中国药物警戒 ›› 2026, Vol. 23 ›› Issue (2): 162-166.
DOI: 10.19803/j.1672-8629.20250760

• 基础与临床研究 • 上一篇    下一篇

间变性淋巴瘤激酶抑制剂致肝损伤的危险因素研究

邓青青1,2, 姚青青1, 胡涛1, 杨佳乐1,2, 边诣聪1,2#, 缪丽燕1,2,*   

  1. 1苏州大学附属第一医院药学部，江苏 苏州 215006;
    2苏州大学药学院，江苏 苏州 215100
  • 收稿日期:2025-10-31 出版日期:2026-02-15 发布日期:2026-02-13
  • 通讯作者: *缪丽燕，女，博士，教授，临床药理。E-mail: miaolysuzhou@163.com; #为共同通信作者。
  • 作者简介:邓青青，女，在读硕士，临床药学。
  • 基金资助:
    国家自然科学基金资助项目（82304633）; 江苏省科技计划专项资金资助项目（BM2023003）; 江苏省医学重点学科-临床药学资助项目（ZDXK202247）; 江苏省青年科技人才托举工程资助项目（JSTJ-2024-514）

Risk Factors for Liver Injury Induced by Anaplastic Lymphoma Kinase Inhibitors

DENG Qingqing1,2, YAO Qingqing1, HU Tao1, YANG Jiale1,2, BIAN Yicong1,2#, MIAO Liyan1,2,*   

  1. 1Department of Pharmacy, the First Affiliated Hospital of Soochow University, Suzhou Jiangsu 215006, China;
    2School of Pharmacy, Soochow University, Suzhou Jiangsu 215100, China
  • Received:2025-10-31 Online:2026-02-15 Published:2026-02-13

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摘要： 目的 探讨间变性淋巴瘤激酶（Anaplastic Lymphoma Kinase，ALK）抑制剂致非小细胞肺癌（Non-Small Cell Lung Cancer，NSCLC）患者发生肝损伤的临床特征及危险因素。方法 收集2019年1月1日至2024年7月31日在苏州大学附属第一医院接受ALK抑制剂治疗的NSCLC患者临床资料，根据患者是否发生肝损伤分为肝损伤组和未肝损伤组，对比两组患者的人口学特征、疾病诊断和基线肝脏生化指标等临床信息，采用单因素和多因素Logistic回归分析肝损伤的危险因素。结果 共纳入75例接受ALK抑制剂治疗的NSCLC患者，肝损伤总体发生率为42.7%（32/75）。肝损伤组和未肝损伤组患者的人口学信息、肺癌分期、基线肝脏生化指标等临床资料差异无统计学意义。Logistic回归分析结果显示，基础疾病[P=0.047，高血压P=0.006，95%CI（1.691，21.312）]和合并用药[P=0.008，合用质子泵抑制剂P=0.022，95%CI（1.274，23.761）]可能是ALK抑制剂致肝损伤的独立危险因素。结论 NSCLC患者接受ALK抑制剂治疗时，发生肝损伤的风险可能与合并基础疾病如高血压或治疗期间合用质子泵抑制剂等药物存在潜在关联。临床用药应密切监测此类患者肝功能变化，以保障ALK抑制剂安全合理用药。

关键词: 间变性淋巴瘤激酶抑制剂, 非小细胞肺癌, 肝损伤, 危险因素

Abstract: Objective To investigate the clinical characteristics of and risk factors for liver injury induced by anaplastic lymphoma kinase (ALK) inhibitors in patients with non-small cell lung cancer (NSCLC). Methods The clinical data of NSCLC patients treated with ALK inhibitors at the First Affiliated Hospital of Soochow University between January 2019 and July 2024 was collected. Patients were divided into a liver injury group and a non-liver injury group based on the occurrence of liver injury. Demographics, disease diagnosis, baseline biochemical indicators of livers, and other clinical data were compared between the two groups. Univariate and multivariate logistic regression analyses were used to identify risk factors for liver injury. Results A total of 75 NSCLC patients treated with ALK inhibitors were included in this study, with an overall incidence of liver injury of 42.7% (32/75). There were no significant differences in clinical characteristics such as demographic information, lung cancer stage, or baseline biochemical indicators of the liver between the two groups. Logistic regression analysis revealed that pre-existing diseases [P=0.047, hypertension P=0.006, 95%CI (1.691, 21.312)] and concomitant medications [P=0.008, concomitant use of proton pump inhibitors P=0.022, 95%CI (1.274, 23.761)] might be independent risk factors for ALK inhibitor-induced liver injury. Conclusion The results of this study suggest that the risk of liver injury in NSCLC patients receiving ALK inhibitor treatment is potentially associated with comorbid underlying diseases such as hypertension, or concurrent use of drugs like proton pump inhibitors during treatment. For such patients, close monitoring of liver function is essential in clinical practice to ensure the safe and rational use of ALK inhibitors.

Key words: Anaplastic Lymphoma Kinase Inhibitor, Non-Small Cell Lung Cancer, Liver Injury, Risk Factors

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