基于FAERS数据库的米氮平睡眠相关不良事件影响因素分析

Influence Factors of Sleep-Related Adverse Event to Mirtazapine Based on FAERS

目的:挖掘米氮平引起睡眠相关不良事件的风险信号以及影响因素,为临床科学使用米氮平提供依据。方法:采集2004-2019年美国FDA不良事件报告系统(FAERS)数据,利用报告比值比法(ROR)和贝叶斯可信区间递进神经网络法(BCPNN)检测睡眠相关不良事件风险信号,并采用Logistic回归分析对其影响因素。结果:提取出68个睡眠相关不良事件,ROR法和BCPNN法筛选出21个共同睡眠相关不良事件风险信号,Logistic回归分析显示性别(OR=1.018,95%CI:1.006,1.030)和年龄(OR=0.999,95%CI:0.998,0.999)是米氮平发生睡眠相关不良事件的影响因素。结论:米氮平可致睡眠相关不良事件的发生,且女性和高龄可增加发生风险。

Objective:To excavate the risk signals and influence factors of sleep-related adverse events caused by mirtazapine,and provide reference for scientific use of mirtazapine in clinic.Methods:The data of FDA's adverse event reporting system(FAERS)from 2004 to 2019 were collected.Risk signals of sleep-related adverse events were detected using the report-to-ratio method(ROR)and Bayesian confidence interval progressive neural network method(BCPNN).Logistic regression was used for multivariate analysis.Results:A total of 68 sleep-related adverse events were extracted.There were 21 common risk signals for sleep-related adverse event screened out by ROR and BCPNN methods.Logistic regression analysis indicated that gender(OR=1.018,95%CI:1.006,1.030)and age(OR=0.999,95%CI:0.998,0.999)were influence factors for sleep-related adverse events induced by mirtazapine.Conclusion:Mirtazapine can cause sleep-related adverse events,which may be increased by women and advanced age.