基于美国FDA不良事件报告系统数据库的恩曲替尼风险信号挖掘与分析

Risk Signal Mining and Analysis of Entratinib Based on FDA Adverse Event Reporting System Database

目的挖掘恩曲替尼不良事件(AE)风险信号,为该药临床安全使用提供参考。方法检索美国FDA不良事件报告系统数据库,收集2019年1月1日至2022年9月30日以恩曲替尼为主要怀疑药物的AE报告。采用国际医学用语词典26.0版的首选术语(PT)和系统器官分类(SOC)对AE进行标准化和分类,采用报告比值比(ROR)法进行恩曲替尼AE风险信号挖掘,报告数≥3、ROR≥2且ROR的95%置信区间(CI)下限>1的AE定义为阳性信号,对得到的阳性PT信号进行描述性分析。结果纳入分析的AE报告为603例,采用ROR法分析,获得56个阳性PT,涉及15个SOC。报告数排在前10位的PT为眩晕、肾功能损害、味觉障碍、共济失调,均为说明书中常见AE。56个PT中共有7个在药品说明书中未收录。结论本研究基于FAERS数据库,对恩曲替尼的ADR信号进行挖掘,使用Open Vigil 2.1数据平台协助进行数据挖掘。在56个阳性信号中有7个ADR信号为说明书未提及的。建议临床应用时,应给予关注,如发生相关ADR,应及时采取干预措施,保障患者安全。

OBJECTIVE To explore the risk signals of Entratinib adverse events(AE)and provide a reference for the safe clinical use of this drug.METHODS The US FDA Adverse Event Reporting System database was searched to collect AE reports from January 1,2019 to September 30,2022 with Entratinib as the primary suspect drug.The preferred terminology(PT)and system organ classification(SOC)of the International Dictionary of Medical Terminology,version 26.0,were used to standardize and classify AEs,and the risk signal mining for the AEs of entretinib was performed using the report ratio(ROR)method,and AEs with≥3 reports,ROR≥2 and lower 95%confidence interval(CI)of ROR>1 were defined as positive signals.descriptive analysis was performed on the obtained positive PT signals.RESULTS The number of AE reports included in the analysis was 603,and 56 positive PTs involving 15 SOCs were obtained using the ROR method.The top 10 reported PTs were vertigo,renal impairment,taste disorder,and ataxia,all of which were common AEs in the instruction s.7 of the 56 PTs were not included in the drug instructions.CONCLUSION This study was based on the FAERS database to mine the ADR signals for Entratinib,using the Open Vigil 2.1 data platform to assist in data mining.7 of the 56 positive signals had ADR signals that were not mentioned in the instructions.It is recommended that clinical applications should be given attention and timely interventions should be taken to ensure patient safety if relevant ADRs occur.