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Biomedical subjects

G Bouvenot

Publications and source records attributed to G Bouvenot.

At least 55 records · Page 3Linked to original sources

[Explanatory or pragmatic trials, the dualism].

A comparative clinical trial may have different objectives. For instance, it may be aimed at finding out whether a new drug is actually efficient in man, as suggested by the results of experimental studies: this occur when new molecules are found, or when new indications are discovered for an old drug. In such cases clinical trials are designed as laboratory experiments and the drug must be used in optimum conditions so that its efficacy can be best proven. The trial is said to have an explicative design. A different objective for a trial may be to evaluate the practical interests of a new treatment, the efficacy of which has already been proven; this treatment will then be compared to those already existing and its advantages as well as its drawbacks will have to be considered when recommendations are given. This approach requires a pragmatic design, in order to help physicians take the best therapeutic decisions (or society to take public health decisions). Finally, it is the experimental or pragmatic design of a trial which determines the choice of patients, endpoint criteria, drug regimen, follow-up and methods of comparison.

Clinical Trials as Topic↗

Lack of evidence of ketoprofen kinetic changes during the oestrous cycle in rats.

This study was designed to document possible changes in ketoprofen kinetics in female rats related to the stage of the oestrous cycle. At 3 different stages of the oestrous cycle (proestrus, oestrus or dioestrus), 3 different groups of 5 animals each received a single 10 mg/kg intraperitoneal dose of ketoprofen and blood samples were taken at 0.25, 0.5, 0.75, 1, 2, 4, 8, 12 and 24 h after administration. Ketoprofen pharmacokinetic parameters (Cmax, T1/2 alpha and beta, AUC and MRT) were calculated. Our data did not reveal any significant differences in ketoprofen kinetics related to the oestrous cycle.

Animals↗

[How to evaluate the long-term course of osteoarthritis. Tests for trials of fundamental treatments (spine excluded)].

The best assessment tests for long term trials on osteoarthritis (OA) of the hip and knee are the following, in order of relevance value (consensus of french experts): 1) the loss of joint space thickness on successive radiographies; 2, 3) the indices of the severity for OA of the hip and knee; the investigator's overall opinion; 4) the patient's overall opinion (visual analogue scale of handicap); 5, 6, 7) the pain level (visual analogue scale); the time for going up and down a standard flight of stairs and the time of pain in this distance; the limitation of two articular movements; 8) the increase of either analgesics or NSAIDs consumption; 9) concerning OA of fingers, the number of joints newly involved on successive radiographies. At present, only the radiological tests 1 and 9 are validated. The clinical tests 2 to 8, valuable for short term trials, have yet to be validated for long term follow-up. Recommended duration of trials is three years. A rigorous organisation is necessary to avoid erroneous inclusions: all data recorded in the pre-inclusion visit have to be checked by the principal investigator. Since we have not yet a validated chondroprotective agent as a reference drug, the trial must be randomised, double blind, placebo controlled, parallel group study.

Anti-Inflammatory Agents, Non-Steroidal↗