107例药物性肝损伤不良反应报告分析  

107 cases of liver injury caused by traditional Chinese medicines

作　　者：王冠杰 杜世芳 刘宝生 韩佳寅[3] 王振华[1] 路长飞 WANG Guanjie;DU Shifang;LIU Baosheng;HAN Jiayan;WANG Zhenhua;LU Changfei(Department of Clinical Pharmacy,Weifang Traditional Chinese Hospital,Weifang Shandong 261041,China;Department of Pharmaceutical Preparations,Weifang Institute of Dermatology,Weifang Shandong 261071,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Shandong Center for ADR Monitoring,Ji’nan Shandong 250014,China)

机构地区：[1]潍坊市中医院临床药学科,山东潍坊261041 [2]潍坊市皮肤病防治所制剂室,山东潍坊261071 [3]中国中医科学院中药研究所,北京100700 [4]山东省药品不良反应监测中心,山东济南250014

出　　处：《中国药物警戒》2023年第3期331-333,338,共4页Chinese Journal of Pharmacovigilance

基　　金：中国毒理学会临床毒理专项研究课题(SCT2019CT307);北京市自然科学基金资助项目(7214291);国家自然科学基金资助项目(82192913、82104519);中国中医科学院科技创新工程(CI2021A04803)。

摘　　要：目的分析中药致肝损伤发生的一般规律和特点,为临床合理用药提供依据。方法检索山东省药品不良反应监测系统数据库,对2018年1月1日至2020年12月31日收集的107例中药致肝损伤不良反应报告使用帕累托图进行分析。结果107例报告中,男性占比更大(57.94%);从年龄上看,51~60岁人群占比较高(29.91%);引起肝损伤的中药涉及11个种类,其中祛湿剂占比最大(34.59%),其次是理血剂(25.24%)和清热剂(14.96%);临床症状中以谷丙转氨酶升高(104例)和谷草转氨酶升高(79例)最为常见;用药时间最短者仅有1天(2例),最长者2年(1例);肝损伤整体预后良好,未见致永久肝损伤或死亡病例的报道。结论临床应加强中药致肝损伤的不良反应监测,以减少肝损伤发生,保证用药安全。Objective To analyze the characteristics of liver injury caused by traditional Chinese medicines in order to provide data for clinical medication.Methods The Pareto diagram was used to analyze 107 cases of liver injury caused by traditional Chinese medicines,which were recorded by Shandong Adverse Drug Reaction Monitoring System between 2018 and 2020.Results Among the 107 cases reported,males accounted for 57.94%.People aged 51 to 60 made up 29.91%.There were 11 types of traditional Chinese medicines that were found to cause liver injury.Desiccating formulas(34.59%)accounted for the largest proportion,followed by blood-regulating agents(25.24%)and heat-clearing agents(14.96%).Elevated levels of alanine aminotransferase and aspartate aminotransferase were the most common clinical symptoms.The shortest duration of medication was only one day(2 cases),and the longest was 2 years.The overall prognosis of liver injury was good,and no permanent liver injury or death was found in these reports.Conclusion Such ADR as liver injury induced by traditional Chinese medicines should be subject to more vigorous monitoring in order to reduce the incidence of liver injury and ensure the safety of medications.

关 键 词：中药 肝损伤 药品不良反应 帕累托图分析 

分 类 号：R994.11[医药卫生—毒理学]