药物不良反应信号检测方法的现状与展望

Present status and future prospect of signal detection methods for adverse drug reaction

上市药物的安全性监测数据的质量是保证上市后药物不良反应信号挖掘的基础,而选择快速有效的信号检测方法能为药品风险管理及评价提供有价值的信号,是上市药物安全性监测的核心。本文阐述了上市后药物安全性监测数据的分流策略、重复检测等数据清理方法,以此提高监测数据质量。同时,对药物不良反应监测数据的各种信号检测方法进行了分析比较,包括各种信号检测方法间的一致性,并展望了目前尚未成熟的、最前沿的信号检测方法。

Data quality of monitoring the safety of marketed drugs is the basis for signal detection of the adverse drug re action database of marketed drugs,and rapid and effective signal detection method is the core of drug safety monitoring. This article not only focuses on data cleaning methods to ensure data quality of the safety of marketed drugs, such as triage strategies and duplicate detection, but also compares the classical signal detection methods in practice, including the conformity of these methods. Furthermore, innovative statistical approaches are discussed in the end.