Faillie Jean-Luc
Département de pharmacologie médicale et toxicologie, centre régional de pharmacovigilance, CHU de Montpellier, 371, avenue du doyen Gaston-Giraud, 34295 Montpellier, France; EA2415, laboratoire de biostatistiques, épidémiologie et santé publique, faculté de médecine, institut universitaire de recherche clinique, université de Montpellier, 34295 Montpellier, France.
Therapie. 2018 May-Jun;73(3):247-255. doi: 10.1016/j.therap.2017.08.006. Epub 2017 Oct 31.
Case-non case studies belongs to the methods assessing drug safety by analyzing the disproportionality of notifications of adverse drug reactions in pharmacovigilance databases. Used for the first time in the 1980s, the last few decades have seen a significant increase in the use of this design. The principle of the case-non case study is to compare drug exposure in cases of a studied adverse reaction with that of cases of other reported adverse reactions and called "non cases". Results are presented in the form of a reporting odds ratio (ROR), the interpretation of which makes it possible to identify drug safety signals. This article describes the principle of the case-non case study, the method of calculating the ROR and its confidence interval, the different modalities of analysis and how to interpret its results with regard to the advantages and limitations of this design.
病例-非病例研究属于通过分析药物警戒数据库中药物不良反应报告的不均衡性来评估药物安全性的方法。该方法于20世纪80年代首次使用，在过去几十年中其使用量显著增加。病例-非病例研究的原理是将所研究不良反应病例中的药物暴露情况与其他报告的不良反应病例（称为“非病例”）中的药物暴露情况进行比较。结果以报告比值比（ROR）的形式呈现，对其进行解读有助于识别药物安全信号。本文描述了病例-非病例研究的原理、ROR及其置信区间的计算方法、不同的分析方式以及如何根据该设计的优缺点来解读其结果。
