中国药物警戒 ›› 2023, Vol. 20 ›› Issue (3): 331-333.
DOI: 10.19803/j.1672-8629.20220330

• 安全与合理用药 • 上一篇    下一篇

107例药物性肝损伤不良反应报告分析

王冠杰1, 杜世芳2, 刘宝生1, 韩佳寅3, 王振华1,*, 路长飞4#   

  1. 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
  • 收稿日期:2022-06-15 出版日期:2023-03-15 发布日期:2023-03-17
  • 通讯作者: * 王振华,女,本科,主任药师,临床药学与药事管理。Email：wzh6606@126.com;#为共同通信作者。
  • 作者简介:王冠杰,男,硕士,主管药师,临床药学。
  • 基金资助:
    中国毒理学会临床毒理专项研究课题（SCT2019 CT307）；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）。

107 cases of liver injury caused by traditional Chinese medicines

WANG Guanjie1, DU Shifang2, LIU Baosheng1, HAN Jiayan3, WANG Zhenhua1,*, LU Changfei4#   

  1. 1Department of Clinical Pharmacy, Weifang Traditional Chinese Hospital, Weifang Shandong 261041, China;
    2Department of Pharmaceutical Preparations, Weifang Institute of Dermatology, Weifang Shandong 261071, China;
    3Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    4Shandong Center for ADR Monitoring, Ji'nan Shandong 250014, China
  • Received:2022-06-15 Online:2023-03-15 Published:2023-03-17

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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。

关键词: 中药, 肝损伤, 药品不良反应, 帕累托图分析

Abstract: 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.

Key words: traditional Chinese medicine, liver injury, adverse drug reaction, Pareto diagram analysis

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