基于FAERS数据库棘白菌素类药物不良事件信号挖掘与分析

Signal Mining and Analysis of Adverse Drug Events for 3 Echinocandins based on FAERS Database

目的基于美国FDA不良事件报告系统(FAERS)数据库,挖掘3种棘白菌素类药物(卡泊芬净、米卡芬净、阿尼芬净)的不良事件信号,为临床安全用药提供参考。方法使用OpenVigil 2.1数据平台,查询和提取2004年第1季度~2021年第3季度3种棘白菌素类药物不良事件报告数据。采用报告比值比法(ROR)和比例报告比值法(PRR)对相关报告进行数据挖掘分析。结果共获得以棘白菌素类为首要怀疑药物的ADE报告2476份,其中卡泊芬净ADE报告1390份、米卡芬净ADE报告869份、阿尼芬净ADE报告217份。共挖掘ADE信号313个,涉及21个系统器官分类(SOC),主要集中在全身性疾病及给药部位各种反应、感染及侵染类疾病、各类损伤/中毒及操作并发症、各类检查、呼吸系统/胸及纵膈疾病、肝胆系统疾病等。3种棘白菌素类药物ADE报告数排名前20位的PT中,肝脏系统、肾脏系统、血液系统及心脏系统等的不良反应报告数较高。结论经ROR法和PRR法分析发现棘白菌素类药物不良事件累及的主要系统器官具有一致性,其ADE报告数排名前20位PT累及的系统主要有肝胆系统疾病、肾脏及泌尿系统疾病、血液及淋巴系统疾病和心脏器官疾病等,临床应用时需密切监测以上系统的不良反应。

OBJECTIVE To excavate the ADE signals of 3 enchinocandins(capofungin,micafungin and anidulafungin)based on FDA adverse event reporting system(FAERS)and to provide references for rational drug use in clinic.METHODS The ADEs of 3 enchinocandins reported from the First quarter of 2004 to the third quarter of 2021 were collected by accessing the OpenVigil 2.1.The ADE signals of 3 enchinocandins were mined by the method of reporting odds ratio(ROR)and proportional reporting ratio(PRR).RESULTS A total of 2476 ADE reports with 3 enchinocandins as the primary suspected drugs were obtained,including 1390 capofungin ADE reports,869 micafungin ADE reports and 217 anidulafungin ADE reports.313 ADE signals were mined,involving 21 system organ classes(SOCs),which mainly concentrated in systemic diseases and various reactions at the administration sites,infections and infestations,injury/poisoning and procedural complications,investigations,respiratory/thoracic and mediastinal disorders,hepatobiliary disorders,etc.Among the top 20 preferred term(PT)in ADE report frequency of 3 enchioncandis,the number of adverse reactions reported in hepatobiliary disorders,blood and lymphatic system disorders,cardiac disorders,renal and urinary disorders were higher.CONCLUSION Through ROR and PRR detecting,it is found that the major systems involved in adverse events of 3 enchinocandins are consistent,and the top 20 PT involved systems mainly include hepatobiliary disorders,blood and lymphatic system disorders,cardiac disorders,renal and urinary disorders.Therefore,the clicic should pay more attention on these above systems.