Citation

Xiao XH, Zhao X, Bai ZF, Wang JB, Song HB. Zhongguo Zhong Yao Za Zhi 2023; 48(10): 2557-2564.

Copyright

(Copyright © 2023, Zhongguo Zhong yi yan jiu yuan Zhong yao yan jiu suo)

DOI

10.19540/j.cnki.cjcmm.20230309.601

PMID

37282916

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.

Language: zh

Keywords

Humans; Internationality; risk prevention; *Drugs, Chinese Herbal/adverse effects; *Medicine, Chinese Traditional/adverse effects; hepatotoxicity; new outlook on TCM safety; safety evaluation; traditional Chinese medicine(TCM)