中国药物警戒 ›› 2026, Vol. 23 ›› Issue (3): 318-322.
DOI: 10.19803/j.1672-8629.20250529

• 安全与合理用药 • 上一篇    下一篇

免疫检查点抑制剂致肠炎病例分析

王雨婷, 朱芳仪△, 吕欣鸽, 潘晨, 武一, 崔向丽*   

  1. 首都医科大学附属北京友谊医院药剂科,北京 100050
  • 收稿日期:2025-08-06 出版日期:2026-03-15 发布日期:2026-03-17
  • 通讯作者: *崔向丽,女,博士,主任药师,器官移植药学。E-mail: cui10@163.com
  • 作者简介:王雨婷,女,在读硕士,免疫检查点抑制剂相关肠炎风险研究。△为并列第一作者。
  • 基金资助:
    国家自然科学基金资助项目（82504778）; 北京慢性病防治与健康教育研究会2024年药学专项科研课题（MBZX0082024001）; 2025年中国高校产学研创新基金（2025XH076）

Cases of Colitis Caused by Immune Checkpoint Inhibitors

WANG Yuting, ZHU Fangyi△, LYU Xinge, PAN Chen, WU Yi, CUI Xiangli*   

  1. Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
  • Received:2025-08-06 Online:2026-03-15 Published:2026-03-17

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摘要： 目的 分析国内外文献报道免疫检查点抑制剂（Immune Checkpoint Inhibitors, ICIs）致肠炎的病例特征,为临床识别、诊断和管理此类免疫不良反应提供参考。方法 通过检索中国知网、维普网、万方数据、PubMed、Web of Science、Embase、Cochrane等数据库建库至2025年6月30日报道ICIs致肠炎的不良反应病例文献,提取相关信息并进行统计分析。结果 共纳入98篇文献148例患者,其中男性108例,女性40例;中位年龄60（53.75,68.00）岁;原患肿瘤以肺癌（61例）和黑色素瘤（45例）为主,消化系统肿瘤和泌尿生殖系统肿瘤各15例,头颈部肿瘤8例,骨骼肌肉及其他（肩部、腹膜后、胸腺等）肿瘤4例;程序性死亡受体1（PD-1）抑制剂单药治疗121例,程序性死亡配体-1（PD-L1）抑制剂单药治疗2例,CTLA-4抑制剂单药治疗6例,联合治疗10例,不详9例;中位发病时间为当次用ICIs后20.50（7.00,41.00）d;G1~G2级不良反应40例,G3~G4级不良反应108例;肠炎治疗以糖皮质激素（87例）和英夫利西单抗（22例）为主;14例痊愈,103例好转,9例致死,不详22例。结论 ICIs使用后若发生肠炎通常较严重,应警惕是否发生免疫性肠炎,密切监测腹泻特征,糖皮质激素冲击治疗有较好的疗效。

关键词: 免疫检查点抑制剂, 免疫治疗, 肠炎, 免疫相关不良事件, 药品不良反应, 肺癌, 黑色素瘤, 肿瘤

Abstract: Objective To analyze cases of colitis induced by immune checkpoint inhibitors (ICIs) reported in literature in order to provide a reference for the clinical identification, diagnosis and management of such immune-related adverse events. Methods Databases including CNKI, VIP, Wanfang, PubMed, Web of Science, Embase and Cochrane Library were searched for related articles published as of June 2025. Reports of colitis caused by ICIs were screened, and patients’ demographics, tumor type, treatment regimens, onset time, severity, therapeutic strategies and outcomes were analyzed statistically. Results Ninety-eight articles involving 148 patients were included. The majority of the patients were male (72.97%), and the median age was 60. Lung cancer (41.21%) and melanoma (30.41%) were the most common primary tumors. PD-1 inhibitors were used in 81.76 % of the regimens. The median onset time from initiation of ICIs was 20.50 days. Severe colitis (grade 3-4) occurred in 72.97% of the cases. Corticosteroids were the major regimens (58.78%), and infliximab used in 14.86% of the cases. Most of the patients improved (69.59%), but 6.08% died. Conclusion Once severe colitis occurs after the use of ICIs, clinicians need to be alert for the possibility of immune-mediated colitis, especially diarrhea. A combination of glucocorticoid pulse therapy can yield good results.

Key words: Immune Checkpoint Inhibitors, Immunotherapy, Colitis, Immune-Related Adverse Events, Adverse Drug Reaction, Lung Cancer, Melanoma, Tumor

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