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埃莱克萨卡夫托尔/特萨卡夫托尔/伊瓦卡夫托尔治疗和与抑郁症有关的事件
Bonnie Ramsey1, Christoph U Correll2,3,4,5, David R DeMaso6
1Seattle Children's Research Institute and Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington.
与安慰剂相比,治疗囊性纤维化 (CF) 的elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) 治疗没有增加抑郁率. 营销后数据和注册研究证实,CF患者的抑郁事件与一般CF人口背景一致.
科学领域:
- 肺部病理学 肺部病理学
- 精神病学是一个精神病学.
- 药物监督 药物监督 药物监督
背景情况:
- 埃莱克萨卡夫托/特萨卡夫托/伊瓦卡夫托 (ELX/TEZ/IVA) 是一种用于囊性纤维化 (CF) 的高效CFTR调节剂.
- 在批准后,人们对使用ELX/TEZ/IVA治疗的CF患者 (pwCF) 潜在的抑郁相关不良事件表示担忧.
结论:
- 在用ELX/TEZ/IVA治疗的pwCF患者中,抑郁症状和相关事件的发生率与一般CF患者的背景率相似.
- 来自临床试验,营销后监测,注册和文献的现有证据不支持ELX/TEZ/IVA治疗与抑郁症增加之间的因果关系.
- 这些发现加强了ELX/TEZ/IVA关于CF患者心理健康的安全概况.
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