中国药物警戒 ›› 2026, Vol. 23 ›› Issue (6): 681-685.
DOI: 10.19803/j.1672-8629.20260039

• 安全与合理用药 • 上一篇    下一篇

免疫检查点抑制剂致相关肠炎不良反应报告分析

王雨婷, 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:2026-01-14 出版日期:2026-06-15 发布日期:2026-06-18
  • 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,硕士,免疫检查点抑制剂相关肠炎风险研究。
  • 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-产业协会智慧医疗创新专项课题（2025XH076）

Reports of Adverse Reactions of Immune Checkpoint Inhibitor-Related Colitis

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

  1. Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
  • Received:2026-01-14 Online:2026-06-15 Published:2026-06-18

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摘要： 目的 分析免疫检查点抑制剂（ICIs）相关肠炎病例,为临床合理用药及不良反应管理提供参考。方法 收集2020年1月1日至2025年8月31日本院收治的ICIs相关肠炎患者临床资料,对患者基本情况、用药特征、肠炎临床特征及治疗转归进行分析。结果 29例患者,男性24例（82.76%）,中位年龄65岁,肠炎总发生率为0.92%（29/3 153）。肠炎中位发生时间为首次用药后16 d,原患肿瘤肺癌9例（31.03%）,胃癌6例（20.69%）,食管癌5例（17.24%）;发生肠炎的患者用药以程序性死亡受体1（PD-1）抑制剂为主（28例,96.55%）,其中,信迪利单抗例数最多（10例）,21例（72.41%）采用免疫联合化疗方案,1~2级不良反应26例（89.66%）,3~4级不良反应3例（10.34%）。治疗以对症支持（22例,75.86%）和糖皮质激素（6例,20.69%）为主,28例（96.55%）病情好转。结论 ICIs相关肠炎多见于老年男性肿瘤患者,PD-1抑制剂单药发生率较低,联合化疗可增加风险,早期干预预后良好,临床需重点监测用药后3个月内的胃肠症状。

关键词: 免疫检查点抑制剂, 程序性死亡受体1, 信迪利单抗, 肠炎, 药品不良反应, 肿瘤

Abstract: Objective To analyze the clinical characteristics of enteritis associated with immune checkpoint inhibitors (ICIs), and to provide a reference for rational clinical medications and management of such immune-related adverse reactions. Methods The clinical data of patients with ICIs-related enteritis admitted to our hospital between January 2020 and August 2025 was collected before the baseline demographics, medications, clinical features of enteritis, treatment regimens and clinical outcomes of these patients were statistically analyzed. Results A total of 29 patients were enrolled in this study, 24 of whom were male (82.76%) with a median age of 65. The overall incidence of ICIs-related enteritis was 0.92% (29/3 153). The median onset time of enteritis was 16 days after the first administration of ICIs. The dominating primary tumors were lung cancer in 9 cases (31.03%), gastric cancer in 6 cases (20.69%), and esophageal cancer in 5 cases (17.24%). Programmed cell death protein 1 (PD-1) inhibitors were the major ICIs used in patients with enteritis (28 cases, 96.55%), among which sintilimab was responsible for the largest number of cases (10 cases). Twenty-one of these patients (72.41%) were treated with ICIs combined with chemotherapy. There were 26 cases (89.66%) of grade 1-2 adverse reactions and 3 cases (10.34%) of grade 3-4 adverse reactions. The main treatments included symptomatic and supportive care (22 cases, 75.86%) and glucocorticoid therapy (6 cases, 20.69%), and 28 patients (96.55%) improved. Conclusion ICIs-related enteritis is more prevalent in elderly male patients with malignant tumors. The incidence of enteritis is relatively low in patients receiving PD-1 inhibitor monotherapy, but ICIs combined with chemotherapy can elevate the risk. Patients with ICIs-related enteritis have a favorable prognosis following quick interventions, and clinicians should monitor gastrointestinal symptoms within 3 months of ICIs administration.

Key words: Immune Checkpoint Inhibitors, PD-1, Sintilimab, Enteritis, Adverse Drug Reactions, Cancer

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