褪黑素补充对 ICU 患者睡眠质量和血清褪黑素评估的影响：一项随机对照试验。

The Effects of Melatonin Supplementation on Sleep Quality and Assessment of the Serum Melatonin in ICU Patients: A Randomized Controlled Trial.

机构信息

Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil.

Cardiologic Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil.

出版信息

Crit Care Med. 2020 Dec;48(12):e1286-e1293. doi: 10.1097/CCM.0000000000004690.

DOI:10.1097/CCM.0000000000004690

PMID:33048904

Abstract

OBJECTIVES

To evaluate whether the use of exogenous melatonin affects sleep, reduces the prevalence of delirium, and decreases the need for analgosedation and to assess whether serum melatonin indices correlate with exogenous administration in critically ill patients.

DESIGN

Double-blind, randomized, placebo-controlled study.

SETTING

Multicenter ICUs of two tertiary hospitals.

PATIENTS

A total of 203 adult patients who were admitted to the ICU and administered with analgesics and/or sedatives.

INTERVENTIONS

Oral melatonin (10 mg) or placebo for up to seven consecutive nights.

MEASUREMENTS AND MAIN RESULTS

The number of observed sleeping hours at night was assessed by the bedside nurse. Sleep quality was evaluated using the Richards Campbell Questionnaire Sleep (RCSQ). The prevalence of delirium, pain, anxiety, adverse reactions, duration of mechanical ventilation, length of ICU and hospital stays, and doses of sedative and analgesic drugs administered were recorded. The use of analgesics and sedatives was assessed daily. Melatonin levels were determined by enzyme-linked immunosorbent assay. Based on the RCSQ results, sleep quality was assessed to be better in the melatonin group than that in the placebo group with a mean (SD) of 69.7 (21.2) and 60.7 (26.3), respectively (p = 0.029). About 45.8% and 34.4% of participants in the melatonin and placebo groups had very good sleep (risk ratio, 1.33; 95% CI, 0.94-1.89), whereas 3.1% and 14.6% had very poor sleep (risk ratio, 0.21; 95% CI, 0.06-0.71), respectively. No significant difference was observed regarding the days free of analgesics or sedatives, the duration of night sleep, and the occurrence of delirium, pain, and anxiety. Melatonin serum peak levels at 2 AM were 150 pg/mL (range, 125-2,125 pg/mL) in the melatonin group and 32.5 pg/mL (range, 18.5-35 pg/mL) in the placebo group (p < 0.001).

CONCLUSIONS

Melatonin was associated with better sleep quality, which suggests its possible role in the routine care of critically ill patients in the future.

摘要

目的

评估外源性褪黑素是否能改善睡眠、降低谵妄发生率、减少镇痛镇静药物的需求，并评估危重患者血清褪黑素指标与外源性给药是否存在相关性。

设计

双盲、随机、安慰剂对照研究。

地点

两家三级医院的多中心 ICU。

患者

共纳入 203 名入住 ICU 并接受镇痛和/或镇静治疗的成年患者。

干预措施

连续 7 个晚上口服褪黑素（10mg）或安慰剂。

测量和主要结果

由床边护士评估夜间观察到的睡眠时间。使用 Richards Campbell 问卷睡眠量表（RCSQ）评估睡眠质量。记录谵妄、疼痛、焦虑的发生率，不良反应，机械通气时间、ICU 和住院时间，以及镇静和镇痛药物的使用剂量。每天评估镇痛和镇静药物的使用情况。通过酶联免疫吸附试验测定褪黑素水平。根据 RCSQ 结果，褪黑素组的睡眠质量优于安慰剂组，平均（标准差）分别为 69.7（21.2）和 60.7（26.3）（p = 0.029）。褪黑素组和安慰剂组分别有 45.8%和 34.4%的参与者睡眠质量极好（风险比，1.33；95%CI，0.94-1.89），而睡眠质量极差的参与者分别为 3.1%和 14.6%（风险比，0.21；95%CI，0.06-0.71）。两组在无镇痛或镇静药物天数、夜间睡眠时间和谵妄、疼痛、焦虑的发生方面无显著差异。褪黑素组凌晨 2 点时的血清峰值为 150pg/ml（范围 125-2125pg/ml），安慰剂组为 32.5pg/ml（范围 18.5-35pg/ml）（p<0.001）。