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目的:挖掘米氮平失眠相关不良反应风险信号,评估米氮平替代治疗失眠的可行性。方法:下载FDA不良事件上报系统(FAERS)2004年第一季度-2019年第四季度的药物不良反应报告数据,采用报告比值比法(ROR)和贝叶斯可信区间递进神经网络法(BCPNN)挖掘米氮平失眠相关不良风险。结果:数据清洗后得到7 212 882对药物-不良反应组合,其中26 750种药物发生33 748种不良反应(ADR)。米氮平-失眠的ROR值为1.55(95%CI:1.40,1.70),米氮平-失眠的信息成分(IC)值为0.61(95%CI:0.48,0.76);米氮平-镇静的ROR值为4.93(95%CI:4.14,5.88),米氮平-镇静的IC值2.20(95%CI:1.95,2.45)。结论:失眠、镇静是米氮平的不良反应风险信号。米氮平临床可用于治疗焦虑和抑郁状态伴随失眠的患者,但不应作为治疗失眠的首选药物。
Abstract：Objective:To explore the risk signals of insomnia related adverse reactions of mirtazapine and evaluate the feasibility of mirtazapine replacement therapy for insomnia.Methods:Data of adverse drug reactions reported by FDA's Adverse Event Reporting System(FAERS)from the first quarter of 2004 to the fourth quarter of 2019 were downloaded,and the risk of insomnia associated with mirtazapine was mined using reported odds ratio method(ROR)and bayesian confidence interval progressive neural network(BCPNN).Results:After cleaning data,there were 7 212 882 combinations of drug-adverse reactions,including 33 748 kinds of adverse drug reactions(ADR)involved by 26 750 kinds of drugs.The ROR of insomnia and sedation those related to mirtazapine were 1.55(95%CI:1.40,1.70)and 4.93(95%CI:4.14,5.88),respectively.Information component(IC)of insomnia and sedation those related to mirtazapine were 0.61（95%CI:0.48,0.76）and 2.20(95%CI:1.95,2.45),respectively.Conclusion:Insomnia and sedation are adverse reaction risk signals of mirtazapine.Mirtazapine can be used in the treatment of anxiety and depression with insomnia,but it should not be the first-line therapy for primary insomnia.
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基本信息:
中图分类号:R969
引用信息:
[1]张晟,唐宝玉.基于FAERS数据库挖掘米氮平失眠相关不良反应风险信号[J].巴楚医学,2021,4(04):85-90.
基金信息:
湖北省自然科学基金项目（No:2015CFC851）
2020-04-17
2020
2020-08-03
2020
2020-06-19
1
2021-12-30
2021-12-30