基于OpenFDA数据库的玛巴洛沙韦不良事件信号挖掘与网络分析

Signal mining and network analysis of adverse drug events of baloxavirmarboxil based upon OpenFDA database

目的:基于OpenFDA数据库对玛巴洛沙韦(baloxavirmarboxil)相关不良事件进行挖掘,探索其发生特点及相互关系,并为临床用药提供参考。方法:对OpenFDA数据库中收录的关于玛巴洛沙韦不良事件进行分析,利用报告比值比法(reporting odds ratio,ROR)和贝叶斯置信度递进神经网络法(Bayesian confidence propagation neural network,BCPNN)对其风险信号进行挖掘,并利用医学用语词典(Medical Dictionary for Drug Regulatory Activities,MedDRA)进行系统归类。结果:共获得7 611 798份报告,其中以玛巴洛沙韦为首要怀疑药物的报告数3 920例,筛选获得89个阳性信号。依据系统器官分类(system organ class,SOC)报告数前5位的依次是呼吸、胸部和纵隔疾病,各类检查,心脏疾病,肝胆系统疾病以及胃肠道功能紊乱。贝叶斯网络图显示心脏、呼吸和血液SOC的相互关系较密切。结论:在玛巴洛沙韦临床使用中,应密切关注相关不良事件的发生,尤其是肝功能异常、心脏症状、神经精神症状、出血等,关注不良事件之间的相互关系,及时采取干预措施,保证用药安全。

OBJECTIVE To explore the relationship of adverse drug events(ADEs)and baloxavirmarboxil based upon the OpenFDA database and provide references for clinical dosing.METHODS ADE reports of baloxavirmarboxil were analyzed.Data mining was performed via reporting odds ratio(ROR)and Bayesian confidence propagation neural network(BCPNN)and the results were systematically classified by Medical Dictionary for Drug Regulatory Activities(MedDRA).RESULTS Among a total of 7611798 reports,3920 cases were reported with baloxavirmarboxil as a primary suspected drug and 89 positive signals obtained after screening.Top five system organ class(SOC)reports were respiratory,chest and mediastinal diseases,miscella⁃neous examinations,heart diseases,hepatobiliary disorders and gastrointestinal dysfunction.Bayesian network suggested that SOCs of heart,respiratory system and blood system were correlated closely.CONCLUSION During clinical dosing of baloxavir⁃marboxil,liver dysfunction,cardiac symptoms,neuropsychiatric symptoms and hemorrhage should be closely monitored.Timely measures are implemented for ensuring drug safety.