Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (6): 600-604.
DOI: 10.19803/j.1672-8629.2022.06.04

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Risk factors of liver injury in traditional Chinese medicine and TCM pharmacovigilance for medications against hepatic insufficiency

ZHANG Zhiqi1,2, ZHANG Xiaomeng1,2, ZHANG Bing1,2,*, LYU Jingtao1,2   

  1. 1School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China;
    2Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China
  • Received:2022-02-09 Online:2022-06-15 Published:2022-06-13

Abstract: Objective To identify the risk factors for liver injury caused by traditional Chinese medicine, and to recommend measures of pharmacovigilance for medications against liver insufficiency of different degrees. Methods Adverse drug reactions of liver injury caused by traditional Chinese medicine as of the end of 2021 were collected from different databases, while possible influencing factors and their correlations with the severity of liver injury were analyzed using Apriori and the Bayesian network. Results A total of 88 cases of liver injury caused by traditional Chinese medicine with exact causality were included, involving 24 types of Chinese herbal medicines. The percentage of patients ages 46 to 64 was the highest. Of the 69 cases whose severity of liver injury could be determined, the majority were mild and severe ones, and the main symptoms ranged from jaundice, nausea, vomiting through aversion to oil, loss of appetite to impaired consciousness. The occurrence of liver injury was associated with drugs, the physique of patients, and medications, and liver injury became severe along with the duration of treatment. Conclusion Targeted measures should be taken among patients with hepatic insufficiency, such as the selection of herbal medicines and medication monitoring according to the degrees of severity, which can effectively reduce the risk of liver injury during the application of traditional Chinese medicine.

Key words: traditional Chinese medicine, drug-induced liver injury, hepatic insufficiency, pharmacovigilance, medication safety

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