基于FAERS的儿童奥司他韦不良事件信号挖掘与分析

Signal Mining and Analysis of Oseltamivir-Related Adverse Drug Events in Children Based on FAERS

目的 为临床安全使用奥司他韦提供参考。方法 检索美国食品和药物管理局不良事件报告系统(FAERS)数据库中2004年第1季度至2023年第1季度以奥司他韦为首要怀疑药物、发生于0~17岁患儿的药品不良事件(ADE)报告,采用报告比值比(ROR)法、比例报告比值比(PRR)法进行信号挖掘,采用《国际医学用语词典》中的首选语(PT)及系统器官分类(SOC)进行编码和归类。结果 共挖掘到奥司他韦相关ADE报告3 100份,检测到阳性信号76个,主要集中在精神病类(34个)、各类神经系统疾病(13个)、胃肠系统疾病(7个)、全身性疾病及给药部位各种反应(6个)、免疫系统疾病(3个)等12个SOC。发生频次排前20位的ADE有幻觉(455次)、异常行为(428次)、呕吐(410次)、谵妄(120次)、意识模糊状态(111次)等,信号强度排前20位的ADE仍以精神病类、各类神经系统疾病、胃肠系统疾病为主。发生频次和信号强度均排前20位的ADE有尖叫、恐惧、睡惊症,药品说明书中均未提及。结论 患儿临床应用奥司他韦时,应关注精神疾病、神经系统和胃肠道系统,以及皮肤和眼部的ADE。

Objective To provide a reference for the safe use of oseltamivir in the clinic.Methods Adverse drug event(ADE)reports with oseltamivir as the primary suspected drug and occurring in children aged 0-17 years old from the first quarter of 2004 to the first quarter of 2023 in the Food and Drug Administration Adverse Event Reporting System(FAERS)database were retrieved,and the ADE signals were mined by the reported odds ratio(ROR)method and proportional reporting ratio(PRR)method.The preferred technique(PT)and preferred system organ classification(SOC)from the International Dictionary of Medical Terminology were used for encoding and classification.Results A total of 3100 oseltamivir-related reports were mined,with 76positive signals detected,mainly concentrated in 12 SOC categories including psychiatric disorders(34 signals),various nervous system disorders(13 signals),gastrointestinal disorders(seven signals),general disorders and administration site conditions(six signals),and immune system disorders(three signals).The top 20 ADEs in terms of frequency were hallucinations(455 times),abnormal behavior(428 times),vomiting(410 times),delirium(120 times),and confusional state(111 times).The top 20 ADEs in terms of signal strength were psychiatric disorders,nervous system disorders,and gastrointestinal disorders.The top 20 ADEs in terms of frequency and signal strength were screaming,fear,and sleep terror,which were not listed in the drug instructions.Conclusion When using oseltamivir in the children in the clinic,attention should be paid to ADEs related to psychiatric disorders,nervous system disorders,gastrointestinal disorders,and skin and eye.