirmed as the treatment of choice when performing free soft tissue grafts.
1312567.9999177841999.01.28++Subconjunctival mitomycin C for the treatment of ocular cicatricial pemphigoid.Ophthalmology
ED Donnenfeld, HD Perry, A Wallerstein, RM Caronia, AJ Kanellopoulos, PD Sforza, G D'Aversa,
PURPOSE: The authors performed a prospective evaluation of the efficacy of treating ocular cicatricial pemphigoid (OCP) with subconjunctival mitomycin C. DESIGN: Unmasked, prospective, internally controlled case series. METHODS: Patients were eligible for treatment with subconjunctival mitomycin C under three criteria: (1) significant complications of systemic immunosuppressant therapy; (2) markedly asymmetric conjunctival disease; and (3) end-stage OCP. All patients received monocular subconjunctival injections of 0.25 ml of 0.2 mg/ml mitomycin C to both the superior and inferior bulbar conjunctivae in the eye with the more severe disease. RESULTS: Nine eyes of nine patients (mean age, 74 years) were treated with subconjunctival mitomycin C to the more-involved eye and were followed for a mean of 23.5 months (range, 12-40 months). Eight of nine patients showed quiescence of their OCP in the treated eye based on serial evaluation of conjunctival cicatrization and grading of conjunctival erythema. Five of the nine untreated eyes showed progression of the conjunctival disease. One patient required concomitant systemic immunosuppressive therapy after subconjunctival mitomycin C. Two patients underwent successful visual rehabilitative surgery in the mitomycin C-treated eye. CONCLUSION: The use of subconjunctival mitomycin C may be effective in preventing progression of conjunctival cicatrization and erythema in patients with OCP. No complications of mitomycin C treatment were noted. Long-term follow-up and further investigation into the efficacy of subconjunctival mitomycin C in the management of OCP is warranted.
1312667.99119787142002.07.12++Erectile dysfunction--the effect of sending a questionnaire to patients on consultations with their family doctor.Fam Pract
E Kitai, S Vinker, F Kijner, A Lustman,
BACKGROUND: Erectile dysfunction (ED) is a common problem among male adults that generally has been ignored by family practitioners. OBJECTIVE: Our aim was to assess the effect of a mailed questionnaire about ED on the readiness of patients to raise the subject with their family doctor. METHODS: The study population included all men aged 40 years and over on the patient list of a family practitioner. A control group made up of males of similar ages was chosen in another family practice. The patient files were reviewed for ED. Anonymous questionnaires including questions about sexual dysfunction and satisfaction with sex life, as well as demographic and medical details, were sent to the study population. Patients who suffered from ED were invited to visit their family doctor. In the following 2 months, the study and control group populations' visits to the family practitioner were monitored for complaints of sexual dysfunction. RESULTS: In the 2 years prior to the study, 14/205 (6.8%) of the study population had complained to their family practitioner of ED in comparison with 6/205 (2.9%) in the control group (P = NS). In the 2 months following the sending of the questionnaire, 23 patients consulted their family practitioner with ED, 19 of whom had not discussed their problem with the family practitioner previously; only a further two patients went to discuss ED in the same period in the control group (P < 0.001). A total of 85/205 (41.5%) patients returned the questionnaire and 35/85 (42.5%) said they suffered from ED. Of 35 patients who reported ED, 15 had been for a consultation; only six of them consulted their family doctor. CONCLUSION: ED is reported infrequently to family doctors. Sending an anonymous questionnaire on the subject increases awareness of the problem and in turn increases the number of cases that can be treated.
1312767.9883846581993.04.27++Clinical efficacy of azithromycin in lower respiratory tract infections.J Chemother
G Morandini, M Perduca, G Zannini, MP Foschino, G Miragliotta, NS Carnimeo,
A total of 51 patients with acute exacerbation of chronic bronchitis and pneumonia were enrolled: 27 treated with azithromycin (500 mg once a day for 3 days), and 24 with roxithromycin (150 mg every 12 hours for 7 days). The two regimens were equally effective, with clinical cure in 80% and 72% of patients respectively. Bacteriological eradication on day 19-23 was obtained in 7/11 cases (64%) and in 6/13 cases (46%) in the two groups, respectively. No side effects occurred in patients treated with azithromycin, while they occurred in the roxithromycin group (2 vomiting and 1 gastritis). Clinical and bacteriological efficacy, excellent tolerability, simplified dosage (single daily dose) and short-course (3 days) therapeutic regimen make azithromycin, in our experience, efficacious for the treatment of acute exacerbation of chronic bronchitis and community-acquired pneumonia.
1312867.98113056232001.05.10++A preliminary open label dose comparison using an antioxidant regimen to determine the effect on viral load and oxidative stress in men with HIV/AIDS.Eur J Clin Nutr
M Batterham, J Gold, D Naidoo, O Lux, S Sadler, S Bridle, M Ewing, C Oliver,
OBJECTIVE: To investigate the effect of antioxidant supplementation on viral load and the antioxidant/reactive oxygen species system in people with HIV. DESIGN: Single centre, prospective, dose comparison study. SETTING: Outpatient clinic specializing in HIV care. SUBJECTS: Sixty-six participants were sequentially recruited by advertisement, and 48 subjects completed the study. INTERVENTIONS: A recommended dose antioxidant regimen (5,450 IU vitamin A as beta-carotene, 250 mg vitamin C, 100 IU vitamin E, 100 microg selenium, 50 mg coenzyme Q10) or a high-dose antioxidant regimen (21,800 IU vitamin A as beta-carotene, 1,000 mg vitamin C, 400 IU vitamin E, 200 microg selenium, 200 mg coenzyme Q10) for a 12 week period. RESULTS: Using repeated measures analysis of variance, the changes over treatment time were significant for selenium, glutathione, glutathione peroxidase and lipid peroxides (P < 0.03). Changes in allantoin, uric acid and viral load were not significant (P > 0.05). The main effects for group and the interaction effects were not significant for any of the parameters measured (P > or = 0.05). CONCLUSION: Antioxidant supplementation significantly improved some measures of oxidative defence. There was no benefit in using a high-dose supplement in this study.
1312967.9726612601989.08.03++Sympathomimetics in acute severe asthma: inhaled or parenteral, nebulizer or spacer?Eur Respir J
A Noseda, JC Yernault,
It is accepted today that all patients with acute asthma should be treated with a sympathomimetic, irrespective of previous therapy. This short review addresses the question of the optimal mode of administration of these drugs in acute severe asthma. Inhaled sympathomimetics are as effective as subcutaneous adrenaline, or intravenous salbutamol or terbutaline, and, as they produce fewer side-effects, are recommended as the best mode of administration. However, self-medication with a ready to use subcutaneous preparation may be indicated in those patients prone to very abrupt attacks. The conventional mode of inhalation therapy in acute asthma is nebulization, but equally effective bronchodilatation may be obtained with metered-dose inhalers combined with valved spacers. Tachypnoeic patients unable to perform a conventional inhalation manoeuvre can use one-way valve inhalation devices with repeated tidal breaths. Finally, sequential or even continuous inhalation techniques have recently been advocated, particularly in patients with impending respiratory failure.
1313067.97121428692002.10.08++Nitrous oxide-oxygen or oral midazolam for pediatric outpatient sedation.Oral Surg Oral Med Oral Pathol Oral Radiol Endod
SA Hulland, MM Freilich, GK Sàndor,
OBJECTIVE: A total of 1112 pediatric outpatient sedations, by either nitrous oxide-oxygen inhalation (N2O) or oral midazolam, administered over a 10-year period were reviewed. Patient responses and outcomes were evaluated to ascertain the safety of these sedation techniques. STUDY DESIGN: A total of 819 patients were included in this study. Patient health status, age, weight, behavior, treatment rendered, and length of treatment were recorded. Vital signs (heart rate, blood pressure, oxygen saturation) were recorded for the N2O group. Complications and successful completion of treatment were also noted. RESULTS: Both the N2O and midazolam groups demonstrated a low complication rate with a high rate of successful completion of treatment. Patients receiving N2O were somewhat older on average and underwent a greater number of surgical procedures than patients in the midazolam group. Vital signs recorded in the N2O group were observed to remain stable throughout treatment. CONCLUSIONS: The use of either oral midazolam or nitrous oxide-oxygen as single agents provides safe and effective conscious sedation in the pediatric outpatient population.
1313167.9775552121995.11.13++Initial treatment of sepsis in non-neutropenic patients: ceftazidime alone versus 'best guess' combined antibiotic therapy.Chemotherapy
M Extermann, C Regamey, L Humair, F Murisier, K Rhyner, HM Vonwiller,
We conducted a prospective, randomized, multicentric study in community hospitals. Patients with clinical sepsis, rectal temperature > or = 38 degrees C and pulse rate > or = 100 bpm were randomized to receive ceftazidime (group CAZ) or a combination of antibiotics freely chosen by the clinician following his 'best guess' (group COMB). On specified grounds, the clinician could also treat patients in an open group with a free combination of antibiotics (group OPEN). The severity of disease at study admission was assessed by a clinical estimation and an Apache II score. There were 128 patients included: 56 randomized in group CAZ, 50 in group COMB, and 22 in the OPEN group. Ninety-one patients were evaluable: 41 in group CAZ, 30 in group COMB, 20 in OPEN group. At the end of the period of empirical treatment (48-72 h), the clinical success rates (improvement of status) were 93, 93 and 75% (p for group OPEN vs. groups CAZ or COMB: 0.10). The bacteriological success rates (sterile blood cultures) were 91, 88 and 80% (p not significant). mean Apache II score was 16.7 and the score correlated significantly with outcome, as did clinical evaluation. In conclusion, ceftazidime alone was a safe antibiotic therapy in this study and we could not demonstrate a superiority of a combined antibiotic therapy chosen by the clinician following his 'best guess' over ceftazidime.
1313267.9726977081990.04.23++Therapy of ocular toxoplasmosis.Int Ophthalmol
A Rothova, HJ Buitenhuis, C Meenken, GS Baarsma, TN Boen-Tan, PT de Jong, CM Schweitzer, Z Timmerman, J de Vries, MJ Zaal,
We performed a prospective multicentre study to evaluate the efficacy of therapeutic strategies currently used for ocular toxoplasmosis in a large number of patients (n = 106). Treatment was given for at least four weeks and consisted of three triple drug combinations: group 1, pyrimethamine, sulphadiazine and corticosteroids (n = 29); group 2. clindamycin, sulphadiazine and corticosteroids (n = 37); and group 3. cotrimoxazole (trimethoprim and sulphamethoxazole) and corticosteroids (n = 8). Patients with peripheral retinal lesions remained without systemic therapy (group 4, n = 32). Patients from group 1 received leucovorin 5 mg twice a week. No difference in the duration of inflammatory activity was observed between the treated and untreated patients or between the separate groups of patients. The most important factor predicting the duration of inflammatory activity was the size of the retinal focus itself, independently of the therapy given (P less than 0.05). We showed a reduction in size of the retinal inflammatory focus in 52% of the pyrimethamine patients as compared to 25% of untreated cases. However the most frequent side effects were also associated with pyrimethamine medication and included hematologic complications as thrombocytopenia and leucopenia despite leucovorin medication.
1313367.97165303382006.05.22++Distal intramural spread of rectal cancer after preoperative radiotherapy: the results of a multicenter randomized clinical study.Int J Radiat Oncol Biol Phys
E Chmielik, K Bujko, A Nasierowska-Guttmejer, MP Nowacki, L Kepka, R Sopylo, A Wojnar, P Majewski, J Sygut, A Karmolinski, T Huzarski, P Wandzel,
PURPOSE: To evaluate the extent of distal intramural spread (DIS) after preoperative radiotherapy for rectal cancer. METHODS AND MATERIALS: A total of 316 patients with T(3-4) primary resectable rectal cancer were randomized to receive either preoperative 5x5 Gy radiation with immediate surgery or chemoradiation (50.4 Gy, 1.8 Gy per fraction plus boluses of 5-fluorouracil and leucovorin) with delayed surgery. The slides of the 106 patients who received short-course radiation and of the 86 who received chemoradiation were available for central microscopic evaluation of DIS. RESULTS: The length of DIS did not differ significantly (p = 0.64) between the short-course group and the chemoradiation group and was 0 in 47% vs. 49%; 1 to 5 mm in 41% vs. 42%; 6 to 10 mm in 8% vs. 9%, and greater than 10 mm in 4% vs. 0, respectively. Among the 11 clinically complete responders, DIS was found 1 to 5 mm from the microscopically detected ulceration of the mucosa in 5 patients. The discontinuous DIS was more frequent in the chemoradiation group as compared with the short-course group (i.e., 57% vs. 16% of cases, p < 0.001). CONCLUSIONS: Approximately 1 out of 10 advanced rectal cancers after preoperative radiotherapy or radiochemotherapy was characterized by DIS of over 5 mm. No significant difference was seen in the length of DIS between the 2 groups.
1313467.96150309642004.07.08++Weight stabilisation is associated with improved survival duration and quality of life in unresectable pancreatic cancer.Clin Nutr
W Davidson, S Ash, S Capra, J Bauer,
BACKGROUND & AIMS: Cancer-induced weight loss is associated with poor outcomes and is common in pancreatic cancer. The aims were to determine whether stabilising weight loss for patients with unresectable pancreatic cancer was associated with improved survival and quality of life (QoL) and to identify determinants of weight stabilisation. METHODS: A post hoc analysis was performed using data from 107 patients in a multicentre trial. Patients were categorised as weight losing (> 1 kg lost) or weight stable (< or = 1 kg lost) after an 8 week nutrition intervention period. Group survival duration (Kaplan Meier) and QoL (EORTC QLQ-C30) were compared. Predictors of weight stability were determined using logistic regression analysis. RESULTS: Patients with weight stabilisation survived longer from baseline (log rank test 5.53, P = 0.019). They also reported higher QoL scores (P = 0.037) and a greater mean energy intake (P <0.001) at Week 8 than those who continued to lose weight. The absence of nausea and vomiting (OR 6.5, P =0.010) and female gender (OR 5.2, P = 0.020) were independent determinants of weight stabilisation. CONCLUSIONS: Weight stabilisation over an 8 week period in weight-losing patients with unresectable pancreatic cancer was associated with improved survival duration and QoL.
1313567.9677478241995.06.09++Management and long-term follow-up of patients with positive cholangiograms during laparoscopic cholecystectomy.Am J Surg
TS Roush, LW Traverso,
BACKGROUND: With a goal of minimal invasion during laparoscopic cholecystectomy, the surgeon confronts a judgement decision if the intraoperative cholangiography (IOC) is positive for common bile duct (CBD) stones. The options are postoperative endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic papillotomy (EP), transcystic laparoscopic techniques (LAP), open CBD exploration, or clinical observation. PATIENTS AND METHODS: To gather this information, we reviewed the clinical course and IOC of 55 patients with positive IOC during laparoscopic cholecystectomy. Long-term follow-up (1.8 years) was obtained in 50 patients. RESULTS: After review, 48 patients were felt to have CBD stones, and a LAP without choledochoscopy was the initial management in 32 (67%) patients. The remaining patients underwent EP (n = 10), CBD exploration (n = 1), or observation (n = 5). By discharge, 19 (59%) of the 32 LAP patients were successful and had avoided EP while the success rate at follow-up was 48% (14/29). There were no complications after LAP, but we observed a 9.5% (2/21) post-EP pancreatitis rate that required readmission. The success rate for CBD stone clearance with LAP was associated with single stones (87%) and surgeon experience (100% in the last year). The average hospital stay was 1.7 days for LAP and 3.3 days for EP. CONCLUSIONS: LAP is safe and eliminates the need for EP in the majority of cases. Although EP is more often successful, it results in a longer hospital stay with an increased risk of complication. We recommend LAP as the initial procedure of choice for a positive IOC.
1313667.9691341411997.07.29++The effect of peritonsillar corticosteroid infiltration in tonsillectomy.Auris Nasus Larynx
E Egeli, S Akkaya,
A prospective, randomized, double-blind, placebo-control clinical study was performed to determine the effects of peritonsillar infiltration of dexamethasone on peroperative and postoperative morbidity in patients undergoing tonsillectomy with local anesthesia. A total of fifty-two patients, aged 14-34, were randomized to infiltrate dexamethasone (0.5 mg/kg, maximum dose, 12 mg) or placebo with local anesthetic at the peritonsillar region. Incidence of postoperative complications, pain medications, appetite, oral intake (type of diet) and fever were also compared between the two groups. Demographics of dexamethasone and placebo groups were similar. No statistically significant differences were noted peroperative procedures, postoperative complications, pain medication, appetite, oral intake (type of diet) between the two groups of patients.
1313767.96147505082004.04.22++Naltrexone and nicotine patch smoking cessation: a preliminary study.Nicotine Tob Res
S Krishnan-Sarin, B Meandzija, S O'Malley,
This preliminary study evaluated the potential efficacy of 50 mg of opioid antagonist naltrexone or placebo in combination with nicotine replacement therapy for smoking cessation, in a small sample of 32 smokers using one to one and a half packs of cigarettes per day. Addition of naltrexone resulted in an increase in continuous abstinence rates (9/16 for naltrexone vs. 5/16 for placebo). Naltrexone reduced the likelihood of relapse among participants who smoked during the first week of treatment, reduced desire to smoke, and prevented weight gain following smoking cessation. These preliminary results suggest that naltrexone augmentation of nicotine patch therapy using procedures designed to optimize the concurrent use of these two medications may be beneficial for smoking cessation.
1313867.9581629801994.05.26++The adequacy of oxygenation in COPD patients undergoing long-term oxygen therapy assessed by pulse oximetry at home.Eur Respir J
P Sliwiński, M Lagosz, D Górecka, J Zieliński,
It is probable that some daily activities may cause marked falls in arterial oxygen saturation (SaO2) in patients undergoing long-term oxygen therapy (LTOT), despite good oxygenation at rest. We estimated the adequacy of LTOT in 34 randomly selected chronic obstructive pulmonary disease (COPD) patients at home by monitoring SaO2 continuously over 24 h. The subjects were also asked to complete a questionnaire listing frequent daily activities. Despite almost normal mean SaO2 (94%) at the beginning of recording (O2 2 l.min-1, at rest) the subjects studied spent 6.9 h below an SaO2 of 90%, with minimum SaO2 of 61%. On average we observed 10 episodes of desaturation in each patient over 24 h, both while breathing air and oxygen. The comparison of SaO2 recordings and questionnaires revealed the highest number of desaturations during sleep, followed by naps, watching the television, eating, washing and talking. The oxygen flow rate prescribed, based on blood gas measurements at rest, did not protect 85% of the patients studied from deep falls in SaO2 during daily life. An increase oxygen flow during some activities and during sleep is suggested.
