基于FAERS数据库的艾塞那肽微球不良事件信号挖掘与研究  

Mining and research on the adverse event signal of exenatide microspheres based on FAERS database

作　　者：张莲卿 骆岩 杨提 姚佳晨[2] 李文艳[2] ZHANG Lianqing;LUO Yan;YANG Ti;YAO Jiachen;LI Wenyan(Department of Pharmacy,The First Affiliated Hospital of Naval Medical University,Shanghai 200433,China;Department of Clinical Pharmacology,Shanghai Pudong New Area Gongli Hospital,Shanghai 200135,China)

机构地区：[1]海军军医大学第一附属医院药剂科,上海200433 [2]上海市浦东新区公利医院临床药学部,上海200135

出　　处：《药学实践与服务》2024年第10期445-450,共6页Journal of Pharmaceutical Practice and Service

基　　金：上海市浦东新区卫健委重点学科(PWZxk2022-26);上海市卫健委卫生行业临床研究专项青年项目(20214Y0400)。

摘　　要：目的运用美国FDA不良事件报告系统(FAERS)挖掘艾塞那肽微球使用中不良事件(ADE)风险信号,为临床合理用药和保障用药安全提供参考。方法以“艾塞那肽微球”为目标药物,检索关键词为“exenatide microspheres for injection”“LY05006”“AC 2993 LAR”及“bydureon”,利用SAS软件提取FAERS数据库中2012年1月2日至2023年3月31日的ADE报告数据并去重,采用报告比值比法与综合标准法对艾塞那肽微球相关ADE报告进行数据挖掘。结果共检索到艾塞那肽微球ADE报告27248份,涉及27个系统器官分类,其中严重ADE报告4719份。上报人员以消费者为主(18435例,占67.66%),上报国家以美国为主(26295例,占96.50%)。采用报告比值比法(ROR)与综合标准法(MHRA)共获得163个ADE风险信号,包括血胆固醇异常、脂肪酶升高及混合型高脂血症等新发不良反应。结论基于FAERS数据库对艾塞那肽微球上市后的ADE进行挖掘分析,可对临床用药安全和提高患者用药依从性提供参考。Objective To explore the risk signals of adverse events(ADE)in the use of exenatide microspheres by the FDA adverse event reporting system(FAERS),and provide reference for clinical rational drug use and drug safety.Methods With exenatide microspheres as the target drug,the search keywords were Exenatide Microspheres for Injection,LY05006,AC 2993 LAR and Bydureon.SAS software was used to extract the ADE report data from January 2,2012 to March 31,2023 in the FAERS database and the duplicates were removed.Data mining of exenatide microspheres-related ADE reports was performed by the reporting odds ratio method and the comprehensive standard method.Results A total of 27248 exenatide microspheres-related ADE reports were retrieved,involving 27 SOCs,of which 4719 were severe ADE reports.The reporting personnel were mainly consumers(18435 cases,67.66%),the United States was the mainly reporting country(26295 cases,96.50%).A total of 163 ADE risk signals were obtained by reporting odds ratio method and comprehensive standard method,including new adverse reactions such as abnormal blood cholesterol,elevated lipase and mixed hyperlipidemia.Conclusion Based on the FAERS database,the post-marketing ADE of exenatide microspheres was mined and analyzed,which could provide reference for clinical medication safety and improvement of patients'medication compliance.

关 键 词：艾塞那肽微球 FDA不良事件报告系统 数据挖掘 

分 类 号：R977.15[医药卫生—药品] G353.1[医药卫生—药学]