1 Division of Wilderness Medicine, Department of Emergency Medicine, Massachusetts General Hospital , Boston, Massachusetts.
High Alt Med Biol. 2013 Sep;14(3):234-9. doi: 10.1089/ham.2013.1023. Epub 2013 Sep 12.
This study is the first comparative trial of sleep medications at high altitude. We performed a randomized, double-blind trial of temazepam and acetazolamide at an altitude of 3540 meters. 34 healthy trekkers with self-reports of high-altitude sleep disturbance were randomized to temazepam 7.5 mg or acetazolamide 125 mg taken at bedtime for one night. The primary outcome was sleep quality on a 100 mm visual analog scale. Additional measurements were obtained with actigraphy; pulse oximetry; and questionnaire evaluation of sleep, daytime drowsiness, daytime sleepiness, and acute mountain sickness. Sixteen subjects were randomized to temazepam and 18 to acetazolamide. Sleep quality on the 100 mm visual analog scale was higher for temazepam (59.6, SD 20.1) than acetazolamide (46.2, SD 20.2; p=0.048). Temazepam also demonstrated higher subjective sleep quality on the Groningen Sleep Quality Scale (3.5 vs. 6.8, p=0.009) and sleep depth visual analog scale (60.3 vs. 41.4, p=0.028). The acetazolamide group reported significantly more awakenings to urinate (1.8 vs. 0.5, p=0.007). No difference was found with regards to mean nocturnal oxygen saturation (84.1 vs. 84.4, p=0.57), proportion of the night spent in periodic breathing, relative desaturations, sleep onset latency, awakenings, wake after sleep onset, sleep efficiency, Stanford Sleepiness Scale scores, daytime drowsiness, or change in self-reported Lake Louise Acute Mountain Sickness scores. We conclude that, at current recommended dosing, treatment of high-altitude sleep disturbance with temazepam is associated with increased subjective sleep quality compared to acetazolamide.
这项研究是首次对高海拔地区的睡眠药物进行的对比试验。我们在海拔 3540 米的高度进行了一项随机、双盲试验,比较了替马唑仑和乙酰唑胺的效果。34 名有高原睡眠障碍自述的健康徒步旅行者被随机分为替马唑仑 7.5 毫克或乙酰唑胺 125 毫克组,在睡前服用一次。主要结局是使用 100 毫米视觉模拟量表评估的睡眠质量。通过活动记录仪、脉搏血氧饱和度和问卷评估睡眠、白天嗜睡、白天嗜睡和急性高原病获得了额外的测量结果。16 名受试者被随机分为替马唑仑组,18 名受试者被随机分为乙酰唑胺组。替马唑仑组的睡眠质量在 100 毫米视觉模拟量表上的评分较高(59.6,标准差 20.1),而乙酰唑胺组的评分较低(46.2,标准差 20.2;p=0.048)。替马唑仑组在格罗宁根睡眠质量量表上的主观睡眠质量也更高(3.5 分比 6.8 分,p=0.009),深度睡眠视觉模拟量表的评分也更高(60.3 分比 41.4 分,p=0.028)。乙酰唑胺组报告的排尿觉醒次数明显更多(1.8 次比 0.5 次,p=0.007)。夜间平均血氧饱和度(84.1 比 84.4,p=0.57)、周期性呼吸的夜间比例、相对缺氧、睡眠潜伏期、觉醒、睡眠后觉醒、睡眠效率、斯坦福嗜睡量表评分、白天嗜睡或自我报告的路易斯湖急性高原病评分的变化方面没有差异。我们的结论是,在目前推荐的剂量下,与乙酰唑胺相比,替马唑仑治疗高原睡眠障碍与更高的主观睡眠质量相关。