基于美国不良事件报告系统数据库的吉非替尼不良反应信号挖掘

Data Mining of Adverse Drug Reactions of Gefitinib Based on the FAERS Database

目的挖掘吉非替尼上市后的不良反应(ADR)信号,为其临床安全用药提供参考。方法采用报告比值比法(ROR)和比例报告比值法(PRR)对美国不良事件报告系统(FAERS)中2004年第1季度至2018年第4季度报告数不低于3的吉非替尼药品不良事件(ADE)报告进行数据挖掘和信号检测。结果共挖掘到吉非替尼ADE报告19610份,ROR法及PRR法共识别到311个信号,最终纳入ROR值前50个信号进行分析;挖掘出的信号较强,与吉非替尼相关的ADR累及13个系统/器官。结论临床使用吉非替尼时,除应密切关注胃肠道、皮肤及皮下组织类疾病等安全问题外,还应警惕各类神经系统疾病、心脏器官疾病等潜在ADE及间质性肺炎等严重ADR。

Objective To explore the adverse drug reaction(ADR)signals of gefitinib after launching and to provide references for its safe clinical medication.Methods Using reporting odds ratio(ROR)and proportional reporting ratio(PRR),data mining and signal detection were performed on gemfitini-related adverse drug events(ADEs)reports in the FDA Adverse Event Reporting System(FAERS)of the United States with the number of reports ≥3 from 2004Q1-2018Q4.Results A total of 19,610 gefitinib-related ADEs reports were excavated,311 signals were identified by ROR method and PRR method,and finally the first 50 ROR values were included for analysis.The signal involved 13 systems/organs.Conclusion In the clinical use of gefitinib,in addition to paying close attention to the safety problems of gastrointestinal tract,skin and subcutaneous diseases,it is also necessary to be alert for the occurrence of various potential ADEs such as nervous system diseases and heart organ diseases,as well as severe ADRs such as interstitial pneumonia.