摘要
目的利用美国FDA不良事件报告系统(FAERS)挖掘依达赛珠单抗的药品不良反应信号,为依达赛珠单抗安全风险控制和临床合理用药提供参考。方法利用比例失衡法对美国FAERS数据库中2015年10月16日至2019年3月31日与依达赛珠单抗相关的不良事件报告进行数据挖掘。结果获得依达赛珠单抗不良反应信号233个,二次筛选后得到信号52个,其中45个有信号的不良反应未在其说明书中出现。结论挖掘和评价基于FAERS数据库获得的依达赛珠单抗不良反应相关信号,可为其临床的合理应用提供依据。
Objective To provide guidance for the safe and rational use of idarucizumab,we analyzed the adverse drug reaction(ADR)signals of idarucizumab with the data from Adverse Event Reporting System(FAERS)by the US FDA.Methods Measures of disproportionality were applied to analyze the data in FAERS,from October 16,2015 to March 31,2019.Results Totally 233 signals were collected,and 45 of the 52 ADR signals were not mentioned in the instructions in the second screening.Conclusion The analysis of data in FAERS may provide ADR signals of idarucizumab,and guidance for rational clinical use.
作者
黄佳
王凤
王浩
钟薇
陈力
HUANG Jia;WANG Feng;WANG Hao;ZHONG Wei;CHEN Li(People’s Hospital of Xindu District,Chengdu 610500;Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041;Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041;Key Laboratory of Birth Defects and Related Diseases of Women and Children(Sichuan University),Ministry of Education,Chengdu 610041)
出处
《中南药学》
CAS
2020年第5期893-897,共5页
Central South Pharmacy
基金
成都药学会赞邦药学科研基金(No.201919)。
关键词
依达赛珠单抗
不良反应信号
比例失衡法
idarucizumab
adverse drug reaction signal
measure of disproportionality
