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基于FAERS数据库的奥司他韦神经精神不良事件数据挖掘研究
引用本文:黎风,彭媛,何梅,刘福.基于FAERS数据库的奥司他韦神经精神不良事件数据挖掘研究[J].中国医院药学杂志,2022,42(6):637-641.
作者姓名:黎风  彭媛  何梅  刘福
作者单位:川北医学院附属医院药剂科, 四川 南充 637000
基金项目:中国药学会全国医药经济信息网2020年重点项目[编号:CMEI2020KPYJ(ZAMM)00305]
摘    要:目的:通过美国FDA不良事件报告系统(FAERS)数据库,挖掘奥司他韦神经精神学不良事件(neuropsychiatric ad-verse events,NPAEs)信号,为用药监护提供依据.方法:采用报告比值比(reporting odds ration,ROR)法对FAERS数据库中于2004-2020年上报的奥...

关 键 词:奥司他韦  FAERS  信号挖掘  不良事件报告系统

Data Mining for neuropsychiatric adverse events of oseltamivir based on FAERS database
LI Feng,PENG Yuan,HE Mei,LIU Fu.Data Mining for neuropsychiatric adverse events of oseltamivir based on FAERS database[J].Chinese Journal of Hospital Pharmacy,2022,42(6):637-641.
Authors:LI Feng  PENG Yuan  HE Mei  LIU Fu
Institution:Department of Pharmacy, The Affiliated Hospital of North Medical College, Sichuan Nanchong 637000, China
Abstract:OBJECTIVE The aim of this study was to evaluate neuropsychiatric adverse events (NPAEs) related to oseltamivir based on adverse event reports of the FDA adverse event reporting system(FAERS) database,to provide an evidence for clinical medication monitoring.METHODS Measures of reporting odds ratio(ROR) were used to conduct data-mining based on FAERS database from 2004 to 2020.RESULTS Among the 3 469 NPAEs of oseltamivir,the age was mainly 7-35 years old,the male was more than the female,and the reporting countries mainly were Japan and the United States.Totally 65 signals were detected with ROR,mainly focusing on abnormal behavior,delusion,hallucination,delirium,sleep disorder,self-injurious behavior.CONCLUSION Oseltamivir has a very high risk of causing NPAEs,and early monitoring should be strengthened during clinical use.
Keywords:oseltamivir  FAERS  signal mining  adverse event reporting system  
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