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E Autret

Publications and source records attributed to E Autret.

134 records · Page 8Linked to original sources
PubMedDate not supplied

[Can the sub-notification of drug adverse effects by capture/recapture method be evaluated?].

The incidence of adverse effects of a drug can be evaluated from the relationship between adverse effects reported to the drug company and to French drug surveillance centres and the number of patients exposed to the drug. Many adverse effects are never reported and this under-reporting is variable. The capture/recapture method can be used in drug surveillance to evaluate the importance of under-reporting for an adverse effect of a drug. This method, based upon the intersection of two different data sources with the aim of identifying the number of common cases, can estimate the number of unreported cases if at least two independent data sources are available. Scrupulous identification of each case and of common cases and study of the independence of the two systems are essential for this method. The application of the capture/recapture method to spontaneous reporting permits the estimation of the total number of cases and the completeness of registration of the two data sources (the drug company and the French drug surveillance centres). This application of the capture/recapture method needs to be validated by comparing the results to the results of prospective studies whenever possible.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

[Methodology of preparing a list of educational objectives: example of application to pharmacology. Groupe Objectifs Pédagogiques de L'Association des Enseignants de Pharmacologie].

Using a structured approach to categorize pharmacological knowledge and a systemic analysis of prescribing practice, we identified the knowledge needed to optimally prescribe and manage treatments with drugs. The approach consisted in finding the branched chains of knowledge beginning with each operation required to solve each problem which arises in prescribing and managing drugs at the most elementary level. This elementary knowledge is then transformed into educational objectives. The next step is to share the educational objectives between basic medical training, continuing medical education and acquisition of therapeutic knowledge. The method could be applied in other medical teaching domains.

Educational Technology↗
PubMedDate not supplied

[Thrombocytopenic purpura after isolated or combined vaccination against measles, mumps and rubella].

A retrospective epidemiological survey was conducted to evaluate the incidence and characteristics of thrombocytopenic purpura (TP) reported in France following measles, mumps or rubella vaccination with monovalent or multivalent vaccines. Sixty cases of TP were reported i.e an incidence/100,000 doses of 0.23 and 0.17 for measles or rubella vaccines respectively given alone, to 0.87 for combined measles-rubella vaccine and 0.95 for MMR vaccine. The mean age was 21 +/- 12 months and the delay of diagnosis was 16 +/- 6 days after vaccination. Thrombopenia was severe (mean platelet count: 8000 +/- 6000/mm3) and always associated with purpura. The immediate outcome was favourable in 89.5 per cent of cases. Vaccine-associated TP appears to be similar to acute childhood idiopathic thrombocytopenic purpura but the clear temporal relationship between MMR vaccination and the occurrence of TP make a causal relationship highly plausible. Acute TP seems a rare complication of measles-rubella and MMR vaccination but clinicians had to be informed of the possibility of their occurrence. Acute TP following vaccination should be reported by physicians to their Regional Drug Surveillance Centre.

Child↗
PubMedDate not supplied

[Aseptic meningitis after mumps vaccination].

The aim of this retrospective study was to evaluate the incidence and the characteristics of spontaneously reported aseptic meningitis (AM) in France following mumps vaccination with monovalent or multivalent vaccines containing the Urabe strain. Fifty-four cases of AM were reported to the regional drug surveillance centres or to the manufacturer from the time each vaccine was launched up until June 1992. Twenty cases were associated with the time off administration of a monovalent mumps vaccine and 34 with a trivalent measles, mumps and rubella vaccine (MMR). A mumps virus was isolated in four cases in the cerebrospinal fluid and an Urabe-like strain was characterised twice by polymerase chain reaction (PCR). A probable mumps origin was assumed in 17 other cases where the patients presented with other clinical or biological signs of mumps infection. The clinical outcome of AM was always favourable. The global incidence of mumps vaccine-associated AM was 0.82/100,000 doses, which is significantly lower than the incidence in the unvaccinated population. Even considering that the actual incidence of AM is much higher when assessed by active surveillance studies, the risk/benefit ratio of mumps vaccine remains in favour of vaccination. The incidence of mumps vaccines containing Jeryl Lynn (ROR Vax et Imu ORR) associated with AM needs to be evaluated.

Adolescent↗
PubMedDate not supplied

[Esophageal involvement after tetracycline ingestion].

Between 1985 and 1992, 81 spontaneous oesophageal injuries associated with tetracycline were notified to the French Regional Pharmacovigilance Centres. The side effects were oesophageal ulcers (79 per cent), esophagitis (11 per cent) and dysphagia (10 per cent). Esophagitis and dysphagia appeared sooner (4 days) than the ulcers (15 days). The mean age of the patients was 29 +/ 13 years and 73 per cent were women. In 92 per cent of cases, the recommendations for administration were not observed (medication taken at bedtime with not enough or without water). With 96 per cent of patients, doxycycline was the tetracycline in question; this prevalence could be explained by its irritant and cytotoxic properties. The oesophageal injuries were 22 times more frequent with capsules than with tablets, because of their easier adhesion to the oesophageal surface. Oesophageal injuries are potentially serious and must be avoided by clear information to patients and prescribers on tetracycline administration; consumption in the middle of a meal with an adequate quantity of water and never less than one hour before bedtime.

Adolescent↗
PubMedDate not supplied

[Toxicology of reproduction: predictive value of experimental models. Round Table No 1 at Giens XIII].

The carrying out of clinical trials with a view to the marketing of drugs for human use is directly related to results of some animal studies. This workshop was devoted to evaluation of the quality and interest of these experimental models in reproductive toxicology. The predictive ability of preclinical trials to make extrapolations from animals to man decreases from foetotoxic to tetratogenic risks respectively and from the effects on fertility in both sexes to postnatal risks. As a result of this workshop, we propose the following improvements: (1) standardization and generalization of fertility test evaluations, especially the spermogram, in order to improve animal and human correlations; (2) development of knowledge and standardization of the follow up of the oestral cycle; (3) improvement of standardization, harmonization and diffusion of postnatal tests that prove relevant in animals; (4) increase in initiatives aimed at better mutual understanding of all drug partners; (5) creation of registers for new drugs, as soon as possible during clinical trials, to study their effects on the whole reproductive process; (6) recommendations for the creation of guidelines for International Conference on Harmonisation (ICH) to enable classification of observed effects in experimental models. This could lead to specific (potentially for each phase of the reproductive cycle) guidelines, precautions for use and/or contraindications which are listed in the summary of product characteristics.

Animals↗