RESUMO
In the light of recent experiences and anticipating an increase in similar requests in the future, it seemed very interesting to a drug safety executives' group from the pharmaceutical industry to propose guidelines for the set-up and follow-up of pharmacoepidemiological studies requested by Health Authorities for the assessment of drug risk. The scope of these guidelines is to establish the responsibility of the teams and structures involved in the study, to define the necessary stages set-up, and to determine the rules in order to ensure its smooth running from the drafting of the protocole to the final use of the data.
Assuntos
Farmacoepidemiologia , Vigilância de Produtos Comercializados/métodos , Ensaios Clínicos como Assunto/métodos , Guias como Assunto , Humanos , Legislação FarmacêuticaRESUMO
A retrospective study conducted by interviewing French gastroenterologists was performed with the objective of evaluating the incidence and etiology of pseudomembranous colitis in cases where the diagnosis has been confirmed by coloscopy. This study allowed to collect data on 878 pseudomembranous colitis observed by 438 gastroenterologists within 6 months. It shows evidence of the importance of various antibiotics in the etiology of pseudomembranous colitis (89% of the identified cases). The following is the list of antibiotics or antibiotic classes, in increasing order of their association with the development of pseudomembranous colitis: macrolides which are very rarely associated, a group represented by cefaclor, cefuroxime axetil and cyclins, which are rarely associated, a third group constituted by amoxicillin, ofloxacin and trimethoprim-sulfamethoxazole which appears to be 2 to 3 times more frequently associated than the previous group, and a fourth group of antibiotics, represented by cefixime and the association amoxicillin-clavulanic acid, which is 7 times more frequently associated than antibiotics of the second group.
