基于FAERS数据库雷珠单抗注射液不良反应信号挖掘

Data mining and safety analysis of ranibizumab based upon FAERS Database

目的:分析美国不良反应报告系统(FAERS)数据库中的有关雷珠单抗注射液的眼部及其他系统不良反应发生情况,为临床安全用药提供参考。方法:利用报告比值比法(ROR)和比例报告比值法(PRR)对FAERS数据库中2004年第1季度至2020年第3季度共69个季度报告中有关雷珠单抗的不良反应进行数据挖掘和信号检测,分析其不良反应上报情况及其他系统不良反应发生情况。结果:去重后提取以雷珠单抗为主要怀疑药物的不良反应报告共57680件,ROR法共识别到656个信号,PRR共检测到1053个信号,最终纳入2种方法的重复信号652个,累计21个系统/器官;绝大部分不良反应为眼部并发症,其次以心血管系统及神经系统不良反应居多。结论:除眼部不良反应外,以心血管及神经系统不良反应居多,临床使用此类药物时如出现心血管系统及神经系统不良反应时应考虑是否与此药物相关。

OBJECTIVE To explore the occurrence of adverse reactions in eye and other systems of ranibizumab injection in the US FDA Adverse Event Reporting System(FAERS)database to provide references for clinical safe medication.METHODS Data mining and signaling of adverse reactions of ranibizumab in 69 quarterly reports from the first quarter of 2004 to the third quarter of 2020 in the FAERS database using the reported odds ratio method(ROR)and proportional report ratio method(PRR)for detecting and analyzing the reporting of adverse reactions and the occurrence of other system adverse reactions.RESULTS A total of 57680 reports of adverse reactions with ranibizumab as a major suspected drug after deduplication were extracted.A total of 656 signals were identified by ROR method and a total of 1053 signals detected by PRR.The duplication of two methods was finally included.There are 652 signals involving a total of 23 systems/organs.A large majority of adverse reactions were ocular complications,followed by cardiovascular and nervous system adverse reactions.CONCLUSION In addition to ocular adverse reactions,cardiovascular and nervous system adverse reactions are the most common.If cardiovascular and nervous system adverse reactions occur during clinical usage of such drugs,it should be considered whether they are related to secondary drugs.