大数据时代的药品安全主动监测:对照选择的挑战与机遇

摘要

电子医疗数据已成为大数据时代开展药品安全主动监测的重要资源.基于此确认药品与不良事件是否存在关联,要回归传统的流行病学研究设计,选取恰当的对照进行对比.本文主要阐述不同对照选取的原理、适用情形,介绍、评价并比较各种对照选取的思路与参数,引入对照选择批量化实现的进展性成果,以期为我国利用电子医疗数据开展上市后药品安全性监测提供方法学参考.%Electronic healthcare databases have become an important source for active surveillance of drug safety in the era of big data.The traditional epidemiology research designs are needed to confirm the association between drug use and adverse events based on these datasets,and the selection of the comparative control is essential to each design.This article aims to explain the principle and application of each type of control selection,introduce the methods and parameters for method comparison,and describe the latest achievements in the batch processing of control selection,which would provide important methodological reference for the use of electronic healthcare databases to conduct post-marketing drug safety surveillance in China.