基于FAERS数据库对儿童使用贝林妥欧单抗的药物警戒分析  

A Pharmacovigilance analysis of blinatumomab in children based on FAERS database

作　　者：周冰花 魏平平 张磊[3] 钟广滨 殷梦婷 赵荣达 闫美兴 莫晓媚 ZHOU Binghua;WEI Pingping;ZHANG Lei;ZHONG Guangbin;YIN Mengting;ZHAO Rongda;YAN Meixing;MO Xiaomei(Key Laboratory of Molecular Pharmacology and Translational Medicine,School of Pharmacy,Weifang Medical University,Weifang 261000,China;Department of Pharmacy,Women and Children′s Hospital,Qingdao University,Qingdao 266000,China;Department of Hematology,Women and Children′s Hospital,Qingdao University,Qingdao 266000,China;Ocean University of China School of Medicine and Pharmacy,Qingdao 266000,China)

机构地区：[1]潍坊医学院药学院分子药理学与转化研究重点实验室,潍坊261000 [2]青岛大学附属妇女儿童医院药学部,青岛266000 [3]青岛大学附属妇女儿童医院血液科,青岛266000 [4]中国海洋大学医药学院,青岛266000

出　　处：《中国小儿血液与肿瘤杂志》2024年第6期424-430,共7页Journal of China Pediatric Blood and Cancer

基　　金：中国医药教育协会2023年临床用药卫生技术评估专项课题(2023WSJSPGZXKT-18);青岛市临床重点专科-医院药学(2022-2024-77)。

摘　　要：目的挖掘与分析儿童使用贝林妥欧单抗的药品不良事件(ADE)信号,为贝林妥欧单抗在儿童群体中的安全使用提供参考依据。方法提取美国FDA不良事件报告系统(FAERS)数据库中2014年第四季度至2024年第一季度儿童使用贝林妥欧单抗的ADE报告,采用报告比值比法(ROR)和贝叶斯置信区间递进神经网络法(BCPNN)进行数据挖掘与分析。结果共提取到贝林妥欧单抗相关ADE报告790份,涉及患儿以男性稍多(53.16%),且年龄以0-6岁居多(38.99%),上报国家以美国为主(34.18%)。挖掘出阳性信号122个,排除与药物治疗无关的信号后得到信号107个,累及17个系统器官分类(SOC),累计报告1181例次ADE的中位发生时间为53.5天,大多数ADE发生在使用贝林妥欧的第一个月内。结论挖掘出的常见ADE信号与贝林妥欧单抗说明书基本一致,但存在肾脏及泌尿系统疾病和眼器官疾病等说明书中未提及的SOC及新的可疑不良事件,患儿用药过程中需重点关注此类不良事件。Objective To mine and analyze the adverse drug events(ADEs)signals of blinatumomab in children and provide references for the safe drug use of blinatumomab in the pediatric population.Methods Relative ADE reports of blinatumomab in children from the fourth quarter of 2014 through the first quarter of 2024 in the FDA adverse event reporting system(FAERS)database were extracted.The reporting odds ratio(ROR)and Bayesian confidence propagation neural network(BCPNN)methods were utilized to mine and analyze ADE signals associated with blinatumomab.Results A total of 790 ADE reports related with blinatumomab were extracted,involving slightly more male patients(53.16%),and most of them were 0~6 years old(38.99%),the main reporting country is the United States(34.18%).A total of 122 positive signals were detected,with 107 signals obtained after excluding signals unrelated to drug therapy,involving 17 system organ classes(SOC),with a total of 1181 cases reported.The median onset time of all ADEs was 53.5 days,and most ADEs occurred within the first month of blinatumomab use.Conclusions The common ADE signals of blinatumomab excavated are consistent with the instructions,but there are SOCs such as renal and urinary disorders and ocular organ disorders,which are not mentioned in the specification,and some new suspected adverse events,which need to be focused on during the administration of the drug to children.

关 键 词：贝林妥欧单抗 儿童 FAERS数据库 药品不良事件 信号挖掘 

分 类 号：R73[医药卫生—肿瘤]