基于FAERS对维泊妥珠单抗不良事件信号的挖掘与分析  

Mining and Analysis of Adverse Event Signals of Polatuzumab Based on FAERS

作　　者：阮聪 杜琼[1,2,3] 叶玲 王祺茹 胡伟琼 钱佳佳 翟青 徐蕊[1] RUAN Cong;DU Qiong;YE Ling;WANG Qiru;HU Weiqiong;QIAN Jiajia;ZHAI Qing;XU Rui(Pharmacy Department,Minhang Branch of Fudan University Cancer Hospital,Shanghai 200240,China;Pharmacy Department,Fudan University Cancer Hospital,Shanghai 200032,China;Department of Oncology,Shanghai Medical College,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属肿瘤医院闵行院区药剂科,上海200240 [2]复旦大学附属肿瘤医院药剂科,上海200032 [3]复旦大学上海医学院肿瘤学系,上海200032

出　　处：《中国现代应用药学》2025年第2期287-292,共6页Chinese Journal of Modern Applied Pharmacy

基　　金：上海市闵行区卫生健康委员会课题(2021MW28);上海市闵行区卫生健康系统优秀青年药学人才培养计划(mwyjyx03)。

摘　　要：目的对靶向CD79b的抗体偶联药物维泊妥珠单抗进行药品不良事件(adverse drug events,ADE)信号挖掘分析,为临床安全用药提供参考。方法从美国食品药品监督管理局不良事件报告系统中提取2019年1月1日至2023年6月30日的ADE报告,合并去除重复报告,并对ADE信号采用比例失衡法筛选分析。结果获得以维泊妥珠单抗为首要怀疑药物的ADE报告共1037例,筛选后得到说明书中未记载的ADE信号23个,包括免疫效应细胞相关神经毒性综合征、细胞因子释放综合征和弥漫性血管内凝血等。结论挖掘的真实世界ADE报告与说明书中相近,同时报告了新的ADE,为维泊妥珠单抗临床安全应用监测提供参考。OBJECTIVE To analyze the adverse drug events(ADE)signal mining of CD79b-targeted antibody conjugate drug polatuzumab,and to provide reference for clinical safe drug use.METHODS ADE reports from January 1,2019 to June 30,2023 were extracted from the USA Food and Drug Administration Adverse Event Reporting System(FAERS).Duplicate reports were pooled and eliminated,and ADE signals were screened and analyzed by the proportional imbalance method.RESULTS A total of 1037 ADE were reported with polatuzumab,23 ADE not recorded in the instructions were obtained after screening,including immune effector cell-associated neurotoxicity syndrome,cytokine release syndrome and diffuse intravascular coagulation.CONCLUSION The excavated real-world ADE report are similar to the instructions,reporting new ADE,and providing reference for clinical monitoring of safe application of polatuzumab.

关 键 词：维泊妥珠单抗 数据挖掘 不良事件 免疫效应细胞相关神经毒性综合征 细胞因子释放综合征 弥漫性血管内凝血 

分 类 号：R969.3[医药卫生—药理学]