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Biomedical subjects

J F Bergmann

Publications and source records attributed to J F Bergmann.

At least 19 recordsLinked to original sources
PubMed1996

[Portal hypertension caused by intra-hepatic block in chronic lymphoid leukemia].

A 83-year-old woman with chronic lymphoid leukemia--well controlled for 14 years with chemotherapy--was admitted for ascitis due to portal hypertension. Liver biopsy showed major portal infiltration with monomorphic little lymphocytes. Portal hypertension during chronic lymphoid leukemia might be caused by this periportal lymphoid infiltration or by intraportal venous thrombosis due to thrombophilia or by increasing of hepatic blood flow. Our observation showed that hepatic localizations of the disease may induce acute symptoms even when the lymphoid leukemia seems to be under control both in terms of blood parameters and lymphadenopathy.

Aged↗
PubMed1996

Prevention of venous thromboembolic risk in non-surgical patients.

The risk of deep-vein thrombosis in hospitalized medical patients varies considerably among diseases and should be systematically assessed as a function of the presence of different risk factors. The need for drug prophylaxis of thromboembolic risk in patients at moderate or high risk of thrombosis is now recommended. In such cases, only standard or low-molecular-weight heparins have been evaluated in controlled trials. The efficacy of heparin prophylaxis has been demonstrated in hospitalized cardiac patients following myocardial infarction, in neurological patients with paralysis of one or both lower limbs, and in intensive-care patients or in those with a serious medical condition, particularly if they have a history of deep-vein thrombosis. The choice between the different heparins, their dosages and treatment durations, and the possible indication for prophylaxis in patients at low thrombotic risk should be evaluated in controlled trials.

Fibrinolytic Agents↗
PubMed1996

[Can one be a urologist without being familiar with the methodology of therapeutic trials?].

OBJECTIVE: To define the principles of the methodology applied to therapeutic trials in medicine and surgery. To define methodological aspects related to therapeutic trials in urology. To exhaustively study three urology journals in order to analyse the methodological quality of the articles published. METHODS: The basic principles of therapeutic trials are described: the randomized double-blind placebo-controlled trial is the most valid trial to demonstrate the efficacy of a treatment. In surgery, and especially in urology, these therapeutic trials comparing two surgical techniques must be conducted by teams accepting the ambivalence of comparison after randomization. Ideally, treatment is evaluated by observers blinded to the technique used. The assessment criteria must be as clinical as possible and must be based on universally accepted standardized measurements. The quality of a therapeutic trial is assessed in terms of its protocol, but also on the quality of practical conduct of the trial, the precision and accuracy of its statistical analysis and the presentation of the results. The first 1995 issue of the "Journal of Urology", the "British Journal of Urology" and "Progrès en Urologie" were studied exhaustively, looking for articles dealing with a therapeutic evaluation. The comparative or non-comparative nature of the study, the presence or absence of randomization, double-blind, and a predetermined sample size were noted for each study. RESULTS: Ten non-comparative retrospective studies, one non-comparative prospective study and five trials with a control group, including two open randomized trials were reported in the "Journal of Urology". Nine retrospective non-controlled studies were reported in the "British Journal of Urology". Seven retrospective studies, including one open, non-randomized study with a control group, were reported in "Progrès en Urologie". CONCLUSION: The principles of the methodology of therapeutic trials can be applied to the evaluation of a treatment or a surgical technique, especially in urology. Compliance with the rules of methodology impose additional constraints, sometimes difficult to implement, but essential to ensure the quality of the results obtained. Randomized trials are rare in urological publications, which still largely consist of retrospective non-comparative series.

Clinical Trials as Topic↗
PubMed1996

A multicenter randomized double-blind study of enoxaparin compared with unfractionated heparin in the prevention of venous thromboembolic disease in elderly in-patients bedridden for an acute medical illness. The Enoxaparin in Medicine Study Group.

A multicenter, randomized double-blind study compared in two parallel groups the efficacy and safety of a low molecular weight heparin (LMWH) enoxaparin 20 mg once daily, with unfractionated heparin (UFH) 5000 IU twice daily, administered subcutaneously for 10 days, in the prevention of venous thrombosis disease in 442 hospitalized elderly patients bedridden for an acute medical illness. The main efficacy endpoint was defined as the occurrence of venous thrombosis, diagnosed by a daily fibrinogen uptake test, and/or documented clinical pulmonary embolism. Intention-to-treat analysis of efficacy showed that the incidence of venous thromboembolic events was low: 4.8% (10/207) in the LMWH group (9 episodes of isotopic venous thrombosis and one of scintigraphic pulmonary embolism), and 4.6% (10/216) in the UFH group (10 episodes of isotopic venous thrombosis). The two treatments were equivalent, where equivalence was defined as a maximum difference of 7% between the two groups (p = 0.0005). There were no significant differences in terms of safety between the 216 patients in the LMWH group and the 223 patients in the UFH group who received at least one injection of the randomized treatment. During the study period, 15 patients (3.4%) died (7 in the LMWH group and 8 in the UFH group): 2 sudden deaths, one in each group including one case in which pulmonary embolism could not be excluded since no autopsy was performed, and 13 others deaths unrelated to the study treatments. Six patients (1.4%) presented a bleeding complication: 2 (0.9%) in the enoxaparin group (one major and one minor hemorrhage), and 4 (1.8%) in the UFH group (2 major and 2 minor hemorrhages). These results indicate that subcutaneous enoxaparin 20 mg once daily for 10 days is as effective and well tolerated as subcutaneous UFH 5000 IU twice daily in the prevention of venous thromboembolic disease in bedridden elderly in-patients presenting an acute medical illness.

