York Trials Unit, Department of Health Sciences, University of York, York, UK.
Social Policy Research Unit, University of York, York, UK.
Dev Med Child Neurol. 2019 Aug;61(8):880-890. doi: 10.1111/dmcn.14157. Epub 2019 Feb 1.
To evaluate the effectiveness of pharmacological interventions for managing non-respiratory sleep disturbances in children with neurodisabilities.
We performed a systematic review and meta-analyses of randomized controlled trials (RCTs). We searched 16 databases, grey literature, and reference lists of included papers up to February 2017. Data were extracted and assessed for quality by two researchers (B.B., C.M., G.S., A.S., A.P.).
Thirteen trials were included, all evaluating oral melatonin. All except one were at high or unclear risk of bias. There was a statistically significant increase in diary-reported total sleep time for melatonin compared with placebo (pooled mean difference 29.6min, 95% confidence interval [CI] 6.9-52.4, p=0.01). Statistical heterogeneity was high (97%). For the single RCT with low risk of bias, the unadjusted mean difference in total sleep time was 13.2 minutes (95% CI -13.3 to 39.7) favouring melatonin, while the mean difference adjusted for baseline total sleep time was statistically significant (22.4min, 95% CI 0.5-44.3, p=0.04). Adverse event profile suggested that melatonin was well-tolerated.
There is a paucity of evidence on managing sleep disturbances in children with neurodisabilities, and it is mostly of limited scope and poor quality. There is evidence of the benefit and safety of melatonin compared with placebo, although the extent of this benefit is unclear.
Melatonin for the management of non-respiratory sleep disturbances in children with neurodisabilities was well tolerated with minimal adverse effects. The extent of benefit and which children might benefit most from melatonin use is uncertain. Benefit may be greatest in those with autism spectrum disorder; however, this finding should be interpreted with caution.
评估药物干预治疗神经发育障碍儿童非呼吸性睡眠障碍的有效性。
我们对随机对照试验（RCT）进行了系统评价和荟萃分析。我们检索了 16 个数据库、灰色文献以及纳入文献的参考文献列表，检索截止日期为 2017 年 2 月。由两位研究人员（B.B.、C.M.、G.S.、A.S.、A.P.）提取和评估数据，并评估其质量。
纳入了 13 项试验，均评估了口服褪黑素。除一项外，其余试验均具有高或不明确的偏倚风险。与安慰剂相比，褪黑素组的日记报告总睡眠时间有统计学显著增加（合并均数差 29.6 分钟，95%置信区间 [CI] 6.9-52.4，p=0.01）。存在高度统计学异质性（97%）。对于仅有低偏倚风险的单一 RCT，总睡眠时间的未调整均数差为 13.2 分钟（95% CI -13.3 至 39.7），有利于褪黑素，而调整基线总睡眠时间后的平均差异具有统计学意义（22.4 分钟，95% CI 0.5-44.3，p=0.04）。不良事件概况表明褪黑素具有良好的耐受性。
目前针对神经发育障碍儿童睡眠障碍管理的证据有限，且大多范围有限且质量较差。与安慰剂相比，褪黑素具有获益和安全性的证据，尽管获益的程度尚不清楚。
褪黑素治疗神经发育障碍儿童非呼吸性睡眠障碍具有良好的耐受性，不良反应最小。获益的程度以及哪些儿童可能从褪黑素使用中获益最大尚不确定。在自闭症谱系障碍儿童中获益可能最大；然而，这一发现应谨慎解释。
