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自杀行为和CFTR调节器:一系列病例和世卫组织数据库不成比例分析分析

Inès Nidegger¹, Julie Macey², Marine Ferey³

¹CHU de Bordeaux, Service de Pharmacologie Médicale, Centre Régional de Pharmacovigilance de Bordeaux, F-33000 Bordeaux.

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

|October 15, 2024

概括

治疗囊性纤维化症的elexacaftor,tezacaftor和ivacaftor (ETI) 与自杀行为报告的增加有关. 需要进一步的研究来探索潜在的剂量依赖效应.

科学领域:

药物监督药物监督药物监督
精神病学是一个精神病学.
医疗安全医疗安全

背景情况:

埃莱克萨卡夫托尔,特萨卡夫托尔和伊瓦卡夫托尔 (ETI) 是一种高效的囊性纤维化 (CF) 治疗方法.
最近的安全问题凸显了与ETI相关的潜在精神疾病不良事件.
这项研究调查了治疗ETI的CF患者的自杀企图.

研究的目的:

在接受ETI的患者中报告自杀企图的情况.
通过使用全球药监数据库,调查ETI和自杀行为之间的潜在因果关系.
评估剂量依赖性影响,并与其他CFTR调节器比较精神病风险.

主要方法:

案例系列描述了四个自杀企图/自伤事件在ETI启动后.
使用Vigibase (世卫组织数据库) 的不成比例分析来评估ETI与自杀行为的关联.
报告几率比率 (ROR) 和灵敏度分析的计算,包括剂量反应评估.

主要成果:

在ETI发病后3至13个月之间报告了4起自杀企图/自伤病例.
ETI显示出与自杀行为报告增加的统计学意义上的关联 (ROR 2.5).
观察到自杀企图的信号 (ROR 1.4),而ivacaftor/lumacaftor仅与自杀念头有关.

结论:

在CF患者中,ETI治疗与报告的自杀行为更高的可能性有关.
潜在的剂量依赖关系需要进一步调查.
这一发现强调了ETI治疗期间精神病监测的重要性.

关键词:

试图进行尝试.囊性纤维化症是什么与药物相关的副作用和不良反应流行病学流行病学药物监督药物监督药物监督精神病学是一个精神病学.自杀自杀的自杀是自杀的自杀.

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