实用肝脏病杂志 ›› 2025, Vol. 28 ›› Issue (6): 862-865.doi: 10.3969/j.issn.1672-5069.2025.06.016

• 药物性肝损伤 • 上一篇    下一篇

恶性肿瘤患者发生免疫检查点抑制剂相关肝损伤危险因素分析研究*

王淼晶, 张宁, 马红, 张广全   

  1. 210031 南京市 南京医科大学第四附属医院药剂科(王淼晶,张宁,马红);常州市肿瘤医院药事科(张广全)
  • 收稿日期:2025-05-21 出版日期:2025-11-10 发布日期:2025-11-13
  • 通讯作者: 马红,E-mail:mahongnanjing@163.com
  • 作者简介:王淼晶,女,34岁,大学本科,主管药师。E-mail:wangmiaojing1991@163.com
  • 基金资助:
    *南京医科大学科技发展基金面上项目(编号:2022NJMU260)

Risk factors for immune checkpoint inhibitors-associated liver injury in patients with malignant tumor

Wang Miaojing, Zhang Ning, Ma Hong, et al   

  1. Department of Pharmacy, Fourth Affiliated Hospital, Nanjing Medical University, Nanjing 210031, Jiangsu Province, China
  • Received:2025-05-21 Online:2025-11-10 Published:2025-11-13

摘要: 目的 分析恶性肿瘤患者发生免疫检查点抑制剂(ICIs)相关肝损伤的危险因素。方法 2024年1月~12月我院收治的恶性肿瘤患者337例,均接受含ICIs抗肿瘤治疗。应用多因素Logistic回归分析恶性肿瘤患者发生ICIs相关肝损伤的危险因素。结果 在337例恶性肿瘤患者中,在抗肿瘤治疗期间发生ICIs相关肝损伤31例(9.2%);肝损伤组肿瘤Ⅳ期、应用细胞毒性T淋巴细胞相关抗原4(CTLA-4)抑制剂治疗和合并肝病病史占比分别为67.7%、25.8%和32.2%,均显著高于非肝损伤组(分别为45.1%、9.2%和13.1%,P<0.05);多因素Logistic回归分析显示,肿瘤分期(OR=2.700,95%CI:1.172~6.223,P<0.05)、肝病病史(OR=3.619,95%CI:1.486~8.815,P<0.05)和应用CTLA-4抑制剂(OR=1.740,95%CI:1.052~2.880,P<0.05)均为影响恶性肿瘤患者发生ICIs相关肝损伤的独立危险因素。结论 实体肿瘤患者治疗复杂,容易发生DILI。了解危险因素,做好监测,早期发现,可能提高治疗效果。

关键词: 药物性肝损伤, 恶性肿瘤, 免疫检查点抑制剂, 危险因素

Abstract: Objective The aim of this study was to investigate the risk factors for immune checkpoint inhibitors (ICIs)-associated liver injury in patients with malignant tumors. Methods A total of 337 consecutive patients with malignant tumors were admitted to our hospital between January and December 2024. All of them received anti-tumor treatment containing ICIs or ICIs with combination of other anti-tumor medicines. Multivariate Logistic regression analysis was applied to identify the risk factors for ICIs-associated liver injury in the patients. Results Of the 337 patients with malignant tumor, 31 (9.2%) patients developed ICIs-associated liver injury during anti-tumor treatment; the proportions of patients at tumor stage IV, the application of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor and with a chronic liver disease history in the liver injury group were 67.7%, 25.8% and 32.2%, all significantly higher than 45.1%, 9.2% and 13.1% (P<0.05) in those without iver injury group; multivariate Logistic regression analysis showed that tumor stage (OR=2.700, 95%CI: 1.172-6.223, P<0.05), CTLA-4 inhibitor administration (OR=1.740, 95%CI: 1.052-2.880, P<0.05) and liver disease history (OR=3.619, 95%CI: 1.486-8.815, P<0.05) were the independent risk factors for occurrence of ICIs-associated liver injury in patients with malignant tumors. Conclusion Clinicians should take risk factors into consideration in order to prevent and early management of ICIs-associated liver injury.

Key words: Drug-induced Liver injury, Malignant tumor, Immune checkpoint inhibitors, Risk factor