中国神经再生研究(英文版) ›› 2017, Vol. 12 ›› Issue (8): 1299-1307.doi: 10.4103/1673-5374.213550

• 原著:脑损伤修复保护与再生 • 上一篇    下一篇

夜间血液褪黑素、γ-氨基丁酸和总抗氧化剂水平与脑卒中后失眠:前瞻性单中心随机对照临床试验

  

  • 收稿日期:2017-05-26 出版日期:2017-08-15 发布日期:2017-08-15
  • 基金资助:

    中国康复研究中心自选研究项目(2014-7),十二五计划项目(2011BAI08B11

Relationship of nocturnal concentrations of melatonin, gamma-aminobutyric acid and total antioxidants in peripheral blood with insomnia after stroke: study protocol for a prospective non-randomized controlled trial

Wei Zhang1, 2, Fang Li1, 2, Tong Zhang1, 2   

  1. 1 Capital Medical University School of Rehabilitation Medicine, Beijing, China;
    2 Neurorehabilitation Center, Beijing Bo’ai Hospital, China Rehabilitation Research Center, Beijing, China
  • Received:2017-05-26 Online:2017-08-15 Published:2017-08-15
  • Contact: Tong Zhang, M.D., Ph.D.,zt61611@sohu.com.
  • Supported by:

    This study was supported by the Optional Research Project of China Rehabilitation Research Center, No. 2014-7; the Sub-Project under National “Twelfth Five-Year” Plan for Science & Technology Support Project, No. 2011BAI08B11.

摘要:

褪黑素和γ-氨基丁酸参与睡眠的调控。夜间血液中褪黑素、γ-氨基丁酸和总抗氧化剂水平可能影响脑卒中患者失眠的形成。作者通过一项正在中国康复研究中心进行的前瞻性单中心随机对照临床试验,试图分析夜间血液褪黑素、γ-氨基丁酸和总抗氧化剂水平与脑卒中后失眠的关系。招募脑卒中康复期患者,按睡眠情况分为脑卒中睡眠障碍组和脑卒中睡眠正常组,同时招募同期非脑卒中且无失眠症状者作为正常对照,每组各25例。将患者夜间外周血液中褪黑素、γ-氨基丁酸和总抗氧化剂水平作为试验的主要观察指标;次要观察指标为评价睡眠情况的匹斯堡睡眠质量量表、失眠严重性量表、Epworth嗜睡量表、疲劳严重程度量表和清晨夜晚型量表(中文版)评分以及评价卒中的严重程度的NIHSS量表评分;同时分析血液中褪黑素、γ-氨基丁酸和总抗氧化剂3者水平与患者失眠情况的关系。根据目前已完成脑卒中睡眠障碍组和脑卒中睡眠正常组患者数据显示,脑卒中睡眠障碍患者夜间血液中褪黑素、γ-氨基丁酸和总抗氧化剂水平低于脑卒中睡眠正常患者,且卒中严重程度高于脑卒中睡眠正常患者。相关性分析结果显示,夜间血液中褪黑素、γ-氨基丁酸水平与脑卒中患者的失眠有关。试验已于2017-06-27在ClinicalTrials.gov注册(注册号为NCT03202121)。

orcid:0000-0001-8245-0029(Tong Zhang)

关键词: 神经再生, 脑卒中, 失眠, 褪黑素, γ-氨基丁酸, 总抗氧化剂, 睡眠相关量表, 美国国立卫生研究院卒中量表

Abstract:

Melatonin and gamma-aminobutyric acid (GABA) have been shown to regulate sleep. The nocturnal concentrations of melatonin, GABA and total antioxidants may relate to insomnia in stroke patients. In this prospective single-center non-randomized controlled clinical trial performed in the China Rehabilitation Research Center, we analyzed the relationship of nocturnal concentrations of melatonin, GABA and total antioxidants with insomnia after stroke. Patients during rehabilitation of stroke were recruited and assigned to the insomnia group or non-insomnia group. Simultaneously, persons without stroke or insomnia served as normal controls. Each group contained 25 cases. The primary outcome was nocturnal concentrations of melatonin, GABA and total antioxidants in peripheral blood. The secondary outcomes were Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, Fatigue Severity Scale, Morningness-Eveningness Questionnaire (Chinese version), and National Institute of Health Stroke Scale. The relationship of nocturnal concentrations of melatonin, GABA and total antioxidants with insomnia after stroke was analyzed and showed that they were lower in the insomnia group than in the non-insomnia group. The severity of stroke was higher in the insomnia group than in the non-insomnia group. Correlation analysis demonstrated that the nocturnal concentrations of melatonin and GABA were associated with insomnia after stroke. This trial was registered at ClinicalTrials.gov, identifier: NCT03202121.

Key words: nerve regeneration, stroke, insomnia, melatonin, γ-aminobutyric acid, total antioxidants, sleep-related scales, National Institute of Health Stroke Scale, neural regeneration