基于FAERS数据库醛固酮受体拮抗剂不良反应信号挖掘与分析  

Mining and analysis of adverse drug reaction signals of aldosterone receptor antagonists based on FAERS database

作　　者：胡润凯 谢保城 韩伟超 徐永祥 HU Runkai;XIE Baocheng;HAN Weichao;XU Yongxiang(Department of Pharmacy,Dongguan People's Hospital,Dongguan 523059,China)

机构地区：[1]东莞市人民医院药学部,广东东莞523059

出　　处：《药物评价研究》2023年第7期1527-1533,共7页Drug Evaluation Research

基　　金：国家自然科学基金青年科学基金项目(82000842);广东省基础与应用基础研究基金项目(2021A1515010151);东莞市社会发展科技面上项目(20211800903072)。

摘　　要：目的 基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库挖掘醛固酮受体拮抗剂依普利酮和螺内酯的不良反应(ADR)信号,对比和分析两者ADR的相关情况,为临床安全用药提供参考依据。方法 基于FAERS数据库,利用Open Vigil FDA分析工具提取2004年1月1日—2022年11月4日上报的目标药物依普利酮与螺内酯相关的不良事件情况数据。采用报告比值比法进行数据挖掘,按国际医学用语词典25.1版中的首选系统器官分类(SOC)和首选术语(PT)对不良事件进行统计分类并分析。结果 共检索到醛固酮受体拮抗剂依普利酮和螺内酯相关的ADR报告112 518份,其中依普利酮ADR报告8 516份,风险信号50个,信号累及12个系统/器官;螺内酯ADR报告104 002份,风险信号60个,信号累及13个系统器官分类;其中36个为重叠信号。依普利酮说明书未提及的有13个风险信号,主要涉及呼吸、胃肠等系统器官分类;螺内酯说明书未提及的有19个风险信号,主要涉及血液及淋巴系统疾病、精神病类等系统器官分类。结论 临床应用醛固酮受体拮抗剂时,除重点关注说明书提及的ADR,还需对未提及的风险信号和原有疾病进展情况引起重视。Objective To mine the adverse drug reaction(ADR) signals of aldosterone receptor antagonists eplerenone and spironolactone based on the Food and Drug Administration adverse event reporting system(FAERS) database,compare and analyze their ADR related conditions,and provide a reference for clinical safe drug use.Methods Based on FAERS database,Open Vigil FDA analysis tool was used to extract the adverse events related to eplerenone and spironolactone reported from January 1,2004 to November 4,2022.The reporting ratio method was used for data mining,and the adverse events were statistical classification and analyzed according to the preferred system organ classification(SOC) and preferred term(PT) in the 25.1 edition of the International Dictionary of Medical Terms.Results A total of 112 518 ADR reports related to eplerenone and spironolactone,aldosterone receptor antagonists,were retrieved,including 8 516 ADR reports of eplerenone,50 risk signals,and 12 systems/organs involved in eplerenone,and 104 002 ADR reports of spironolactone,60 risk signals,involving 13 system organ classifications.Among them,36are overlapping signals.There are 13 risk signals that are not mentioned in the instruction manual of eplerenone,mainly involving the classification of respiratory,gastrointestinal and other systemic organs.There are 19 risk signals not mentioned in the instructions of spironolactone,which mainly involve the classification of blood and lymphatic system diseases,mental diseases and other system organs.Conclusion In the clinical application of aldosterone receptor antagonists,in addition to the ADR mentioned in the instructions,attention should also be paid to the risk signals not mentioned and the original disease progress.

关 键 词：醛固酮受体拮抗剂 依普利酮 螺内酯 不良反应 美国食品药品监督管理局不良事件报告系统 

分 类 号：R972[医药卫生—药品]