Biomedical subjects
Publications and source records attributed to J F Bergmann.
The presence of antibodies to Ebola virus among 1,517 apparently healthy persons in five regions of the Cameroons was tested using indirect immunofluorescence. A positive rate of 9.7% was found, confirming that the virus circulates in the absence of clinical cases. Highest rates were found among Pygmies, young adults, and rain forest farmers.
A single blind cross-over study was performed comparing a new microencapsulated potassium chloride tablet (MET) with two reference formulations of oral potassium, namely potassium chloride solution (PS), and microencapsulated potassium chloride capsules (MEC), in 18 normal healthy volunteers. The potassium chloride induced change in gastric potential difference (PD) of the mucosa was the main criterion of comparison and was assessed by the area above curve (AAC), the total duration of the effect (TDE), the maximal variation of PD (delta MAX), and the aggression index (AI). The results showed that all three formulations induced a fall in PD; the delta MAX and AAC were significantly greater for PS indicating a higher aggressive effect of the solution; MET had significantly less aggressive effect than MEC when assessed by all parameters.
The pharmacokinetic characteristics of reboxetine, a unique selective noradrenaline reuptake inhibitor (selective NRI) for the treatment of depression, were studied in 12 healthy, elderly volunteers (mean age 81 years +/- 9 years). All subjects received a single 4-mg dose of reboxetine, and plasma reboxetine concentrations were measured by HPLC. Reboxetine was well tolerated by all subjects. Exposure to reboxetine was higher in this group of very elderly subjects, compared with data obtained in a similar study of young, healthy volunteers. Cmax in the elderly was 271 +/- 86 ng/ml, compared with 111 +/- 28 ng/ml in the young subjects after a single 4-mg dose, although in both groups Cmax was observed after 2 h. The AUC infinity was nearly four times that in the younger subjects (8345 +/- 3107 ng.h/ml vs. 2106 +/- 881 ng.h/ml) and the t1/2 was twice as long (24 +/- 6 h vs. 12 +/- 3 h). Renal clearance was also reduced. Reboxetine 8-10 mg/day has been effective and well tolerated in clinical trials in non-elderly depressed patients. The increased exposure to reboxetine observed in our very elderly subjects supports a reduction of the starting dose to 4 mg/day (in two divided doses) in the elderly.
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We compared, in a cross-over study, the toxicity of 300 mg enteric-coated aspirin with regular aspirin used for the prevention of cardiovascular events. In terms of endoscopic haemorrhagic lesions, enteric-coated aspirin is less gastrotoxic than regular aspirin.
In medical patients there are numerous and variable risk factors for deep vein thrombosis. Placebo-controlled clinical trials are rare. The efficacy of standard heparin or low molecular weight heparin for the prevention of deep vein thrombosis is clearly demonstrated for patients with recent myocardial infarction, ischaemic stroke with hemiplegia or severe pulmonary sepsis with lung failure. Pharmacological prophylaxis is probably also efficient in patients with a severe acute disease and a certain history of deep vein thrombosis. For all other medical and especially for bedridden elderly patients, use of low molecular weight heparin might decrease the incidence of deep vein thrombosis but might not modify the overall mortality. In these situations, placebo-controlled clinical trials are needed for best evaluation of the benefit-risk ratio.
Familial adenomatous polyposis is a rare genetic disease characterized by the development of colorectal adenomatous polyps. Extracolonic digestive and extra-digestive manifestations can also appear. Inevitably, colorectal cancer occurs if a colectomy is not performed. Sulindac is an indolic non-steroidal anti-inflammatory indole drug which decreases colonic tumoral proliferation. The different trials published since 1983 have shown that sulindac caused regression of colorectal adenomatous polyps, but it does not affect the other manifestations of familial adenomatous polyposis. However, colorectal polyps recurred after cessation of this therapy; the effect of long-term sulindac therapy is unknown; and sulindac may cause, as a non-steroidal anti-inflammatory drug, digestive side-effects. Moreover, treatment with sulindac does not completely eliminate the risk of cancer. For patients with familial adenomatous polyposis, total colectomy and ileal pouch-anal anastomosis is the recommended procedure for most patients. However, sulindac is useful for patients who have had subtotal colectomy and ileorectal anastomosis, if these patients have only a few rectal stump polyps and accept regular and strict follow-up of the rectal stump. Sulindac is also indicated for patients who have not undergone colectomy because surgery is contraindicated or has been refused.
