肝脏 ›› 2025, Vol. 30 ›› Issue (7): 967-971.

• 药物性肝损伤 • 上一篇    下一篇

免疫检查点抑制剂相关肝损伤的临床特征分析

赵梦鱼, 王艳, 刘立伟, 陈炜, 赵新颜   

  1. 100050 北京 首都医科大学附属北京友谊医院肝病中心,国家消化系统疾病临床医学研究中心(赵梦鱼,王艳,赵新颜),消化内科(陈炜);100069 北京 首都医科大学附属北京佑安医院肝病四科(刘立伟)
  • 收稿日期:2024-11-20 出版日期:2025-07-31 发布日期:2025-08-11
  • 通讯作者: 赵新颜,Email: zhao_xinyan@ccmu.edu.cn
  • 基金资助:
    中国肝炎防治基金会王宝恩肝纤维化研究基金(WBE2020058)。

Analysis of clinical characteristics of liver injury associated with immune checkpoint inhibitors

ZHAO Meng-yu1, WANG Yan1, LIU Li-wei2, CHEN Wei3, ZHAO Xin-yan1   

  1. 1. Liver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing 100050, China;
    2. Fourth Department of Liver Disease, Beijing You’an Hospital, Capital Medical University, Beijing 100069, China;
    3. Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
  • Received:2024-11-20 Online:2025-07-31 Published:2025-08-11
  • Contact: ZHAO Xin-yan, Email: zhao_xinyan@ccmu.edu.cn

摘要: 目的 探索免疫检查点抑制剂(immune checkpoint inhibitors,ICIs)相关肝损伤患者的临床特征。方法 回顾性分析2016年4月至2022年12月在首都医科大学附属北京友谊医院住院并使用ICIs的恶性肿瘤患者。比较ICIs相关肝损伤组、非ICIs相关肝损伤组患者的临床特征。结果 共纳入1355例应用ICIs的恶性肿瘤患者,其中出现ICIs相关肝损伤66例(4.9%),未出现ICIs相关肝损伤1289例(95.1%)。两组年龄、性别、肿瘤部位、应用ICIs周期、ICIs种类、ICIs药物类型、其他系统irAEs等差异无统计学意义。ICIs相关肝损伤组基线ALP、GGT明显低于非ICIs相关肝损伤组(87 vs. 98,P=0.03;37.5 vs. 49,P<0.01),峰值ALT、AST、GGT、TBil明显高于非ICIs相关肝损伤组(122 vs. 24,P<0.01;133 vs. 29,P<0.01;189 vs. 97,P=0.04;23.9 vs. 16.4,P<0.01)。ICIs相关肝损伤患者1年内死亡率与非ICIs相关肝损伤组差异无统计学意义(7.6% vs. 3.0%,P=0.065)。两组患者的死亡率与应用激素与否差异无统计学意义(8.3% vs. 10.7%,P=0.85)。结论 应用ICIs的恶性肿瘤患者的ICIs相关肝损伤发生率为4.9%,ICIs相关肝损伤可表现为ALT、AST升高,可伴GGT、TBil升高,轻症患者多,因ICIs相关肝损伤死亡的患者少,预后较好。

关键词: 免疫检查点抑制剂, 肝损伤, 预后

Abstract: Objective To explore the clinical characteristics of patients with immune-mediated liver injury induced by immune checkpoint inhibitors (ICIs). Methods A retrospective analysis was conducted on patients with malignant tumors who were hospitalized at Beijing Friendship Hospital, Capital Medical University, and received ICIs from April 2016 to December 2022. The clinical characteristics of patients with ICIs-related liver injury and non-ICIs-related liver injury were compared. Results A total of 1,355 patients with malignant tumors treated with ICIs were included in the study, among whom 66 cases (4.9%) developed ICIs-related liver injury, while 1,289 cases (95.1%) did not develop ICIs-related liver injury. There were no statistically significant difference between the two groups in age, gender, tumor location, number of ICIs cycles, type of ICIs, type of ICIs drug, and other systemic immune-related adverse events (irAEs). The baseline levels of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) in the ICIs-related liver injury group were significantly lower than those in the non-ICIs-related liver injury group (87 vs. 98, P=0.025; 37.5 vs. 49, P=0.003), while the peak levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), GGT, and total bilirubin (TBil) were significantly higher in the ICIs-related liver injury group than in the non-ICIs-related liver injury group (122 vs. 24,P<0.01; 133 vs. 29,P<0.01; 189 vs. 97,P=0.04; 23.9 vs. 16.4, P<0.01). The mortality rate within twelve months was not statistically different between the ICIs-related liver injury group and the non-ICIs-related liver injury group (7.6% vs. 3.0%, P=0.065). There was also no statistically significant difference in mortality rate between patients who received corticosteroids and those who did not (8.3% vs. 10.7%, P=0.85). Conclusion The incidence of ICIs-related liver injury in patients with malignant tumors treated with ICIs was 4.9%. ICIs-related liver injury mainly manifested as elevated ALT and AST levels, with increased GGT and TBil levels. Most cases were mild, and deaths due to ICIs-related liver injury were rare, indicating a relatively better prognosis.

Key words: Immune checkpoint inhibitors, Liver injury, Prognosis