New outlook on safety of traditional Chinese medicine: concept and practice.
10.19540/j.cnki.cjcmm.20230309.601
- Author:
Xiao-He XIAO
1
;
Xu ZHAO
1
;
Zhao-Fang BAI
1
;
Jia-Bo WANG
2
;
Hai-Bo SONG
3
Author Information
1. Department of Hepatology,The Fifth Medical Centre of Chinese PLA General Hospital Beijing 100039,China.
2. School of Traditional Chinese Medicine,Capital Medical University Beijing 100069,China.
3. Center for Drug Reevaluation (National Center for ADR Monitoring),National Medical Products Administration Beijing 100045,China.
- Publication Type:Journal Article
- Keywords:
hepatotoxicity;
new outlook on TCM safety;
risk prevention;
safety evaluation;
traditional Chinese medicine(TCM)
- MeSH:
Humans;
Medicine, Chinese Traditional/adverse effects*;
Internationality;
Drugs, Chinese Herbal/adverse effects*
- From:
China Journal of Chinese Materia Medica
2023;48(10):2557-2564
- CountryChina
- Language:Chinese
-
Abstract:
Profound changes have taken place in human disease spectrum, constitution spectrum, and drug use behavior, and the safety of traditional Chinese medicine(TCM) faces new trends and problems. In particular, serious adverse reactions/events such as liver injury and kidney injury caused by non-toxic TCM have been frequently reported, overturning people's understanding of TCM safety, and even shaking the public's confidence in the development of TCM. In the new era of globalization, correctly understanding the situation and problems of TCM safety and addressing the dilemmas in safety evaluation and risk prevention of TCM are the key missions to be undertaken by TCM practitioners. This paper suggests that the situation and problems of TCM safety should be viewed objectively and dialectically, and the use standard of TCM should be advanced with the times. Furthermore, this paper puts forward the new conception and methodology of TCM safety(including one innovative understanding, two types of evaluation modes, tri-elements injury hypothesis; four-quadrant risk decision processes, and five-grade safety evidence body) for the first time, hoping to provide new theories, new strategies, new methods and successful examples for solving the safety problems of TCM.