Rosenberg Russell, Roach James M, Scharf Martin, Amato David A
Northside Hospital Sleep Medicine Institute, 1000 Johnson Ferry Road NE, Atlanta, GA 30342, USA.
Sleep Med. 2007 Aug;8(5):464-70. doi: 10.1016/j.sleep.2006.10.007. Epub 2007 May 18.
To evaluate the effects of eszopiclone on measures of respiration and sleep using polysomnography in patients with mild to moderate obstructive sleep apnea syndrome (OSAS).
This double-blind, randomized crossover study included patients (35-64 years) with mild-to-moderate OSAS [apnea and hypopnea index (AHI) range 10 and 40]. Patients received either eszopiclone 3mg or placebo for two consecutive nights, with a 5-7 day washout between treatments. Continuous positive airway pressure (CPAP) was not allowed on nights in the sleep laboratory.
The primary endpoint, mean total AHI, was not significantly different from placebo (16.5 with placebo and 16.7 with eszopiclone; 90% confidence interval (CI) -1.7, 1.9). No significant differences in total arousals, respiratory arousals, duration of apnea and hypopnea episodes, or oxygen saturation were noted. Significant differences in spontaneous arousals (13.6 versus 11.4 for placebo and eszopiclone, respectively; 90% CI -3.7, -0.7), sleep efficiency (85.1% and 88.4%; p=0.0075), wake time after sleep onset (61.8 and 48.1 min; p=0.0125), and wake time during sleep (55.9 and 43.2 min; p=0.013) were noted after eszopiclone treatment. Eszopiclone was well tolerated.
In this pilot study, eszopiclone did not worsen AHI, and it improved sleep maintenance and efficiency. Further study is warranted to determine whether eszopiclone could improve CPAP compliance or next-day function in patients with OSAS.
采用多导睡眠图评估艾司佐匹克隆对轻至中度阻塞性睡眠呼吸暂停低通气综合征(OSAS)患者呼吸及睡眠指标的影响。
这项双盲、随机交叉研究纳入了年龄在35 - 64岁的轻至中度OSAS患者(呼吸暂停低通气指数[AHI]范围为10至40)。患者连续两晚接受3mg艾司佐匹克隆或安慰剂治疗,两次治疗之间有5 - 7天的洗脱期。睡眠实验室监测当晚不允许使用持续气道正压通气(CPAP)。
主要终点指标,即平均总AHI,与安慰剂相比无显著差异(安慰剂组为16.5,艾司佐匹克隆组为16.7;90%置信区间[CI]为 - 1.7,1.9)。总觉醒次数、呼吸相关觉醒次数、呼吸暂停和低通气发作时长或血氧饱和度方面均未发现显著差异。艾司佐匹克隆治疗后,自发觉醒次数(安慰剂组和艾司佐匹克隆组分别为13.6和11.4;90%CI为 - 3.7, - 0.7)、睡眠效率(85.1%和88.4%;p = 0.0075)、入睡后觉醒时间(61.8和48.1分钟;p = 0.0125)以及睡眠期间觉醒时间(55.9和43.2分钟;p = 0.013)存在显著差异。艾司佐匹克隆耐受性良好。
在这项初步研究中,艾司佐匹克隆未使AHI恶化,且改善了睡眠维持及效率。有必要进一步研究以确定艾司佐匹克隆是否能提高OSAS患者对CPAP的依从性或改善其次日功能。