Acute Disease↗
PubMed1995

[Prognostic factors of the speed of cicatrization in duodenal ulcer. Controlled trial of omeprazole versus ranitidine].

OBJECTIVES: The treatment of duodenal ulcers has changed greatly since the introduction of anti-H2 drugs and sodium pump inhibitors. However the effect of several factors influencing prognosis and the rate of healing remain to be elucidated. METHODS: Five hundred forty five patients with a fibroscopically proven duodenal ulcer were included in a randomized controlled trial and were treated for one month with omeprazole (20 mg) or ranitidine (300 mg). Twenty epidemiological, clinical and fibroscopic factors of prognosis were recorded when the patients entered in the study and were analyzed after the treatment period. RESULTS: Endoscopic healing was obtained in 90% of the omeprazole treated patients and in 78% of the ranitidine group (p < 0.001). Multifactorial analysis of the 20 prognostic factors showed that, excepting the treatment factor, only the size of the ulcer (less than 11 mm), its shape (round), its localisation (not on the posterior side) and a moderate pain were factors of good prognosis. Paradoxically, in our study, male patients and alcohol consumption were also positive factors of prognosis. CONCLUSION: The probability of healing is best for round, small duodenal ulcers located on the anterior side of the bulb.

Adult↗
PubMed1995

Orocecal transit time in humans assessed by sulfapyridine appearance in saliva after sulfasalazine intake.

PURPOSE: We propose a noninvasive method for the measurement of orocecal transit time assessed by the sulfapyridine appearance time in saliva after ingestion of sulfasalazine. METHOD: In 12 healthy volunteers, we studied the correlation between plasma and saliva sulfapyridine appearance times and then the sulfapyridine appearance times in saliva under various experimental conditions to assess the reproducibility, the effects of meals, and the role of the formulation, and the effects of gastrointestinal kinetic drugs. RESULTS: The correlation between saliva and plasma sulfapyridine appearance times was strong (r = 0.84; p = 0.0004). The sulfapyridine saliva appearance time was significantly delayed by the meal. Compared with placebo, the saliva sulfapyridine appearance time was reduced by cisapride (312 +/- 128 versus 551 +/- 97 minutes; p = 0.0001) and increased by loperamide (674 +/- 267 versus 501 +/- 131 minutes; p = 0.044). CONCLUSION: We propose the salivary sample method as a validated simplification of the plasma sulfasalazine-sulfapyridine test for the measurement of orocecal transit time.

Adult↗
PubMed1995

Value of a new rapid non-radioactive sequencing method for analysis of the cytomegalovirus UL97 gene in ganciclovir-resistant strains.

Various DNA changes located within a restricted region of the UL97 open reading frame were shown to be associated with the resistance of cytomegalovirus strains to ganciclovir (GCV). In order to analyse this UL97 region in sensitive and GCV-resistant strains, a non-radioactive sequencing assay (Promega, Madison, WI, USA) which combines the dideoxy visualisation by silver-staining of the gel was used. Using this assay, polymerase chain reaction products from results were obtained within 1 day. Point mutations modifying the amino acid sequence of the putative UL97 catalytic site were detected in three isolates. These led to an alanine to valine substitution in residue 594 in one strain with reduced GCV sensitivity, and to a cysteine to glycine substitution in residue 592 in two GCV-resistant isolates. These mutations were different from the DNA changes previously mapped in GCV-resistant laboratory or field strains. No amino acid substitution in the UL97 catalytic site was found in GCV-sensitive isolates. Transfer marker experiments are in progress in order to test the significance of these DNA changes for GCV resistance. This rapid non-radioactive sequencing protocol could be a useful tool for analysing the UL97 region encoding the putative UL97 catalytic site of clinical isolates.

Amino Acid Sequence↗
PubMed1995

[Therapeutic principles in gastroesophageal reflux].

