中国药物警戒 ›› 2021, Vol. 18 ›› Issue (11): 1025-1028.
DOI: 10.19803/j.1672-8629.2021.11.06

• 药品安全方法学研究专栏 • 上一篇    下一篇

真实世界研究设计在上市后药品安全性评价的应用

薛雪1,2, 金信妍2, 鲁春丽2, 戴宁2, 刘建平2,*   

  1. 1湖北中医药大学第一临床学院,湖北 武汉 430061;
    2北京中医药大学循证医学中心,北京 100029
  • 收稿日期:2021-03-16 发布日期:2021-11-18
  • 通讯作者: *刘建平,男,教授·博导,中医药循证评价。E-mail：Liujp@bucm.edu.cn
  • 作者简介:薛雪,女,副教授,中医内科学与中西医结合循证医学。
  • 基金资助:
    国家自然科学基金重点项目（81830115）; 国家中医药管理局中医药创新团队及人才支持计划项目（ZYYCXTD-C-202006）

Application of Real-World Study Designs in Post-Marketing Evaluation of Drug Safety

XUE Xue1,2, JIN Xinyan2, LU Chunli2, DAI Ning2, LIU Jianping2,*   

  1. 1First Clinical College of Hubei University of Traditional Chinese Medicine, Wuhan Hubei 430061, China;
    2Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2021-03-16 Published:2021-11-18

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摘要： 目的 探讨真实世界研究设计在上市后药品安全性评价中的应用,以提高临床合理用药,保障用药安全。方法 借鉴真实世界研究理念,系统介绍常用研究设计在上市后药品安全性评价中的应用并予实例分析。结果 在上市后药品安全性评价中,试验性研究最常用的设计类型为实效性随机对照试验;分析性研究常用设计类型包括队列研究、巢氏病例对照研究和病例对照研究;描述性研究常用设计类型包括横断面调查、病例系列与病例报告。其中,实效性随机对照试验、队列研究、巢氏病例对照研究常用于推断药品暴露与医学事件之间的因果关系。其他设计类型由于论证强度较弱,仅能为因果关联建立假说。结论 真实世界研究设计广泛应用于上市后药品安全性评价。与解释性随机对照试验相比,能更好地贴近真实临床环境,更加充分认识药品安全问题,从而保障公众用药安全。

关键词: 真实世界研究设计, 药品安全性评价, 上市后

Abstract: Objectiv eTo explore the applicability of real-world study designs in post-marketing drug safety evaluation so as to improve the rationality of clinical drug use and ensure drug safety. Methods Theories on real-world study were used. The applications of commonly used study designs in post-marketing evaluation of drug safety were described in detail along with case analysis. Results In post-marketing evaluation of drug safety, the most commonly used type of design of experimental studies was the pragmatic randomized controlled trial. Common types of design of analytical studies included cohort study, nested case-control study and case-control study. Common types of design of descriptive studies included cross-sectional survey, case series and case reports. Among these types of design, the pragmatic randomized controlled trial, cohort study, and nested case-control study could be used to infer the causal relationships between drug exposure and medical events. Other types of design could do nothing more than establish hypotheses for causal associations due to their weak validity. Conclusion Real-world study designs have been widely used in post-marketing evaluation of drug safety. Compared with explanatory randomized controlled trials, they are closer to the real clinical environment and attaches more importance to drug safety so as to ensure the safety of medication.

Key words: real-world study designs, drug safety evaluation, post-marketing

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