1313967.9520411471991.07.08++[Clinical studies on the utility of ofloxacin for lower respiratory infections]Jpn J Antibiot
Y Sawae, S Kashiwagi, Y Kumagai, T Ishimaru, M Takii, H Shigeoka, K Kuwabara, A Takita, T Muranishi, S Nagafuchi,
One hundred and thirteen patients who were treated at the Kyushu University Hospital and other related hospitals were randomly assigned to 2 groups to compare the effect of twice daily administration of 200 mg each and that of 300 mg each of ofloxacin (OFLX). The patients included 41 cases with pneumonia, 18 with acute bronchitis, 33 with chronic bronchitis, 15 with bronchiectasis with infection, 3 with diffused panbronchiolitis, and 3 with other secondary infectious diseases. Fifty-five cases were administered 400 mg OFLX a day and 58 cases received 600 mg. The number of severe cases in the 600 mg group was greater than that in the 400 mg group. The ratios of general amelioration of clinical symptoms were 92.6% in the 400 mg group and 82.1% in the 600 mg group. Thus, the ratio of the 400 mg group was better than that of the 600 mg group. However, the ratio of significant amelioration in the 600 mg group was 35.7% which was better than that in the 400 mg group, 27.8%. For bacteriological effects the rate of disappearance and decrease in number of bacteria was 92% in the 400 mg group and was significantly better than that of the 600 mg group, 70%. The incidence of side effects in the 600 mg group was 22.4% and this was high in contrast to that in the 400 mg group, 3.6%. Most of the side effects in the 600 mg group involved symptoms of the central nervous system such as sleeplessness. No significant differences were observed in incidences of abnormalities of laboratory tests at 1.8% and 1.7%, respectively. Safety in the 400 mg group were 96.4% which was significantly higher in number than those in the 600 mg group, 77.6%. Efficacy rates of twice daily administrations each with 200 mg and 300 mg OFLX for lower respiratory infections were 94.4 and 79.3%, respectively. In conclusion, the daily dose of 400 mg was the most effective.
1314067.95111972942001.02.08++Peptic ulcer bleeding: comparison of two hemostatic procedures.Am J Gastroenterol
F Buffoli, M Graffeo, F Nicosia, C Gentile, P Cesari, F Rolfi, A Paterlini,
OBJECTIVE: Bleeding is a serious complication of peptic ulcer. Endoscopic injection therapy is accepted as a homeostatic endoscopic treatment in acute nonvariceal of upper GI hemorrhages, particularly in bleeding peptic ulcers. The risk of rebleeding is predicted by the endoscopic appearance of ulcer features classified according to Forrest's criteria. METHODS: Two hundred twenty-three patients were selected from 1,003 emergency upper endoscopies for GI bleeding. According to Forrest's criteria, 99 well-matched patients with ulcers F1 and F2 were considered at risk of rebleeding; 54 patients (group A) received local ulcer injection of epinephrine solution 1:10,000, whereas (group B) patients were treated with local epinephrine injection and then with endoscopic Hemoclips. (1) We considered the control of bleeding, the number of rebleeding episodes, the need for emergency surgery, and mortality. RESULTS: Bleeding ulcers stopped completely in 83.3% group A patients, and in 95.6% group B patients (p = not significant). In a subset of F1b patients the rebleeding rate was 31 % for group A and 0% for group B (p < 0.05). There was no mortality as a result of the procedure. There was a trend toward reducing surgery in favor of the combined therapy (0% vs 7.4%). No differences were found in transfusion requirements or mean hospitalization days. CONCLUSIONS: We conclude that endoscopic injection of l:10,000 epinephrine solution alone and epinephrine solution plus application of Hemoclips are equivalent therapies in treating bleeding and rebleeding from peptic ulcers. There was no difference between therapies in terms of need for surgery or mortality. Possibly combination therapy is more effective in treating ulcers that are actively oozing.
1314167.9429269451989.05.02++A randomized trial to increase smoking intervention by physicians. Doctors Helping Smokers, Round I.JAMA
TE Kottke, ML Brekke, LI Solberg, JR Hughes,
Sixty-six physicians were randomized to three groups to conduct a 1-month campaign to help their patients stop smoking. The workshop group received free patient education materials and a 6-hour training workshop. The materials group received free patient education materials, and the no-assistance group received nothing. A telephone interview was completed with 89% of the 6767 eligible adult patients seen during the month of the campaign. The brief training program and patient education materials marginally increased the smoking intervention activities of volunteer physicians in private practice. Both workshop and materials physicians asked 54% of their smoking patients to stop; no-assistance physicians asked 40%. One year later, 36% of patients who had not even been asked by their doctors if they smoked reported that they had tried to stop smoking. If the physician had asked the patient if he or she smoked, the probability of a quit attempt was 47%. Patients who had been asked if they smoked were more likely to claim to have stopped (13%) than patients who had not been asked (9%). However, the proportion of patients claiming continued abstinence (range, 12% to 14%) was not related to the group of the physician.
1314267.9426920221990.02.22++[Treatment of nocturnal bronchial asthma]Pneumologie
D Schnabel, GW Sybrecht,
To date, the pathogenesis of nocturnal bronchiale asthma has not been completely clarified. For the treatment of nocturnal asthma that fails to respond to beta-2-sympathomimetics or inhalative glucocorticosteroids, theophylline in a delayed release form or delayed-release oral beta-2-sympathomimetics are available. In a double-blind crossover study, 10 patients with nocturnal or early-morning bronchial asthma were treated for one week with theophylline 390-900 mg daily (1/3 of the total dose being given in the morning, 2/3 in the evening) and one week with terbutaline 15 mg daily (7.5 mg in the morning and 7.5 mg in the evening). No significant differences were observed with respect to the measured peak flow values in the night and early morning. However, those receiving terbutaline more frequently required the additional application of inhalative beta-2-sympathomimetics for respiratory distress. Thus, the sustained-release form of theophylline is the more suitable drug for the treatment of nocturnal bronchial asthma. As a further study revealed, the sole administration of a sustained-release form of theophylline in the evening suffices. In the future, apart from theophylline in a delayed-release form, inhalative beta-2-sympathomimetics with a long-term effect will play an important role in the treatment of nocturnal breathing disorders.
1314367.94163850882006.03.01++Low-dose aspirin for prevention of stroke in low-risk patients with atrial fibrillation: Japan Atrial Fibrillation Stroke Trial.Stroke
H Sato, K Ishikawa, A Kitabatake, S Ogawa, Y Maruyama, Y Yokota, T Fukuyama, Y Doi, S Mochizuki, T Izumi, N Takekoshi, K Yoshida, K Hiramori, H Origasa, S Uchiyama, M Matsumoto, T Yamaguchi, M Hori,
BACKGROUND AND PURPOSE: Although the efficacy of anticoagulant therapy for primary prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF) has been established, efficacy of antiplatelet therapy for low-risk patients is disputable in Japanese patients because of the frequent hemorrhagic complications. We examined the efficacy and safety of aspirin therapy in Japanese patients with NVAF in a prospective randomized multicenter trial. METHODS: Patients with NVAF were randomized to an aspirin group (aspirin at 150 to 200 mg per day) or a control group without antiplatelet or anticoagulant therapy. Primary end points included cardiovascular death, symptomatic brain infarction, or transient ischemic attack. RESULTS: A total of 426 patients were randomized to aspirin group and 445 to no treatment. The trial was stopped earlier because there were 27 primary end point events (3.1% per year; 95% CI, 2.1% to 4.6% per year) in the aspirin group versus 23 (2.4% per year; 95% CI, 1.5% to 3.5% per year) in the control group, suggesting a low possibility of superiority of the aspirin treatment for prevention of the primary end point. In addition, treatment with aspirin caused a marginally increased risk of major bleeding (7 patients; 1.6%) compared with the control group (2 patients; 0.4%; Fisher exact test P=0.101). CONCLUSIONS: For prevention of stroke in patients with NVAF, aspirin at 150 to 200 mg per day does not seem to be either effective or safe. Further prospective studies are needed to determine the best preventive therapy for cerebrovascular events in Japanese patients with NVAF.
1314467.9318355491992.01.02++Concentration-response relationship in paroxetine treatment of diabetic neuropathy symptoms: a patient-blinded dose-escalation study.Ther Drug Monit
SH Sindrup, E Grodum, LF Gram, H Beck-Nielsen,
A single-blind dose-escalation study with the selective serotonin reuptake inhibitor paroxetine was conducted in 19 diabetic patients with neuropathy symptoms. The effect of treatment was evaluated by self-rating using visual analog scales. After an initial placebo period, paroxetine doses were increased from 10 mg/day in 10 mg steps, until the dose was 30-70 mg/day. In all except four patients, there was a marked relief of symptoms. Plasma concentrations of paroxetine above 300-400 nM were required to insure maximal relief in the majority of patients responding on paroxetine, but a considerable interindividual variation was observed (10-800 nM, median of 195 nM). The therapeutic effect appeared to increase gradually as the plasma concentration increased. The great interindividual variation in the pharmacokinetics of paroxetine was confirmed, but as the effect is maximal within approximately 1 week, and the drug is nontoxic, it may be clinically feasible simply to titrate the dose from 20 mg/day until the maximal effect is achieved. However, it is advised that titration to an effect, in diabetic neuropathy using doses above 50 mg/day, be undertaken with care as there is limited experience with doses above this level in any population. The beneficial effect of paroxetine appeared to be maintained unaltered during an additional 1 month open-label treatment on optimal paroxetine doses.
1314567.9391412571997.05.29++Evaluation of sponging and antipyretic medication to reduce body temperature in febrile children.Acta Paediatr Jpn
S Aksoylar, S Akşit, S Cağlayan, I Yaprak, R Bakiler, F Cetin,
Two hundred and twenty-four children aged 6 months to 5 years, with rectal temperatures greater than or equal to 30 degrees (104 degrees F), were randomly treated with sponging alone or with medication including a single oral dose of aspirin 15 mg/kg, or paracetamol 15 mg/kg, or ibuprofen 8 mg/kg. Twenty-three children were excluded from the final analysis because they did not complete the study. Demographic characteristics of the patients were found to be comparable in all groups. Rectal temperatures were recorded every 30 min for a 3 h period. During the first 30 min of intervention, sponging was found to be more effective than all of the three medications. After 60 min, the effects of each medication became superior to sponging with tepid water in reducing body temperature. Twenty-three children were excluded from the final analysis because they did not complete the study. Comparing the effect of the three different medications, it was seen that the antipyretic efficacy of aspirin and ibuprofen were significantly more than paracetamol 3 h after intervention (P < 0.05). For the management of fever over 39 degrees C, it is therefore recommended to give children an antipyretic drug, preferably ibuprofen, and at the same time to begin sponging to provide a rapid and sustained antipyresis
1314667.9387371331996.10.17++Comparative efficacy of sparfloxacin versus ciprofloxacin in the treatment of complicated urinary tract infection.J Antimicrob Chemother
KG Naber, F di Silverio, A Geddes, J Guibert,
A total of 686 adult patients with complicated urinary tract infections were enrolled in a double-blind, randomised, multicentre study to compare sparfloxacin (200 mg loading dose on day 1 followed by 100 mg daily) with ciprofloxacin (500 mg orally twice daily) for 10 to 14 days. Urinary tract infection was defined as pyuria and bacteriuria (cfu > or = 10(5)/mL). Evaluations were performed at four time-points. The clinical efficacy of the two antibacterial agents was equivalent at the end of treatment: clinical cure in 88.6% of the intent-to-treat population and 87.3% in the evaluable population treated with sparfloxacin compared to 85.4% and 84.8% of the intent-to-treat and evaluable populations, respectively, treated with ciprofloxacin. The clinical results were also equivalent at follow-up. The bacteriological efficacy of the two agents was not equivalent. At the end of treatment, bacteriological cure was observed in 72.6% of the intent-to-treat and 72.1% of the evaluable populations treated with sparfloxacin and in 81.4% and 80.8% of the intent-to-treat and evaluable populations, respectively, treated with ciprofloxacin. The difference was primarily because of a higher number of persisting pathogens, which included Enterobacteriaceae other than Escherichia coli, Pseudomonas aeruginosa and enterococci, which exhibited moderate susceptibility to sparfloxacin. Tolerability was similar in the two treatment groups.
1314767.9235110171986.03.18++A randomized trial of oral iron on tests of short-term memory and attention span in young pregnant women.J Adolesc Health Care
JA Groner, NA Holtzman, E Charney, ED Mellits,
Recent studies suggest that infant behavior and psychological test performance are impaired by iron deficiency and may be improved by iron. Comparable studies have not been performed in older populations. Young women early in pregnancy whose nutritional intake may be impaired by poverty constitute a high-risk population. Women aged 14-24 years coming for prenatal care at or before 16 weeks gestation whose hematocrits were greater than or equal to 31% were randomized in a double-blind trial to receive vitamins supplemented with iron (experimental group) or vitamins alone (controls). Hematologic status and tests of short-term memory and attention span were assessed at entry and conclusion of the one-month treatment period. The experimental group showed significant improvement on the most sensitive measure of short-term memory and three subtests. On comparison of the change between initial and final scores, the experimental group showed significant or borderline greater improvement than controls on three tests. These results indicated a beneficial effect of iron therapy on psychometric test-score performance.
1314867.92151339202004.06.10++A brief intervention to increase physical activity in sedentary working women.Can J Nurs Res
J Purath, AM Miller, G McCabe, J Wilbur,
The purpose of this study was to determine whether a brief, tailored counselling intervention is effective for increasing physical activity in sedentary women when delivered in the workplace. This prospective randomized trial used a brief intervention based on the Transtheoretical Model. The intervention group received health screening, a brief intervention, and, 2 weeks later, a booster telephone call from a nurse practitioner. The intervention was tailored to each woman's reported exercise behaviour. The 134 women randomized to the intervention were compared with 153 women in a control group who received health counselling not tailored to their exercise behaviour and no telephone call. Six weeks later, the intervention group, when compared to baseline, had significantly improved their physical activity, increasing their amount of weekend physical activity as well as minutes walked for exercise, on errands, total walking, and total daily blocks walked. When compared to controls, they showed significantly greater gains. This test of a brief, tailored strategy provides a critical contribution to the search for efficient, effective ways for nurses to deliver workplace health promotion interventions.
1314967.9262232891983.08.11++A single dose comparison of a combination of fenoterol and ipratropium aerosols in bronchial asthma.Postgrad Med J
P Lawford, KN Palmer,
Nine patients with reversible obstructive airways disease were studied to compare the bronchodilator response to a combination of fenoterol and ipratropium aerosols with two dose levels of fenoterol alone. Using a double-blind, cross-over, single dose regime, 200 micrograms fenoterol hydrobromide and 80 micrograms ipratropium bromide was compared to 400 micrograms fenoterol + placebo, and to 200 micrograms fenoterol + placebo. There was no significant difference between the combination and either dose of fenoterol in terms of peak or duration of response as determined by absolute or percent change in forced expiratory volume in one second, or forced vital capacity, over baseline.
1315067.9176589531995.10.03++Profile of mood states and cardiac rehabilitation after acute myocardial infarction.Med Sci Sports Exerc
N Oldridge, D Streiner, R Hoffmann, G Guyatt,
Following an acute myocardial infarction, evaluation of a patient's own perceptions of health, including mood state, provides useful information about the efficacy of rehabilitation when data are available for patients randomized to both control and intervention. Data are presented on the Profile of Mood States (POMS) in 187 patients, with mild to moderate scores for Spielberger state anxiety and/or Beck depression, who were randomized within 6 wk of acute myocardial infarction to usual care or to brief cardiac rehabilitation lasting 8 wk and who were followed-up during the 12 months following the acute event. Repeated measures multivariate analysis of covariance identified significant main as well as time effects in POMS scores over 12 months. Repeated measures analysis of variance over the 12 months demonstrated significant improvement for both depression and anxiety in both groups. At 8 wk, improvement was greater in the rehabilitation patients than usual care patients but only in the tension-anxiety, depression-dejection and vigor-activity dimensions of POMS and only in anxiety in those patients with above mean anxiety scores. Overall, rehabilitation and control patients showed similar and significant improvements in anxiety, depression and in mood states over the duration of the 12-month trial.
1315167.9184910691993.06.16++A placebo-controlled model for assaying systemic analgesics in children.Clin Pharmacol Ther
BP Schachtel, WR Thoden,
To assess the sore throat pain model in children as an assay for systemic analgesic agents in children under double-blind, placebo-controlled conditions, we conducted a single-dose parallel study that compared 10 mg/kg ibuprofen (n = 39), a new analgesic agent for children, and 15 mg/kg acetaminophen (n = 38), an approved analgesic for children, to placebo (n = 39) in children from 2 to 12 years of age with acute sore throat. At 1/2, 1, 2, 3, 4, 5, and 6 hours (2 hours in the pediatrician's office followed by 4 hours at home), children assessed pain intensity with a pain thermometer and pain relief with a smiley-face scale. The parent and pediatrician assessed pain intensity and change in pain; the parent also provided an overall evaluation at 6 hours. The children rated ibuprofen and acetaminophen as significantly effective compared with placebo (p < 0.05) on both scales at most posttreatment time points and overall. The parent and pediatrician also rated both active medications as significantly different from placebo on both of their scales (p < 0.05) at several time points and overall. On the parent's overall evaluation, ibuprofen was rated as effective compared with placebo (p < 0.05). Both active agents significantly (p < 0.05) reduced oral temperature in children with baseline temperatures > 99 degrees F. No treatment-related adverse effects were observed. We conclude that the sore throat pain model is a sensitive assay for identification of the activity of oral analgesic drugs in children and that ibuprofen is an effective analgesic in children.
1315267.9119594731992.01.09++Dietary therapy in diabetes mellitus. Is there a single best diet?Diabetes Care
SM Grundy,
The ideal diet for diabetic patients remains to be determined. Recommendations generally call for low-fat high-carbohydrate diets. The primary purpose of this recommendation is to reduce the risk for coronary heart disease, a major killer of diabetic patients. Some investigators also suggest that high-carbohydrate diets also improve glucose tolerance, even in patients with non-insulin-dependent diabetes mellitus (NIDDM). Another potential advantage of a low-fat diet (high percentage of carbohydrate) is that it may promote weight reduction. High-fat diets are thought by many investigators to stimulate weight gain. Thus, in obese NIDDM patients a trial of a low-fat weight-reduction diet may be worthwhile. However, if after an adequate trial of this diet, weight reduction is not achieved, this suggests that the patient is consuming large quantities of carbohydrates. The continued feeding of a high-carbohydrate diet to a persistently obese patient with NIDDM may have several untoward effects. For example, it can heighten hyperglycemia, raise plasma triglycerides, and lower high-density lipoproteins. In such dietary failures, it may be better to replace carbohydrate with fat to avoid these responses. Ideally, the fat should not raise the serum cholesterol level, and hence it should be unsaturated. Monounsaturated fatty acids seem preferable to polyunsaturated fatty acids, because polyunsaturates may increase the risk for cancer or promote the oxidation of low-density lipoprotein, another potentially atherogenic change. Many NIDDM patients, particularly obese patients in the earlier stages of diabetes, tolerate weight-maintenance high-carbohydrate diets without deterioration of glucose tolerance.(ABSTRACT TRUNCATED AT 250 WORDS)
1315367.9187061741996.09.09++[A double-blind parallel group study of beclomethasone dipropoinate nasal spray of two different sources in the treatment of allergic rhinitis]Zhongguo Yi Xue Ke Xue Yuan Xue Bao
H Zhang, L Wang, F Yu, J Yi, Z Wu,
In order to compare the clinical efficacy and safety of beclomethasone dipropionate nasal spray (BDNS) manufactured in Chongqing Glaxo Limited (Group A) and Glaxo UK (Group B), a randomised double-blind parallel group study was performed. A total of 204 patients with seasonal or perennial allergic rhinitis were recruited into the study for a period of 2 weeks. Overall efficacy (excellent/good) was 88% for Group A (excellent 55%) and 90% for Group B (excellent 51%) respectively. Side effects were similar for both groups where dry nose was the most common complaint (4.9% for both groups). However, there was no statistical difference (P > 0.05) between the two groups either in efficacy or side effects. Pollen count was monitored throughout the study period. Pollen season was divided into three periods, i.e. the beginning, the peak and the end. There was no statistical difference (P > 0.05) between the two groups in any period.
