中国药业2024,Vol.33Issue(6) :后插1-后插4.DOI:10.3969/j.issn.1006-4931.2024.06.029

替雷利珠单抗免疫相关不良事件研究进展

Research Progress of Tislelizumab-Induced Immune-Related Adverse Events

卢少欢 李杨 蒙光义
中国药业2024,Vol.33Issue(6) :后插1-后插4.DOI:10.3969/j.issn.1006-4931.2024.06.029

替雷利珠单抗免疫相关不良事件研究进展

Research Progress of Tislelizumab-Induced Immune-Related Adverse Events

卢少欢 1李杨 1蒙光义1
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作者信息

  • 1. 广西壮族自治区玉林市第一人民医院,广西 玉林 537000
  • 折叠

摘要

目的 为临床安全使用替雷利珠单抗提供参考.方法 检索中国知网、维普、万方、中国生物医学文献数据库及 PubMed,Embase,Web of Science等数据库(检索时限自建库起至 2023 年 4 月 30 日),对替雷利珠单抗安全性的相关临床研究、上市后不良反应的个案报道等 30 多篇文献进行系统整理,总结替雷利珠单抗免疫相关不良事件(irAE)的发生特点.结果 不同的临床试验中,替雷利珠单抗irAE总发生率为 22.2%~76.7%;其中≥3 级irAE的发生率为 7.0%~36.7%.替雷利珠单抗相关irAE常发生于皮肤系统、内分泌系统、消化系统、泌尿系统、呼吸系统、心血管系统,临床表现为皮疹,甲状腺功能异常、高血糖,腹泻,肾功能损伤,肺炎,心肌病等.基于目前的临床观察及相关研究,替雷利珠单抗irAE程度大多轻微,未导致治疗中断.结论 irAE发生情况显示,替雷利珠单抗用于临床恶性肿瘤的抗肿瘤治疗有一定安全性,但作为新上市的药物,临床应用时间短,经验相对不足,建议临床医师严格把握适应证,做好用药监护,以确保用药安全.

Abstract

Objective To provide a reference for the safe use of tislelizumab in clinical practice.Methods More than 30 literature such as clinical studies on the safety of tislelizumab and case reports of adverse reactions after its marketing in the CNKI,VIP,WanFang,CBM,PubMed,Embase,Web of Science and others from the inception of these databases to April 30,2023 were searched to systematically summarize the characteristics of tislelizumab-induced immune-related adverse events(irAEs).Results In different clinical trials,the total incidence of tislelizumab-induced irAEs was in the range of 22.2%to 76.7%,with the incidence of irAEs≥grade three in the range of 7.0%to 36.7%.Tislelizumab-induced irAEs commonly occured in the skin system,endocrine system,digestive system,urinary system,respiratory system,cardiovascular system,and clinical manifestations included rash,thyroid dysfunction,hyperglycemia,diarrhea,renal function damage,pneumonia,cardiomyopathy and so on.The current clinical observations and related studies showed that the tislelizumab-induced irAEs were mostly mild and did not lead to treatment interruption.Conclusion The occurrence of irAEs indicates that tislelizumab has a certain safety in the clinical application for malignant tumor treatment.However,as a newly marketed drug,the clinical application time of tislelizumab is short,and clinical physicians have limited experience in its application.It is suggested that clinical physicians should pay more attention to the indication control and medication monitoring to ensure the medication safety.

关键词

替雷利珠单抗/免疫相关不良事件/恶性肿瘤/药品不良反应/安全性评价

Key words

tislelizumab/immune-related adverse event/malignant tumor/adverse drug reaction/safety evaluation

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基金项目

白求恩·求索药学科研能力建设项目(YLSY-ZH-KY-202208035)

广西药学会医院药学科研项目(GXYXH1-202209)

出版年

2024
中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
参考文献量38
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