药品不良反应发生时间信号检测法在药品安全性监测中的应用

摘要

目的 传统的信号检测方法主要基于不相称理论,这些方法主要基于观测与理论频数之比来识别信号.最近有学者最新提出药品不良反应发生时间(TTO)信号检测法,通过药品不良反应发生时间的分布来发现信号,本文对该方法 原理及应用现状做一介绍.方法 通过文献检索,对TTO的原理、特点、信号检测能力等诸多方面进行回顾与综述.结果 既往研究表明TTO方法在药品不良反应信号检测中发挥了一定的作用,然而TTO方法在不同数据库中表现效果存在差异.结论 TTO方法可以作为传统不相称测定分析的一种重要补充手段应用于信号检测中.%Objective Disproportionality analysis is the main method for signal detection and disproportionality analysis is based on the observed and expected values.Recently,time-to-onset (TTO) has been proposed as an effective tool in the adverse drug reactions surveillance.In this study,we aimed to introduce the principle and application of TTO method.Methods We discussed the theory,characteristic,signal detection performance of TTO method through literature review.Results TTO method has played role in signal detection,however,the performance result differed in different studies.Conclusion TTO method could act as an important complementary tool of disproportionality analysis for signal detection.