基于BCPNN法的依那西普药物警戒信号的挖掘

目的:挖掘和评价依那西普上市后的不良反应信号,为临床安全合理用药提供参考。方法:提取2018年1月至2020年12月美国食品药品监督管理局不良事件报告系统数据库(FDA Adverse Event Reporting System,FAERS)发布的依那西普为首要怀疑对象的药品不良事件报告,采用贝叶斯置信区间递进神经网络(Bayesian confidence propagation neural network,BCPNN)法,以信息成分(information component,IC)的95%置信区间下限＞0且报告数≥3为条件,挖掘该药品的警戒信号。结果:共计检索依那西普相关不良事件报告25 790份,女性患者(74.62%)多于男性患者(25.38%),年龄主要分布在45~65岁(50.54%),报告主要来源于美国(84.54%)。利用BCPNN法识别得到166个警戒信号,涉及16个系统器官分类。信号强度大且报告频数较多的不良反应有注射部位反应、上呼吸道感染、支气管炎等,与说明书收录的一致;另有7个说明书未载明的警戒信号,分别为胎儿畸形、耳漏、呼吸道充血、咳嗽、注射恐惧、睡眠障碍、肾石症。结论:临床在使用依那西普时既要关注说明书已明确的不良反应,也应关注新检测出的7种警戒信号。育龄期、妊娠期以及老年患者应慎用该药。

Pharmacovigilance signal detection of etanercept based on the Bayesian confidence propagation neural network

OBJECTIVE To excavate and evaluate the adverse drug reaction signals of etanercept aiming to provide reference for safe and rational drug use.METHODS The adverse drug event reports with etanercept as the primary suspect published by FDA Adverse Event Reporting System(FAERS)database from January 2018 to December 2020 were searched.The Bayesian Confidence Propagation Neural Network(BCPNN) method was used to analyze pharmacovigilance signals.The lower limit of the 95% confidence interval for the information component(IC) is>0,and the number of reports is ≥3.RESULTS A total of 25 790 reports of etanercept-related adverse events were retrieved.The proportion of female patients(74.62%)was higher than that of male patients(25.38%),and the age was mainly distributed between 45 and 65 years old(50.54%).The reports were mainly from the United States(84.54%).A total of 166 alert signals were identified by the BCPNN method,involving 16 organ system.The adverse reactions with high signal intensity and frequent reports were injection site reactions,upper respiratory tract infection,bronchitis,etc.,which are consistent with the instructions.In addition,seven warning signs were found,including fetal malformation,otorrhea,respiratory congestion,cough,fear of injection,sleep disorder,and nephrolithiasis.CONCLUSION Attention should be paid not only to the adverse reactions that have been documented in the instruction,but also to the seven newwarning signals.Etanercept should be used with caution in patients of childbearing age,pregnancy and the elderly.