湿毒清制剂肝损伤风险分析及思考

doi:10.19803/j.1672-8629.20240137

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (6): 666-670.
DOI: 10.19803/j.1672-8629.20240137

湿毒清制剂肝损伤风险分析及思考

邵波¹, 徐丽丽^2△, 朱兰¹, 刘硕¹, 万浩³, 黄光瑞⁴

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

收稿日期:2024-02-29 出版日期:2024-06-15 发布日期:2024-06-18
作者简介:邵波,女,硕士,主治医师,中药上市后安全性研究。^△为并列第一作者。
基金资助:
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）

Risks of liver injury caused by Shiduqing preparations

SHAO Bo¹, XU Lili^2△, ZHU Lan¹, LIU Shuo¹, WAN Hao³, HUANG Guangrui⁴

¹Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
²Institute of Information on Tradition Chinese Medicine, Beijing 100700, China;
³Chinese Center for Disease Control and Prevention, Beijing 102206, China;
⁴School of Life Sciences, Beijing University of Chinese Medicine, Beijing 100029, China

Received:2024-02-29 Online:2024-06-15 Published:2024-06-18

摘要/Abstract

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。

关键词: 湿毒清, 白鲜皮, 肝损伤, 中草药, 不良反应, 安全性, 风险

Abstract: 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.

Key words: Shiduqing, Cortex Dictamni, liver injury, Chinese patent drug, adverse reaction, safety, risk

中图分类号:

R994.11
R986

邵波, 徐丽丽, 朱兰, 刘硕, 万浩, 黄光瑞. 湿毒清制剂肝损伤风险分析及思考[J]. 中国药物警戒, 2024, 21(6): 666-670.

SHAO Bo, XU Lili, ZHU Lan, LIU Shuo, WAN Hao, HUANG Guangrui. Risks of liver injury caused by Shiduqing preparations[J]. Chinese Journal of Pharmacovigilance, 2024, 21(6): 666-670.

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湿毒清制剂肝损伤风险分析及思考

Risks of liver injury caused by Shiduqing preparations

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