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咪达唑仑、氟硝西泮及安慰剂对挪威北部冬季失眠的疗效

Effect of midazolam, flunitrazepam, and placebo against midwinter insomnia in northern Norway.

作者信息

Lingjaerde O, Bratlid T, Westby O C, Gordeladze J O

出版信息

Acta Psychiatr Scand. 1983 Feb;67(2):118-29. doi: 10.1111/j.1600-0447.1983.tb06731.x.

DOI:10.1111/j.1600-0447.1983.tb06731.x
PMID:6133412
Abstract

Forty-three outpatients with "midwinter insomnia" (an early type insomnia commonly seen north of the Polar Circle when the sun stays below the horizon) were randomly allocated to one of three treatment groups, receiving either 15 mg midazolam, 1 mg flunitrazepam, or placebo, for 5 nights, double blind, after 3 nights without drug. In all three groups, this was followed by 5 nights on placebo (single blind). Several subjective sleep variables were recorded every morning, some variables also at noon. Placebo had practically no effect on any sleep variable, whereas both active drugs markedly improved sleep with regard to the following variables: sleep latency, number of awakenings, total duration of sleep, quality of sleep, total evaluation of sleep, and feelings of drowsiness in the morning and at noon. In the withdrawal period, patients who had received active drug showed a deterioration of sleep on most variables, but not beyond the baseline level. A true "rebound insomnia" could thus not be demonstrated. There was no significant difference in any of the variables between midazolam and flunitrazepam treatment. Side effects were reported by very few patients. Midazolam seems to be as effective as flunitrazepam in this type of insomnia, in spite of its much shorter biological half-life.

摘要

43名患有“冬季中期失眠症”(北极圈以北常见的一种早期失眠症,此时太阳位于地平线以下)的门诊患者被随机分配到三个治疗组之一,在停药3晚后,接受15毫克咪达唑仑、1毫克氟硝西泮或安慰剂治疗,为期5晚,采用双盲法。之后,所有三组均接受5晚安慰剂治疗(单盲)。每天早晨记录几个主观睡眠变量,有些变量在中午也进行记录。安慰剂对任何睡眠变量几乎没有影响,而两种活性药物在以下变量方面均显著改善了睡眠:入睡潜伏期、觉醒次数、总睡眠时间、睡眠质量、睡眠总体评价以及上午和中午的嗜睡感。在撤药期,接受活性药物治疗的患者在大多数变量上睡眠质量恶化,但未超过基线水平。因此,未证实存在真正的“反跳性失眠”。咪达唑仑和氟硝西泮治疗在任何变量上均无显著差异。很少有患者报告副作用。尽管咪达唑仑的生物半衰期短得多,但在这类失眠症中似乎与氟硝西泮一样有效。

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