中国药物警戒 ›› 2025, Vol. 22 ›› Issue (4): 442-446.
DOI: 10.19803/j.1672-8629.20240795

• 安全与合理用药 • 上一篇    下一篇

159例免疫检查点抑制剂不良反应分析

张云惠1, 陈浩云1, 钟陆华1, 房财富1, 黄焕均1, 郭晨晨2, 董心仪2, 石凤2, 梁蔚婷1,*   

  1. 1中山大学肿瘤防治中心药学部,华南恶性肿瘤防治全国重点实验室,广东省恶性肿瘤临床医学研究中心,广东 广州 510060;
    2中山大学药学院,广东 广州 510006
  • 收稿日期:2024-10-17 发布日期:2025-04-17
  • 通讯作者: *梁蔚婷,女,硕士,副主任药师,抗肿瘤药物临床综合评价。E-mail: liangwt@sysucc.org.cn
  • 作者简介:张云惠,女,硕士,药师,药品不良反应管理。
  • 基金资助:
    广东省药品临床综合评价项目（2022-1115-28）; 吴阶平医学基金会临床科研专项资助基金项目（320.6750.2024-18-31）

159 Cases of Adverse Reactions to Immune Checkpoint Inhibitors

ZHANG Yunhui1, CHEN Haoyun1, ZHONG Luhua1, FANG Caifu1, HUANG Huanjun1, GUO Chenchen2, DONG Xinyi2, SHI Feng2, LIANG Weiting1,*   

  1. 1Department of Pharmacy, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou Guangdong 510060, China;
    2School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou Guangdong 510006, China
  • Received:2024-10-17 Published:2025-04-17

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摘要： 目的 分析免疫检查点抑制剂（Immune Checkpoint Inhibitors, ICIs）相关药品不良反应（Adverse Drug Reactions, ADR）发生情况与临床特征,以期为临床安全使用ICIs提供参考。方法 收集某肿瘤医院2018年6月1日至2024年8月31日上报的159例ICIs相关ADR报告,分析并统计患者年龄、性别、ADR严重程度、发生时间、累及系统-器官及临床表现等。结果 159例ADR报告中,患者年龄主要分布在41~70岁（74.84%）,男性为女性的1.94倍。涉及ICIs药物共11种,严重ADR占比28.93%,80.63%的ADR发生在ICIs治疗的前5个周期。ADR累及系统-器官广泛,主要分布在皮肤及皮下组织类疾病。6种ICIs发生了说明书中未载明的ADR。结论 ICIs引起的ADR广泛且复杂,建议实施基于风险评估的个性化监测策略,早期识别和干预ADR。

关键词: 免疫检查点抑制剂, 程序性死亡受体-1抑制剂, 程序性死亡配体-1抑制剂, 免疫相关不良反应, 药品不良反应, 安全性

Abstract: Objective To analyze the incidence and clinical characteristics of adverse drug reactions (ADR) associated with immune checkpoint inhibitors (ICIs) in order to provide a reference for safe clinical use of ICIs. Methods One hundred and fifty-nine ICIs-related ADR reports submitted between June 1, 2018 and August 31, 2024 in a cancer hospital were collected before the patients’ age, gender, severity of ADR, occurrence times, system organs involved, and clinical manifestations were analyzed. Results According to the 159 ADR reports, the age of most of the patients ranged from 41 to 70 (74.84%), and there were 1.94 times as many male patients as female ones. There were 11 types of ICIs medicines involved. 28.93% of these ADR were serious and 80.63% occurred in the first five cycles of ICIs therapy. ADR involved a wide range of system organ classes, particularly the skin and subcutaneous tissues. Six types of ICIs caused ADR that were not mentioned in drug inserts. Conclusion The spectrum of ADR caused by ICIs is extensive and complicated. The implementation of personalized risk-based surveillance strategies for early identification and intervention is critical to effective management of ICIs-related ADR.

Key words: Immune Checkpoint Inhibitor, Programmed Death 1 Inhibitor, Programmed Death Ligand 1 Inhibitor, Immune-Related Adverse Reaction, Adverse Drug Reaction, Safety

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