中国药物警戒 ›› 2026, Vol. 23 ›› Issue (8): 892-897.
DOI: 10.19803/j.1672-8629.20260414

• 安全与合理用药 • 上一篇    下一篇

免疫检查点抑制剂相关甲状腺功能障碍的多中心病例分析

吕欣鸽1,2, 刘艾嘉3, 武一1, 潘晨1, 王雨婷1,2, 崔向丽1,*   

  1. 1首都医科大学附属北京友谊医院药剂科,北京 100050;
    2首都医科大学药学院,北京 100069;
    3首都医科大学基础医学院,北京 100069
  • 收稿日期:2026-05-22 出版日期:2026-08-15 发布日期:2026-08-17
  • 通讯作者: *崔向丽,女,博士,主任药师,药物警戒与药事管理。E-mail: cui10@163.com
  • 作者简介:吕欣鸽,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（82504778）; 2025年中国高校产学研创新基金资助项目（2025XH076）

Multicenter case analysis of thyroid dysfunction associated with immune checkpoint inhibitors

Lyu Xinge1,2, Liu Aijia3, Wu Yi1, Pan Chen1, Wang Yuting1,2, Cui Xiangli1,*   

  1. 1Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China;
    2School of Pharmaceutical Sciences, Capital Medical University, Beijing 100069, China;
    3School of Basic Medical Sciences, Capital Medical University, Beijing 100069, China
  • Received:2026-05-22 Online:2026-08-15 Published:2026-08-17

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摘要： 目的 分析免疫检查点抑制剂相关甲状腺功能障碍（Immune Checkpoint Inhibitors-Associated Thyroid Dys-function, ICIs-TD）多中心和文献病例特征,为临床早期识别和优化ICIs-TD的管理策略提供参考。方法 回顾性纳入2024年8月1日至2025年7月31日6家医院使用ICIs治疗后发生甲状腺功能障碍的恶性肿瘤患者病例,并检索中国知网、万方数据、维普网、PubMed、Web of Science、Scopus、Embase、Cochrane Library自建库至2025年10月31日关于纳入ICIs-TD病例的文献,提取临床特征并进行统计分析。结果 6家医院共纳入70例ICIs-TD病例,包括甲状腺功能减退47例、甲状腺功能亢进17例以及甲状腺炎6例。文献回顾共纳入238篇文献265例ICIs-TD病例,包括甲状腺功能减退127例,甲状腺功能亢进53例及甲状腺炎85例。甲状腺功能减退为主要表现类型,使用程序性细胞死亡受体-1（Programmed Death-1, PD-1）抑制剂占比最高。60%以上患者在首次使用ICIs后4个月内发生ICIs-TD,多中心与文献回顾的中位发生时间分别为97（66.5, 133.5）d和63（42, 105）d。严重程度整体较轻,半数以上患者未停用ICIs。管理策略采用甲状腺激素替代或β受体阻滞剂对症治疗,总体预后良好。结论 在ICIs治疗过程中,建议规范甲状腺指标与抗体的动态监测,提高高发人群监测频率,早期识别甲状腺损害,同时建议避免过度中断免疫治疗,以加强个体化精准管理。

关键词: 甲状腺功能障碍, 免疫检查点抑制剂, 免疫相关不良事件, 病例分析, 药品不良反应

Abstract: Objective To analyze cases of immune checkpoint inhibitors-related thyroid dysfunction (ICIs-TD) from both multicenter and literature sources in order to provide a reference for early clinical identification and optimization of management strategies. Methods Patients with malignancies who developed thyroid dysfunction following ICIs therapy were retrospectively enrolled from six hospitals between August 2024 and July 2025. CNKI, Wanfang, VIP, PubMed, Web of Science, Scopus, Embase, and Cochrane Library were searched for literature related to ICIs-TD that was published as of October 2025. Clinical characteristics were summarized and statistically analyzed. Results A total of 70 patients with ICIs-TD were enrolled from six hospitals, including 47 cases of hypothyroidism, 17 cases of hyperthyroidism, and 6 cases of thyroiditis. A total of 238 articles involving 265 cases of ICIs-TD were included in literature review, comprising 127 cases of hypothyroidism, 53 cases of hyperthyroidism, and 85 cases of thyroiditis. Hypothyroidism was the dominating condition, and most patients received programmed cell death-1 (PD-1) inhibitors. More than 60% of the patients developed ICIs-TD within 4 months of ICIs therapy. The median time to onset was 97 (66.5, 133.5) days in the multicenter cohort and 63 (42, 105) days in literature, respectively. The symptoms were generally mild, with more than half of the patients continuing ICIs. Management strategies included thyroid hormone replacement or symptomatic treatment with β-blockers, and the overall prognosis was favorable. Conclusion Regular monitoring of thyroid function and antibodies during ICIs therapy is recommended, especially in high-risk populations, in order to facilitate early detection of thyroid injury. Frequent interruption of immunotherapy should be avoided to support individualized precision management.

Key words: Thyroid Dysfunction, Immune Checkpoint Inhibitors, Immune Related Adverse Events, Case Analysis, Adverse Drug Reaction

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