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

doi:10.19803/j.1672-8629.20240471

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (11): 1280-1283.
DOI: 10.19803/j.1672-8629.20240471

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

梁际洲¹, 陈晨鑫¹, 白汪洋², 郭晓晶¹, 许金芳¹, 贺佳¹, 叶小飞^1,*

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

收稿日期:2024-07-11 出版日期:2024-11-15 发布日期:2024-11-20
通讯作者: ^*叶小飞,男,博士,副教授,药物流行病学与新药评价。E-mail: yexiaofei@smmu.edu.cn
作者简介:梁际洲,男,在读博士,药物流行病学。
基金资助:
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）

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

LIANG Jizhou¹, CHEN Chenxin¹, BAI Wangyang², GUO Xiaojing¹, XU Jinfang¹, HE Jia¹, YE Xiaofei^1,*

¹Department of Health Statistics, Faculty of Health Service, Naval Medical University, Shanghai 200433, China;
²School of Medicine, Tongji University, Shanghai 200092, China

Received:2024-07-11 Online:2024-11-15 Published:2024-11-20

摘要/Abstract

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。

关键词: 个例安全报告, 药物警戒, 信号检测, 解读, 启示

Abstract: 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.

Key words: Individual Case safety Reports, Pharmacovigilance, Signal Detection, Explanation, Elaboration

中图分类号:

R994.11

梁际洲, 陈晨鑫, 白汪洋, 郭晓晶, 许金芳, 贺佳, 叶小飞. 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[J]. 中国药物警戒, 2024, 21(11): 1280-1283.

LIANG Jizhou, CHEN Chenxin, BAI Wangyang, GUO Xiaojing, XU Jinfang, HE Jia, YE Xiaofei. Standards for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance[J]. Chinese Journal of Pharmacovigilance, 2024, 21(11): 1280-1283.

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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

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