79例替雷利珠单抗相关不良反应分析  

Seventy-nine cases of tislelizumab-related adverse reactions

作　　者：汪滢 黄珊 沈钦勇 连霞 常颖 江彦 林兵 黄爱文 WANG Ying;HUANG Shan;SHENG Qinyong;LIAN Xia;CHANG Ying;JIANG Yan;LIN Bing;HUANG Aiwen(Department of Clinical Pharmacy,the 900th Hospital of the Joint Logistic Support Force of Chinese PLA,Fuzhou Fujian 350025,China;Department of Pharmacy,the 900th Hospital of the Joint Logistic Support Force of Chinese PLA,Fuzhou Fujian 350025,China)

机构地区：[1]中国人民解放军联勤保障部队第九〇〇医院临床药学科,福建福州350025 [2]中国人民解放军联勤保障部队第九〇〇医院药剂科,福建福州350025

出　　处：《中国药物警戒》2024年第10期1148-1153,共6页Chinese Journal of Pharmacovigilance

基　　金：福建省科技创新联合资金项目(2020Y9041)。

摘　　要：目的分析替雷利珠单抗相关药品不良反应(ADR)的发生规律及临床表现特点,为临床安全合理使用提供参考。方法回顾性分析本院上报的79例替雷利珠单抗相关ADR报告(2020年1月1日至2024年3月31日),对患者基本情况、药物使用情况、ADR发生时间、累及系统-器官、临床表现、严重程度、处置与转归、关联性评价等信息进行统计分析。结果79例替雷利珠单抗相关ADR报告中,88.61%的ADR发生在替雷利珠单抗治疗1~5个周期后,累及多个系统-器官,主要表现为骨髓抑制、皮肤毒性、甲状腺功能异常、肝功能异常、肌炎、肺炎等,其中重症肌无力样综合征和过敏性休克为说明书未载明的严重ADR。经停药和对症治疗后大部分ADR逐渐好转。结论替雷利珠单抗少数严重ADR可危及生命,临床应合理使用,加强用药监护,及时对症处理,减少严重ADR的发生。Objective To analyze the regularity and clinical characteristics of adverse drug reactions(ADR)induced by tislelizumab in order to provide references for safe and rational drug use.Methods Seventy-nine reports of adverse reactions related to tislelizumab submitted by our hospital to the national ADR Monitoring System from January 1,2020 to March 31,2024 were retrospectively analyzed,involving patients’demographics,types of drugs used,times of adverse reactions,clinical presentations,organs and/or systems involved,severity,management and outcomes,causality assessment,and off-label use.Results Among these cases of tislelizumab-related adverse reactions,88.61%occurred after one to five medication cycles.Affecting multiple organs and systems,the main manifestations included bone marrow suppression,skin toxicity,thyroid dysfunction,and liver function abnormalities.Myasthenic syndrome and anaphylactic shock were serious ADR not specified in drug instructions.After discontinuation of the drug and symptomatic treatment,most of the cases improved.Conclusion A few severe adverse reactions of tislelizumab can lead to life-threatening consequences.Close monitoring during clinical use is recommended,with timely symptomatic treatment to reduce severe adverse reactions.

关 键 词：替雷利珠单抗 免疫检查点抑制剂 药品不良反应 骨髓抑制 重症肌无力样综合征 过敏性休克 安全性 

分 类 号：R979.1[医药卫生—药品] R994.11[医药卫生—药学]