1315467.90118509762002.03.19++Role of Bi-pap in acute respiratory failure due to acute exacerbation of COPD.J Pak Med Assoc
N Rizvi, N Mehmood, N Hussain,
OBJECTIVE: To assess the efficacy of Bi-level Positive Airway Pressure (Bi-pap), administered by nasal mask in patients with acute respiratory failure due to acute exacerbation of COPD. DESIGN: Prospective non-randomized study in a hospital setting. METHODS: Eighteen patients were recruited from those admitted in the Chest Unit of Jinnah Postgraduate Medical Centre, Karachi with acute exacerbation of COPD. Along with conventional treatment, Bi-pap was administered by a nasal mask. Arterial blood gas analysis, respiratory and heart rate and subjective sensation of dyspnoea, before and during Bi-pap application were monitored. RESULTS: The respiratory rate decreased from 33.2 +/- 5.3/min to 22.0 +/- 3.5 (P < 0.001), heart rate also decreased from 113.2 +/- 7.6/min to 90.2 +/- 11.9 (P < 0.001). A rise in pH was observed from 7.2 +/- 0.09 to 7.4 +/- 0.06 (P > 0.41 n.s.), PaCO2 decreased from 76.5 +/- 15.5 to 51.3 +/- 10.5 (P < 0.001). PaO2 also increased from 52.1 +/- 14.3 to 62.9 +/- 11.5 (P < 0.01). The mean hospital stay was shorter i.e., 10.6 +/- 5.6 days and the hospital mortality rate 11.1%. Bi-pap administered by nasal mask was generally well tolerated with few minor complications. CONCLUSION: Bi-pap is particularly useful in patients presenting with acute respiratory failure due to acute exacerbation of COPD particularly in our setting where invasive ventilation is not easily available.
1315567.9080928301994.10.17++Prospective randomized comparison of imipenem monotherapy with imipenem plus netilmicin for treatment of severe infections in nonneutropenic patients.Antimicrob Agents Chemother
A Cometta, JD Baumgartner, D Lew, W Zimmerli, D Pittet, P Chopart, U Schaad, C Herter, P Eggimann, O Huber,
Nosocomial pneumonia and sepsis, as well as severe diffuse peritonitis, must be treated early in order to prevent complications such as septic shock and organ dysfunctions. With the availability of new broad-spectrum and highly bactericidal antibiotics, the need of combining beta-lactams with aminoglycosides for the treatment of severe infections should be reassessed. A prospective randomized controlled study was performed to compare imipenem monotherapy with a combination of imipenem plus netilmicin in the empiric treatment of nosocomial pneumonia, nosocomial sepsis, and severe diffuse peritonitis. A total of 313 patients were enrolled, and 280 were assessable. The antibiotic treatment was successful in 113 of 142 patients (80%) given the monotherapy and in 119 of 138 patients (86%) given the combination (P = 0.19). The failure rates for the most important type of infection, i.e., pneumonia, were similar in the two groups, as well as the number of superinfections. While creatinine increase was associated with factors not related to antibiotic therapy for all eight patients of the monotherapy group, no factor other than the antibiotics could be found for 6 of the 14 cases of nephrotoxicity observed in the combination group (P = 0.014). Finally, the emergence of Pseudomonas aeruginosa resistant to imipenem occurred in 8 monotherapy patients and in 13 combination therapy patients. In conclusion, imipenem monotherapy appeared as effective as the combination of imipenem plus netilmicin for the treatment of severe infection. The addition of netilmicin increased nephrotoxicity, and it did not prevent the emergence of P. aeruginosa resistant to imipenem.
1315667.89157466822005.04.01++Second trimester abortion using isosorbide mononitrate in addition to gemeprost compared with gemeprost alone: a double-blind randomized, placebo-controlled multicenter trial.Am J Obstet Gynecol
W Eppel, F Facchinetti, E Schleussner, F Piccinini, C Pizzi, DM Gruber, B Schneider, W Tschugguel,
OBJECTIVE: We aimed to determine whether second-trimester abortion using isosorbide mononitrate (IMN) in addition to gemeprost is more effective and reduces side effects compared with gemeprost alone. STUDY DESIGN: Eighty women who were age 13 to 23 weeks' gestation were randomly assigned to receive per vaginam either IMN 40 mg (group 1, 40 women) or placebo (group 2, 40 women) in addition to gemeprost 1 mg up to 3 times daily 3 hours apart for 2 days. Analysis of variance, a chi 2 test, and a multivariate analysis were performed. RESULTS: Of the 72 women analyzed, 68% (group 1) and 38% (group 2) underwent abortion within day 1 (P < .05). However, group 1 was associated with more headache (18% of women) 3 hours after induction compared to group 2 (0% of women, P = .038). CONCLUSION: IMN in addition to gemeprost is effective for second-trimester abortion, but is associated with more headache compared with gemeprost alone.
1315767.8929812921985.02.08++Co-trimoxazole prophylaxis during high-dose chemotherapy of small-cell lung cancer.J Clin Oncol
AT Figueredo, WM Hryniuk, I Strautmanis, G Frank, S Rendell,
In 103 patients with small-cell lung cancer, we compared four courses of standard doses of Adriamycin (A) (Adria Laboratories, Columbus, Ohio), vincristine (V), and cyclophosphamide (C) with a regimen of increased doses of cyclophosphamide and to a lesser extent, Adriamycin. We found no significant difference in rate (22% v 21%) or median duration (seven v nine months) of complete remission. Patients not in complete remission after the four cycles of AVC received two courses of VP-16 (etoposide) and cisplatin: the complete remission rate increased to 49% and 48% respectively. Patients on the high-dose arm received co-trimoxazole prophylaxis; those on the standard arm did not. Patients on the high-dose arm had a higher incidence of neutropenia (nadir less than 500 cells/microL) but a lower incidence of infection for similar degrees of neutropenia. However, they also suffered more severe side effects of a different kind. Cotrimoxazole thus allowed for the administration of higher doses of chemotherapy to outpatients by protecting them from infection. However, the higher doses of cyclophosphamide and Adriamycin, did not improve treatment results, produced more severe side effects, and is not recommended.
1315867.88124139992002.12.09++Effect of diagnosis, age, sperm quality, and number of preovulatory follicles on the outcome of multiple cycles of clomiphene citrate-intrauterine insemination.Fertil Steril
RP Dickey, SN Taylor, PY Lu, BM Sartor, PH Rye, R Pyrzak,
OBJECTIVE: To determine how diagnosis, age, sperm quality, and number of preovulatory follicles affect pregnancy rates when multiple cycles of clomiphene citrate (CC)-IUI are performed. DESIGN: Fifteen-year prospective observational study. SETTING: Private infertility clinic. PATIENT(S): Three thousand, three hundred eighty-one cycles of husband or donor IUI. INTERVENTION(S): Ovulation induction with CC and IUI. MAIN OUTCOME MEASURE(S): Per-cycle pregnancy rate (PR), cumulative pregnancy rate (CPR). RESULT(S): Pregnancy rates remained constant through four cycles, then fell significantly for diagnoses other than ovulatory dysfunction. Mean PRs for cycles 1-4 were significantly lower for patients with the following characteristics: age >/=43 years, poor semen quality, single preovulatory follicles, and diagnoses other than ovulatory dysfunction. Additional cycles of CC-IUI compensated for low PRs because of age, semen quality, or number of follicles. After four cycles, CPRs were 46% for ovulatory dysfunction; 38% for cervical factor, male factor, and unexplained infertility; 34% for endometriosis; and 26% for tubal factor. After six cycles, CPRs were 65% for ovulation dysfunction, 35% for endometriosis, and unchanged for other diagnoses. CONCLUSION(S): Clomiphene citrate-intrauterine insemination should be performed for a minimum of four cycles. Additional cycles of CC-IUI can compensate for low pregnancy rates due to age, semen quality, or follicle number in patients with ovulation dysfunction.
1315967.88103606551999.06.23++Multi-institutional randomized clinical study on the comparative effects of intracavital chemotherapy alone versus immunotherapy alone versus immunochemotherapy for malignant effusion.Br J Cancer
Y Nio, H Nagami, K Tamura, M Tsubono, M Nio, M Sato, K Kawabata, H Hayashi, T Shiraishi, S Imai, T Tsuchitani, J Mizuta, M Nakagawa, M Fukumoto,
The current prospective randomized study was designed to compare the effects of intracavitary (i.c.) chemotherapy vs immunotherapy vs immunochemotherapy for malignant effusion. Between 1992 and 1995, a total of 42 patients with malignant effusion were registered, and 41 patients were eligible for statistical analysis. The primary diseases of the eligible patients included 27 gastric, four colorectal, four pancreatic, three lung, two liver and one oesophageal cancers. The patients with malignant effusion were randomly assigned into one of three i.c. therapeutic regimens: chemotherapy alone with weekly injection of anticancer agents (ACAs: cisplatin, mitomycin-C, adriamycin, etc.) (Group A, n = 13); immunotherapy alone with weekly injection of streptococcal preparation OK-432 (Group B, n = 14); or immunochemotherapy with ACAs and OK-432 (Group C, n = 14). The response of the effusion, patient survival and the kinetics of cytokines in the effusion were compared. There were no differences in the patients' backgrounds. The side-effects of the regimens included pain, anorexia, fever, leucopenia and anaemia and there were no differences in their incidence among the three groups. One patient died after cisplatin (CDDP) administration in Group A. Cytologic examination revealed that tumour cells in the effusion disappeared in 23% of Group A cases, 36% of Group B cases and 36% of Group C cases. The malignant effusion did not disappear in any of the Group A cases; however, the effusion disappeared in 29% of Group B cases and 43% of Group C cases (P = 0.03, Group A vs Group C). Furthermore, the 50% survival period was 1.6 months for Group A, 2.4 months for Group B and 3.5 months for Group C. The 6-month survival rate was 7% for Group A, 6% for Group B and 34% for Group C, and the 1-year survival rate was 0%, 0% and 17% respectively (P = 0.048, Group A vs Group C by the log-rank test). The analysis of the cytokine kinetics revealed a prominent increase in the level of interleukin-6 in the effusion in Group C. These results suggest that i.c. immunochemotherapy with OK-432 and ACAs may be more beneficial than i.c. chemotherapy alone or immunotherapy alone.
1316067.88159853392006.12.05++A randomised-controlled pilot study using nicotine patches with pregnant women.Addict Behav
ED Hotham, AL Gilbert, ER Atkinson,
Stopping smoking in pregnancy is a public health priority and a clinical imperative. However, many women who have not been able to 'quit' in early pregnancy find it very difficult to do so. This randomised-controlled pilot study examined feasibility issues in offering free nicotine patches with counselling to a group of 20 mid-trimester pregnant women at the Women's and Children's Hospital, Adelaide. A further 20 were offered counselling only. Smoking status at each visit was measured by self-report, carbon monoxide monitoring, and salivary cotinine. The most common pattern (eleven of the twenty women) was intermittent patch use. Only five women used patches continuously up to the 12 week maximum available. Three women in the patch group were abstinent at delivery compared with none in the control group. Notable features of the study were the low interest in participation and the high withdrawal rate. Nicotine patches may not be highly useful for pregnant women. Continuing tobacco control measures and customized support for women and their partners, often smokers, may prove more fruitful.
1316167.8888985591996.12.24++Effects of a community health nursing parent-baby (ad)venture program on depression and other selected maternal-child health outcomes.Public Health Nurs
SW Vines, C Williams-Burgess,
This pilot study measured the effects of a community health nursing parent-baby (ad)venture program for first time mothers who were at risk for child abuse or neglect and depression. A quasi-experimental pretest-posttest design was used. Fifteen high-risk mothers in the program were compared with 15 similar mothers who received home visits from the community health nursing staff. Measures of depression, health behaviors, self-esteem, state anxiety, and maternal-infant adaptation were measured in both groups when the mothers were 4 and 16 weeks postpartum. After controlling for pretest differences, the findings showed that program mothers reported significantly higher levels of self-esteem at the three-month period than those receiving home visits (P < 0.013). In addition, over time these mothers had significantly decreased levels of depression (P < 0.009) and significantly improved their health habits (P < 0.003). Those who received home visits showed no significant changes over time.
1316267.88128858372003.10.23++Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma.J Clin Oncol
M Tempero, W Plunkett, V Ruiz Van Haperen, J Hainsworth, H Hochster, R Lenzi, J Abbruzzese,
PURPOSE: To conduct a randomized phase II trial of dose-intense gemcitabine using a standard 30-minute infusion or the fixed dose rate (FDR) infusion (10 mg/m2/min) in patients with pancreatic adenocarcinoma. PATIENTS AND METHODS: In this prospective trial, patients with locally advanced and metastatic pancreatic adenocarcinoma were treated with 2,200 mg/m2 gemcitabine over 30 minutes (standard arm) or 1,500 mg/m2 gemcitabine over 150 minutes (FDR arm) on days 1, 8, and 15 of every 4-week cycle. The primary end point of this trial was time to treatment failure. Secondary end points included time to progression, median survival, safety, and pharmacokinetic studies of gemcitabine. RESULTS: Ninety-two patients were enrolled onto this study; 91% of the patients had metastatic disease. Time to treatment failure was comparable in both treatment groups; however, the median survival for all patients was 5.0 months in the standard arm and 8.0 months in the FDR arm (P =.013). For patients with metastases, the median survival was 4.9 months in the standard arm and 7.3 months in FDR arm (P =.094). The 1- and 2-year survival rates for all patients were 9% (standard arm) versus 28.8% (FDR; P =.014) and 2.2% (standard arm) versus 18.3% (FDR; P =.007), respectively. Patients in the FDR infusion arm experienced consistently more hematologic toxicity. Pharmacokinetic analyses demonstrated a two-fold increase in intracellular gemcitabine triphosphate concentration in the FDR arm (P =.046). CONCLUSION: Pharmacokinetic and clinical data in this trial supports the continued evaluation of the FDR infusion strategy with gemcitabine.
1316367.8883508861993.09.13++Effect of dietary fish oil on renal function and rejection in cyclosporine-treated recipients of renal transplants.N Engl J Med
JJ van der Heide, HJ Bilo, JM Donker, JM Wilmink, AM Tegzess,
BACKGROUND. Dietary fish oil exerts effects on renal hemodynamics and the immune response that may benefit renal-transplant recipients treated with cyclosporine. To evaluate this possibility, we studied the effect of fish oil on renal function, blood pressure, and the incidence of acute rejection episodes in cyclosporine-treated recipients of renal transplants. METHODS. In a randomized, double-blind trial, 33 recipients of first cadaveric kidney transplants who were treated with cyclosporine and prednisolone ingested 6 g of fish oil daily during the first postoperative year (the fish-oil group), whereas another 33 renal-graft recipients treated with cyclosporine and prednisolone ingested 6 g of coconut oil daily for three months after which time it was stopped (the control group). RESULTS. One year after transplantation, the fish-oil group had higher median values than the controls for glomerular filtration rate (53 vs. 40 ml per minute per 1.73 m2, P = 0.038) and effective renal plasma flow (214 vs. 178 ml per minute per 1.73 m2, P = 0.023) and lower mean arterial pressure (103 vs. 118 mm Hg, P = 0.0011). The cyclosporine doses in the two groups were similar. The cumulative number of rejection episodes was 20 in the controls, as compared with 8 in the fish-oil group (P = 0.029). One-year graft survival also tended to be better in the fish-oil group, (97 vs. 84 percent, P = 0.097). CONCLUSIONS. The daily administration of 6 g of fish oil during the first postoperative year has a beneficial effect on renal hemodynamics and blood pressure in renal-transplant recipients treated with cyclosporine. Although the fish-oil group had significantly fewer rejection episodes than the control group, graft survival at one year was not significantly better in the fish-oil group.
1316467.8782815881994.02.17++Comparison of the 25-gauge Whitacre with the 24-gauge Sprotte spinal needle for elective caesarean section: cost implications.Can J Anaesth
DC Campbell, MJ Douglas, TJ Pavy, P Merrick, ML Flanagan, GH McMorland,
Spinal anaesthesia provides rapid, safe anaesthesia for Caesarean section. The pencil-point spinal needles (Sprotte and Whitacre) are reported to have a low incidence of post-dural puncture headache (PDPH). As the 25G Whitacre is less expensive than the 24G Sprotte needle, this prospective, randomized, double-blind study was designed to compare the incidence of PDPH and ease of insertion of these needles in 304 ASA 1 and 2 women having elective Caesarean section under spinal anaesthesia. Each patient was assessed daily for five consecutive days following Caesarean section by an investigator blinded to the needle used. The results indicate that the two needles have a similar ease of insertion, number of failed insertions, and failed subarachnoid blockade. An inability to insert the spinal needles occurred in two patients in each group. Therefore, 150 patients in each group completed the study. The incidence of PDPH with the 24G Sprotte needle was 4.0% (6/150) compared with 0.66% (1/150) with the 25G Whitacre (NS). There was no correlation between the occurrence of PDPH and the difficulty of needle insertion, presence of transient hypotension or the effectiveness of anaesthesia delivered. This study indicates that both needles are comparable with respect to ease of insertion and incidence of PDPH. As the Whitacre needle is less expensive it is a reasonable alternative to the more expensive Sprotte needle.
1316567.8792016371997.08.14++The efficacy of cryotherapy following arthroscopic knee surgery.J Orthop Sports Phys Ther
LA Lessard, RA Scudds, A Amendola, MD Vaz,
Cryotherapy has historically been used as a treatment following knee surgery. In the literature, there is little evidence of beneficial effects which support this practice. This study examined the effects of cryotherapy treatments on 45 subjects following minor arthroscopic knee surgery. Subjects were randomized to one of two treatment groups and the assessor remained blind to treatment group allocation. Subjects performed a 1-week home program of either cryotherapy and exercises or exercises alone. One week following surgery, a statistically significant difference was found between the groups for the affective dimension of the McGill pain questionnaire, medication consumption, compliance, and weight-bearing status. No significant differences were found between the groups for other outcome variables. These results indicate that the addition of cryotherapy to a regime of exercises following arthroscopic knee surgery produced benefits of increased compliance, improved weight-bearing status, and lower prescription medication consumption.
