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三环类抗抑郁药治疗失眠症:多导睡眠图随机对照试验的荟萃分析

Treatment of insomnia with tricyclic antidepressants: a meta-analysis of polysomnographic randomized controlled trials.

作者信息

Liu Yang, Xu Xiaomin, Dong Meixue, Jia Shiyu, Wei Youdong

机构信息

Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China; Chongqing Key Laboratory of Neurobiology, Chongqing, China.

Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China; Chongqing Key Laboratory of Neurobiology, Chongqing, China.

出版信息

Sleep Med. 2017 Jun;34:126-133. doi: 10.1016/j.sleep.2017.03.007. Epub 2017 Mar 27.

DOI:10.1016/j.sleep.2017.03.007
PMID:28522080
Abstract

BACKGROUND

Insomnia represents a significant public health burden worldwide. Antidepressants have often been the insomnia treatment of choice in recent decades. Some tricyclic antidepressants (TCAs) have been shown to improve sleep efficiency.

OBJECTIVE

Assess the efficacy and safety of TCAs for the treatment of insomnia using a meta-analysis of randomized control trials (RCTs).

METHODS

Relevant studies were identified in electronic databases such as PubMed, Cochrane, Embase, and Web of Science, up until July 2016. We included all polysomnographic (PSG) RCTs using TCAs to treat insomnia. The primary outcome measure was the total sleep time (TST), although other polysomnographic measures were also investigated. Next-day somnolence and dropout rates were also assessed.

RESULTS

The meta-analysis included nine RCTs. TCAs significantly improved TST compared with placebo (SMD = 0.61, 95% CI = 0.50-0.71, P < 0.00001). Participants receiving TCAs were not more likely to drop out than those receiving a placebo because of adverse side effects (1.71% vs 1.19%, RR = 1.37, 95% CI = 0.67-2.80, P = 0.39) or any other reason (7.08% vs 8.20%; RR = 0.86, 95% CI = 0.60-1.23, P = 0.42). However, the incidence of somnolence was higher in participants receiving TCAs (6.06% vs. 3.21%; RR = 1.82, 95% CI = 1.10-3.00, P = 0.02).

CONCLUSIONS

Based on our limited data analysis with two medications at particular doses (most studies included extremely low doxepin), we assert that TCAs can be an effective pharmacological treatment for insomnia. TCAs were found to improve sleep outcome measures, with the notable exception of an 82% increase in somnolence. Overall TCAs have very problematic and dangerous side effects, while TCAs were not found to increase the dropout rate compared with the placebo.

摘要

背景

失眠是全球范围内一项重大的公共卫生负担。近几十年来,抗抑郁药常常是失眠治疗的首选药物。一些三环类抗抑郁药(TCA)已被证明可提高睡眠效率。

目的

通过对随机对照试验(RCT)进行荟萃分析,评估三环类抗抑郁药治疗失眠的疗效和安全性。

方法

截至2016年7月,在PubMed、Cochrane、Embase和Web of Science等电子数据库中检索相关研究。我们纳入了所有使用三环类抗抑郁药治疗失眠的多导睡眠图(PSG)随机对照试验。主要结局指标是总睡眠时间(TST),同时也研究了其他多导睡眠图指标。还评估了次日嗜睡情况和脱落率。

结果

荟萃分析纳入了9项随机对照试验。与安慰剂相比,三环类抗抑郁药显著改善了总睡眠时间(标准化均数差=0.61,95%置信区间=0.50 - 0.71,P<0.00001)。接受三环类抗抑郁药治疗的参与者因不良反应退出的可能性并不比接受安慰剂治疗的参与者更高(1.71%对1.19%,风险比=1.37,95%置信区间=0.67 - 2.80,P = 0.39),因任何其他原因退出的可能性也不更高(7.08%对8.20%;风险比=0.86,95%置信区间=0.60 - 1.23,P = 0.42)。然而,接受三环类抗抑郁药治疗的参与者嗜睡发生率更高(6.06%对3.21%;风险比=1.82,95%置信区间=1.10 - 3.00,P = 0.02)。

结论

基于我们对两种特定剂量药物的有限数据分析(大多数研究纳入的多塞平剂量极低),我们认为三环类抗抑郁药可以作为一种治疗失眠的有效药物治疗方法。三环类抗抑郁药被发现可改善睡眠结局指标,但值得注意的是嗜睡发生率增加了82%。总体而言,三环类抗抑郁药有非常严重且危险的副作用,不过与安慰剂相比,未发现三环类抗抑郁药会增加脱落率。

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