Problems and thoughts in clinical safety evaluation of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20230123.503
- Author:
Meng-Yuan ZHONG
1
;
Chun-Yang WANG
1
;
Ming ZHUANG
1
;
Jia-Li AN
1
;
Xue-Chen DU
1
;
Jia-Ni ZHAI
1
;
Wen-Ke ZHENG
2
Author Information
1. Center for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
2. Center for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China Haihe Laboratory of Modern Chinese Medicine Tianjin 301617, China.
- Publication Type:Journal Article
- Keywords:
clinical safety evaluation;
life cycle;
methodology;
traditional Chinese medicine
- MeSH:
Medicine, Chinese Traditional/adverse effects*;
Social Change
- From:
China Journal of Chinese Materia Medica
2023;48(12):3404-3408
- CountryChina
- Language:Chinese
-
Abstract:
Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.