1316667.86104518051999.10.04++Induction of ovulation with clomiphene citrate in combination with metoclopramide in patients with amenorrhea of hypothalamic origin.Gynecol Endocrinol
MC Mendes, RA Ferriani, MM Sala, MD Moura, MF de Sá,
Literature data have demonstrated that the chronic use of metoclopramide (MCP), a dopamine antagonist, causes increased gonadotropin secretion in patients with hypothalamic amenorrhea but without triggering ovulation. It has also been observed that women with hypothalamic amenorrhea respond poorly to ovulation induction with clomiphene citrate (CC). On this basis, the objective of the present study was to determine the effect of MCP on the response to CC in patients with hypothalamic amenorrhea in order to evaluate the validity of the simultaneous use of these drugs as ovulation inducers in this type of chronic anovulation. Twenty-two patients with amenorrhea of hypothalamic origin were submitted to a randomized double blind study in which one tablet of 5 mg MCP or placebo was administered every 8 hours for 2 months. After the 30th day of medication (MCP or placebo), CC, 100 mg orally, was additionally administered to both groups for 5 days. Blood samples were collected on days 1, 15 and 30 during the first month of the study and on days 7, 14 and 21 after the last CC tablet during the second month, for later measurement of follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin, estradiol and progesterone by radioimmunoassay. The group that received MCP showed a significant increase in LH and FSH during the first month of the study, as well as a slighter increase in estradiol. Prolactin increased only during the second stage of treatment. No significant increases in gonadotropins, prolactin or estradiol occurred in the placebo group. In the group treated with MCP, 40% of the patients ovulated after CC, with menstruation occurring in 60% of them. In the placebo group, 33.3% of the women ovulated after CC and 44.4% menstruated at the end of the study. We conclude that MCP increases the circulating levels of LH, FSH, estradiol and prolactin in patients with hypothalamic amenorrhea and low estrogen levels, supporting the hypothesis that an increase in hypothalamic dopaminergic tonus occurs in these patients. On the other hand, the combination of MCP and CC does not improve the rate of ovulation compared to placebo.
1316767.86126288642003.04.02++A physiologic comparison of nasal and oral positive airway pressure.Chest
PL Smith, CP O'Donnell, L Allan, AR Schwartz,
STUDY OBJECTIVES: The effectiveness of nasal continuous positive airway pressure (CPAP) in treating obstructive sleep apnea (OSA) is based on raising the intramural pressure above a critical collapsing pressure of the oropharyngeal airway. It is currently unclear whether CPAP delivered orally is also capable of raising pressure in the oropharynx above the critical collapse pressure. DESIGN: We tested a novel oral CPAP device to determine whether the pressure-flow relationships are similar to nasal CPAP and whether the device alters these relationships. Patients were selected based on having moderately severe apnea and were randomized to nasal CPAP, nasal CPAP with oral device, or oral CPAP. SETTING: Johns Hopkins University, The Johns Hopkins Asthma and Allergy Center, Baltimore, MD. PATIENTS: Five men and two women with OSA were studied. INTERVENTIONS: Individual pressure-flow curves were constructed during the application of nasal or oral CPAP. RESULTS: We found the following: (1) a similar effective pressure eliminated inspiratory flow limitation for the nasal or oral CPAP; (2) as pressure in the nose or mouth was lowered below the effective pressure, a linear pressure-flow curve was obtained and a critical closing pressure was described; (3) similar mean (+/- SD) critical pressures of -0.3 +/- 5.3, 1.7 +/- 4.0, and 0.5 +/- 2.8 cm H(2)O, respectively, occurred for nasal CPAP, nasal CPAP with the oral device in place, and oral CPAP conditions (p > 0.1); and (4) the comparable mean values for upstream resistance were 27.8 +/- 19, 19.1 +/- 8.3, and 26.5 +/- 26.7 cm H(2)O/L/s, respectively, for the above three conditions (p > 0.1). CONCLUSIONS: We concluded that comparable upper airway pressure-flow relationships were obtained during oral and nasal breathing. Moreover, effective treatment pressure is obtained when constant pressure is applied through either the nasal or oral route.
1316867.8516151011992.07.29++Subjective response to neuroleptics and outcome in schizophrenia: a re-examination comparing two measures.Psychol Med
TP Hogan, AG Awad,
The schizophrenic patient's early psychological response to neuroleptic treatment has been demonstrated to be a significant predictor of treatment response. The validity of the construct of subjective response is evaluated by comparison of two measures. Fifty-five recently admitted and unmedicated schizophrenic patients were randomly allocated to chlorpromazine or haloperidol. Subjective responses at 24 and 48 hours as assessed by two different scales, the Van Putten & May scale and the self-administered Drug Attitude Inventory, were strongly correlated with outcome at three weeks. Early emergence of extrapyramidal symptoms was not related to subjective response, but dysphoric patients had a greater incidence of EPS by the end of treatment than did non-dysphoric patients. The two measures showed high concordance in identification of early drug dysphoria.
1316967.8514207541992.12.18++Short report: comparison of two doses of balsalazide in maintaining ulcerative colitis in remission over 12 months.Aliment Pharmacol Ther
JR Green, CH Swan, A Rowlinson, JA Gibson, P Brown, GD Kerr, ET Swarbrick, P Thornton,
In a four-centre prospective double-blind trial, 108 patients with ulcerative colitis in remission were randomized to receive balsalazide in doses of 3 g or 6 g/day for 12 months. The patients were assessed at 3-monthly intervals clinically, sigmoidoscopically and with routine haematology and biochemistry. Remission rates of 77% (3 g/day) and 68% (6 g/day) at 12 months were not significantly different. Intolerance reactions leading to withdrawal from the study occurred in only 9 patients (8%), all occurring in the first 7 weeks of the study. Balsalazide is therefore both highly effective in maintaining remission in ulcerative colitis and well tolerated in both conventional and high dosage (the latter equivalent to 5.5 g/day of sulphasalazine). In this study no distinct advantage in maintenance of remission has been found for the higher dose of balsalazide.
1317067.8590266801997.02.20++[Comparative study of the efficiency of ultralente insulin and NPH insulin combined with sulfonylurea in type 2 diabetes patients with secondary tolerance to sulfonylurea. Possible selection criteria]Minerva Endocrinol
L Sangiorgio, MA Rabuazzo, G Cordaro, G Grasso, L Condorelli, M Lunetta,
The treatment of NIDDM patients with secondary failure to sulfonylureas is still a debated problem. In this study we compared in NIDDM patients with secondary failure to glyburide, the effect of adding a single, low-dose bed time either NPH or ultralent insulin injection (0.15-0.2 U/kg) to the previously ineffective sulfonylurea treatment. Both NPH and ultralent insulin therapy have been demonstrated to be effective in ameliorating metabolic control in NIDDM patients with secondary failure to sulfonylureas. However, the addition of bed-time ultralent insulin caused a greater and significant decrease in post prandial plasma glucose. In contrast, the average fasting plasma glucose decrease was significantly greater after NPH insulin administration. These results indicate that in NIDDM patients with secondary failure to glyburide bed-time ultralent insulin administration is a better tool to improve the post prandial plasma glucose.
1317167.8588910871997.02.28++An open trial of adjunctive sertraline in the treatment of chronic schizophrenia.Acta Psychiatr Scand
JH Thakore, C Berti, TG Dinan,
While the positive symptoms of schizophrenia are amenable to treatment with standard neuroleptics, negative symptoms are often difficult to treat. Co-prescribing antidepressants, such as sertraline, for patients on stable neuroleptic depot preparations is one pharmacological method of overcoming this problem. A total of 20 patients with chronic schizophrenia were enrolled in an open trial over a 12-week period during which sertraline was added to their usual antipsychotic medication. Prior to this, baseline scores for positive and negative symptoms, and extrapyramidal side-effects, were measured. The addition of sertraline resulted in global improvement, with a significant reduction in positive and negative symptom scores and no increase in undesirable neuroleptic side-effects. Sertraline may act by indirectly reducing dopaminergic activity.
1317267.8487240251996.10.10++Long-term clinical outcome of post-cholecystectomy patients with biliary-type pain: results of manometry, non-invasive techniques and endoscopic sphincterotomy.Eur J Gastroenterol Hepatol
T Bozkurt, KH Orth, B Butsch, G Lux,
OBJECTIVE: The purpose of the present study was to investigate prospectively the value of manometry, non-invasive techniques and endoscopic sphincterotomy in biliary type II and III patients with suspected sphincter of Oddi dysfunction. METHODS: All patients (n = 31) had undergone a cholecystectomy from 1 to 45 years before entry into the study, and had a history of biliary-type pain ranging from 4 to 156 months. In a primary diagnostic work-up, including ERCP, other causes of gastrointestinal disease were excluded. The width of the common bile duct, pain induced by the injection of contrast medium into the common bile duct, delayed contrast drainage and the results of a morphine-neostigmine test were analysed. Manometric measurements of basal sphincter of Oddi pressure were performed. Twenty-three patients with an elevated basal pressure (> 40 mmHg) underwent endoscopic sphincterotomy. RESULTS: During the follow-up period (8-62 months) 83% of the patients became symptom free or experienced an improvement. Basal sphincter of Oddi pressure and long-term clinical outcome of patients correlated to different degrees with the results of non-invasive techniques. CONCLUSIONS: Our data suggest that endoscopic sphincterotomy may be an effective therapeutic modality in group II and III patients with sphincter of Oddi dysfunction in whom other gastrointestinal disorders have previously been excluded.
1317367.8495119461998.05.20++The effects of clozapine on negative symptoms in patients with schizophrenia with minimal positive symptoms.Ann Clin Psychiatry
JS Brar, KN Chengappa, H Parepally, AR Sandman, SB Kreinbrook, SA Sheth, R Ganguli,
The effectiveness of clozapine in the treatment of the negative symptoms of schizophrenia remains controversial, as improvements in negative symptoms are invariably accompanied by improvements in positive symptoms and neurological side effects. We examined the effectiveness of treatment with clozapine on negative symptoms in a cohort of patients with minimal positive symptoms. Improvements in positive and negative symptoms were measured by BPRS ratings in a subgroup of schizophrenic patients (n=17, from a state hospital cohort of 75) with minimal positive symptoms, who had received clozapine for 6 months. In this subgroup, significant improvements were noted by a composite score on the three negative symptom items of emotional withdrawal, blunted affect, and motor retardation. Positive and depressive symptoms remained unchanged. The remaining cohort (n=58) showed improvements in overall psychopathology including positive, negative, and depressive symptoms. Interestingly, nearly 50% of each group were discharged from the hospital. These findings suggest that clozapine may be beneficial in the treatment of core negative symptoms, even in the absence of other improvements in psychopathology. This effect of clozapine may be a function of its unique pharmacological profile.
1317467.84155846302005.01.03++Treatment of chronic cough in children with montelukast,a leukotriene receptor antagonist.J Asthma
F Kopriva, L Sobolová, J Szotkowská, M Zápalka,
Twenty-two children (13 boys and 9 girls) with chronic cough were treated with the leukotriene receptor antagonist montelukast (Singulair tbl. 5 mg) administered once daily for four weeks. In 14 children (68%), the cough ceased during the third week of treatment. Children responding to montelukast were found to have higher blood levels of eosinophil cationic protein (S-ECP) in the pretreatment blood sample than children with no response (responders 14.88+/-2.651 microg/l versus nonresponders 6.62+/-0.948 microg/l; p<0.01). Blood S-ECP levels remained higher also in the post-treatment blood sample in responders (10.55+/-1.631 microg/l) compared to nonresponders (6.13+/-0.937 microg/l; p<0.05). The difference is statistically significant. There were also differences in absolute eosinophil blood count and IgE blood levels between the two groups in the pretreatment blood sample. Using 24-hour pH-metry, two children not responding to therapy were subsequently diagnosed to have gastroesophageal reflux. Judging from the results, one might deduct that patients with chronic cough who have increased levels of serum ECP and absolute eosinophil blood counts are likely to benefit from treatment with montelukast.
1317567.8422211641990.11.19++Successful treatment of nonpurging bulimia nervosa with desipramine: a double-blind, placebo-controlled study.Am J Psychiatry
UD McCann, WS Agras,
Twenty-three women with nonpurging bulimia underwent a 12-week, double-blind, placebo-controlled trial of desipramine hydrochloride. Repeated standardized rating scales, mood assessments, and self-reports of dietary habits were used to measure changes in binge frequency and cognitive processes associated with food intake. The women who received desipramine reduced their frequency of binge eating by 63%, but women receiving placebo increased their frequency of binge eating by 16%. Twelve weeks after initiating treatment, 60% of the treatment group but only 15% of the placebo group abstained from binge eating. The women who received desipramine showed significantly more dietary restraint and reported significantly less hunger, suggesting that desipramine acts to suppress appetite. These preliminary findings suggest that the therapeutic effects of desipramine established in the treatment of purging bulimia nervosa extend to patients with nonpurging bulimia.
1317667.84159675502005.10.18++Preliminary evaluation of a coping strategy enhancement method of preparation for labour.Midwifery
D Escott, P Slade, H Spiby, RB Fraser,
OBJECTIVES: To compare the use and effects of enhanced pre-existing coping strategies with the use and effects of coping strategies usually taught in National Health Service (NHS) antenatal education on women's experience of pain and emotions during labour. DESIGN: A between-group comparison of women who chose to attend NHS antenatal education where courses of preparation were randomly assigned to include either a new method of coping strategy enhancement (CSE) or standard taught coping strategies. SETTING: Two large maternity units in one city in the North of England. PARTICIPANTS: 20 women participated in antenatal classes incorporating the CSE method and 21 women participated in antenatal classes incorporating the standard approach to developing coping strategies for labour. FINDINGS: Women who attended CSE classes used enhanced coping strategies for a larger proportion of their labour than women who attended standard classes who used taught coping strategies. Birth companions were more involved in women's use of enhanced than taught strategies. Self-efficacy for use of coping strategies and subsequent experiences of pain and emotions during labour were equivalent between groups. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: An approach based on enhancing pre-existing coping strategies was associated with greater coping strategy use and involvement from the birth companion, and provided benefits to women's overall experience of labour at least equivalent to that associated with standard preparation. Further research should explore this novel approach in larger groups, and for women who may choose not to attend group antenatal preparation.
1317767.83109125462000.11.30++Long-term effects of growth hormone treatment on growth and puberty in patients with chronic renal insufficiency.Pediatr Nephrol
A Hokken-Koelega, P Mulder, R De Jong, M Lilien, R Donckerwolcke, J Groothof,
Several prospective trials have shown that recombinant human growth hormone (GH) accelerates growth significantly during the first years of therapy, but the effects of long-term GH therapy with regard to long-term growth response and safety have not yet been established. Forty-five Dutch prepubertal children [28 boys, 17 girls, mean (SD) age 7.8 (3.4) years] with chronic renal insufficiency (CRI) and severe growth retardation started GH therapy between 1988 and 1991 within one of the randomized Dutch trials. Long-term GH therapy, in this study a maximum of 8 years, resulted in a sustained and significant improvement of height standard deviation score (SDS) compared with baseline values (P<0.001). The mean height SDS reached the lower end (-2 SDS) of the normal growth chart after 3 years of GH therapy. During the following years the mean height SDS gradually increased, thereby approaching the mean target height SDS after 6 years of GH therapy. Three factors were significantly associated with the height SDS after 4 years of GH therapy: height SDS at the start (+) of therapy, age at the start of therapy (-), and the duration of dialysis treatment (-). Bone maturation did not accelerate during long-term GH therapy. Children on a conservative regimen at the start of GH therapy had no accelerated deterioration of renal function during 6 years of GH therapy. The average daily GH dose administered over the years had no significant influence on the glomerular filtration rate after 4 years. GH therapy had no adverse effects or significant effect on parathyroid hormone concentration, nor were there any radiological signs of renal osteodystrophy. Puberty started at a median age, within the normal range, of 12.4 years in boys and 12.0 years in girls, respectively. Long-term GH therapy leads to a sustained improvement in height SDS in children with growth retardation secondary to CRI, resulting in a normalization of height in accordance with their target height SDS, without evidence of deleterious effects on renal function or bone maturation. A GH dosage of 4 IU/m2 per day appears efficient and safe. Our long-term data show that final height will be within the normal target height range when GH therapy is continued for many years.
1317867.83151615822007.11.07++Management of hot flashes in breast cancer survivors and men with prostate cancer.Curr Oncol Rep
V Stearns,
Hot flashes are a significant complaint among many breast cancer survivors and many men undergoing androgen deprivation therapy for prostate cancer. Several therapeutic approaches are available to the suffering man or woman. Many of these individuals have tried nonpharmacologic and nonconventional approaches. However, most nonpharmacologic treatments have not been compared with placebo or were not more effective than placebo in prospective, randomized clinical trials. The most effective nonhormonal treatments for hot flashes include agents from the selective serotonin or noradrenergic reuptake inhibitor (SSRI/SNRI) family. Paroxetine, 10 mg/d, or venlafaxine, 37.5 mg/d, are reasonable initial dosages, and if symptoms do not improve within a week or two, the dosage can be doubled. Gabapentin appears to provide similar benefits, but direct comparisons have not been reported. Because of the strong association between gonadal hormones and breast and prostate cancer, the use of hormonal agents to treat hot flashes in these patients has been limited. However, such hormonal therapies as depomedroxyprogesterone acetate can be prescribed for an informed individual who experiences bothersome symptoms despite nonhormonal treatments.
1317967.8339849751985.05.21++Factors influencing adolescents' responses to regimens of naproxen for dysmenorrhea.Am J Dis Child
RH DuRant, MS Jay, T Shoffitt, CW Linder, W Taylor,
The efficacy of different regimens of naproxen sodium for relief of dysmenorrhea in female adolescents was compared and the effect of other social/psychologic factors on the response to treatment tested. Following pretesting, 45 female adolescents were randomly assigned in a double-blind fashion to one of five treatment regimens and were followed up after 1, 2, and 3 months of treatment. There was a dose-related response to naproxen sodium therapy, with subjects receiving loading doses of 550 mg reporting better symptom relief than subjects receiving loading doses of 275 mg. During the first month of treatment, adolescents who reported increased life crisis events experienced greater symptom severity following naproxen therapy. Also, adolescents who reported more severe dysmenorrhea symptoms following three months of naproxen therapy had significantly lower self-concepts than adolescents who reported less symptoms following treatment.
