One case of severe liver injury caused by Tianma Shouwu tablets

doi:10.19803/j.1672-8629.20230466

Abstract

Abstract: Objective To explore the correlation between severe liver injury and Tianma Shouwu Tablets. Methods A case of adverse reactions of severe liver injury caused by Tianma Shouwu Tablets were analyzed. The traditional Chinese medicine that may cause hepatotoxicity was analyzed by consulting the literature. The classification of liver injury and the causal relationship with Tianma Shouwu Tablets were evaluated by using the relevant standards of Chinese guideline for diagnosis and management of drug-induced liver（2023 version) and the updated RUCAM scale, and the rationality of the treatment strategy was discussed and analyzed. The human leukocyte antigen (HLA) -B* 35:01 allele is a risk factor for liver injury of Polygonum multiflorum from literature review, and can be used as a potential biomarker to predict liver injury caused by polygonum multiflorum. Results The processed Radix Polygoni Multiflori and stir-fried Tribulus terrestris in Tianma Shouwu Tablets may cause liver damage. The patient’s liver injury is hepatocyte injury type, and the RUCAM score is 7 points (most likely). Treatment strategies usually include liver protection, cholagogue, and anti-inflammatory. Literature analysis found that the human leukocyte antigen (HLA)-B*35: 01 allele was a risk factor for liver injury caused by Polygonum multiflori, which could be used as a potential biomarker to predict it’s liver injury. Conclusion In this case, there were some correlations between severe liver injury and Gastrodia multiflorum tablets; Marketing authorization holders of drug should actively monitor the adverse reactions of related varieties and update the instructions in time to reduce the risk of patients’ medication.

Key words: Tianma Shouwu tablets, liver injury, Radix Polygoni Multiflori, Tribulus terrestris, adverse drug reactions

CLC Number:

CAO Guiping, DENG Linlin, ZHU Ganhong, LU Ying, MA Shuang, CHEN Linlin, Liu Lili. One case of severe liver injury caused by Tianma Shouwu tablets[J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 216-218.

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