PURPOSE: The purpose of the French Transparency Commission is to provide scientific advice concerning the usefulness, interest and good use of drugs. DRUG APPROVAL: The work of the Transparency Commission lies at the interface between the French or European marketing approval procedures and the health and economic prerequisites of the French community. ASSESSMENT: The opinion of the French Transparency Commission is used to assess the medical service provided by a new drug and the improvement of this medical service subsequent to its use. This opinion is taken into consideration for establishing the reimbursement rate applied by the social security organizations and the selling price set by the administration. The expert opinions and recommendations established by the Transparency Commission participate in implementing good use of drugs.
The prevention of preventable adverse therapeutic events (iatrogenic), especially drug related, is a major medical goal for patients, economics and the community. Its incidence is 5 to 15 per cent of hospitalization days. Preventable iatrogenic is a main problem in terms of public health owing to its human and economic consequences. Prevention of iatrogenic is based on better knowledge of its reality, on well-adapted initial and long-term intensive training of physicians, other healthcare workers and also patients and citizens. A better healthcare system is also needed.
Quality in healthcare has to evaluate the efficacy, the cost effectiveness and patient satisfaction. Quality of treatment could be evaluated with randomized clinical trials and with satisfaction measurement, leading to professional recommendations. Quality of therapeutic strategy is based on the evaluation of patient monitoring. The quality of the healthcare worker is based on initial training, accreditation and various audits. The final quality in healthcare depends on the competence of the prescriber but also on the medical information, the logistics and the control of prescriptions. Improvements in quality will be obtained by better medical training, patient information and application of professional recommendations. These recommendations have to change gradually to be adapted to medical progress and evidence-based medicine.
Compliance is the appropriateness of patient behaviour to therapeutic prescriptions. Good compliance increases treatment efficacy although its constraints may harm quality of life. Factors affecting compliance are related to the patient, the disease, health-care workers, family and treatment itself. Psycho-sociologic theories have attempted to explain patient behaviour. In clinical trials, compliance has to be optimized, i.e. in the protocol, during the study and the statistical analysis. In real life, compliance concerns all those involved in health-care, particularly for education, training and motivation of the patients and their immediate environment. Observational surveys relating to compliance are needed to determine prioriites and to develop a "compliance approach" based on improving information and the use of tools for better therapeutic adherence. Evaluation of the quality of life and patient satisfaction aspects is necessary to validate this approach.
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Various methods can be used to investigate human hepatic drug metabolism in vivo. a) Indirect methods based on the assessment of atoxic substances metabolism in order to investigate: --hepatic oxidative activity by antipyrine or caffeine clearance and aminopyrine breath test determination. Such an activity can be modified by drug-induced enzyme induction or inhibition and in case of hepatic disease; --genetic polymorphism of hepatic drug metabolism assessed by the determination of debrisoquine or dextrometorphane metabolic ratio and of N-acetylation phénotype. Unusual therapeutic or adverse effects could be explained by such a polymorphism; --hepatic blood flow, which variations could modify hepatic clearance of drugs with a high hepatic extraction ratio, by the assessment of indocyanine green clearance. b) Direct methods based on pharmacokinetics data and their alterations under various circumstances: simultaneous administration of other drugs, liver disease.
In ten healthy volunteers, we evaluated the effects of a 6 days antacid treatment (Rocgel) on the aspirin induced changes in gastric potential difference (PD). In this placebo controlled cross-over study, PD was measured twelve hours after the last take of the antacid. Aspirin induced drop of PD was less pronounced after antacid compared to placebo; maximal fall of PD and area upper the curve decreased (p less than 0.001). This effect was observed twelve hours after the last take of the antacid. It may suggested a long-term protective effect on the gastric mucosa.
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Explore the source record for details and available documents.