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右佐匹克隆与安慰剂对健康老年人的残留效应:一项随机双盲研究。

Residual effects of eszopiclone and placebo in healthy elderly subjects: a randomized double-blind study.

作者信息

Takahashi Jun, Kanbayashi Takashi, Ito Uemura Sachiko, Sagawa Youhei, Tsutsui Kou, Takahashi Yuya, Omori Yuki, Imanishi Aya, Takeshima Masahiro, Satake Masahiro, Shimizu Tetsuo

机构信息

Department of Psychiatry, Akita University Graduate School of Medicine, Akita, Japan.

International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Japan.

出版信息

Sleep Biol Rhythms. 2017;15(3):235-241. doi: 10.1007/s41105-017-0101-2. Epub 2017 May 19.

Abstract

Next-day residual effects are a common problem with current hypnotics. The purpose of the present study was to evaluate the residual effects of eszopiclone on the physical and cognitive functions of healthy elderly people in the early morning and the day following drug administration. Four men and six women aged 63-72 years were administered eszopiclone 1 mg or placebo in a randomized, double-blind and crossover design. Measures of objective parameters and subjective ratings were obtained at 4:00, 6:00, and every 2 h from 6:00 to 16:00 hours. For the timed up-and-go test, the main effects of time were seen. For the critical flicker fusion, eszopiclone had significantly worse results compared to placebo in early morning (4:00). There were no significant differences between eszopiclone and placebo in other objective assessments. For the sleep latency, eszopiclone had significantly shorter results compared to placebo (eszopiclone vs placebo = 28.4 vs 52.5 min,  = 0.047). Feeling of deep sleep and the number of wake after sleep onset did not show any significant differences between eszopiclone and placebo. Based on the above results, the changes of physical and cognitive functions in the healthy elderly after taking hypnotics, it was found that eszopiclone 1 mg is likely to be unharmful for the healthy elderly. Further studies of elderly insomniacs with midnight awakenings are needed.

摘要

次日残留效应是当前催眠药物常见的问题。本研究的目的是评估右佐匹克隆对健康老年人在给药后清晨及次日身体和认知功能的残留效应。4名男性和6名年龄在63 - 72岁的女性采用随机、双盲和交叉设计,服用1毫克右佐匹克隆或安慰剂。在4:00、6:00以及从6:00至16:00每2小时获取客观参数测量值和主观评分。对于计时起立行走测试,观察到时间的主要效应。对于临界闪烁融合,在清晨(4:00)时,与安慰剂相比,右佐匹克隆的结果显著更差。在其他客观评估中,右佐匹克隆和安慰剂之间没有显著差异。对于睡眠潜伏期,与安慰剂相比,右佐匹克隆的结果显著更短(右佐匹克隆与安慰剂分别为28.4分钟和52.5分钟,P = 0.047)。深度睡眠感觉和睡眠开始后的觉醒次数在右佐匹克隆和安慰剂之间未显示出任何显著差异。基于上述结果,即健康老年人服用催眠药物后身体和认知功能的变化,发现1毫克右佐匹克隆可能对健康老年人无害。需要对有午夜觉醒的老年失眠患者进行进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/00b6/5489573/5ffe394d755b/41105_2017_101_Fig1_HTML.jpg

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