中国药物警戒 ›› 2024, Vol. 21 ›› Issue (4): 435-439.
DOI: 10.19803/j.1672-8629.20240091

• 安全与合理用药 • 上一篇    下一篇

424例替雷利珠单抗致免疫相关不良事件分析

张健1,2, 张伶俐2, 李歆2,3,*   

  1. 1南京医科大学第一附属医院药学部,江苏 南京 210029;
    2 南京医科大学药学院,江苏 南京 211166;
    3南京医科大学全球健康中心, 江苏 南京 211166
  • 收稿日期:2024-02-02 出版日期:2024-04-15 发布日期:2024-04-18
  • 通讯作者: *李歆,男,博士,教授·博导,临床药学与药物经济学。E-mail : xinli@njmu.edu.cn
  • 作者简介:张健,男,在职硕士,主管药师,临床药学。
  • 基金资助:
    国家自然科学基金资助项目（72074123、72304150）

Immune-related adverse events of tirelizumab in 424 cases of cancer patients

ZHANG Jian1,2, ZHANG Lingli2, LI Xin2, 3,*   

  1. 1Department of Pharmacy, the First Affiliated Hospital of Nanjing Medical University, Nanjing Jiangsu 210029, China;
    2School of Pharmacy, Nanjing Medical University, Nanjing Jiangsu 211166, China; 3Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing Jiangsu 211166, China
  • Received:2024-02-02 Online:2024-04-15 Published:2024-04-18

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摘要： 目的 对使用替雷利珠单抗进行免疫治疗的肿瘤患者临床资料进行回顾性研究,总结分析其免疫相关不良事件（immune-related adverse events , irAEs）的发生规律和特点,制定合理的应对措施,为临床早期识别和合理应对提供参考。方法 回顾性分析2021年10月1日至 2023年9月30日南京医科大学第一附属医院使用替雷利珠单抗免疫治疗恶性肿瘤患者的临床资料,包括患者年龄、性别、所患疾病、合并用药、irEAs发生时间、临床表现、毒性分级和临床处置信息,总结其致irAEs的规律和特点。结果 收集的424例使用替雷利珠单抗患者中,181例（42.69%）未发生irAEs ,243例（57.31%）患者共发生364例次irAEs;发生1例次irAEs的有163例（67.08%）,发生2例次及2例次以上irAEs的有80例（32.92%）。发生的irAEs累及系统-器官11种,排名前5位分别是内分泌系统异常161例次（44.23%）、血液系统异常51例次（14.01%）、消化系统损害33例次（9.07%）、心血管系统29例次（7.97%）,皮肤及其附件19例次（5.22%）。irAEs为G1~G2级的共345例次（94.78%）,经对症处理后好转;G3级14例次（3.85%）,需要住院治疗;G4级5例次（1.37%）,涉及危害生命需抢救和治疗;未出现irAEs导致的死亡病例。结论 替雷利珠单抗致irAEs可累计全身多种系统-器官,总体来说可以监测和管控,但若不及时采取干预措施可造成患者严重损伤。临床应实现对其早期监测,尽早识别并采取合理应对措施以保障患者用药安全。

关键词: 替雷利珠单抗, 抗肿瘤治疗, 免疫相关不良事件, 免疫检查点抑制剂, 免疫治疗

Abstract: Objective To find out about the occurrence, development and characteristics of immune-related adverse events (irAEs) among tumor patients under immunotherapy with tirelizumab and recommend countermeasures so as to provide reference for early clinical identification and effective response. Methods The clinical data of patients with malignant tumor who received immunotherapy with tirelizumab in the First Affiliated Hospital of Nanjing Medical University between October 1, 2021 and September 30, 2023 was analyzed retrospectively, including the age, gender, disease, concomitant medications, occurrence of irAEs, clinical manifestations, toxicity classification and clinical treatments. The characteristics of IREAS caused by tirelizumab were summarized. Results Among the 424 patients who used tirelizumab, 243 patients (57.31%) had 364 cases of irAES while the rest (42.69%) did not. IrAEs occurred once in 163 cases (67.08%), and twice or more in 80 cases (32.92%). IrAEs involved 11 kinds of systems and organs, the highest incidence is 161cases (44.23%) of endocrine system abnormalities, and 51 cases of blood system abnormalities (14.01%), digestive system damage in 33 cases (9.07%)、Cardiovascular system in 29 cases (7.97%), skin and its accessories in 19 cases (5.22%). There were 345 cases (94.78%) with irAEs of G1-G2 grades, which improved after symptomatic treatment. There were 14 cases (3.85%) of G3 grade, which required hospitalization. Five cases (1.37%) were G4 that involved rescue and treatment. There was no death caused by irAEs. Conclusion Tirelizumab-related irAEs can involve a variety of organs and systems in the body, which can be generally monitored and controlled. Patients can be seriously injured without quick interventions. Early monitoring, quick identification and effective countermeasures can help ensure the safety of medications.

Key words: tirelizumab, tumor treatment, immune-related adverse events(irAEs）, immune checkpoint inhibitors(ICIs), immunotherapy

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