1318067.8237366001986.09.19++A prospective comparison of selective and universal electronic fetal monitoring in 34,995 pregnancies.N Engl J Med
KJ Leveno, FG Cunningham, S Nelson, M Roark, ML Williams, D Guzick, S Dowling, CR Rosenfeld, A Buckley,
We investigated the effects of using intrapartum electronic fetal monitoring in all pregnancies, as compared with using it only in cases in which the fetus is judged to be at high risk. Predominant risk factors included oxytocin stimulation of labor, dysfunctional labor, abnormal fetal heart rate, or meconium-stained amniotic fluid. This prospective alternate-month clinical trial took place over a 36-month period during which 34,995 women gave birth. In alternate months, either 7 (for "selective monitoring") or 19 (for "universal monitoring") fetal monitors were made available in the labor and delivery unit. During the "selective" months, 6420 of 17,409 women (37 percent) were electronically monitored, as compared with 13,956 of 17,586 women (79 percent) during the "universal months." Universal monitoring was associated with a small but significant increase in the incidence of delivery by cesarean section because of fetal distress, but perinatal outcomes as assessed by intrapartum stillbirths, low Apgar scores, a need for assisted ventilation of the newborn, admission to the intensive care nursery, or neonatal seizures were not significantly different. We conclude that not all pregnancies, and particularly not those considered at low risk of perinatal complications, need continuous electronic fetal monitoring during labor.
1318167.82145307632003.11.05++Decompressive craniectomy for severe traumatic brain injury: Evaluation of the effects at one year.Crit Care Med
J Albanèse, M Leone, JR Alliez, JM Kaya, F Antonini, B Alliez, C Martin,
OBJECTIVE: To assess the effect on outcome (1 yr) of decompressive craniectomy performed within or after the first 24 hrs post-trauma in severely head-injured trauma patients with intractable cerebral hypertension. DESIGN: Retrospective cohort study. SETTINGS: Intensive care unit of a university hospital. PATIENTS: Among 816 patients with severe head trauma (Glasgow Coma Scale < or =8), 40 underwent decompressive craniectomy. After data collection, patients were divided into two groups: early and late decompressive craniectomy. An early decompressive craniectomy was performed within the first 24 hrs in patients according to the following criteria: a Glasgow Coma Scale score <6 and the existence of clinical signs of cerebral herniation (absence of pupillary reflexes), correlated with abnormalities in computed tomography scan including hematoma, appearance of diffuse or unilateral brain swelling, and/or cerebral herniation. The intracranial pressure in these patients was not measured before the decompressive craniectomy was performed. A late decompressive craniectomy (>24 hrs) was performed according to following criteria: an intractable intracranial hypertension with intracranial pressure >35 mm Hg, a unilateral or bilateral absence of pupillary reflexes, and the same abnormalities in computed tomography scan as previously described. INTERVENTION: Twenty-seven patients with signs of cerebral herniation required the procedure at the time of initial evacuation of a mass lesion. In 13 patients, decompressive craniectomy was performed because of elevated intracranial pressure refractory to medical treatment consisting of cerebrospinal fluid derivation, deep sedation, osmotherapy, hyperventilation, and nesdonal or propofol. MEASUREMENTS AND MAIN RESULTS: Five patients (19%) in whom an early decompressive craniectomy was performed had good recoveries (social rehabilitation), eight patients (30%) remained in a persistent vegetative state or with a severe disability, and 14 died (52%). On the other hand, the performance of late decompressive craniectomy in case of medical treatment failure was followed by social rehabilitation in five patients (38%) and death in three patients (23%). A persistent vegetative state or a severe disability was observed in five patients (38%). Meningitis or cerebral abscess occurred in six patients after decompressive craniectomy and were easily cured by antibiotic treatment. CONCLUSIONS: In 40 patients with intractable intracranial hypertension and at very high risk of brain death, decompressive craniectomy allowed 25% of patients to attain social rehabilitation at 1 yr.
1318267.8296851021998.08.05++Lactic acid accumulation in cardiac patients performing circuit weight training: implications for exercise prescription.Arch Phys Med Rehabil
DW DeGroot, TJ Quinn, R Kertzer, NB Vroman, WB Olney,
OBJECTIVE: Because blood lactic acid (LA) levels may be important in prescribing exercise for cardiac patients, this study documented the LA response to four different circuit weight training (CWT) protocols and compared these responses to both maximal treadmill and LA threshold values. DESIGN: Intervention study following a crossover trial design. SETTING: A phase III community-based setting. PATIENTS: All subjects had documented cardiac disease and were volunteers. INTERVENTIONS: We used 40% and 60% of the one-repetition maximum (1-RM) for six exercises and 30 or 60sec of rest between each station, resulting in four protocols, performed in random order. A discontinuous treadmill test was conducted, and the LA threshold was determined. MAIN OUTCOME MEASURE: The main dependent variable was LA after each CWT protocol. RESULTS: No signs or symptoms suggestive of cardiovascular distress during any of the four CWT protocols were reported. A repeated-measures analysis of variance showed that the LA threshold value was significantly less than all four CWT protocols (p < .05). The CWT responses were also compared with the traditional LA threshold value of 4.0mmol/L, and both 60% protocols were significantly elevated (p < .05). CONCLUSION: Because no positive signs or symptoms were reported, we recommend starting stable cardiac patients on a CWT program with an initial load between 40% and 60% 1-RM and allowing at least 60sec of rest between exercises.
1318367.81127046752003.06.16++Effective PSA contamination in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer.Int J Cancer
SJ Otto, IW van der Cruijsen, MK Liem, IJ Korfage, JJ Lous, FH Schröder, HJ de Koning,
The extent of effective prostate-specific antigen (PSA) contamination in the Rotterdam section of the ongoing European Randomized Study of Screening for Prostate Cancer (ERSPC) trial was evaluated and defined as when opportunistic PSA testing of >/= 3.0 ng/ml was followed by biopsy, similar to the regular procedure within the trial. Records of participants aged 55-74 years at entry were linked to the regional database of the general practitioner (GP) laboratory to obtain PSA tests requested by GPs in the period 1 July 1997 to 31 May 2000 (2.9 years), and to the national pathology database to quantify the number of biopsies. All men randomized were included, only those with prostate cancer screen-detected or clinically diagnosed before July 1997 were omitted from the analyses. 2,895 out of the 14,349 men (20.2%) in the control arm and 1,981 out of the 14,052 men (14.1%) in the screening arm were PSA-tested, at an average annual rate of 73 and 52 per 1,000 person-years, respectively. These rates were higher than those recorded at the national and regional levels, 33 and 38 per 1,000 person-years, respectively. Opportunistic PSA testing in the control arm reached a peak within the first months of randomization, after which it decreased to around 70 per 1,000 person-years. An opposite pattern was observed in the screening arm, where participants already had received the scheduled screening within the trial. The proportion of men in the control arm with PSA >/= 3.0 ng/ml followed by biopsy and prostate cancer was 7-8% and 3%, respectively (3% and 0.4-0.6% in the screening arm), over the whole study period. Over a 4-year rescreening interval, the average PSA and effective contamination amount were approximately 28% and 10%, respectively. PSA testing in the control arm in the Rotterdam ERSPC section is high, but was not followed by a substantial increase in prostate biopsies. Although the reasons for ordering PSA test or indicating biopsy are unknown, effective PSA contamination in the Rotterdam ERSPC section is low and not likely to jeopardize the power of the trial.
1318467.8116880651992.09.23++Clinical trial of corticosteroid and beta-2 bronchodilator in acute wheezing infants.Zhonghua Min Guo Xiao Er Ke Yi Xue Hui Za Zhi
YZ Lin, KH Hsieh, W Chen, KW Wu,
To evaluate the effect of a combination of corticosteroid and beta-2 bronchodilator on acute, young, wheezing patients, a total of 80 patients, ages below 36 months who were hospitalized for this condition during the period November 1988 to March 1990 were studied. They were divided into three groups. Group A consisted of 29 cases, under 12 months old, and treated with hydrocortisone and procaterol; Group B included 23 cases, between 12 and 36 months old, treated as in Group A; Group C, of 28 cases younger than 12 months, received neither drug. The clinical severity scores for Group B were significantly more improved than Group A on days 4 and 5 (p less than 0.05 and p less than 0.05, respectively), and better than that of Group C on days 3, 4, and 5 (p less than 0.05, 0.005, and 0.05, respectively). No significant difference was found between Group A and C from days 1 to 5. The previous wheezy coughing episodes were significantly more frequent in Group B than in Groups A and C (p less than 0.05). Two-thirds of the quick responders to hydrocortisone and procaterol were 12 months old or older. The personal and family allergic history, serum IgE level, and total eosinophil count could not be used as parameter to predict responsiveness to the combined therapy of hydrocortisone and procaterol.
1318567.8183559271993.09.21++Randomized comparison of home uterine activity monitoring and routine care in patients discharged after treatment for preterm labor.Obstet Gynecol
DA Nagey, C Bailey-Jones, AA Herman,
OBJECTIVE: To determine whether home uterine activity monitoring reduces the likelihood of preterm birth in women successfully treated for preterm labor in their current pregnancies. METHODS: Women between 20-34 weeks' gestation who had been treated successfully for preterm labor were solicited to participate in a randomized clinical trial of home uterine activity monitoring versus routine high-risk care. The sample size of 56 was based on power calculations using the results of earlier investigators. Twenty-eight women were randomized to home uterine activity monitoring and 29 were assigned to the type of care appropriate for women discharged after hospitalization for parenteral treatment of preterm labor. One of the routine-care subjects was lost to follow-up. The two groups were comparable in distribution for race, insurance status, multiple gestation, marital status, gestational age at beginning of the study, and incidence of prior preterm birth. RESULTS: The 28 women receiving routine care had a 54% incidence of preterm birth, whereas the incidence was 57% in monitored women (relative risk 1.08, 95% confidence interval 0.6-1.9; P = .79). The incidences of delivery before 32 weeks and 34 weeks also were unaffected by the intervention. CONCLUSION: Home uterine activity monitoring is not effective in reducing the likelihood of preterm delivery in patients successfully treated for preterm labor in their current pregnancies.
1318667.8190651331997.03.17++Antiphospholipid antibody-associated recurrent pregnancy loss: treatment with heparin and low-dose aspirin is superior to low-dose aspirin alone.Am J Obstet Gynecol
WH Kutteh,
OBJECTIVE: The purpose of this study was to compare the use of low-dose aspirin alone with heparin and low-dose aspirin in the treatment of the antiphospholipid antibody syndrome. STUDY DESIGN: A prospective, single-center trial included 50 patients who were alternately assigned to treatment. Each patient had at least three consecutive spontaneous pregnancy losses, positive antiphospholipid antibodies on two occasions, and a complete evaluation. Data were compared by chi(2) analysis and Fisher's exact test. RESULTS: Viable infants were delivered of 11 of 25 (44%) women treated with aspirin and 20 of 25 (80%) women treated with heparin and aspirin (p < 0.05). There were no significant differences between the low-dose aspirin and the heparin plus low-dose aspirin groups with respect to gestational age at delivery (37.8 +/- 2.1 vs 37.2 +/- 3.4 weeks), number of cesarean sections (18% vs 20%), or complications. CONCLUSION: Heparin plus low-dose aspirin provides a significantly better pregnancy outcome than low-dose aspirin alone does for antiphospholipid antibody-associated recurrent pregnancy loss.
1318767.81164401152006.02.21++Adrenocortical function in hospitalised patients with active pulmonary tuberculosis receiving a rifampicin-based regimen -- a pilot study.S Afr Med J
WD Francois Venter, VR Panz, C Feldman, BI Joffe,
OBJECTIVE: To assess whether adrenocortical function was compromised in patients with active tuberculosis (TB) during the first 5 days of therapy with either a rifampicin-based or ciprofloxacin-based regimen. DESIGN: Patients were randomised into two groups of 10 each. Adrenocortical function was compared in both groups by the measurement of biochemical indices, electrolytes, osmolality and pituitary-adrenocortical hormones. Adrenal reserve was assessed by intravenous 250 mug adrenocorticotropin hormone (ACTH) stimulation tests. SETTING: Department of Medicine, Johannesburg Hospital. SUBJECTS: Twenty hospitalised patients who were diagnosed with TB. OUTCOME MEASURES: Respiratory rate, pulse rate and blood pressure were recorded, and urinary sodium and osmolality were measured. Serum ACTH, cortisol, dehydroepiandrosterone- sulphate (DHEA-S) and aldosterone were assayed. RESULTS: None of the patients demonstrated biochemical evidence of overt adrenal insufficiency. There were no significant differences between the two groups before or during therapy for any biochemical indices, electrolytes, hormones or calculated osmolality. Mean basal cortisol concentrations were substantially elevated and DHEA-S levels were consistently subnormal, resulting in a high cortisol/ DHEA-S ratio. In the ciprofloxacin group, cortisol responses to ACTH stimulation on day 1 were not significantly lower than on day 5. In the rifampicin group, cortisol concentrations decreased at each time point on day 5 compared with day 1 (p = 0.001). However, a significantly higher mean incremental rise from the basal cortisol concentration was measured on day 5 at 60 minutes (p = 0.04). In the entire cohort of 20 patients, 40% demonstrated an incremental cortisol rise of < 250 nmol/l after ACTH stimulation on day 1. CONCLUSIONS: Rifampicin did not additionally impair adrenocortical function during the initial period of therapy. The high cortisol/DHEA-S ratio might be of clinical relevance.
1318867.8183382861993.08.26++Laparoscopic appendectomy for acute appendicitis: is there really any benefit?Am Surg
DM Schroder, JC Lathrop, LR Lloyd, JE Boccaccio, A Hawasli,
Laparoscopic appendectomy is emerging as a popular treatment modality for acute appendicitis. Although claims have been made to potential superiority over traditional appendectomy, comparisons of operative difficulty, hospital stay, hospital costs, complication rates, postoperative pain, and convalescence have not been well studied. Two hundred consecutive patients presenting with signs and symptoms of acute appendicitis underwent appendectomy. Traditional appendectomy was employed in 101 patients, while 99 underwent laparoscopy. Successful laparoscopic appendectomy was possible in 89 patients who were compared with the 101 patients with traditional appendectomy. There were two pregnant patients with appendicitis in each group. The incidence of acute appendicitis was 72 per cent for traditional appendectomy and 74 per cent for laparoscopic appendectomy. Operating time was significantly longer with laparoscopic appendectomy (60.1 vs 45.4 minutes, P = 0.0001). This was reflected in higher (although not significant) hospital costs ($8,683 vs $6,213). Post-op hospital stay was shorter for laparoscopic appendectomy (2.7 vs 3.8 days, P = 0.001). Complication rates were no different between the two groups. Post-op pain, as evaluated by a patient grading scale, was less for laparoscopic appendectomies up to the third post-op week (P = 0.003). The amount of IM pain medication was greater with traditional appendectomy (P = 0.009). Convalescence was significantly shorter with laparoscopic appendectomy as measured by: 1) return to normal household activity (7.8 vs 13.2 days, P = 0.016), 2) returned ability to exercise (19.7 vs 29.0 days, P = 0.009), 3) patient feeling well enough to return to work (14.1 vs 19.2 days, P = 0.032), and 4) actual return to work (15.4 vs 20.5 days, P = 0.038).(ABSTRACT TRUNCATED AT 250 WORDS)
1318967.8073730871980.07.28++A prospective double-blind study of side effects associated with the administration of amantadine for influenza A virus prophylaxis.J Infect Dis
YJ Bryson, C Monahan, M Pollack, WD Shields,
During a study of efficacy of amantadine prophylaxis of influenza A virus infection in young adults, gross and subtle side effects were monitored. Eighty-eight students were randomly selected to receive either amantadine or placebo for four weeks or both in a sequential crossover design of two weeks each. Side effects (i.e., dizziness, nervousness, and insomnia) occurred in 33% of those receiving amantadine and in 10% of those receiving placebo (P less than 0.005). Although side effects were well tolerated by most subjects, six volunteers discontinued amantadine because of marked complaints. Cessation of side effects occurred in more than half of those continuing amantadine. Sixteen students receiving amantadine had decreased performance on sustained attention tasks as compared with ones receiving placebo (P less than 0.05). Gross and subtle side effects of amantadine observed in this study on currently recommended dosage are higher than previously reported, which may be an important factor in consideration of mass prophylaxis.
1319067.80152309992004.07.20++School-milk intervention trial enhances growth and bone mineral accretion in Chinese girls aged 10-12 years in Beijing.Br J Nutr
X Du, K Zhu, A Trube, Q Zhang, G Ma, X Hu, DR Fraser, H Greenfield,
A 2-year milk intervention trial was carried out with 757 girls, aged 10 years, from nine primary schools in Beijing (April 1999 - March 2001). Schools were randomised into three groups: group 1, 238 girls consumed a carton of 330 ml milk fortified with Ca on school days over the study period; group 2, 260 girls received the same quantity of milk additionally fortified with 5 or 8 microg cholecalciferol; group 3, 259 control girls. Anthropometric and bone mineralisation measurements, as well as dietary, health and physical-activity data, were collected at baseline and after 12 and 24 months of the trial. Over the 2-year period the consumption of this milk, with or without added cholecalciferol, led to significant increases in the changes in height (> or =0.6 %), sitting height (> or =0.8 %), body weight (> or 2.9 %), and (size-adjusted) total-body bone mineral content (> or =1.2 %) and bone mineral density (> or =3.2 %). Those subjects receiving additional cholecalciferol compared with those receiving the milk without added 25-hydoxycholecalciferol had significantly greater increases in the change in (size-adjusted) total-body bone mineral content (2.4 v. 1.2 %) and bone mineral density (5.5 v. 3.2 %). The milk fortified with cholecalciferol significantly improved vitamin D status at the end of the trial compared with the milk alone or control groups. It is concluded that an increase in milk consumption, e.g. by means of school milk programmes, would improve bone growth during adolescence, particularly when Ca intake and vitamin D status are low.
1319167.8078360271995.03.02++Dynamic training and circulating neuropeptides in patients with rheumatoid arthritis: a comparative study with healthy subjects.Int J Clin Pharmacol Res
C Ekdahl, R Ekman, I Petersson, B Svensson,
This study aimed at evaluating the effects of a dynamic physical training programme on circulating levels of corticotropin-releasing hormone (CRH), beta-lipotropin (beta-LPH), and beta-endorphin (beta-EP) after high-intensity training for 6 weeks (60 min twice a week) and after low-intensity training (home-training) for another 6 months in patients with rheumatoid arthritis (RA) and in healthy subjects. Additionally, differences in neuropeptide levels between the two groups were studied. A total of 30 patients with RA were randomly allocated to the study, 15 in the training group (TG) and 15 in the control group (CG). In addition, 20 healthy subjects (10 in TG; 10 in CG) participated. In addition to the biochemical analyses, the following variables were assessed for the RA group: pain and disability (Stanford health assessment questionnaire), joint tenderness (Ritchie articular index), disease activity, muscle function, aerobic capacity, sociodemographic data and attitudes. The results obtained at the start revealed significant differences (p < 0.05) between RA patients and healthy subjects concerning CRH levels, RA patients showing the lower levels (RA-group Md = 24 pmol/L, healthy group Md = 29 pmol/L). No significant differences concerning beta-LPH and beta-EP were found here. After the high-intensity training period, a significant increase of the CRH levels were found for the RA-TG (pretest Md = 24 pmol/L, after 6 weeks Md = 27 pmol/L, p < 0.05). No such results were found for the healthy-TG or the control groups. Concerning beta-EP, significant differences between the RA-TG and healthy-TG were found after the training. RA patients generally showing higher levels as compared with the healthy (RA-group Md = 42 pmol/L, healthy group Md = 36 pmol/L, p < 0.05). The same pattern was found for the beta-LPH levels. In conclusion, the effects of physical training on circulating neuropeptides remain still incompletely examined, and there is no definite answer to the question whether increased beta-EP levels are good or bad.
