中国药物警戒 ›› 2025, Vol. 22 ›› Issue (6): 649-653.
DOI: 10.19803/j.1672-8629.20250098

• 安全与合理用药 • 上一篇    下一篇

447例替雷利珠单抗注射液不良反应报告分析

朱磊1, 张弦1, 汪瑞妍2, 李颖3*   

  1. 1安徽省药品不良反应监测中心,安徽 合肥 230051;
    2安徽中医药大学药学院,安徽 合肥 230031;
    3安徽中医药大学第一附属医院药学部,安徽 合肥 230031
  • 收稿日期:2025-02-28 发布日期:2025-06-18
  • 通讯作者: *李颖,女,硕士,主任药师·硕导,临床药学。E-mail: ymh2003@126.com
  • 作者简介:朱磊,男,硕士,副主任药师,药品不良反应监测与评价。
  • 基金资助:
    安徽省卫生健康科研项目计划（AHWJ2023BAc10045）

Adverse Reactions Reports about Tislelizumab Injection in 447 Cases

ZHU Lei1, ZHANG Xian1, WANG Ruiyan2, LI Ying3*   

  1. 1Center for ADR Monitoring of Anhui, Hefei Anhui 230051, China;
    2School of Pharmacy, Anhui University of Chinese Medicine, Hefei Anhui 230031, China;
    3Pharmacy Department of the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei Anhui 230031, China
  • Received:2025-02-28 Published:2025-06-18

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摘要： 目的 探讨替雷利珠单抗注射液不良反应（ADR）发生情况及特征。方法 收集2024年1月1日至2024年12月31日安徽省上报至国家药品不良反应监测系统中的替雷利珠单抗注射液ADR报告,统计患者的基本情况、用药情况、ADR累及系统-器官和临床表现、转归等,分析ADR发生特点。结果 447例替雷利珠单抗注射液ADR报告中,男性348例（77.85%）,女性99例（22.15%）,平均年龄（57.00±15.56）岁,主要分布在50岁以上年龄段;发生ADR的用药周期跨度较大（0~483 d）,其中第1周期（1~21 d）内出现ADR的频率最高（89.71%）;ADR累及多个系统-器官,主要累及血液系统228例次（44.79%）;后遗症ADR 2例（0.45%）,临床表现均为甲状腺功能减退。G3级严重ADR 270例（60.40%）,G4级严重ADR 4例（0.90%）,累及多个系统-器官,均发生在用药第1周期后,经治疗后好转。80.31%ADR临床转归为痊愈或好转。结论 替雷利珠单抗注射液临床用于多种肿瘤的治疗,ADR累及多个系统-器官,少数严重ADR可危及生命,建议临床合理使用,加强用药监护,关注如过敏性休克等ADR,早期发现,及时干预。

关键词: 免疫检查点抑制剂, 替雷利珠单抗注射液, 血液系统, 皮肤及皮下组织, 胃肠系统, 甲状腺功能减退, 不良反应

Abstract: Objective To explore the incidence and characteristics of adverse drug reactions (ADR) related to tislelizumab injection. Methods ADR reports submitted by medical institutions to the national ADR monitoring system database in 2024 were collected, involving the basic information of patients, use of drugs, organs and systems involved, and manifestations. Charts were used to analyze the characteristics of ADR. Results In the 447 reports, 348 men (77.85%) and 99 women (22.15%) were involved. The mean age was (57.00±15.56) years. Most of the patients were above 50. The drug cycle of ADR ranged from 0 to 483 days. ADR were the most frequent in the first cycle (1 to 21 days) of treatment (89.71%). The ADR involved multiple systems-organs. There were 228 cases that involved the blood system (44.79%) and 2 cases of sequelae (0.45%). The clinical manifestations were all hypothyroidism. There were 270 cases (60.40%) of severe ADR of G3 and 4 cases of severe ADR of G4 (0.90%). All these ADR occurred after cycle 1 medication, but patients improved after treatment. Most of these ADR were mitigated (80.31%). Conclusion Tislelizumab injection is mostly used for treating a wide range of tumors. The related ADR involve multiple systems and organs, and some severe ADR are potentially life-threatening. Rational clinical use of this drug is recommended. Monitoring is required. Early detection and interventions are critical to management of ADR.

Key words: Immune Checkpoint Inhibitors, Tislelizumab Injection, Blood System, Skin System, Gastrointestinal System, Hypothyroidism, Adverse Drug Reactions

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