褪黑素对长期意识障碍的疗效：一项双盲随机临床试验。

Efficacy of melatonin for prolonged disorders of consciousness: a double-blind, randomized clinical trial.

作者信息

Wen Xinrui, Yu Jie, Zhu Genying, Wang Jinhua, Sun Yangyang, Zhou Jiajia, Cai Jiaye, Meng Fanxia, Ling Yi, Sun Yi, Zhao Jiajia, He Fangping, Cheng Qisheng, Xu Chuan, Gao Jian, Li Jingqi, Luo Benyan

机构信息

Department of Neurology, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310003, China.

Department of Neurology, Guangdong Neuroscience Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, 510080, China.

出版信息

BMC Med. 2024 Dec 3;22(1):576. doi: 10.1186/s12916-024-03793-2.

DOI:10.1186/s12916-024-03793-2

PMID:39627786

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11616348/

Abstract

BACKGROUND

Sleep is essential for the recovery of patients with disorders of consciousness (DoC). However, few approaches targeting sleep were applied. Melatonin has been shown to enhance sleep efficiency with virtually no side effects. This study explored melatonin's benefits for patients with prolonged DoC, as well as the underlying mechanisms involved.

METHODS

A cohort of 46 patients with prolonged DoC were randomly assigned to either the melatonin treatment group or the placebo group. Assessments were conducted using the Coma Recovery Scale-Revised (CRS-R), electroencephalography (EEG), and polysomnography (PSG) before and after the intervention, with follow-up CRS-R evaluations performed 6 months post-treatment.

RESULTS

Compared to the placebo, melatonin demonstrated a significant improvement in CRS-R scores after a 2-week period in patients with unresponsive wakefulness syndrome (UWS) (F = 6.86, P = 0.032; F = 4.03, P = 0.045) and this improvement was particularly pronounced in visual scores (F = 7.03, P = 0.030; F = 4.90, P = 0.027). Moreover, patients with UWS who received melatonin exhibited a higher relative spectral density of the alpha band in the frontal lobe compared to those who received placebo (F = 4.55, P = 0.033) and benefited for their prognosis after 6 months (Pseudo R = 0.370, F = 12.03, P = 0.034).

CONCLUSIONS

Overall, melatonin intervention seems to have a better response in UWS patients with preserved sleep cycles. These positive effects may not be solely attributed to improvements in the patients' sleep quality.

TRAIL REGISTRATION

ClinicalTrials.gov: NCT05285124.

摘要

背景

睡眠对于意识障碍（DoC）患者的恢复至关重要。然而，针对睡眠的治疗方法应用较少。褪黑素已被证明可提高睡眠效率且几乎无副作用。本研究探讨了褪黑素对长期DoC患者的益处及其潜在机制。

方法

将46例长期DoC患者随机分为褪黑素治疗组和安慰剂组。在干预前后使用昏迷恢复量表修订版（CRS-R）、脑电图（EEG）和多导睡眠图（PSG）进行评估，并在治疗后6个月进行CRS-R随访评估。

结果

与安慰剂相比，褪黑素在无反应觉醒综合征（UWS）患者中，2周后CRS-R评分有显著改善（F = 6.86，P = 0.032；F = 4.03，P = 0.045），且这种改善在视觉评分中尤为明显（F = 7.03，P = 0.030；F = 4.90，P = 0.027）。此外，接受褪黑素治疗的UWS患者额叶α波段的相对频谱密度高于接受安慰剂的患者（F = 4.55，P = 0.033），且6个月后预后较好（伪R = 0.370，F = 12.03，P = 0.034）。