1319267.8071124571982.10.12++Airway response to salbutamol: effect of regular salbutamol inhalations in normal, atopic, and asthmatic subjects.Thorax
JE Harvey, AE Tattersfield,
This study was designed to determine whether resistance to the airway effects of the beta-agonist, salbutamol, would develop in three groups of subjects while taking large doses of inhaled salbutamol. Six normal non-atopic, six atopic non-asthmatic, and eight atopic asthmatic subjects were studied by an identical technique. The development of resistance was assessed from salbutamol dose-response studies in which the airway response was measured as specific airway conductance (sGaw). Further evidence was sought in the atopic and asthmatic subjects by measuring the airway response to a standard histamine inhalation challenge and the protective effect of 100 micrograms salbutamol on this challenge, and by six-hourly peak flow recordings. Subjects were assessed before and during four weeks in which they took inhaled salbutamol regularly in doses increasing to 500 microgram quid in week 4. Normal subjects showed a progressive reduction in the bronchodilator (sGaw) response to salbutamol during the four weeks, indicating the progressive development of resistance. The atopic subjects, both asthmatic and non-asthmatic, showed no reduction in the response to salbutamol during the four weeks, nor any change in the response to histamine challenge or in regular peak flow readings. These results demonstrate that asthmatic patients do not develop bronchial beta-adrenoceptor resistance easily and suggests that they and atopic non-asthmatic subjects are less susceptible to its development than normal subjects.
1319367.8038959621985.09.19++Efficacy of single- versus multiple-dose clotrimazole therapy in the management of vulvovaginal candidiasis.Am J Obstet Gynecol
T Lebherz, E Guess, N Wolfson,
Single-dose treatment of vulvovaginal candidiasis with a 500 mg clotrimazole vaginal tablet was compared to 3-day treatment with two 100 mg vaginal tablets administered daily in 115 patients enrolled in a double-blind trial, 101 of whom were evaluated for efficacy. Patients with clinically and mycologically active disease were treated (visit 1) and examined at 5 to 10 days (visit 2) and again at least 27 days (visit 3) post treatment. At visit 2, mycologic tests and clinical examinations were negative in 37 of 48 patients receiving single-dose treatment (77%) and in 47 of 53 patients receiving 3-day treatment (89%). Corresponding results for visit 3 were 65% and 74%, respectively. There were no significant differences in treatment response between groups, and only three patients reported adverse reactions. These data show that single-dose treatment with clotrimazole, 500 mg, is as safe and effective as the more complex 3-day regimen.
1319467.7983729521993.10.14++Effectiveness of permethrin-impregnated bed nets and curtains for malaria control in a holoendemic area of western Kenya.Am J Trop Med Hyg
RF Beach, TK Ruebush, JD Sexton, PL Bright, AW Hightower, JG Breman, DL Mount, AJ Oloo,
The effectiveness of village-wide use of permethrin-impregnated bed nets or eave, window, and door curtains as control measures for Plasmodium falciparum malaria was evaluated during two successive high-transmission seasons in western Kenya. Pairs of villages were assigned to one of three study groups: bed net, curtain, or control. Clinical, parasitologic, and entomologic measures were made from March to July 1990 and again 12 months later. When compared with the controls in 1990 and 1991, we observed a marked reduction in the incidence of P. falciparum infections in children less than six years old in the bed net villages (reduced by 40% and 48%) and a smaller but still significant reduction in the curtain villages (10% and 33%). Significant reductions were also seen in the incidence of P. falciparum parasitemias greater than 2,500/mm3 in the bed net group (reduced by 44% and 49%) and curtain group (16% and 32%). Additionally, we observed significant reductions in the incidence of documented fevers in association with P. falciparum parasitemia in bed net (reduced by 63%) and curtain villages (53%) when compared with controls. Entomologic inoculation rates in both bed net and control villages decreased by more than 50% below control values during both high transmission seasons. The results of this study, together with a 1988 study in the same area during the low transmission season, show that bed nets offer greater year-round of protection against P. falciparum infection than curtains. However, during the high transmission season, this technique reduces the frequency of P. falciparum infection rather than preventing it entirely.
1319567.79104716081999.10.14++Impact of immunomodulating therapy on morbidity in patients with severe sepsis.Am J Respir Crit Care Med
D Pittet, S Harbarth, PM Suter, K Reinhart, A Leighton, C Barker, F Macdonald, E Abraham,
We assessed the impact, over a 28-d period, of therapy with the tumor necrosis factor (TNF) neutralizing receptor fusion protein (p55-IgG) on the incidence of end-organ failures in patients with severe sepsis or early septic shock in a subgroup of 165 patients recruited into a randomized, multicenter clinical trial to receive placebo (n = 78) or a single infusion of p55-IgG, 0.083 mg/kg (n = 87). At study entry, distribution of organ dysfunctions and other baseline characteristics were similar for the two study groups. Treatment with p55-IgG was associated with a trend toward reduced 28-d mortality (p = 0.07), a decreased incidence of new organ dysfunctions (relative risk [RR], 0.57; 95% confidence interval [95% CI] 0.29 to 1.10, p = 0.10), and a decreased overall incidence-density of organ failures (RR 0.65; 95% CI 0.60 to 0.71, p = 0.0001). Patients treated with p55-IgG had more organ failure-free days after study entry than those who received placebo. Average intensive care unit (ICU) stay was 2.6 d shorter (95% CI 0.2 to 5.0) for patients who received p55-IgG than for those who received placebo. For those patients who survived, this difference was 4.1 d (95% CI 1.6 to 6.6). Duration of ventilatory support was 3.2 d shorter (95% CI 0.1 to 6.3) among 28-d survivors who received p55-IgG, compared with placebo. In conclusion, in the population of septic patients studied, treatment with p55-IgG was associated with a trend toward shorter need for mechanical ventilatory support, a decreased length of stay (LOS), and a decreased incidence and duration of organ failure.
1319667.7980093461994.07.18++Reduction of back and posterior pelvic pain in pregnancy.Spine
HC Ostgaard, G Zetherström, E Roos-Hansson, B Svanberg,
STUDY DESIGN: This study analyzed an education and training program concerning back and pelvic problems among pregnant women. OBJECTIVE. The program was aimed at reducing back and pelvic posterior pain during pregnancy. SUMMARY OF BACKGROUND DATA. Low back and posterior pelvic pain accounts for the majority of sick leave among pregnant women. No previous study has suggested any type of solution to this problem. METHODS. Four hundred and seven consecutive pregnant women were included in the study and randomly assigned into three groups. Group A served as controls while different degrees of interventions were made in groups B and C. RESULTS. Serious back or posterior pelvic pain developed in 47% of all women. Pain-related problems were reduced in groups B and C (P < 0.05), and sick-leave frequency was reduced in group C (P < 0.01). For some of the women in this group, pain intensity was also reduced 8 weeks post partum (P < 0.05). Weekly physical exercise before pregnancy reduced the risk for back pain problems in pregnancy (P < 0.05). A non-elastic sacro-iliac belt offered some pain relief to 82% of the women with posterior pelvic pain. CONCLUSIONS. An individually designed program reduced sick leave during pregnancy. Working with groups was less effective. Differentiation between low back and posterior pelvic pain was essential. Good physical fitness reduced the risk of back pain in a subsequent pregnancy. Reduction of posterior pelvic pain by a non-elastic pelvic support was experienced by 82% of the women with posterior pelvic pain.
1319767.7975153871994.07.05++Effects of replacement dose of dehydroepiandrosterone in men and women of advancing age.J Clin Endocrinol Metab
AJ Morales, JJ Nolan, JC Nelson, SS Yen,
Aging in humans is accompanied by a progressive decline in the secretion of the adrenal androgens dehydroepiandrosterone (DHEA) and DHEA sulfate (DS), paralleling that of the GH-insulin-like growth factor-I (GH-IGF-I) axis. Although the functional relationship of the decline of the GH-IGF-I system and catabolism is recognized, the biological role of DHEA in human aging remains undefined. To test the hypothesis that the decline in DHEA may contribute to the shift from anabolism to catabolism associated with aging, we studied the effect of a replacement dose of DHEA in 13 men and 17 women, 40-70 yr of age. A randomized placebo-controlled cross-over trial of nightly oral DHEA administration (50 mg) of 6-month duration was conducted. During each treatment period, concentrations of androgens, lipids, apolipoproteins, IGF-I, IGF-binding protein-1 (IGFBP-1), IGFBP-3, insulin sensitivity, percent body fat, libido, and sense of well-being were measured. A subgroup of men (n = 8) and women (n = 5) underwent 24-h sampling at 20-min intervals for GH determinations. DHEA and DS serum levels were restored to those found in young adults within 2 weeks of DHEA replacement and were sustained throughout the 3 months of the study. A 2-fold increase in serum levels of androgens (androstenedione, testosterone, and dihydrotestosterone) was observed in women, with only a small rise in androstenedione in men. There was no change in circulating levels of sex hormone-binding globulin, estrone, or estradiol in either gender. High density lipoprotein levels declined slightly in women, with no other lipid changes noted for either gender. Insulin sensitivity and percent body fat were unaltered. Although mean 24-h GH and IGFBP-3 levels were unchanged, serum IGF-I levels increased significantly, and IGFBP-1 decreased significantly for both genders, suggesting an increased bioavailability of IGF-I to target tissues. This was associated with a remarkable increase in perceived physical and psychological well-being for both men (67%) and women (84%) and no change in libido. In conclusion, restoring DHEA and DS to young adult levels in men and women of advancing age induced an increase in the bioavailability of IGF-I, as reflected by an increase in IGF-I and a decrease in IGFBP-1 levels. These observations together with improvement of physical and psychological well-being in both genders and the absence of side-effects constitute the first demonstration of novel effects of DHEA replacement in age-advanced men and women.
1319867.78110741092001.02.02++Can critically timed sleep deprivation be useful in pregnancy and postpartum depressions?J Affect Disord
BL Parry, ML Curran, CA Stuenkel, M Yokimozo, L Tam, KA Powell, JC Gillin,
BACKGROUND: The aim of this study was to test the efficacy of critically timed sleep deprivation in major mood disorders (MMD) occurring during pregnancy and postpartum. METHODS: Nine women who met DSM-IV criteria for a MMD with onset during pregnancy or within 1 year postpartum underwent a trial of either early-night sleep deprivation (ESD), in which they were sleep deprived in the early part of one night and slept from 03:00-07:00 h, or late-night sleep deprivation (LSD), in which they were deprived of sleep in the latter part of one night and slept from 21:00-01:00 h. Mood was assessed before the night of sleep deprivation, after the night of sleep deprivation, and after a night of recovery sleep (sleep 22:30-06:30 h) by trained clinicians, blind to treatment condition, using standardized scales. RESULTS: More patients responded to LSD (nine of 11 trials: 82%) compared with ESD (two of six trials: 33%) and they responded more after a night of recovery sleep (nine of 11 nights: 82%) than after a night of sleep deprivation (six of 11 nights: 55%). Pregnant women were the only responders to ESD and the only nonresponders to LSD. LIMITATIONS: The small and heterogeneous sample size prevents us from making more definitive conclusions based on statistical analyses. CONCLUSIONS: Although the findings are preliminary, the results suggest that with further study, critically timed sleep deprivation interventions may benefit women with pregnancy or postpartum major mood disorders and potentially provide a viable alternative treatment modality for those women who are not candidates for pharmacologic or psychotherapeutic interventions. Such interventions are needed to help prevent the devastating effects of depression during pregnancy and the postpartum period on the mother, infant, her family and society.
1319967.7830843151986.06.13++Effect of glibenclamide in insulin-treated diabetic patients with a residual insulin secretion.Diabete Metab
T Mauerhoff, JM Ketelslegers, AE Lambert,
We have studied the effect of the combination of a sulfonylurea (Hb 420 or glibenclamide) with insulin in 22 type II diabetic patients, treated with insulin and with residual insulin secretion (fasting plasma C peptide level greater than 0.2 pmol/ml). After a 3 week run-in period, the patients received either glibenclamide (7 mg of Hb 420 before breakfast and 3.5 mg before supper) or placebo in double blind fashion. Clinical and biological parameters (body weight, number of hypoglycemic episodes, daily insulin dose, fasting and postprandial glucose and C peptide levels after a standard meal) were collected during the basal (run-in) period and after 8 and 16 weeks of treatment. In the glibenclamide group, a significant increase in the number of hypoglycemic episodes was observed in spite of a 8 to 10% reduction in insulin requirements. A 18% reduction of both fasting and postprandial plasma glucose levels was found after 8 and 16 weeks of glibenclamide therapy. Concomitantly, a 35% increase of fasting and postprandial plasma C peptide levels occurred. The data suggest that the use of combined sulfonylurea and insulin therapy may be beneficial to type II diabetic patients with residual insulin secretion and poor glycemic control under insulin therapy alone.
1320067.7813137461992.05.13++Sumatriptan in the treatment of acute migraine with aura.Cephalalgia
M Banerjee, LJ Findley,
The efficacy of the selective 5HT1-like agonist sumatriptan in acute treatment of classical migraine (i.e. migraine with aura) was assessed in a double-blind, placebo-controlled, parallel group randomized trial. An oral dose of 200 mg was chosen on the basis of the efficacy rates achieved (70-85%) with 70-280 mg in open studies (1, 2). The dose of 200 mg was also chosen for the study because preliminary data from an oral pilot study indicated that efficacy increased with increasing dose up to 200 mg. Each patient was treated for a maximum of three separate attacks of migraine with aura within a three months' period. Three attacks were treated so that we could examine consistency of response across more than one attack. For attack 1, 200 mg sumatriptan was significantly more effective, safe and well tolerated than placebo at relieving headache 2 h after treatment was given (p = 0.023). In subsequent attacks, i.e. in attacks 2 and 3, there was no such significant effect of sumatriptan compared with placebo in relieving headache. This reduced efficacy of sumatriptan in the second and third attacks may be due to a high incidence of vomiting induced by the high dose of dispersible formulation and also by the bitter taste of the tablets. In addition, there was an increase in placebo response in attacks 2 and 3 compared to the first attack.
1320167.7898468001999.02.16++Guided tissue regeneration in the treatment of human infrabony defects. Clinical, radiographical and microbiological results: a pilot study.J Clin Periodontol
G Bratthall, G Söderholm, AM Neiderud, B Kullendorff, S Edwardsson, R Attström,
The aim of the study was to evaluate the clinical, radiographical and microbiological outcome after using guided tissue regeneration (GTR) with a bioabsorbable membrane, Resolut. Subjects with bilateral infrabony defects at single rooted teeth were selected. A total of 22 teeth, 2 in each 1 of 7 patients and 4 in 2 patients, with probing pocket depth > or =5 mm, 3 months after scaling, participated. At baseline, assessments of plaque and gingival indices, bleeding on probing, probing pocket depth and probing attachment level were recorded and reproducible radiographs for computer-based bone level measurements were taken. Bacterial samples were collected to investigate the presence of periodontitis-associated bacteria, e.g., Porphyromonas/Prevotella- and Fusobactrium-like micro-organisms. One tooth was randomly treated with GTR and the contralateral with an open debridement procedure as a control. Clinical, radiographical and microbiological examinations were repeated 6 and 12 months postoperatively. Both procedures demonstrated a statistically significant improvement of gingival conditions, reduction of pocket depths and gain of attachment. When evaluating the differences between test and control teeth, none of the clinical parameters yielded statistical difference. Computer-based bone-level measurements showed only small differences in the majority of both test and control sites. The differences were not significant. Periodontitis-associated bacteria were present at baseline, but the appearance was not related to any specific site or patient and did not demonstrate any unwanted change in the 6- and 12-month samples. The findings suggest that the clinical, radiographical and microbiological improvements were not significantly enhanced with the GTR therapy.
1320267.7895754611998.06.08++Can postal prompts from general practitioners improve the uptake of breast screening? A randomised controlled trial in one east London general practice.J Med Screen
AM O'Connor, CJ Griffiths, MR Underwood, S Eldridge,
OBJECTIVE: To determine the effect on the uptake of breast screening of a personalized letter from the general practitioner recommending mammography, sent to coincide with an invitation from the NHS breast screening programme. DESIGN: Randomised control trial with stratification of prognostic variables. SETTING: A group practice in Hackney, east London. SUBJECTS: 473 women invited for breast screening by the City and East London Breast Screening Service. OUTCOME MEASURE: Attendance for mammography. RESULTS: All women in the randomised trial were followed up; 134 of 236 (57%) randomly allocated to receive the prompting letter attended for mammography compared with 120 of 234 (51%) controls This difference was not significant (chi 2 = 1.43, p = 0.23) CONCLUSION: Personal recommendation by a letter prompting attendance for mammography from the general practitioner known best to women due to be screened did not improve uptake of breast screening in this east London practice. Other strategies are needed to increase uptake of mammography in inner cities.
1320367.7770212621981.10.25++A double-blind comparison of ibuprofen, ASA-codeine-caffeine compound and placebo in the treatment of dental surgery pain.J Int Med Res
DJ Squires, EL Masson,
A double-blind randomized clinical trial was conducted in eighty-seven patients with mild, moderate or severe dental surgery pain to evaluate the analgesic activity of a single dose of the following compounds: (i) ibuprofen 400 mg, (ii) ACC-30 (a compound containing ASA 375 mg; codeine phosphate 30 mg; caffeine citrate 30 mg), (iii) placebo. Ibuprofen was significantly better than ACC-30 and placebo on almost all pain intensity, degree of relief and duration of analgesia parameters. ACC-30 was not significantly different from placebo on any analgesic measurement. No serious side-effects were reported with any of the study medications.
1320467.7795508881998.05.14++Does adjunctive fluoxetine influence the post-hospital course of restrictor-type anorexia nervosa? A 24-month prospective, longitudinal followup and comparison with historical controls.Psychopharmacol Bull
M Strober, R Freeman, M DeAntonio, C Lampert, J Diamond,
A 24-month naturalistic, prospective longitudinal followup study was conducted on 33 patients with anorexia nervosa who had participated in an intensive, multidisciplinary inpatient treatment program and were receiving fluoxetine as part of their continuing treatment regimen. Data on course, outcome, and treatment exposure in this cohort were obtained using standardized, comprehensive interviews administered at 6-month intervals after hospital discharge. Longitudinal course data for these patients were compared with data for matched historical controls who had received identical inpatient and followup treatment but without adjunctive fluoxetine. Analyses failed to show that fluoxetine had a significant effect on the cumulative probability of remaining at target weight during the followup period, the risk of sustained weight loss, or other clinical measures of outcome. Thus, adjunctive treatment with fluoxetine may not have additive long-term therapeutic benefit when measured against the effects of sustained and intensive followup treatment.
