中国药物警戒 ›› 2026, Vol. 23 ›› Issue (8): 904-908.
DOI: 10.19803/j.1672-8629.20260055

• 安全与合理用药 • 上一篇    下一篇

691例新型抗肿瘤药品不良反应报告分析

李剑屏, 杜宁, 唐敏, 周子原, 左靖*   

  1. 国家癌症中心,国家肿瘤临床医学研究中心,中国医学科学院北京协和医学院肿瘤医院深圳医院药学部,广东 深圳 518116
  • 收稿日期:2026-01-19 出版日期:2026-08-15 发布日期:2026-08-17
  • 通讯作者: *左靖,女,硕士,副主任药师,临床药学。E-mail: ahzuojing@126.com
  • 作者简介:李剑屏,女,本科,主管药师,临床药学。
  • 基金资助:
    深圳市药学会医院药学研究基金资助项目（sz2022A29）; 广东省药学会肿瘤领域超说明用药评价研究基金资助项目（2023ZLCS14）

691 cases of adverse drug reactions caused by new antineoplastic drugs

Li Jianping, Du Ning, Tang Min, Zhou Ziyuan, Zuo Jing*   

  1. Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen Guangdong 518116, China
  • Received:2026-01-19 Online:2026-08-15 Published:2026-08-17

PDF (PC)

79

摘要： 目的 分析新型抗肿瘤药物药品不良反应（Adverse Drug Reaction, ADR）的特征与规律,为临床用药安全提供参考。方法 收集2020年10月1日至2025年10月31日某肿瘤专科医院疑似新型抗肿瘤药物引起的ADR报告691例,并对患者性别、年龄、药物种类、累及系统-器官及临床表现、ADR分级与转归、超说明书用药等进行统计分析。结果 691例ADR报告中,男性374例（54.12%）,女性317例（45.88%）,平均年龄为（57.02±12.34）岁。新的ADR 32例（4.63%）,严重ADR 397例（57.45%）。涉及新型抗肿瘤药物70种,其中免疫检查点抑制剂271例次（35.61%）,以替雷利珠单抗为主（72例次）。涉及超说明书用药121例。ADR累及20个系统-器官,最常见的是血液及淋巴系统疾病516例次（48.59%）,且78.00%的ADR临床转归为痊愈或好转。结论 新型抗肿瘤药物安全信息尚不完善,其引发的ADR可累及多个系统-器官,建议临床强化患者基线评估与动态监测。针对超说明书用药的安全隐患,应加强多学科协作与伦理审查,以应对循证滞后与临床需求的矛盾,保障用药安全。

关键词: 新型抗肿瘤药物, 免疫检查点抑制剂, 大分子单克隆抗体, 超说明书用药, 药品不良反应

Abstract: Objective To study the patterns and characteristics of adverse drug reactions (ADRs) related to new antineoplastic drugs, and provide a reference for clinical medication. Methods A total of 691 cases of ADRs caused by new antineoplastic drugs were collected in a cancer hospital between October 2020 and October 2025. Data on gender, age, types of drugs, systems-organs involved in ADRs, clinical manifestations, off-label medication, grading and outcomes of ADRs and correlations was analyzed via the Microsoft Excel. Results Among the 691 cases, 374 (54.12%) were males and 317 (45.88%) females, and the average age was (57.02±12.34) years. There were 397 (57.45%) cases of serious ADRs and 32 (4.63%) cases of new ADRs. A total of 70 new antineoplastic drugs were involved. Immune checkpoint inhibitors were responsible for 271 cases (35.61%),and tislelizumab was the leading cause (72 cases). There were 121 cases involved in off-label medication and 20 systems-organs involved. The most frequently affected systems were blood and the lymphatic system (48.59%). Most of these ADRs were mitigated (78.00%). Conclusion Data on pharmacovigilance concerning new antineoplastic drugs remains lacking. ADRs associated with these agents can involve multiple systems-organs. Therefore, it is recommended that patients undergo baseline and dynamic monitoring. Off-label medications pose a risk to safety. Multidisciplinary collaboration and ethical review should be enforced to reconcile the conflict between delayed generation of evidence and pressing clinical needs.

Key words: New Antitumor Drugs, Immune Checkpoint Inhibitors, Macromolecular Monoclonal Antibody, Off-Label Medication, Adverse Drug Reaction

中图分类号: