CAJ | 학술논문

药品不良反应监测是药品上市后安全性再评价的重要工作之一。国外很早就开始了研究基于自发呈报系统（spontane-ous reporting system，SRS）的不良反应信号的检测方法，但具体采用的检测方法各有不同，目前尚无信号检测方法的金标准。该文阐述了国内外经典的药品不良反应（adverse drug reaction，ADR）信号检测方法和联合用药 ADR 信号检测方法及其应用情况，比较各检测方法的优缺点。探讨适合我国 ADR 监测体系的信号检测方法，以期为我国不良反应信号检测工作的推进提供参考。
약품불량반응감측시약품상시후안전성재평개적중요공작지일。국외흔조취개시료연구기우자발정보계통（spontane-ous reporting system，SRS）적불량반응신호적검측방법，단구체채용적검측방법각유불동，목전상무신호검측방법적금표준。해문천술료국내외경전적약품불량반응（adverse drug reaction，ADR）신호검측방법화연합용약 ADR 신호검측방법급기응용정황，비교각검측방법적우결점。탐토괄합아국 ADR 감측체계적신호검측방법，이기위아국불량반응신호검측공작적추진제공삼고。
Adverse drug reaction(ADR)monitoring work is one of the important components of post -marketing safety evaluation.In for-eign countries studies had been carried out early on the adverse reactions of signal detection method based on spontaneous reporting sys-tem(SRS),but the specific ones vary.Now,there is no gold standard.This article analyzes the classical and drug combinational adverse drug reaction signal detection methods at home and abroad and their use condition,and discusses the advantages and disadvantages of each one.Signal detection system for adverse drug reactions(ADR)adaptable to China was proposed to provide some references for ad-verse drug reaction signal detection work.