Gastroesophageal reflux is a common disease. Its chronic course, even if mild, is sometimes complicated by erosive oesophagitis. Drug therapy acts against gastric acidity and motility disorders. Treatment of gastroesophageal reflux disease has three aims: improvement of symptoms and quality of life, healing erosive lesions and prevention of symptomatic and endoscopic relapses. Non-drug measures are always useful, even if their efficacy is not well established. Initial therapy of a symptomatic reflux or mild oesophagitis is most of the time effective (antacids, prokinetics, H2 receptor antagonists). Proton-pump inhibitors are also effective in healing and preventing severe oesophagitis. Questions about long-term treatment adverse events with powerful acid inhibitors, such as hypergastrinemia and the risk of gastric carcinoid tumours seem to be resolved. Studies are requested to define the optimal long-term maintenance treatment with cisapride, H2 receptor antagonists or proton-pump inhibitors at low doses in prevention of symptomatic and mild oesophagitis relapses.

Esophagitis, Peptic↗
PubMed1995

[Comparison of the cost-efficacy ratio of omeprazole and ranitidine in the treatment of reflux esophagitis].

OBJECTIVE: The objective of this study was to compare the cost of achieving a unit of clinical success for treatment of reflux oesophagitis with either ranitidine or omeprazole. METHODS: After randomisation 430 patients with reflux oesophagitis (grade 2 or 3) were assigned to receive omeprazole 20 mg or ranitidine 150 b.i.d. for 8 weeks. Patients were given diary cards to assess their symptoms every day, and record every two weeks a life satisfaction index. Patients were seen after 4 and 8 weeks for symptoms assessment and repeat endoscopy at 8 weeks. The perspective of the analysis was that of the payer. The costs of medical care were based in French drug costs currently advertised, payment for physician and actual mean payment for upper GI endoscopy. RESULTS: The healing rates at 8 weeks in the omeprazole group and the ranitidine group were 93 and 67.5% respectively. After 8 weeks of treatment, life satisfaction was good in 81 and 53.6% and the relief of pain was 86,6 and 69,5% respectively. For each effectiveness criteria, omeprazole was more cost effective than ranitidine: cost per healed patient (2,338 F vs 2,744 F), cost per asymptomatic patient (2,510 F vs 2,964 F), cost per patient with a good or very good life satisfaction index (2,687 F vs 3,456 F). This advantage remained independent of the oesophagitis initial severity. The sensitivity analysis showed that the results were unsensitive to the variations of the efficacy variables in their confidence interval. CONCLUSIONS: This cost-effectiveness analysis suggests that in the treatment of reflux oesophagitis, the strategy with the more effective treatment is more cost-effective.

Anti-Ulcer Agents↗
PubMed1995

[Methodology of the evaluation of antiemetics].

A number of clinical trials have only recently been conducted in the evaluation of chemotherapy-induced emesis prophylaxis. This is related to the development of new antiemetic drugs, the 5-HT3 serotoninergic receptors antagonists which are very effective. Methodological principles of drug development have been respected for the commercialization of this new class of antiemetics. The essential phase I and II studies have allowed to establish the maximal tolerated doses and the efficacy-dose relation in order to conduct phase III clinical trials. At this time, the reference treatment for emesis was metoclopramide and thus, phase III trials have been initially conducted with this comparative treatment. These randomized studies have been carried out in parallel group and in double-blind in accordance with a methodology adapted to cancer. The inclusion criteria have allowed to define an homogeneous population of chemotherapy naive patients and clinical trials have been conducted with a stratification related to the emetic power of the chemotherapy. The number of patients to include in the studies was calculated related to the expected efficacy rates of the comparative drugs. The evaluation criteria of nausea and vomiting were standardized and the primary clinical end point to assess the efficacy of antiemetic agents was determined by a complete control (no emetic episode). Nausea, which is a more subjective criterion, was assessed by the patient himself and the results could be included in the global analysis. Furthermore, the persistence of the efficacy over repeated courses has been assessed by clinical trials carried out on two to six cycles.

Adolescent↗
PubMed1994

Inhibition of gastric alcohol dehydrogenase activity by histamine H2-receptor antagonists has no influence on the pharmacokinetics of ethanol after a moderate dose.

Ethanol undergoes gastric first pass metabolism by alcohol dehydrogenase (ADH). We have shown that cimetidine and famotidine both cause competitive inhibition of human gastric ADH in vitro. However, in a randomized 4-way cross-over study in 12 healthy subjects a 7-day course of treatment with cimetidine (800 mg day-1), ranitidine (300 mg day-1) or famotidine (40 mg day-1), did not modify the pharmacokinetics of ethanol given as a post-prandial 0.3 g kg-1 dose. We conclude that gastric mucosal concentrations of histamine H2-receptor blockers achieved after oral dosing are probably too low to cause significant inhibition of gastric ADH in vivo.

Administration, Oral↗