中国药物警戒 ›› 2025, Vol. 22 ›› Issue (10): 1154-1158.
DOI: 10.19803/j.1672-8629.20250482

• 安全与合理用药 • 上一篇    下一篇

148例药物致肝脏不良反应报告分析

庹康秀, 杨成莉, 李明, 姜曼*   

  1. 贵州医科大学附属医院药学部,贵州 贵阳 550001
  • 收稿日期:2025-07-23 出版日期:2025-10-15 发布日期:2025-10-20
  • 通讯作者: *姜曼,女,博士,主管药师,临床药学。E-mail: jiangman@gmc.edu.cn
  • 作者简介:庹康秀,女,硕士,主管药师,临床药学。
  • 基金资助:
    2025年贵州省基础研究计划（自然科学）面上项目（黔科合基础MS〔2025〕面上426）

148 Case of Drug-Induced Liver Adverse Reactions

TUO Kangxiu, YANG Chengli, LI Ming, JIANG Man*   

  1. Department of Pharmacy, the Affiliated Hospital of Guizhou Medical University, Guiyang Guizhou 550001, China
  • Received:2025-07-23 Online:2025-10-15 Published:2025-10-20

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摘要： 目的 分析药物致肝脏不良反应的病例特点,为临床安全用药和预防提供参考。方法 回顾性分析贵州医科大学附属医院2021年1月1日至2024年12月30日上报至国家药品不良反应监测系统中药物致肝脏不良反应的病例。结果 共收集到148例药物致肝脏不良反应报告,RUCAM评分：6~8分109例,3~5分39例。其中,满足肝损伤分型标准的有59例,肝细胞损伤型最多（44例）,其次为胆汁淤积型（10例）、混合型（5例）。按我国药物性肝损伤诊治指南分级标准对肝损伤病例严重程度进行分级：1级55例,2级4例。导致药物致肝脏不良反应的药物,排名前3位为抗肿瘤药物（41.58%）、抗感染药物（36.63%）、心血管系统药物（13.86%）。使用药物后至首次检出肝脏生化指标异常的时间主要集中在2~15 d。137例（92.57%）患者使用了保肝药物,其中129例详细报告了保肝药使用情况,使用1种、2种、3种保肝药的患者分别为73例（56.59%）、43例（33.33%）和13例（10.08%）。结论 导致药物致肝脏不良反应的药物种类较多,最常见的为肝细胞损伤型。临床应进一步加强对肝损伤高危药物的监测,制定保肝治疗方案时应慎重权衡联合用药的利弊。

关键词: 肝脏, 药品不良反应, 药物性肝损伤, 抗肿瘤药物, 抗感染药物, 心血管系统药物

Abstract: Objective To investigate the characteristics of drug-induced liver injury and provide references for related medications and prevention. Methods The case reports of drug-induced liver adverse reactions submitted to the National Adverse Drug Reaction Monitoring System by the Affiliated Hospital of Guizhou Medical University in 2021-2024 were collected and analyzed. Results A total of 148 cases of drug-induced liver adverse reactions were collected. Using the RUCAM scale, 109 cases were scored 6 to 8, and 39 cases 3 to 5. Among the 59 cases of liver injury whose detection indicators met the classification criteria, hepatocyte injury was the dominating type (44 cases), followed by the cholestatic type (10 cases) and the mixed type (5 cases). There were 55 grade Ⅰ cases and 4 grade Ⅱ cases. The top three drug categories responsible for live injury were antineoplastic drugs (41.58%), anti-infective drugs (36.63%) and drugs for the cardiovascular system (13.86%). The time from drug administration to the first detection of abnormal liver biochemical indicators was 2 to 15 days. Clinically, hepatoprotective drugs were used by 137 patients (92.57%) with drug-induced liver adverse reactions, 129 of whom provided detailed reports on their usage of hepatoprotective drugs. The types of hepatoprotective agents used ranged from 1 to 3 types: 73 cases (56.59%) took one type of hepatoprotective agent, 43 cases (33.33%) received two types of hepatoprotective agents, and 13 cases (10.08%) were given three types of hepatoprotective agents. Conclusion A wide range of drugs can cause drug-induced liver adverse reactions, with those causing hepatocellular injury as the dominating type. In clinical practice, high-risk drugs for liver injury should be monitored more rigorously. When formulating liver-protecting treatment plans, clinicians are advised to weigh the advantages and disadvantages of combined medications.

Key words: Liver, Adverse Drug Reaction, Drug-Induced Liver Injury, Antineoplastic Drugs, Anti-Infective Drugs, Cardiovascular System Drugs

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