基于自发呈报系统的联合用药不良反应信号检测方法研究进展

摘要/Abstract

摘要： 联合用药引发的药品安全性问题已被业界广泛关注。自发呈报系统中联合用药不良反应报告数据特征与单种药品不同，因此需要根据不同数据特征探索信号检测方法。本文基于文献研究，梳理国内外该领域现有研究，以各种方法建立的回归模型、频数统计模型、贝叶斯统计模型、和关联规则模型等不同模型分类，介绍各类方法原理，分析常用方法的优势及局限性。在此基础上，总结现有研究不足并结合我国上市后药品监测数据特征，为我国联合用药不良反应信号检测方法学发展提供参考。

关键词: font-size:medium, ">联合用药；药品不良反应；信号检测；自发呈报系统

Abstract: The drug safety problems caused by combination therapy have received more and more attention. In the spontaneous reporting system， the data characteristics of adverse drug reaction reports of combination drugs are different from those of single drugs， so it is necessary to explore signal detection methods according to different data characteristics. Based on literature research， this paper sorts out the existing research in this field at home and abroad， and categorizes different models such as regression models， frequency statistical models， Bayesian statistical models， and association rule models established by various methods， introduces the principles of various methods， and analyzes commonly used models. Strengths and limitations of the method. On this basis， this paper summarizes the insufficiency of existing research and combines the characteristics of post-marketing drug monitoring data in China to provide a reference for the development of my country′s combination drug adverse reaction signal detection methodology.

Key words: font-size:medium, ">Combination medication； Adverse drug reaction； Signal detection； Spontaneous reporting system

中图分类号:

关瑜, 李雷, 朱旭, 王力剑, 王馨淳 , 王威, 徐晓丽, 柳鹏程. 基于自发呈报系统的联合用药不良反应信号检测方法研究进展[J]. 中国药物评价, 2022, 39(6): 489-495.

GUAN Yu, LI Lei, ZHU Xu, WANG Li-jian, WANG Xin-chun, WANG Wei, XU Xiao-li, LIU Peng-cheng. Research Progress on Detection Method of Adverse Drug Reaction Signal Detection Method Based on Spontaneous Reporting System[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2022, 39(6): 489-495.

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