基于自发呈报系统药品不良反应信号检测方法的研究进展

摘要

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.%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。