Post-marketing effectiveness evaluation of traditional Chinese medicine in paradigm based on "proving efficacy, conforming standard, and exploring mechanism":a case study of Danhong Injection

• Published in: Zhongguo zhongyao zazhi Vol. 48; no. 1; p. 279
• Main Authors: Yu, Ya-Nan, Liu, Jun, Wang, Zhong
• Format: Journal Article
• Language: Chinese
• Published: China 01.01.2023
• Subjects: Angina, Stable - drug therapy; Drugs, Chinese Herbal - pharmacology; Drugs, Chinese Herbal - therapeutic use; Humans; Medicine, Chinese Traditional; Treatment Outcome; Danhong Injection; traditional Chinese medicine clinical research; pharmacological mechanism of Chinese medicine compound; modular pharmacology; adaptive design
• ISSN: 1001-5302
• DOI: 10.19540/j.cnki.cjcmm.20221012.501

At present, new concepts, new technologies, and new methods are emerging in the field of medical research, breaking through the inherent thinking patterns and research models, and promoting the transformation of the research paradigm of traditional Chinese medicine(TCM). This paper gave a case study of clinical research in Danhong Injection in the treatment of chronic stable angina, and based on the background of the study, index evaluation model, experimental design method, blind implementation of placebo, data management system, and exploration of clinical efficacy mechanism of traditional Chinese medicine compounds under the framework of modular pharmacology, the scientific idea of "proving efficacy, conforming standard, and exploring mechanism" was used as the guideline to discuss the research model of reevaluation of the effectiveness of post-marketing TCM varieties. This paper drew a target network map of Danhong Injection in the treatment of chronic stable angina for the first time, which was composed