基于FAERS的新型冠状病毒肺炎治疗用药安全信号挖掘研究:利巴韦林

Data Mining and Safety Analysis of Drugs for Novel Coronavirus Pneumonia Treatment based on FAERS:Ribavirin

目的基于美国食品药品管理局(FDA)不良事件报告系统(FAERS)对利巴韦林相关不良事件进行数据挖掘,为该药的临床安全使用提供参考。方法下载FAERS数据库2004年至2019年共64个季度数据,经MedEx药品名称标准化、MedDRA不良事件系统分类等数据处理后,提取以利巴韦林为首要怀疑药品的不良事件报告病例,采用比例报告比值法(PRR)和报告比值比法(ROR)进行信号检测。结果提取以利巴韦林为首要怀疑药品的不良事件报告病例共9854例,其中男性占51.00%,男女比例为1.32,平均年龄为54.01岁。报告国家主要为美国、法国、澳大利亚、英国和德国。用药途径多为口服给药,其次为经胎盘、皮下、静脉以及吸入给药。全身性疾病及给药部位各种反应、胃肠道系统疾病、各类检查异常、血液及淋巴系统疾病以及各类神经系统疾病的不良事件报告例数较多。结论利巴韦林用于新型冠状病毒肺炎治疗时应密切监护药品不良事件并定期进行血常规监测,以避免因不良反应导致的停药或疾病进程误判。

Objective To provide a reference for the safe use of ribavirin in clinic,adverse drug events signals of ribavirin were detected and analyzed through data mining methods based on FAERS database.Methods Sixty-four quarterly data of FARES database from 2004 to 2019 were downloaded.After drug names standardization by MedEx and adverse drug events classification by MedDRA,the safety signal reports setting ribavirin as the primary suspected drug was searched and detected,using proportional reporting ratio(PRR)and reporting odds ratio(ROR)methods.Results A total of 9854 ribavirin related death events were gathered.Among them,51.00%of reports were males,and the male/female ratio was 1.32,and the average age was 54.01 years old.The reporting countries are mainly the United States,France,Australia,the United Kingdom,and Germany.Most of the routes of administration were oral administration,followed by transplacental,subcutaneous,intravenous,and inhalation.There are many adverse events reported in systemic and administration site reactions,gastrointestinal system events,various examination abnormalities,blood and lymphatic system events,and nervous system events.Conclusion To avoid drug withdrawal or misdiagnosis of disease progression,adverse drug events and blood routine monitoring should be monitored when ribavirin is used in the treatment of novel coronavirus pneumonia.