基于真实世界数据的中成药安全性评价模式构建

doi:10.19803/j.1672-8629.2022.01.04

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (1): 18-22.
DOI: 10.19803/j.1672-8629.2022.01.04

• 真实世界数据支持药械监测与评价(一）专栏 • 上一篇下一篇

基于真实世界数据的中成药安全性评价模式构建

李玲^1,2,3, 刘艳梅^1,2,3, 谭婧^1,2,3, 王雯^1,2,3, 姚明宏^1,2,3, 马玉^1,2,3, 罗小超^1,2,3, 廖星⁴, 刘岩⁵, 宋海波⁶, 温泽淮^7#, 孙鑫^1,2,3,*

¹四川大学华西医院中国循证医学中心,四川成都 610041;
²国家药品监督管理局海南真实世界数据研究与评价重点实验室,海口海南 570100;
³四川省真实世界数据技术创新中心,四川成都 610041;
⁴中国中医科学院中医临床基础医学研究所,北京100700;
⁵北京中医药大学东直门医院中医内科学教育部和北京市重点实验室,北京 100700;
⁶国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022;
⁷广东省中医院临床研究方法学重点研究室,广东广州 510120

收稿日期:2021-10-08 出版日期:2022-01-15 发布日期:2022-01-20
通讯作者: ^*孙鑫,男,博士,研究员,临床流行病学与循证医学。E-mail：sunx79@hotmail.com。^#为共同通信作者。
作者简介:李玲,女,博士,副研究员,临床流行病学与循证医学。
基金资助:
国家重点研发计划（2017YFC1700406,2019YFC 1709804）; 国家自然科学基金青年科学基金项目（71904134）; 四川省青年科技创新研究团（2020JDTD0015）; 中国中医药循证医学中心“业务研究室主任专项”（2020YJSZX-3）; 四川大学华西医院学科卓越发展1•3•5工程项目（ZYYC08003）

Developing a safety assessment model for Chinese patent medicines based on real-world data

LI Ling^1,2,3, LIU Yanmei^1,2,3, TAN Jing^1,2,3, WANG Wen^1,2,3, YAO Minghong^1,2,3, MA Yu^1,2,3, LUO Xiaochao^1,2,3, LIAO Xing⁴, LIU Yan⁵, SONG Haibo⁶, WEN Zehuai^7#, SUN Xin^1,2,3,*

¹Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu Sichuan 610041, China;
²NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Haikou Hainan 570100, China;
³Sichuan Center of Technology Innovation for Real World Data, Chengdu Sichuan 610041, China;
⁴Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
⁵Key Laboratory of Chinese Internal Medicine of Ministry of Education, Beijing Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China;
⁶Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China;
⁷Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou Guangdong 510120, China

Received:2021-10-08 Online:2022-01-15 Published:2022-01-20

摘要/Abstract

摘要： 目的构建基于真实世界数据的中成药安全性评价模式,为研究者和决策者正确生产和使用基于真实世界数据的中成药安全性评价证据提供参考。方法通过查阅国内外文献总结真实世界数据在中成药安全性评价中的作用,探索构建基于真实世界数据的中成药安全性评价模式。结果从药品监管的角度,提出了基于常规收集和主动收集的真实世界数据开展中成药安全性评价的研究模式,并通过实例进行应用阐述。结论真实世界数据在中成药安全性评价中具有重要作用,但仍存在诸多局限,迫切需要引入新的研究设计和统计分析方法。

关键词: 真实世界数据, 中成药, 安全性, 评价

Abstract: Objective To develop a safety assessment model for Chinese patent medicines based on real-word data, so as to provide reference for researchers and decision makers to scientifically and rationally produce and use real-world-data-based safety assessment evidence of Chinese patent medicines. Methods We summarized the role of real-world data in the safety assessment of Chinese patent medicines by referring to domestic and foreign literatures, explored and developed the safety assessment model of Chinese patent medicines based on real-world data. Results We proposed, from the perspective of drug regulation, a safety assessment research model for Chinese patent medicines based on routinely collected and actively collected real-world data, and its application was illustrated with an example. Conclusion Real-world data plays an important role in the safety assessment of Chinese patent medicines, but there are still some limitations. There is an urgent need to introduce new study design and statistical analysis methods in this field.

Key words: real-world data, Chinese patent medicine, safety, assessment

中图分类号:

R994.11

李玲, 刘艳梅, 谭婧, 王雯, 姚明宏, 马玉, 罗小超, 廖星, 刘岩, 宋海波, 温泽淮, 孙鑫. 基于真实世界数据的中成药安全性评价模式构建[J]. 中国药物警戒, 2022, 19(1): 18-22.

LI Ling, LIU Yanmei, TAN Jing, WANG Wen, YAO Minghong, MA Yu, LUO Xiaochao, LIAO Xing, LIU Yan, SONG Haibo, WEN Zehuai, SUN Xin. Developing a safety assessment model for Chinese patent medicines based on real-world data[J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 18-22.

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基于真实世界数据的中成药安全性评价模式构建

Developing a safety assessment model for Chinese patent medicines based on real-world data

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