基于FAERS数据库以奥拉帕利为例探讨不同时段对数据挖掘结果的影响

Impact of Different Mining Periods on the Results of Data-Mining Based on FDA Adverse Events Reporting System:Exemplication by Olaparib

目的基于美国食品药品管理局(FDA)不良事件(ADE)报告系统(FAERS)数据库挖掘2015—2021年奥拉帕利ADE信号,比较不同时间段挖掘出ADE信号数量的差异,为合理进行ADE信号挖掘提供参考。方法采用报告比值比法(ROR)与比例报告比值法(PRR)对FAERS数据库2015年第一季度至2021年第二季度共26个季度奥拉帕利ADE进行数据挖掘,并按一定规则分组,比较各组挖掘结果差异。结果奥拉帕利ADE上报数逐年增加,其中报告数最多的是北美洲,上报报告中女性人数远大于男性人数。可能因为FAERS数据库位于美国。对奥拉帕利ADE进行信号挖掘后发现:信号数随着挖掘时间的延长而增加,但增加率逐步降低。倒序挖掘时,奥拉帕利ADE信号数变化也遵循以上规律。结论随着奥拉帕利上市时间延长,ADE信号数增加率降低,ADE信号数进入稳定阶段,最近年份真实世界数据能更好地预警现阶段及未来奥拉帕利与ADE的关联性,也能较完整体现上市以来所有ADE信号。

Objective To explore the difference in data mining of adverse drug event(ADE)signals for olaparib in different mining periods based on the FDA adverse events reporting system(FAERS)database and provide a certain reference for reasonable adverse signal mining.Methods Using reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods to mine ADE signals of olaparib,which are grouped in different mining periods,from the first quarter of 2015 to the second quarter of 2021 in the FAERS database.Results The number of olaparib adverse events is increasing yearly,with the most significant number of reports coming from North America,and far more women than men reported it.The reason might be that FAERS database are located in the United States American.After signal mining of olaparib adverse events,we found that the number of ADE increases with the increase of mining time.But the increase rate is gradually decreasing.The change also follows the above rules when data mining is in reverse order.Conclusion With the prolonged time to market for olaparib,the number of ADE will enter a stable stage,It can better warn the relationship between olaparib with ADE and obtain a more comprehensive signal since the listing by using the real-world data in recent years.Therefore,it is recommended to mine the recent data after the drug has been on the market for a time to have enough reports when digging for ADE.