基于美国FDA公共数据项目的利司扑兰不良事件真实世界研究  

Real-world study of adverse event of risdiplam based on the Public Data Open Project of the US Food and Drug Administration

作　　者：李波[1] 张科[1] 孙璇 李正翔[1] LI Bo;ZHANG Ke;SUN Xuan;LI Zheng-xiang(Department of Pharmacy,Tianjin Medical University General Hospital,Tianjin 300052,China)

机构地区：[1]天津医科大学总医院药剂科,天津300052

出　　处：《中国新药杂志》2023年第14期1482-1488,共7页Chinese Journal of New Drugs

基　　金：天津市自然科学基金资助项目(20JCQNJC01810)。

摘　　要：目的:基于美国食品药品监督管理局公共数据项目(US Food and Drug Administration Public Data Open Project,OpenFDA)中药物不良事件报告数据,挖掘利司扑兰上市后的不良事件,为临床安全用药提供参考。方法:检索OpenFDA数据库中2020年8月7日—2022年5月31日时间段内有关利司扑兰的所有不良事件报告,采用报告比值比(reporting odds ratio,ROR)法和比例报告比值(proportional reporting ration,PRR)法对利司扑兰上市后的不良事件报告数据进行风险信号挖掘和分析。结果:共检索到以利司扑兰为首要怀疑药物的不良事件报告844例,经检测获得不良反应风险信号68个,其中位置性眩晕、血氧饱和度下降、心动过速、心率加快为说明书中未收录的不良反应。报告频数前5位的不良事件依次为腹泻、虚弱、肺炎、产品存储错误、肌肉无力。不良事件风险信号的ROR值排名前5位的依次为尿布性皮炎、位置性眩晕、呼吸系统病毒感染、产品温度漂移问题、皮肤接触暴露。结论:基于利司扑兰不良事件的真实世界数据深入分析其潜在的不良事件,提示临床予以关注及进一步进行安全性评价,其中位置性眩晕说明书未提及且风险信号的ROR值较高,还需密切关注。Objective:To explore the adverse reactions of risdiplam based on Public Data Open Project of the US Food and Drug Administration(OpenFDA)in order to provide reference for clinical drug safety.Methods:The relevant data of risdiplam were searched and extracted from the OpenFDA database from August 7,2020 to May 31,2022.And the report odds ratio(ROR) and proportional report odds ratio(PRR) were applied for signal detection.Results:A total of 844 adverse event(ADE) reports with risdiplam as a primary suspicious drug were retrieved,and 68 adverse drug reactions(ADR) risk signals were detected,including positional vertigo,decreased oxygen saturation,tachycardia,and accelerated heart rate,which were not labeled in package insert.Top 5 ADE reports were product storage errors,gastrointestinal dysfunction,muscle weakness,diarrhea and weakness.Top 5 ADES in signal strength included diaper dermatitis,positional vertigo,respiratory tract infection virus,product temperature drift,and skin contact exposure.Conclusion:It is helpful to use real-world data for assessing the potential adverse reactions of risdiplam,suggesting clinicians to monitor specific adverse events and conduct further drug safety evaluations.The signal strength of positional vertigo is high and is not mentioned in the instruction manual,thus it is necessary for clinicians to pay close attention.

关 键 词：利司扑兰 药物不良事件 美国食品药品监督管理局公共数据项目 数据挖掘 

分 类 号：R969.3[医药卫生—药理学]