[Medical penal, civil, administrative and disciplinary responsibility. Definition and elementary notions].
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Biomedical subjects
Publications and source records attributed to C Piva.
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The achievement of therapeutical experiments is from now on submitted to the December 20, 1988 Law which specifies that an agreement must be obtained from the consultative Committee for the Protection of People in biomedical research (Comité consultatif de Protection des Personnes), in order to appreciate the relevance of the project, its research validity and the practical conditions of the experiment. Penal sanctions are estimated for transgressors. In neurosurgery, two specific points are worth stressing: the obtainment of consent and the technical specificity of further investigations. Whereas this consent can be easily obtained from patients still conscious, coma makes its application more difficult, even impossible in case of chronic coma or brain death. Para clinical investigations in neurosurgery entail risks for the patient which must be taken into account and which do not seem in keeping with medical ethics, when they are used in the unique purpose of research.
The pharmacokinetics of the tricyclic antidepressant amineptine (Survector) and its main metabolite were studied in 12 young healthy adults (6 men, 6 women; mean age 35.8 yr). Plasma samples were taken over 24 h following a single oral dose of 100 mg amineptine chloryhdrate. Plasma levels of both compounds were determined by means of high performance liquid chromatography. Amineptine was rapidly absorbed. Mean peak plasma concentrations of amineptine and its metabolite occurred 1 h and 1.5 h, respectively, after product administration. The mean apparent volume of distribution was large: 2.4 l.kg-1. Elimination was rapid; the mean half-lives of the 2 compounds were short: 0.8 h for amineptine and 2.5 h for the metabolite. The mean apparent plasma clearance of amineptine was high (124.8 l.h-1). When the results were adjusted for body weight and surface area, no significant difference in pharmacokinetic parameters was found between men and women. Given its pharmacokinetic characteristics there is no risk of amineptine accumulation and thus it is a particularly easy drug to manage. A standard dosage of amineptine was defined for use in healthy young adults.
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This report presents the ultrastructural nerve study of a patient with sensorimotor neuropathy by a shoe glue containing an association of n-hexane and methylethylketone. Giant axons, distended by microfilamentous proliferation typical of such cases of neuropathy, were found in significant amounts. An unusual histological feature of this case was the considerable distension by a marked accumulation of glycogen granules in certain unmyelinated axons. Such a lesion has never been described in neuropathy induced by industrial agents.
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