1320567.7720129091991.05.13++Randomised controlled trial of day and in-patient psychiatric treatment. 2: Comparison of two hospitals.Br J Psychiatry
F Creed, D Black, P Anthony, M Osborn, P Thomas, D Franks, R Polley, S Lancashire, P Saleem, B Tomenson,
Acutely ill patients presenting for admission in two district psychiatric services were randomly allocated to day-hospital or in-patient care. In both services a quarter of all admissions could not be allocated because they were too ill (half of these were compulsory admissions); these patients were predominantly manic and schizophrenic patients with pronounced psychotic symptoms and disturbed behaviour. In one service 80% (41/51) of patients randomly allocated to day-hospital treatment were successfully engaged in treatment compared with 54% (19/35) in the other service. This difference arose because only patients with mildly disturbed behaviour could be treated at the second day hospital. For patients who were successfully allocated, the outcome of treatment was similar in terms of psychiatric symptoms and social functioning. The results of a treatment trial for acutely ill patients in one district service cannot be generalised to other district services without due attention to the factors, such as staffing levels, which determine the degree of disturbed behaviour that can be tolerated in the day hospital.
1320667.77100509821999.03.11++Evaluation of clinical benefit of chemotherapy in patients with upper gastrointestinal cancer.Acta Oncol
K Hoffman, B Glimelius,
A new endpoint, the Clinical Benefit Response (CBR), was recently suggested as a means of measuring the effectiveness of palliative chemotherapy in patients with pancreatic cancer. We took advantage of extensive recordings of measurements of treatment effects in two trials in patients with gastrointestinal cancer in order to assess the relevance of CBR criteria. In 151 patients, 53 with pancreatic cancer, 37 with biliary cancer and 61 with gastric cancer, who were randomized between chemotherapy with best supportive care and best supportive care alone, CBR criteria were applied retrospectively to the evaluations of the effects on the patients' well-being made by the treating physician and by the patient in quality-of-life questionnaires, chiefly EORTC QLQ C-30. When compared with subjective response evaluations made by both the physician and the patients' questionnaire data, it was found that CBR overestimated the beneficial effects in certain patients and underestimated them in others. The reason for this overestimation was mainly that the adverse effects of the chemotherapy were not considered appropriately. The underestimation was mainly due to the fact that CBR in practice is dominated by pain assessment, and alterations in other symptoms are also clinically relevant. CBR did, however, show the same differences between the two randomized groups as the subjective response evaluations and the quality-of-life estimations. It is concluded that CBR can be used as a method of measuring the beneficial clinical impact of a treatment strategy in clinical trials, but its limitations in reflecting several important aspects influencing the overall well-being of patients do, however, restrict its use. The criteria designed for use in patients with pancreatic cancer cannot be immediately applied to patients with other cancer types.
1320767.7694666391998.02.19++Pulmonary infiltrates, eosinophilia, and cardiomyopathy following corticosteroid withdrawal in patients with asthma receiving zafirlukast.JAMA
ME Wechsler, E Garpestad, SR Flier, O Kocher, DA Weiland, AJ Polito, MM Klinek, TD Bigby, GA Wong, RA Helmers, JM Drazen,
CONTEXT: Zafirlukast is a potent leukotriene antagonist that recently was approved for the treatment of asthma. As use of this drug increases, adverse events that occur at low frequency or in populations not studied in premarketing clinical trials may become evident. OBJECTIVE: To describe a clinical syndrome associated with zafirlukast therapy. DESIGN: Case series. PATIENTS: Eight adults (7 women and 1 man) with steroid-dependent asthma who received zafirlukast. MAIN OUTCOME MEASURES: Development of a clinical syndrome characterized by pulmonary infiltrates, cardiomyopathy, and eosinophilia following the withdrawal of corticosteroid treatment. RESULTS: The clinical syndrome developed while patients were receiving zafirlukast from 3 days to 4 months and from 3 days to 3 months after corticosteroid withdrawal. All 8 patients developed leukocytosis (range, 14.5-27.6 x 10(9)/L) with eosinophilia (range, 0.19-0.71). Six patients had fever (temperature >38.5 degrees C), 7 had muscle pain, 6 had sinusitis, and 6 had biopsy evidence of eosinophilic tissue infiltration. The clinical syndrome improved with discontinuation of zafirlukast treatment and reinitiation of corticosteroid treatment or addition of cyclophosphamide treatment. COMMENT: Development of pulmonary infiltrates, cardiomyopathy, and eosinophilia may have occurred independent of zafirlukast use or may have resulted from an allergic response to this medication. We suspect that these patients may have had a primary eosinophilic infiltrative disorder that had been clinically recognized as asthma, was quelled by steroid treatment, and was unmasked following corticosteroid withdrawal facilitated by zafirlukast.
1320867.76153337232004.10.14++Blood pressure response to dietary modifications in free-living individuals.J Nutr
CA Nowson, A Worsley, C Margerison, MK Jorna, AG Frame, SJ Torres, SJ Godfrey,
A diet rich in fruits, vegetables, and low-fat dairy foods has been shown to lower blood pressure (BP) when all foods are provided. We compared the effect on BP (measured at home) of 2 different self-selected diets: a low-sodium, high-potassium diet, rich in fruit and vegetables (LNAHK) and a high-calcium diet rich in low-fat dairy foods (HC) with a moderate-sodium, high-potassium, high-calcium DASH-type diet, high in fruits, vegetables and low-fat dairy foods (OD). Subjects were randomly allocated to 2 test diets for 4 wk, the OD and either LNAHK or HC diet, each preceded by a 2 wk control diet (CD). The changes in BP between the preceding CD period and the test diet period (LNAHK or HC) were compared with the change between the CD and the OD periods. Of the 56 men and 38 women that completed the OD period, 43 completed the LNAHK diet period and 48 the HC diet period. The mean age was 55.6 +/- 9.9 (+/-SD) years. There was a fall in systolic pressure between and the CD and OD [-1.8 +/- 0.5 mm Hg (P < 0.001)]. Compared with OD, systolic and diastolic BPs fell during the LNAHK diet period [-3.5 +/- 1.0 (P < 0.001) and -1.9 +/- 0.7 (P < 0.05) mmHg, respectively] and increased during the HC diet period [+3.1 +/- 0.9 (P < 0.01) and +0.8 +/- 0.6 (P = 0.15) mm Hg, respectively]. A self-selected low-sodium, high-potassium diet resulted in a greater fall in BP than a multifaceted OD, confirming the beneficial effect of dietary intervention on BP in a community setting.
1320967.7635162571986.06.06++A collaborative, double-blind randomized study of cetiedil citrate in sickle cell crisis.Blood
LJ Benjamin, LR Berkowitz, E Orringer, VN Mankad, AS Prasad, LM Lewkow, RK Chillar, CM Peterson,
We have recently completed a double-blind, placebo-controlled, noncrossover study, the goal of which was to determine whether cetiedil citrate (cetiedil) could affect the course of vaso-occlusive crises in sickle cell disease. Patients, who presented to the emergency room at least 4 but no more than 24 hours after the onset of a painful vasoocclusive crisis severe enough to require hospitalization, were considered candidates for the study. Each patient received either placebo or cetiedil at one of the following three dosages: 0.2, 0.3, or 0.4 mg/kg body weight. The assigned drug dosage was given as a 30 minute intravenous infusion every 8 hours for 4 consecutive days. A total of 67 patients was enrolled in the study. Cetiedil, at its highest dosage (0.4 mg/kg body weight), was found to be significantly superior to placebo both in reducing the number of painful sites present on all 4 treatment days and in shortening the total time in crisis. No serious adverse reactions were observed during the course of the study. We conclude that cetiedil, given at a dosage of 0.4 mg/kg body weight, is therapeutically advantageous for sickle cell crisis.
1321067.7538861221985.05.31++Interim analysis of a phase III study on preoperative radiation therapy in resectable rectal carcinoma. Trial of the Gastrointestinal Tract Cancer Cooperative Group of the European Organization for Research on Treatment of Cancer (EORTC).Cancer
A Gerard, JL Berrod, F Pene, J Loygue, A Laugier, R Bruckner, G Camelot, JP Arnaud, U Metzger, M Buyse,
To improve surgical results of potentially operable rectal cancer (T2, T3, T4, Mo), the European Organization for Research on Treatment of Cancer (EORTC) conducted a two-arm randomized clinical trial to evaluate the effect of administering radiotherapy before radical surgery. Four hundred ten patients were allocated to be treated either by surgery alone or by 34.5 Gy of radiotherapy (in 19 days overall) followed by surgery. The tolerance of the adjuvant radiation therapy was fairly good. The 5-year survival rate was 65% overall and showed no difference between both therapeutic regimens. Similarly, the metastases-free rate was the same in both groups. In contrast, the preoperative radiation therapy showed a marked effect on local control of the disease, the comparison of the time to local recurrence being highly significant between the two treatment groups (P = 0.001). The proportion of patients free of local recurrence at 5 years was 85% in the combined treatment versus 65% in the group of patients treated by surgery alone.
1321167.7577509171995.06.21++Treatment with two growth hormone regimens in girls with Turner syndrome: final height results. Dutch Growth Hormone Working Group.Horm Res
G Massa, BJ Otten, SM de Muinck Keizer-Schrama, HA Delemarre-van de Waal, M Jansen, T Vulsma, W Oostdijk, JJ Waelkens, JM Wit,
In 1987 a multicentre trial of recombinant human growth hormone (GH) was started in girls with Turner syndrome. Fifty-four patients were randomly assigned to receive GH, 8 IU/m2 3 times/week (group 1), or 4 IU/m2 6 times/week (group 2). In addition, the 35 patients older than 12 years received ethinyloestradiol, 100 ng/kg body weight/day, and after 2 years GH therapy was increased to 6 IU/m2 6 times/week. Recombinant human GH treatment was stopped when the height increment during the previous 6 months of treatment was less than 0.5 cm. Treatment has so far been stopped in 48 patients: treatment was stopped early in 2 patients due to lack of motivation, 1 patient died suddenly and the treatment protocol was completed in 45 patients. The last height measurement obtained, which was considered as (near) final height, was 152.3 +/- 5.3 cm (mean +/- SD) in these patients, which is higher (p < 0.001) than the adult height of 147.0 +/- 6.3 cm reported in 63 untreated adult Dutch patients with Turner syndrome. No differences in outcome were found between the two dose regimens.
1321267.7576400381995.09.18++Neurotoxicity is not enhanced by increased dose intensities of cisplatin administration.Eur J Cancer
PH Hilkens, ME van der Burg, JW Moll, AS Planting, WL van Putten, CJ Vecht, MJ van den Bent,
It is uncertain whether intensive dosing schedules of cisplatin, intended to attain a higher anti-tumour efficacy, alter the severity of cisplatin-induced neuropathy. We assessed the development of neuropathy in three groups of patients treated with cisplatin in different dosing schedules. The severity of neuropathy was determined by measurement of the vibration perception threshold (VPT) before treatment and during follow-up for 2-12 months after the last cycle. 66 patients were treated with an intensive weekly regimen of doses varying from 70 to 85 mg/m2 in 1 day (trial A), 21 patients with a 3-weekly combination chemotherapy containing cisplatin 75 mg/m2 in 1 day (trial B) and 20 patients with a 3-weekly regimen containing cisplatin 20 mg/m2 for 5 consecutive days (trial C). The mean dose intensity achieved was 59 mg/m2/week in trial A, 21 mg/m2/week in trial B and 33 mg/m2/week in trial C. The maximum post-treatment VPT correlated significantly with pretreatment VPT (P < 0.001) and with the cumulative dose of cisplatin (P < 0.001). Following correction for these two variables, the maximum posttreatment VPT did not show a statistically significant association with dose intensity. These results suggest that neuropathy is not related to dose intensity of cisplatin. This implies that treatment with more intensive dosing schedules, employing equal cumulative doses of cisplatin, does not result in a concomitant increase in neurotoxicity within a cumulative dose range of 280-675 mg/m2.
1321367.75153155962004.10.05++Impact of recombinant FSH dose adjustments on ovarian response in the second treatment cycle with IVF or ICSI in "standard" patients treated with 150 IU/day during the first cycle.Acta Obstet Gynecol Scand
B Popovic-Todorovic, A Loft, S Ziebe, AN Andersen,
BACKGROUND: A dose of 150 IU/day of recombinant follicle stimulating hormone (rFSH) is commonly used as a "standard" dose for "standard" patients in the first in vitro fertilization (IVF) treatment cycle. In the second cycle, the starting dose is adjusted in those patients who had an inappropriate response during the first cycle. The purpose of the study was to assess the impact of dose adjustments on ovarian response. MATERIALS AND METHODS: Retrospective study including 567 first IVF/intracytoplasmic sperm injection (ICSI) cycles using the long agonist protocol in "standard" patients. In the second cycle 385 patients who had failed to achieve an ongoing pregnancy were included. The starting dose in the second cycle was adjusted according to the response in the first cycle. RESULTS: A total of 215 patients (55.8%) had altered starting dose in the second cycle: 193 (50.1%) received >150 IU/day, whereas 22 (5.7%) had <150 IU/day. In the group given >150 IU/day, significantly more follicles (9.8 vs. 8.3, p = 0.002) and oocytes (8.4 vs. 6.7, p <0.0001) were obtained in the second cycle. In the group given <150 IU/day, there were significantly fewer follicles (20.4 vs. 13.5, p <0.0001) and oocytes (16.4 vs. 11.4, p = 0.005) in the second cycle. In the group given <150 IU/day in the second cycle, six (27.3%) had an appropriate ovarian response (5-14 oocytes) in the first cycle compared to 14 (63.6%) women in the second cycle (p = 0.01). The ongoing pregnancy rates in all of the first (32.1%) and second cycles (27%) were similar (p = NS). CONCLUSION: In a "standard" patient population, 55.8% needed an altered starting dose in the second cycle and rFSH dose adjustments had a significant impact on the ovarian response.
1321467.75110681592000.12.07++Complementary and alternative medicine in the management of pain, dyspnea, and nausea and vomiting near the end of life. A systematic review.J Pain Symptom Manage
CX Pan, RS Morrison, J Ness, A Fugh-Berman, RM Leipzig,
To review the evidence for efficacy of complementary and alternative medicine (CAM) modalities in treating pain, dyspnea, and nausea and vomiting in patients near the end of life, original articles were evaluated following a search through MEDLINE, CancerLIT, AIDSLINE, PsycLIT, CINAHL, and Social Work Abstracts databases. Search terms included alternative medicine, palliative care, pain, dyspnea, and nausea. Two independent reviewers extracted data, including study design, subjects, sample size, age, response rate, CAM modality, and outcomes. The efficacy of a CAM modality was evaluated in 21 studies of symptomatic adult patients with incurable conditions. Of these, only 12 were directly accessed via literature searching. Eleven were randomized controlled trials, two were non-randomized controlled trials, and eight were case series. Acupuncture, transcutaneous electrical nerve stimulation, supportive group therapy, self-hypnosis, and massage therapy may provide pain relief in cancer pain or in dying patients. Relaxation/imagery can improve oral mucositis pain. Patients with severe chronic obstructive pulmonary disease may benefit from the use of acupuncture, acupressure, and muscle relaxation with breathing retraining to relieve dyspnea. Because of publication bias, trials on CAM modalities may not be found on routine literature searches. Despite the paucity of controlled trials, there are data to support the use of some CAM modalities in terminally ill patients. This review generated evidence-based recommendations and identified areas for future research.
1321567.7422888261991.04.04++A comparison of the central nervous system effects of haloperidol, chlorpromazine and sulpiride in normal volunteers.Br J Clin Pharmacol
GR McClelland, SM Cooper, AJ Pilgrim,
1. Twelve healthy male volunteers participated in four experimental occasions during each of which they were dosed with one of the following anti-psychotic drugs: chlorpromazine (50 mg), haloperidol (3 mg), sulpiride (400 mg) and placebo. Drugs were allocated to subjects in a double-blind, crossover fashion. 2. The subject's mood state, psychometric performance and electroencephalogram (EEG) were assessed pre-dose, and at 2, 4, 6, 8, 24 and 48 h post-dose. Mood states were assessed using 16 visual analogue scales and psychomotor performance was measured using the following tests: elapsed time estimation, tapping rate, choice reaction times, a rapid information processing task, flash fusion threshold, a manipulative motor task, digit span, body sway and tremor. 3. Chlorpromazine and haloperidol significantly reduced subjective ratings of 'alertness' and 'contentedness', and haloperidol significantly reduced feelings of 'calmness'. Sulpiride did not significantly affect any of the visual analogue scales. 4. All three anti-psychotic drugs had similar EEG effects with peak effect 2 to 4 h postdose. The profile was characterised by an increase in the proportion of slow wave activity (delta and theta) as well as decreased alpha (8-14 Hz) and faster (beta) wave activity. 5. Chlorpromazine reduced tapping rate and increased choice reaction movement times. Haloperidol reduced the flash fusion threshold frequency at 6 h post-dose. Sulpiride prolonged the duration of the manipulative motor task, particularly at 48 h post-dose. 6. All three anti-psychotic drugs impaired performance on the rapid information processing task. Chlorpromazine significantly reduced the number of correct letter pair identifications at 2, 4 and 6 h post-dose, haloperidol at 4, 6, 8, 24 and 48 h post-dose, and sulpiride at 24 h post-dose.(ABSTRACT TRUNCATED AT 250 WORDS)
1321667.7464286191984.08.03++The difficult choice of treatment for poorly controlled maturity onset diabetes: tablets or insulin?Br Med J (Clin Res Ed)
I Peacock, RB Tattersall,
Patients with maturity onset diabetes that is poorly controlled on maximal doses of oral hypoglycaemic agents are difficult to treat. A prospective randomised crossover study was performed in 58 predominantly non-obese patients on maximal doses of glibenclamide or metformin, or both, to find out if insulin would improve control or well being. The patients were given daily injections of up to 48 units of highly purified porcine lente insulin. Glycaemic control was improved by 15% or more in only 18 patients; 14 others felt better but their diabetes was no better controlled. Those whose control was improved by insulin could not be distinguished by age, duration of diabetes, body mass index, or their own treatment preference. C peptide concentrations, however, did help predict the response to insulin, the fasting C peptide to glucose ratio being considerably lower in those patients whose control was better on insulin. These findings suggest that a simple insulin regimen does not necessarily lead to better glycaemic control in maturity onset diabetes. Nevertheless, a trial of insulin is often justified since it poses few practical difficulties and makes some patients feel better even if their control is not improved. A more complex regimen might improve control in more cases, but it might also be less acceptable to older patients.
