中国食品药品监管Issue(1)：28-35,8.DOI:10.3969/j.issn.1673-5390.2025.01.003
真实世界研究与中药审评机制创新探讨
Exploration of Real-World Research and Innovation in the Evaluation Mechanism of Traditional Chinese Medicine
李阳 1罗兴洪 2曾渝3
作者信息
- 1. 沈阳药科大学
- 2. 江苏中药产业研究院
- 3. 海南南海健康产业研究院
- 折叠
摘要
Abstract
Objective:This study explores the significance of real-world study(RWS)for the registration standards and innovation of traditional Chinese medicine(TCM),along with its implementation steps.Methods:A dual Black Box model,based on the Black Box theory,was established to analyze and compare the applicability of RWS and randomized controlled trials in TCM registration research.Results:The study highlights that contradictions exist between the international gold standard of randomized controlled trials,rooted in modern medicine,and the theoretical system of TCM.RWS aligns more closely with the dual Black Box diagnostic and treatment model of TCM.RWS should not be considered merely as a supplement to randomized controlled trials but as a pivotal approach with greater responsibilities in the innovation of TCM evaluation mechanisms and research and development.Conclusion:Real-world exploration presents promising new pathways for the development of TCM and the internationalization of TCM registration standards.Developing RWS standards tailored to TCM innovation and implementing relevant policies are of great significance for advancing TCM registration standards and supporting the implementation of the"Belt and Road"initiative.关键词
中药审评机制/真实世界/黑箱理论/中药创新/药品注册Key words
traditional Chinese medicine evaluation mechanism/real-world study/Black Box theory/traditional Chinese medicine innovation/drug registration分类
医药卫生引用本文复制引用
李阳,罗兴洪,曾渝..真实世界研究与中药审评机制创新探讨[J].中国食品药品监管,2025,(1):28-35,8.
