基于美国FDA不良事件报告系统数据库对瑞波西利安全警戒信号挖掘与分析

Data mining and analysis of security alert signals of ribociclib based on FDA adverse event reporting system database

目的:基于美国FDA不良事件报告系统(FDA Adverse Event Reporting System,FAERS)数据库挖掘瑞波西利的安全警戒信号,为临床安全用药提供参考。方法:收集FAERS数据库2017年第2季度—2023年第1季度的瑞波西利不良事件(adverse drug event,ADE)数据,利用比例失衡法中的报告比值比(reporting odds ratio,ROR)法联合贝叶斯可信区间递进神经网络(bayesian confidence propagation neural network,BCPNN)法进行数据挖掘。结果:共收集到瑞波西利为首要怀疑药物的ADE报告54160份,涉及患者11566例,共挖掘出瑞波西利ADE信号312个;对信号进行二次筛选后得到信号175个,累及17个系统;其中说明书中未提及的新信号共113个,累及16个系统。不良反应结局报告为死亡的患者2396例(20.72%),与非死亡病例相比,性别、年龄、体重、发生时间对不良反应的结局影响显著(P<0.05);肺水肿、腹水、黄疸、血乳酸脱氢酶升高等报告死亡结局的风险更高。结论:在真实世界中使用瑞波西利时须全面监测患者的ADE并及时干预,重点关注患者的肺水肿、腹水、黄疸、血乳酸脱氢酶升高等死亡风险较高的ADE,以保障治疗的安全性。

Objective:To mine the security alert signals of ribociclib based on the FDA Adverse Event Reporting System(FAERS)database to provide a reference for the safety of clinical medication.Methods:The adverse drug event(ADE)signals data of ribociclib from the FAERS database from the second quarter of 2017 to the first quarter of 2023 were collected.The data mining was performed using the reporting odds ratio(ROR)and the bayesian confidence propagation neural network(BCPNN)in the proportional imbalance method.Results:A total of 54160 ADE reports with ribociclib as the primary suspected drug were collected,and 312 ribociclib ADE signals were mined involving 13 systems.Among them,a total of 113 new signals were not mentioned in the instructions,accumulating 16 systems.Death occurred in 2396 patients(20.72%).Significant differences were found in gender,weight and time to onset for fatal vs.non-fatal cases(P<0.05).Pulmonary oedema,ascites,jaundice,and blood lactate dehydrogenase increased,etc.had higher risk of death.Conclusion:In the real world,it is necessary to comprehensively monitor and timely intervene the ADE of ribociclib.More attention should be paid to ADE with greater risk of death,including pulmonary oedema,ascites,jaundice,and increased blood lactate dehydrogenase,so as to guarantee the safety of treatment.