基于FAERS数据库对拉罗替尼药品不良事件信号的挖掘与分析OA
Data Mining and Analysis on Adverse Events Signal of Larotrectinib Based on FAERS
目的:挖掘拉罗替尼不良事件(AE)风险信号,为该药的临床安全应用提供参考.方法:检索美国食品药品监督管理局不良事件报告系统(FAERS)数据库,收集2019年第1季度～2022年第4季度以拉罗替尼为首要怀疑药物的AE报告.采用比例失衡测量法中报告比值比(ROR)法挖掘拉罗替尼AE风险信号,报告数≥3、ROR的95%CI下限>1的AE定义为阳性信号,ROR值越大,AE信号越强.采用监管活动医学词典26.0(MedDRA v26.0)的优选术语…查看全部>>
Objective:To explore the risk signals of adverse events(AE)of larotrectinib and provide reference for the safe clinical application of larotrectinib.Methods:The study collected the AE reports involving larotrectinib as the primary suspected drug from 2019 Q1 to 2022 Q4 by searching the Food and Drug Administration Adverse Event Reporting System(FAERS).The reporting odds ratio(ROR)method of proportion imbalance method was used to mine data on the AE risk sign…查看全部>>
杨琤琤;陈慧慧;张晶敏
商丘市第一人民医院药学部,商丘 476100商丘市第一人民医院药学部,商丘 476100郑州大学第一附属医院药学部,郑州 450000
药学
拉罗替尼美国食品药品监督管理局不良事件报告系统报告比值比信号挖掘信号分析
larotrectinibFood and Drug Administration Adverse Event Reporting Systemreporting odds ratiosignal miningsignal analysis
《中国合理用药探索》 2023 (12)
106-112,7
河南省医学科技攻关计划联合共建项目(LHGJ20210992)
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