药物警戒中基于个例安全报告的药品安全性信号检测报告规范解读与启示  

Standards for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance

作　　者：梁际洲 陈晨鑫 白汪洋 郭晓晶 许金芳 贺佳[1] 叶小飞[1] LIANG Jizhou;CHEN Chenxin;BAI Wangyang;GUO Xiaojing;XU Jinfang;HE Jia;YE Xiaofei(Department of Health Statistics,Faculty of Health Service,Naval Medical University,Shanghai 200433,China;School of Medicine,Tongji University,Shanghai 200092,China)

机构地区：[1]海军军医大学军队卫生统计学教研室,上海200433 [2]同济大学医学院,上海200092

出　　处：《中国药物警戒》2024年第11期1280-1283,共4页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82073671);上海市卫生健康委员会科研项目(202340038)。

摘　　要：目的对药物警戒中基于个例安全报告进行药品安全性信号检测报告规范(READUS-PV)进行分析并解读,为国内更好地基于个例安全报告进行药品安全性信号检测研究提供参考。方法整理分析并解读国际上信号检测领域专家共同发表药物警戒中基于个例安全报告进行药品安全性信号检测报告规范(READUS-PV)。结果READUS-PV从题目、引言、方法、结果、讨论、宣言、摘要等7个方面给出14个条目的建议。结论在实际药品安全性信号检测研究中,可参考READUS-PV,提升研究质量。Objective To analyze and interpret the READUS-PV standard for drug safety signal detection based on individual safety reports in pharmacovigilance so as to provide references for related research in China.Methods The reporting of a disproportionality analysis for drug safety signal detection using individual case safety reports in pharmacovigilance(READUS-PV)jointly delivered by experts in pharmacovigilance worldwide was analyzed and interpreted.Results READUS-PV included 14 items concerning the title,introduction,methods,results,discussion,declaration and abstracts.Conclusion In actual drug safety signal detection research,READUS-PV can be consulted to improve research quality.

关 键 词：个例安全报告 药物警戒 信号检测 解读 启示 

分 类 号：R994.11[医药卫生—毒理学]