四肢瘫痪患者的睡眠障碍：一项关于3毫克褪黑素的随机、双盲、安慰剂对照交叉试验。

Sleep disruption in tetraplegia: a randomised, double-blind, placebo-controlled crossover trial of 3 mg melatonin.

作者信息

Spong J, Kennedy G A, Tseng J, Brown D J, Armstrong S, Berlowitz D J

机构信息

Institute for Breathing and Sleep, Austin Hospital, Melbourne, Victoria, Australia.

1] Institute for Breathing and Sleep, Austin Hospital, Melbourne, Victoria, Australia [2] Psychology Department, College of Arts, Victoria University, Melbourne, Victoria, Australia [3] The Bronowski Institute of Behavioural Neuroscience, Kyneton, Victoria, Australia.

出版信息

Spinal Cord. 2014 Aug;52(8):629-34. doi: 10.1038/sc.2014.84. Epub 2014 Jun 3.

DOI:10.1038/sc.2014.84

PMID:24891007

Abstract

STUDY DESIGN

Randomised, double-blind, placebo-controlled crossover trial of melatonin supplementation to people with complete tetraplegia.

OBJECTIVES

To investigate the effect that 3 mg melatonin supplementation has on objective and subjective sleep, quality of life and mood of people living with complete tetraplegia.

SETTING

Austin Hospital Sleep Laboratory and participants' homes, Melbourne, Victoria, Australia.

METHODS

Two week run-in followed by 3 week nightly administration of 3 mg melatonin or placebo, 2-week washout and further 3 week administration of the opposite treatment. Four testing sessions were conducted; the last nights of the run-in, treatment and washout periods. Testing sessions involved recording full polysomnography, completing a questionnaire battery and collecting urine and blood samples. The questionnaires assessed mood, sleep symptoms and health-related quality of life, and the urine and plasma samples assayed 6-sulphatoxymelatonin (aMT6s) and melatonin levels, respectively. A sleep diary was completed throughout the study.

RESULTS

Eight participants (mean (s.d.): age 49.5 years (16), postinjury 16.9 years (7.1)) were recruited in which seven concluded the protocol. Endogenous-circulating melatonin was significantly higher (P < or = 0.01) following melatonin (urine: 152.94 μg h(-1) (74.51), plasma: 43,554.57 pM (33,527.11)) than placebo (urine: 0.86 μg h(-1) (0.40), plasma: 152.06 pM (190.55)). Subjective sleep improved significantly following melatonin specifically for duration of sleep per night and psychological wellbeing. Objective sleep showed a significant increase in light sleep with melatonin, with all other sleep parameters being unchanged.

CONCLUSION

These results suggest that increasing melatonin in people with complete tetraplegia is beneficial, especially for subjective sleep. Investigation of the pharmacokinetics of melatonin metabolism in this population is warranted.

SPONSORSHIP

This project is proudly supported by the Transport Accident Commission.

摘要

研究设计

对完全性四肢瘫痪患者补充褪黑素的随机、双盲、安慰剂对照交叉试验。

目的

研究补充3毫克褪黑素对完全性四肢瘫痪患者的客观和主观睡眠、生活质量及情绪的影响。

地点

澳大利亚维多利亚州墨尔本奥斯汀医院睡眠实验室及参与者家中。

方法

两周导入期，随后每晚服用3毫克褪黑素或安慰剂3周，两周洗脱期，再服用相反治疗药物3周。进行了四次测试；导入期、治疗期和洗脱期的最后一晚。测试包括记录全夜多导睡眠图、完成一系列问卷并采集尿液和血液样本。问卷评估情绪、睡眠症状和与健康相关的生活质量，尿液和血浆样本分别检测6-硫酸氧褪黑素（aMT6s）和褪黑素水平。在整个研究过程中完成睡眠日记。

结果

招募了8名参与者（平均（标准差）：年龄49.5岁（16岁），受伤后16.9年（7.1年）），其中7人完成了方案。服用褪黑素后内源性循环褪黑素显著更高（P≤0.01）（尿液：152.94μg·h⁻¹（74.51），血浆：43554.57pM（33527.11）），高于安慰剂（尿液：0.86μg·h⁻¹（0.40），血浆：152.06pM（190.55））。服用褪黑素后主观睡眠显著改善，特别是每晚的睡眠时间和心理健康。客观睡眠显示服用褪黑素后浅睡眠显著增加，其他所有睡眠参数均未改变。