中国药物警戒 ›› 2026, Vol. 23 ›› Issue (5): 553-557.
DOI: 10.19803/j.1672-8629.20250928

• 安全与合理用药 • 上一篇    下一篇

121例PD-1/PD-L1抑制剂不良反应报告分析

杜妍1,2, 杨春兰1,2, 孙旭群1,2, 方玲1,2,*   

  1. 1安徽医科大学第一附属医院药剂科,安徽 合肥 230022;
    2国家中医药管理局中药化学三级实验室,安徽 合肥 230022
  • 收稿日期:2025-12-23 发布日期:2026-05-20
  • 通讯作者: *方玲,女,博士,主任药师,临床药学。E-mail: fangling@ahmu.edu.cn
  • 作者简介:杜妍,女,博士,主管药师,医院药学。
  • 基金资助:
    安徽省教育厅-安徽省高校协同创新项目（GXXT-2021-068）

Analysis of 121 Reports of Adverse Drug Reactions to PD-1/PD-L1 Inhibitors

DU Yan1,2, YANG Chunlan1,2, SUN Xuqun1,2, FANG Ling1,2,*   

  1. 1Department of Pharmacy, the First Affiliated Hospital of Anhui Medical University, Hefei Anhui 230022, China;
    2The Grade 3 Pharmaceutical Chemistry Laboratory of State Administration of Traditional Chinese Medicine, Hefei Anhui 230022, China
  • Received:2025-12-23 Published:2026-05-20

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摘要： 目的 研究程序性细胞死亡蛋白1（Programmed Death-1, PD-1）及其配体1（Programmed Death-Ligand 1, PD-L1）抑制剂不良反应（Adverse Drug Reaction, ADR）发生特点及影响因素,为临床合理用药提供参考。方法 收集安徽省某三甲医院2024年1月1日至2025年12月31日的PD-1/PD-L1抑制剂相关ADR报告,分析患者性别、年龄、体重、原患疾病、ADR累及系统-器官及临床表现。结果 共纳入121份ADR患者报告,男性86例（71.07%）,女性35例（28.93%）,年龄集中于51~80岁（110例,90.91%）,体重集中于41~80 kg（113例,93.39%）,原患疾病包括胃、食管、肺、肝等恶性肿瘤,ADR累及系统-器官包括血液及淋巴系统损害（53例,39.85%）、皮肤及附件损害（27例,20.30%）、内分泌系统损害（10例,7.52%）等,临床表现包括白细胞减少、中性粒细胞减少、血小板减少、骨髓抑制、皮疹、甲状腺及肾上腺功能异常等。PD-1/PD-L1抑制剂引起血液及淋巴系统损害不良反应与年龄（>70岁）和原患疾病（胃、食管、贲门类消化系统肿瘤）有显著关联性（P<0.05）。结论 肿瘤患者在使用PD-1/PD-L1抑制剂治疗过程中,不同性别、年龄、体重和原患疾病的患者发生ADR情况存在差异,临床应加强PD-1/PD-L1抑制剂的使用管理和培训,密切监测相关指标,预防和减少严重ADR的发生。

关键词: PD-1/PD-L1抑制剂, 抗肿瘤药物, 血液及淋巴系统损害, 皮肤及附件损害, 内分泌系统损害, 药品不良反应

Abstract: Objective To investigate the characteristics and influencing factors of adverse drug reactions (ADRs) induced by PD-1/PD-L1 inhibitors in order to contribute to rational medication. Methods ADR reports related to PD-1/PD-L1 inhibitors and collected by a tertiary hospital in Anhui Province in 2024-2025 were analyzed in terms of the patients' gender, age, weight, underlying diseases, systems and organs involved in ADRs, and clinical manifestations. Results A total of 121 ADR reports were included, involving 86 males (71.07%) and 35 females (28.93%). Most of the patients were aged 51 to 80 (110 cases, 90.91%), and weighed 41 to 80 kg (113 cases, 93.39%). The underlying diseases included stomach, esophagus, lung and liver malignancies. The systems involved were damage to hematological and lymphatic systems (53 cases, 39.85%), the skin and its appendages (27 cases, 20.30%), and the endocrine system (10 cases, 7.52%). The clinical manifestations included leukopenia, neutropenia, thrombocytopenia, bone marrow suppression, rash, and abnormal thyroid and adrenal functions. Damage to hematological and lymphatic systems induced by PD-1/PD-L1 inhibitors was significantly associated with age (>70 years) and underlying diseases (gastric, esophageal and cardia digestive system tumors) (P<0.05). Conclusion During the treatment of tumor patients with PD-1/PD-L1 inhibitors, the prevalence of ADRs varies by gender, age, body weight, and underlying disease. Clinicians should be better informed of PD-1/PD-L1 inhibitors, and look out for risk indicators to prevent and reduce the occurrence of severe ADRs.

Key words: PD-1/PD-L1 Inhibitors, Antineoplastic Drugs, Hematologic and Lymphatic System Damage, Skin and Appendage Damage, Endocrine System Damage, Adverse Drug Reaction

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