1321767.74121743322002.10.24++[Long-term effect of indoor rehabilitation on children and young people with moderate and severe asthma]Pneumologie
CP Bauer, F Petermann, D Kiosz, R Stachow,
In a multi-centre trial the effect of indoor rehabilitation in case of bronchial asthma in childhood and adolescence was evaluated on a prospective basis in comparison to an ambulant group of patients. 195 children and adolescents aged between 8 and 16 suffering from bronchial asthma (grading of severity 3 and 4) were included in the trial. The rehabilitation group (RG) included 149 patients, whereas the out-patient reference group consisted of 46 patients. At the beginning of the trial (in the rehabilitation group about 14 days before rehabilitation started) and 12 months afterwards, the pulmonary function (FEV 1, peak flow and MEF50), asthma-related school day off, participation in school sport, asthma management and quality of life were recorded. 12 months after the indoor rehabilitation, the rehabilitation group had significantly better MEF50-values (P = 0.007) than the ambulant group. The rehabilitation group also had significantly better values (P < 0.01) with regard to the asthma management. Already at the beginning of the study both groups indicated a satisfactory participation in school sport with 3.5 hours a week which could not be increased further. The baseline values for asthma-related school day off and quality of life of the rehabilitation group were worse than those of the ambulant group. 12 months after rehabilitation, however, the values were significantly better (P < 0.01) compared to baseline and almost similar to the levels of the ambulant group. Significantly improvements with regard to MEF50, asthma management, school day off and quality of life could thus be achieved by indoor rehabilitation.
1321867.74120028782002.10.16++Unilateral versus bilateral injections of botulinum toxin in patients with adductor spasmodic dysphonia.J Voice
S Bielamowicz, SV Stager, A Badillo, A Godlewski,
Both unilateral and bilateral thyroarytenoid muscle injections of Botox provide effective management of voice symptoms in patients with adductor spasmodic dysphonia; however, the preferred injection technique has not been established. In this study, 16 patients were treated with unilateral injections (72 injections total) and 33 patients were managed with bilateral injections (133 injections total). Individual assignments to injection type were based on treatment previously received and dose was adjusted according to the patient's previous treatment response. An optimal treatment included a benefit lasting 3 months or more with side effects lasting 2 weeks or less. Compared to patients receiving bilateral injections, those receiving unilateral injections more frequently noted a benefit of 3 months or more (p = 0.03), side effects of 2 weeks or less duration (p = 0.03), as well as both a 3-month benefit and a 2-week or less side effect (p = 0.0004). Injection type had no effect on optimal Botox dosing with repeat injections. Successive unilateral injections at the same dose were more likely (p = 0.012) than successive bilateral injections to produce the same or longer duration of benefit. We conclude that a unilateral injection routine has a more optimal and consistent treatment effect/side effect profile.
1321967.7373338511982.05.12++A test of interventions to increase adherence to hypertensive medical regimens.Health Educ Q
JP Kirscht, JL Kirscht, IM Rosenstock,
Low rates of adherence to hypertensive therapy limit patients' securing the full benefits of treatment. While some factors related to adherence have been identified research on the effectiveness of interventions to increase adherence levels is sparse. The present study was designed to assess the impact of a series of different interventions on a group of some 400 patients, all under the care of private physicians in a small community. A factorial design was employed to deliver four, sequential educational interventions, about four months apart, to randomly selected sub-groups. Interviews before and after each intervention provided information concerning self-reported adherence, health status, health beliefs, and personal characteristics. Pertinent medical records and pharmacy data were also obtained. The first intervention - printed material - did not significantly affect adherence. The second and fourth interventions - nurse telephone calls and social support - each increased medication taking and the third intervention - self-monitoring - led to better weight control. There was no cumulative impact of the interventions and different aspects of regimens were not significantly related to one another.
1322067.7310894011975.04.16++Psychoactive drugs in mania. A controlled comparison of lithium carbonate, chlorpromazine, and haloperidol.Arch Gen Psychiatry
B Shopsin, S Gershon, H Thompson, P Collins,
Lithium carbonate, haloperidol, and chlorpromazine hydrochloride were compared in a double-blind controlled study with severely ill hospitalized manics. Lithium carbonate and haloperidol produced a highly significant improvement of manic symptoms without sedation. Although producing considerable sedation, chlorpromazine did little to alter the underlying mania qualitatively. Qualitative differences between lithium carbonate and haloperidol indicate that, while haloperidol has a more dramatically rapid impact on behavior-motor activity, lithium carbonate acted more evenly on the entire manic picture, with total normalization realized during active treatment. The majority of lithium carbonate-treated patients met discharge criteria at study termination, but not the patients receiving either neuroleptic drug. The rating scales are not sensitive enough to monitor manic psychopathology; this accounts for the lack of statistically significant differences among drug groups at treatment termination, despite the widely disparate discharge rates.
1322167.7319777401990.12.19++Valproate use in the older manic patient.J Clin Psychiatry
BH McFarland, MR Miller, AA Straumfjord,
The authors present a case series of seven older (mean age = 66 years) state hospital patients treated with valproate as an adjunct to conventional medications. The patients had had affective disorder (chiefly bipolar disorder) for an average of 31 years. Most had been hospitalized at the state hospital for several years. Previous unsuccessful treatments had included lithium, carbamazepine, antipsychotics, benzodiazepines, and antidepressants and electroconvulsive therapy in one patient. After 1 month of adjunctive treatment, valproate led to marked improvement in three patients, moderate improvement in two, minimal improvement in one, and no change in one patient with delusional depression. Global Assessment Scale scores increased over baseline an average of 29 points (p = .01). Valproate proved to be safe in these older individuals, many of whom had several medical conditions.
1322267.7313482261992.05.01++Coronary heart disease risk factors before and after bypass surgery: results of a controlled trial on multifactorial rehabilitation.Eur Heart J
E Engblom, T Rönnemaa, H Hämäläinen, V Kallio, E Vänttinen, LR Knuts,
The effect of a three-phase multifactorial institution-based rehabilitation programme on coronary heart disease (CHD) risk factors was studied in an open randomised trial comprising 228 patients undergoing coronary artery bypass surgery allocated into a rehabilitation (R) group (n = 119) and a hospital (H = control) group (n = 109). Follow-up examinations were performed at 6 and 12 months. Serum total cholesterol and triglyceride levels decreased significantly in both groups during follow-up. These decreases were not significantly different between the R and H groups. Serum high density lipoprotein (HDL) cholesterol level increased significantly at 6 and 12 months in the R group, but not in the H group. The differences in the changes between the groups were not significant. The ratio of serum HDL cholesterol to total cholesterol increased significantly in the R group from the preoperative value of 0.154 to 0.179 (P less than 0.001) at 6 months and to 0.180 (P less than 0.001) at 12 months. In the H group these values were 0.152, 0.166 (P less than 0.001) and 0.168 (P less than 0.001), respectively. The significance of the differences in the changes between the groups were P = 0.01 at 6 months and 0.06 at 12 months. These differences were more obvious in patients aged 55 years or under. There was a significant decrease (P = 0.005) in the proportion of smokers in the R group and a significant increase in the proportion of patients taking regular exercise in both groups as assessed by questionnaire.(ABSTRACT TRUNCATED AT 250 WORDS)
1322367.7287716421996.11.19++The Latin American trial of psychosocial support during pregnancy: effects on mother's wellbeing and satisfaction. Latin American Network For Perinatal and Reproductive Research (LANPER).Soc Sci Med
A Langer, U Farnot, C Garcia, F Barros, C Victora, JM Belizan, J Villar,
A randomized controlled trial including 2235 women at high risk of low birthweight was conducted in four Latin American institutions. The objective of this trial was to evaluate a psychosocial support intervention during pregnancy aimed at improving perinatal health and mothers' psychosocial conditions. The core of the intervention was four to six home visits where emotional support, counseling and strengthening of the woman's social network was provided. Outcomes were measured at 36 weeks of pregnancy, post-partum and 40 days after delivery. The intervention was not successful in either altering women's perception of social support and satisfaction with the reproductive experience, as well as maternal and newborn's health care. It is concluded that although high levels of psychosocial distress during pregnancy may play an independent role in determining adverse pregnancy outcomes, this adverse effect does not appear to be ameliorated by psychosocial interventions conducted only during pregnancy, particularly those of a magnitude that can be realistically implemented (in content and frequency) at public care services in most developing countries.
1322467.7282681171994.01.31++A comparison between lidocaine alone and lidocaine with meperidine for continuous spinal anesthesia.Reg Anesth
P Maurette, G Bonada, V Djiane, P Erny,
BACKGROUND AND OBJECTIVES. Experimental investigations have demonstrated a synergistic interaction between opioids and local anesthetics. This study aims to assess the effective benefit-risk ratio of continuous spinal anesthesia (CSA) induced with either 1.6% lidocaine alone or in combination with 1% meperidine. METHODS. Thirty-four elderly patients (80.7 +/- 7.3 years) operated on for fracture of the neck of the femur were randomly allocated to two groups. In the first group (n = 15), CSA was induced with lidocaine 1.6% plain, whereas in the second group (n = 19) 1% meperidine was added. Reinjections were performed in both groups using lidocaine 1.6% alone. RESULTS. In the lidocaine group, 43 +/- 13 mg was used for induction whereas in the other group the addition of 18 +/- 5 mg of meperidine significantly reduced the dose of lidocaine required to 28 +/- 8 mg (p < 0.001). Delay between two reinjections was increased to 51 +/- 7 minutes in the lidocaine plus meperidine group, compared to 35 +/- 6 minutes in the lidocaine group (p < 0.001). Ephedrine was required for 9 out of the 19 patients in the lidocaine plus meperidine group, whereas it was required for only two patients in the other group (p = 0.05). Mean plasma concentrations of meperidine 1 hour and 3 hours after induction was 45.5 +/- 12 ng/ml and 59 +/- 22 ng/ml, respectively, and drowsiness was observed in 95% of the patients in the second group. Delay before requirement for pain medication was 2.2 +/- 2 hours in the lidocaine group and 14.1 +/- 8 hours in the lidocaine plus meperidine group (p < 0.001). CONCLUSIONS. The association of 1% meperidine with 1.6% lidocaine during the induction of CSA decreases the initial induction dose, prolongs analgesia, produces initial drowsiness, and provides long-lasting pain relief. However, such benefits are offset by some impairment of hemodynamic stability that is likely to make this combination of drugs unacceptable as an enhanced analgesic technique.
1322567.7220000551991.04.08++Acupuncture for bronchial asthma? A double-blind crossover study.Med J Aust
MK Tandon, PF Soh, AT Wood,
The therapeutic effectiveness of classic Chinese acupuncture was compared with "placebo" acupuncture in 15 patients with stable bronchial asthma. The patients received treatments with real and placebo acupuncture in a randomly ordered, subject and evaluator-blind crossover fashion twice weekly for five weeks. Both real and placebo treatment periods were preceded by three week periods when no acupuncture was administered. Five patients felt better on real treatment, five patients preferred placebo and five did not feel any improvement on either of the two treatments. Treatment with real acupuncture when compared with no treatment and placebo treatment failed to provide any improvement in daily peak flow rates, asthma symptom scores, number of puffs of beta 2-agonist aerosol use, and pulmonary function results.
1322667.7219061521991.08.09++Adjunctive leuprolide therapy does not improve cycle fecundity in controlled ovarian hyperstimulation and intrauterine insemination of subfertile women.Obstet Gynecol
WC Dodson, DK Walmer, CL Hughes, SE Yancy, AF Haney,
Problems arising from controlled ovarian hyperstimulation for intrauterine insemination, such as premature luteinization and asynchronous ovarian follicular development, are identical to those encountered with controlled ovarian hyperstimulation for in vitro fertilization (IVF) and gamete intrafallopian transfer (GIFT). It has been suggested that the adjunctive use of GnRH agonists for controlled ovarian hyperstimulation improves the efficiency of GIFT and IVF cycles. We hypothesized that adjunctive use of leuprolide acetate, a GnRH agonist, would have a similarly beneficial effect on cycle quality and cycle fecundity in subfertile women treated with controlled ovarian hyperstimulation and intrauterine insemination. We randomly assigned the first cycle of controlled ovarian hyperstimulation and intrauterine insemination for each of 97 subfertile women to include either human menopausal gonadotropins (hMGs) alone or hMGs following midluteal pre-treatment with leuprolide. If a pregnancy did not occur in the first cycle, the woman was given the other treatment in the second cycle. Although the cycles that included leuprolide required a larger amount of hMGs and more days of stimulation per cycle, the mean estradiol concentrations and numbers of follicles were not different. Despite prevention of premature luteinization with leuprolide, the cycle fecundity was not different between groups (0.11 with adjunctive leuprolide treatment and 0.22 with hMGs alone). We conclude that in unselected subfertile patients, the adjunctive use of leuprolide for controlled ovarian hyperstimulation and intrauterine insemination does not improve cycle fecundity compared with treatment cycles that do not include adjunctive leuprolide therapy.
1322767.71146361942004.04.07++Clinical and economic impact of Apligraf for the treatment of nonhealing venous leg ulcers.Int J Dermatol
D Fivenson, L Scherschun,
BACKGROUND: Controlled studies have shown that Apligraf(R) (Organogenesis Inc., Canton, USA) is more economical and more effective at healing venous leg ulcers (VLUs) than compression therapy alone. However, the clinical and economic impact of Apligraf on healing VLUs in clinical practice has not been fully examined. METHODS: A medical chart review was conducted of patients who were treated with Apligraf for one or more nonhealing VLUs over a 2-year period at the Henry Ford Hospital. Following Apligraf treatment, patients were followed for up to 9 months. Primary clinical outcome measures were mean change in baseline ulcer size (cm2) per week and percent reduction in baseline ulcer size at final study visit. Economic evaluation of Apligraf treatment was based on VLU-related medical care costs (US$) in relation to ulcer size (cm2) changes before and after Apligraf therapy. RESULTS: Thirteen patients with 21 chronic VLUs were treated with Apligraf. All had at least one comorbidity, most commonly hypertension (38%). Twelve patients were known to have had a prior history of VLU. At baseline, mean ulcer duration was 23.9 months and median ulcer size was 13.5 cm2; for the 6 months preceding Apligraf treatment, in which patients received conventional compression therapy, mean ulcer size increased +0.72 cm2 per week. During the Apligraf post-treatment study period, mean ulcer size decreased by -2.37 cm2 per week. At final clinic visit, ulcers exhibited an average 60.5% reduction in baseline size; 21 ulcers (n = 13) showed 75% or greater reduction in size, compared with baseline. Economic data were available for five patients; among these individuals ulcer-related medical costs per unit change in ulcer size were lower following Apligraf treatment relative to such costs with conventional compression therapy applied during the Apligraf pretreatment period. CONCLUSIONS: In a clinical practice setting, Apligraf is more effective and more economical at healing VLUs than conventional therapy alone.
1322867.71113529632001.06.07++Improved treatment results in high-risk pediatric acute myeloid leukemia patients after intensification with high-dose cytarabine and mitoxantrone: results of Study Acute Myeloid Leukemia-Berlin-Frankfurt-Münster 93.J Clin Oncol
U Creutzig, J Ritter, M Zimmermann, D Reinhardt, J Hermann, F Berthold, G Henze, H Jürgens, H Kabisch, W Havers, A Reiter, U Kluba, F Niggli, H Gadner,
PURPOSE: To improve outcome in high-risk patients, high-dose cytarabine and mitoxantrone (HAM) was introduced into the treatment of children with acute myelogenous leukemia (AML) in study AML-BFM 93. Patients were randomized to HAM as either the second or third therapy block, for the purpose of evaluation of efficacy and toxicity. PATIENTS AND METHODS: A total of 471 children with de novo AML were entered onto the trial; 161 were at standard risk and 310 were at high risk. After the randomized induction (daunorubicin v idarubicin), further therapy, with the exception of HAM, was identical in the two risk groups and also comparable to that in study Acute Myeloid Leukemia-Berlin-Frankfurt-Münster (AML-BFM) 87. RESULTS: Overall, 387 (82%) of 471 patients achieved complete remission, and 5-year survival, event-free survival (EFS), and disease-free survival rates were 60%, 51%, and 62%, respectively. Idarubicin induction resulted in a significantly better blast cell reduction in the bone marrow on day 15. Estimated survival and probability of EFS were superior in study AML-BFM 93 compared with study AML-BFM 87 (P =.01, log-rank test). This improvement, however, was restricted to the 310 high-risk patients (remission rate and probability of 5-year EFS in study AML-BFM 93 v study AML-BFM 87: 78% v 68%, P =.007; and 44% v 31%, P =.01, log-rank test). Probability of 5-year EFS among standard-risk patients in study AML-BFM 93 was similar to that in study AML-BFM 87 (65% v 63%, P = not significant). Whether HAM was placed as the second or third therapy block was of minor importance. However, patients who received the less intensive daunorubicin treatment during induction benefited from early HAM. CONCLUSION: Improved treatment results in children with high-risk AML in study AML-BFM 93 must be attributed mainly to the introduction of HAM.
1322967.71145682692004.07.20++A randomized trial of consensus interferon in combination with ribavirin as initial treatment for chronic hepatitis C.J Hepatol
G Fattovich, I Zagni, E Minola, M Felder, P Rovere, A Carlotto, S Suppressa, A Miracolo, C Paternoster, C Rizzo, A Rossini, P Benedetti, M Capanni, C Ferrara, P Costa, T Bertin, M Pantalena, L Lomonaco, C Scattolini, G Mazzella, M Giusti, S Boccia, S Milani, R Marin, M Lisa Ribero, A Tagger,
BACKGROUND/AIMS: The aim of the present, open-labeled, randomized study was to determine the efficacy and safety of different doses of consensus interferon plus ribavirin in the initial treatment of chronic hepatitis C. METHODS: One hundred and one genotype 2/3 patients were randomized to receive 9 mcg (group A, n=48) or 18 mcg (group B, n=53) of consensus interferon thrice weekly plus ribavirin (1000/1200 mg/daily) for 24 weeks and 92 genotype 1 patients to receive 9 mcg (group C, n=47) or 18 mcg (group D, n=45) of consensus interferon plus ribavirin for 48 weeks. RESULTS: In an intention-to-treat analysis, the sustained virologic response at 24-week follow-up was 69% and 66% for group A and B (P=0.77) and 40% and 36% for group C and D (P=0.63). The overall sustained response was 67% and 38% in patients with genotype 2/3 and 1, respectively. Among genotype 1 patients the sustained virologic response was 39% and 41% for high or low baseline viremia levels. CONCLUSIONS: Higher consensus interferon dose does not increase sustained virologic response. Naive genotype 1 patients may achieve significant response rate of approximately 40% if treated with 9 mcg of consensus interferon plus ribavirin for 48 weeks.
1323067.7082178881993.12.09++The sedative effect of intranasal midazolam administration in the dental treatment of patients with mental disabilities. Part 1. The effect of a 0.2 mg/kg dose.J Clin Pediatr Dent
O Fukuta, RL Braham, H Yanase, N Atsumi, K Kurosu,