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  

Research Progress on Detection Method of Adverse Drug Reaction Signal Detection Method Based on Spontaneous Reporting System

作　　者：关瑜 李雷 朱旭 王力剑 王馨淳 王威 徐晓丽 柳鹏程[4] GUAN Yu;LI Lei;ZHU Xu;WANG Li-jian;WANG Xin-chun;WANG Wei;XU Xiao-li;LIU Peng-cheng(Jilin Provincial Drug Safety Monitoring Center,Jilin Changchun 130062,China;Jilin Provincial Drug Review and Inspection Center,Jilin Changchun 130062,China;Jilin Drug Re-evaluation Association,Jilin Changchun 130062,China;China Pharmaceutical University International Pharmaceutical Business School,Jiangsu Nanjing 211198,China)

机构地区：[1]吉林省药品安全监测中心,吉林长春130062 [2]吉林省药品审核查验中心,吉林长春130062 [3]吉林省药品再评价协会,吉林长春130062 [4]中国药科大学国际医药商学院,江苏南京211198

出　　处：《中国药物评价》2022年第6期489-495,共7页Chinese Journal of Drug Evaluation

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。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.

关 键 词：联合用药 药品不良反应 信号检测 自发呈报系统 

分 类 号：R95[医药卫生—药学]