基于FAERS的新型冠状病毒肺炎治疗用药安全信号挖掘研究:α-干扰素

Data Mining and Safety Analysis of Drugs for Novel Coronavirus Pneumonia Treatment Based on FAERS:α-Interferon

目的基于美国FDA不良事件报告系统(FAERS),对α-干扰素(IFN-α)相关不良事件进行数据挖掘,为临床安全使用IFN-α提供参考。方法下载2004Q1至2019Q4共64个季度的FAERS数据,经过MedEx药品名称标准化、MedDRA不良事件系统分类等数据清洗后,提取以IFN-α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。结果共提取到以IFN-α为首要怀疑药品不良事件报告病例2889例;男女比例为1.32;中位年龄55岁;医师报告占39.91%;来自美国的报告占58.81%;主要给药途径为皮下、静脉和肌内给药,共占43.89%;另有超过半数的病例未报告给药途径。全身性及给药部位各种反应、各类检查、血液及淋巴系统事件报告例数相对较多。检出信号前20位事件中,“低磷酸盐血症”和“血清肌酸磷酸激酶升高”尚未收载于药品说明书。结论IFN-α部分高频不良事件与新型冠状病毒肺炎症状相似,IFN-α雾化吸入相比传统给药途径在理论上不良事件发生率可能更低,临床仍应做好相关用药监护和判断。

Objective To detect and analyze safety signals ofα-interferon(IFN-α)through data mining methods based on FAERS,in order to provide reference for clinical safe use of IFN-α.Methods Data of FARES from 2004Q1 to 2019Q4(64 quarters)were downloaded.After drug names standardized by MedEx and adverse events classified by MedDRA,the adverse event report cases with IFN-αas the primary suspect drug was extracted,and the safety signal detection was conducted using PRR and ROR methods.Results A total of 2889 adverse event reports with IFN-αas the first suspected drug were gathered.Among them,the male/female ratio was 1.32,and the median age was 55 years old.Reports from doctors accounted for 39.91%.Reports from United States accounted for 58.81%.The main routes of administration reported were subcutaneous,intravenous,and intramuscular,accounting for 43.89%.More than half of the cases did not report the route of IFN-αadministration.The number of reported cases of“general disorders and administration site conditions”,“investigations”,“blood and lymphatic system disorders”was relatively large.Among the top 20 signal detected events,“hypophosphataemia”and“blood creatine phosphokinase increase”have not been included in IFN-αspecification yet.Conclusion Some high frequency adverse events of IFN-αare similar to the symptoms of novel coronavirus pneumonia.Compared with the traditional routes of administration,the incidence of adverse events of IFN-αatomization inhalation may be lower in theory,however,it is necessary to monitor and judge the related drugs and events in clinical practice.