湿毒清制剂肝损伤风险分析及思考  

Risks of liver injury caused by Shiduqing preparations

作　　者：邵波 徐丽丽[2] 朱兰 刘硕 万浩 黄光瑞 SHAO Bo;XU Lili;ZHU Lan;LIU Shuo;WAN Hao;HUANG Guangrui(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China;Institute of Information on Tradition Chinese Medicine,Beijing 100700,China;Chinese Center for Disease Control and Prevention,Beijing 102206,China;School of Life Sciences,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100076 [2]中国中医科学院中医药信息研究所,北京100700 [3]中国疾病预防控制中心,北京102206 [4]北京中医药大学生命科学学院,北京100029

出　　处：《中国药物警戒》2024年第6期666-670,共5页Chinese Journal of Pharmacovigilance

基　　金：中国中医科学院基本科研业务费优秀青年科技人才培养专项(传承类)(ZZ15-YQ-076);国家重点研发计划(2018YFC1707409)。

摘　　要：目的分析湿毒清制剂安全性风险,特别是致肝功能异常风险,为临床合理用药提供参考。方法对我国药品不良反应监测系统数据库(2004年1月1日至2023年12月31日)、国内文献数据库(建库至2023年12月31日)中的湿毒清制剂肝损伤相关不良反应/事件进行整理与分析。结果国家药品不良反应监测系统数据库共收到涉及湿毒清制剂肝胆损害相关不良反应/事件病例报告24例;临床研究文献未见肝胆损害相关不良反应;个例报道涉及的不良反应/事件表现为药物性肝病、肝损伤。结论临床使用湿毒清制剂应关注肝损伤风险,提高安全合理用药意识,加强用药监测。同时,药品上市许可持有人应加强药物警戒及风险管理,做好用药指导与宣传,切实保障患者用药安全。Objective To analyze the risks of liver injury posed by Shiduqing preparations and provide reference for proper clinical use.Methods Literature about adverse reactions related to Shiduqing preparations in China’s adverse drug reaction monitoring database(collected between 2004 and 2023)and domestic database(from inception to December 31,2023)was sorted out and analyzed.Results The National Adverse Drug Reaction Monitoring System Database documented 24 cases of adverse reactions related to liver and gallbladder damage and involving Shiduqing preparations.No adverse reactions related to hepatobiliary damage were found in clinical studies.The adverse reactions mentioned in individual reports were drug induced liver disease and liver injury.Conclusion Clinicians should be alert to the risk of liver injury when Shiduqing preparations are used in clinic.The awareness of safe and proper medications should be raised,and medications monitored.At the same time,drug marketing authorization holders should strengthen pharmacovigilance and provide guidance to ensure safe medication.

关 键 词：湿毒清 白鲜皮 肝损伤 中草药 不良反应 安全性 风险 

分 类 号：R994.11[医药卫生—毒理学] R986[医药卫生—药学]