天麻首乌片致严重肝损伤1例分析  

One case of severe liver injury caused by Tianma Shouwu tablets

作　　者：曹桂萍[1] 邓琳琳 朱干红 陆颖[1] 马爽 陈玲玲 刘丽丽 CAO Guiping;DENG Linlin;ZHU Ganhong;LU Ying;MA Shuang;CHEN Linlin;Liu Lili(Department of Pharmacy,Yancheng TCM Hospital Affiliated to Nanjing University of Chinese Medicine,Yancheng Jiangsu 224001,China;Department of Hepatology,Yancheng TCM Hospital Affiliated to Nanjing University of Chinese Medicine,Yancheng Jiangsu 224001,China;Yancheng Food and Drug Supervision and Inspection Center,Yancheng Jiangsu 224000,China)

机构地区：[1]南京中医药大学附属盐城中医院药剂科,江苏盐城224001 [2]南京中医药大学附属盐城中医院肝胆科,江苏盐城224001 [3]盐城市食品药品监督检验中心,江苏盐城224000

出　　处：《中国药物警戒》2024年第2期216-218,共3页Chinese Journal of Pharmacovigilance

基　　金：国家中医药管理局全国中药特色技术传承人才培训项目(T20194828003)。

摘　　要：目的 探讨严重肝损伤与天麻首乌片的相关性。方法 通过1例服用天麻首乌片导致严重肝损伤的不良反应,梳理其组方中药肝毒性的文献研究结果,采用《中国药物性肝损伤诊治指南(2023年版)》相关标准及更新后的RUCAM量表对肝损伤分型及与天麻首乌片的因果关系进行评估,探讨治疗策略的合理性。结果 天麻首乌片中制何首乌和炒蒺藜可能造成肝损伤,本例患者肝损伤为肝细胞损伤型,RUCAM评分7分(很可能),治疗策略通常包括保肝、利胆、抗炎等。文献分析发现,人类白细胞抗原(HLA)-B*35:01等位基因是何首乌肝损伤的风险因素,可作为预测何首乌所致肝损伤的潜在生物标志物。结论 本例患者严重肝损伤与天麻首乌片存在相关性;药品上市许可持有人应主动监测相关品种的不良反应,并及时更新说明书,减少患者用药风险。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.

关 键 词：天麻首乌片 肝损伤 何首乌 蒺藜 药品不良反应 

分 类 号：R961.1[医药卫生—药理学] R994.11[医药卫生—药学]