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艾司佐匹克隆对精神分裂症合并失眠患者睡眠和认知的影响:一项双盲、随机、安慰剂对照试验。

The impact of eszopiclone on sleep and cognition in patients with schizophrenia and insomnia: a double-blind, randomized, placebo-controlled trial.

作者信息

Tek Cenk, Palmese Laura B, Krystal Andrew D, Srihari Vinod H, DeGeorge Pamela C, Reutenauer Erin L, Guloksuz Sinan

机构信息

Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.

Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.

出版信息

Schizophr Res. 2014 Dec;160(1-3):180-5. doi: 10.1016/j.schres.2014.10.002. Epub 2014 Oct 29.

DOI:10.1016/j.schres.2014.10.002
PMID:25454802
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5589464/
Abstract

BACKGROUND

Insomnia is frequent in schizophrenia and may contribute to cognitive impairment as well as overuse of weight inducing sedative antipsychotics. We investigated the effects of eszopiclone on sleep and cognition for patients with schizophrenia-related insomnia in a double-blind placebo controlled study, followed by a two-week, single-blind placebo phase.

METHODS

Thirty-nine clinically stable outpatients with schizophrenia or schizoaffective disorder and insomnia were randomized to either 3mg eszopiclone (n=20) or placebo (n=19). Primary outcome measure was change in Insomnia Severity Index (ISI) over 8 weeks. Secondary outcome measure was change in MATRICS Consensus Cognitive Battery (MATRICS). Sleep diaries, psychiatric symptoms, and quality of life were also monitored.

RESULTS

ISI significantly improved more in eszopiclone (mean=-10.7, 95% CI=-13.2; -8.2) than in placebo (mean=-6.9, 95% CI=-9.5; -4.3) with a between-group difference of -3.8 (95% CI=-7.5; -0.2). MATRICS score change did not differ between groups. On further analysis there was a significant improvement in the working memory test, letter-number span component of MATRICS (mean=9.8±9.2, z=-2.00, p=0.045) only for subjects with schizophrenia on eszopiclone. There were improvements in sleep diary items in both groups with no between-group differences. Psychiatric symptoms remained stable. Discontinuation rates were similar. Sleep remained improved during single-blind placebo phase after eszopiclone was stopped, but the working memory improvement in patients with schizophrenia was not durable.

CONCLUSIONS

Eszopiclone stands as a safe and effective alternative for the treatment of insomnia in patients with schizophrenia. Its effects on cognition require further study.

摘要

背景

失眠在精神分裂症患者中很常见,可能导致认知障碍以及增加导致体重增加的镇静性抗精神病药物的过度使用。我们在一项双盲安慰剂对照研究中,对与精神分裂症相关失眠的患者,研究了艾司佐匹克隆对睡眠和认知的影响,随后进行了为期两周的单盲安慰剂阶段。

方法

39名患有精神分裂症或分裂情感性障碍且伴有失眠的临床稳定门诊患者被随机分为3毫克艾司佐匹克隆组(n = 20)或安慰剂组(n = 19)。主要结局指标是8周内失眠严重程度指数(ISI)的变化。次要结局指标是MATRICS共识认知成套测验(MATRICS)的变化。还监测了睡眠日记、精神症状和生活质量。

结果

艾司佐匹克隆组ISI的改善程度(均值=-10.7,95%置信区间=-13.2;-8.2)显著大于安慰剂组(均值=-6.9,95%置信区间=-9.5;-4.3),组间差异为-3.8(95%置信区间=-7.5;-0.2)。两组间MATRICS评分变化无差异。进一步分析发现,仅对于服用艾司佐匹克隆的精神分裂症患者,MATRICS的工作记忆测试、字母数字广度分量有显著改善(均值=9.8±9.2,z=-2.00,p = 0.045)。两组的睡眠日记项目均有改善,组间无差异。精神症状保持稳定。停药率相似。在停用艾司佐匹克隆后的单盲安慰剂阶段,睡眠仍保持改善,但精神分裂症患者的工作记忆改善并不持久。

结论

艾司佐匹克隆是治疗精神分裂症患者失眠的一种安全有效的替代药物。其对认知的影响需要进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2003/5589464/f118a5f73ad2/nihms900255f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2003/5589464/f118a5f73ad2/nihms900255f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2003/5589464/f118a5f73ad2/nihms900255f1.jpg

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