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Am J Psychiatry:治疗抑郁症,鼻腔喷一喷

2020-06-29 MedSci原创 MedSci原创

约有三分之一的抑郁症患者在接受多种抗抑郁药治疗后仍未能获得缓解。本研究比较了治疗耐药的抑郁症患者从无效抗抑郁药换成灵活剂量的艾司他敏鼻腔喷雾剂加新开始的抗抑郁药或新开始的抗抑郁药(活性比较者)加安慰剂

约有三分之一的抑郁症患者在接受多种抗抑郁药治疗后仍未能获得缓解。本研究比较了治疗耐药的抑郁症患者从无效抗抑郁药换成灵活剂量的艾司他敏鼻腔喷雾剂加新开始的抗抑郁药或新开始的抗抑郁药(活性比较者)加安慰剂鼻腔喷雾剂的疗效和安全性。

 

这是一项在39个门诊转诊中心进行的3期、双盲、主动对照、多中心研究。研究入选了中度至重度非精神性抑郁症的成年人,并且在当前的发作中对至少两种抗抑郁药物无反应的历史,其中一种抗抑郁药物的评估是前瞻性的。确认无反应者被随机分配到用艾司凯明鼻腔喷雾剂(56或84mg,每周两次)和一种抗抑郁药或抗抑郁药和安慰剂鼻腔喷雾剂治疗。主要疗效终点是蒙哥马利-埃斯伯格抑郁评分量表(MADRS)评分从基线到第28天的变化,采用重复测量的混合效应模型进行评估。

 

筛选出的435名患者中,227人进行了随机化治疗,197人完成了28天的双盲治疗阶段。在第28天,艾司他敏加抗抑郁剂的MADRS评分变化明显大于抗抑郁剂加安慰剂(最小方差均值=-4.0,SE=1.69,95%CI=-7.31,-0.64);同样,在更早的时间点,艾司他敏加抗抑郁剂组也观察到有临床意义的改善。五种最常见的不良事件(解离、恶心、眩晕、眩晕症和头晕)的发生频率在艾司他敏加抗抑郁剂组中更高;各治疗组中分别有7%和0.9%的患者因不良事件而停止研究药物。艾司他明加抗抑郁剂组的不良事件一般在用药后不久出现,并在用药后1.5小时内缓解。

 

目前治疗耐药性抑郁症的治疗方案在疗效和患者接受度方面有很大的局限性。艾司凯特明有望通过其新颖的作用机制和快速起效的抗抑郁药疗效,解决这一人群未被满足的医疗需求。该研究支持艾司克他敏鼻腔喷雾剂作为一种快速起效的抗抑郁药,对治疗耐药抑郁症患者的疗效和安全性。

 

原始出处:

 

Vanina PopovaElla J Daly, et al., Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study. Am J Psychiatry. 2019 Jun 1;176(6):428-438. doi: 10.1176/appi.ajp.2019.19020172. 

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    2020-11-28 liuyichuan1990

    艾司**酮

    0

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    2020-10-20 ms8000001152689483

    期待这个药和***喷雾剂的对比实验

    0

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    2020-07-01 mnda

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