Safety evaluation of new drugs of traditional Chinese medicine based on human use experience.
10.19540/j.cnki.cjcmm.20241108.501
- Author:
Zhong-Qi YANG
1
;
Ya-Qin TANG
1
;
Hui-Min TANG
1
;
Yan LING
1
;
Yan-Ping DU
1
Author Information
1. the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510405, China Guangdong Clinical Research Academy of Chinese Medicine Guangzhou 510405, China.
- Publication Type:Journal Article
- Keywords:
human use experience;
new drugs of traditional Chinese medicine;
safety evaluation
- MeSH:
Humans;
Drugs, Chinese Herbal/adverse effects*;
Medicine, Chinese Traditional/adverse effects*;
Drug-Related Side Effects and Adverse Reactions;
Female
- From:
China Journal of Chinese Materia Medica
2025;50(3):812-816
- CountryChina
- Language:Chinese
-
Abstract:
Because of the unclear active substances, metabolic pathways, and targets of new drugs of traditional Chinese medicine(TCM), non-clinical safety evaluation often fails to accurately locate the target organs and tissue exposed to medicinal toxicity. The human use experience(HUE) contains important safety information of TCM, while the clinical safety data in the past HUE are few and have not been effectively applied. Standardized prospective HUE studies should be carried out to collect the clinical safety data, in which appropriate physical and chemical indicators(including blood, urine, and stool routine), liver biochemical indicators, kidney biochemical indicators, and cardiovascular biochemical indicators should be selected for safety evaluation, and the detection time point and sample size should be rationally designed. Importance should be attached to the observation of symptoms and signs of adverse events/reactions in patients as well as the safety information of special groups such as the elderly, children, and pregnant women. The adverse events of TCM should be observed, judged, and treated according to the theory and the diagnosis and treatment mode of TCM. The clinical safety information about the HUE should be comprehensively collected for new drugs of TCM to make up for the lack of extrapolation of toxicological test results to humans. The unique advantages of clinical origin of new drugs of TCM should be given full play for cross-reference of the results of toxicological research and the conclusions of HUE safety evaluation. In addition, benefit-risk assessment should be conducted based on HUE, and a panoramic safety evaluation system characterized by macro and micro combination and in line with the characteristics of TCM should be established to improve the success rate in the research and development of new drugs of TCM.
