Phillips Louise, Appleton Richard E
Department of Neurology, Royal Liverpool Children's NHS Trust, Liverpool L12 2AP, UK.
Dev Med Child Neurol. 2004 Nov;46(11):771-5. doi: 10.1017/s001216220400132x.
Sleep disturbances in children with neurodevelopmental disabilities are common and frequently difficult to treat with conventional pharmacological and behavioural methods. Melatonin is a pineal hormone known to be important in the regulation of the circadian rhythm, including the sleep-wake cycle. This systematic review of available evidence from randomized clinical trials assesses whether melatonin plays a beneficial role in these children and, in particular, its effect on total sleep time, time to sleep onset (sleep latency), and number of awakenings. We also looked at a parental view of the effect. Randomized clinical trials were identified where oral melatonin was compared with a placebo in children with any type of neurodevelopmental disability and associated sleep disturbance. Only three studies, reporting a total of 35 children, fulfilled the criteria for inclusion. The two studies that reported time to sleep onset showed a significant decrease (p<0.05) in this specific outcome where melatonin was compared with a placebo. There was no significant effect of melatonin compared with a placebo on the other outcome measures of total sleep time, night-time awakenings, and parental opinions. Despite the extremely limited randomized clinical trial data, melatonin appears to remain a commonly prescribed drug for disturbed sleep in children with neurodevelopmental abnormalities.
神经发育障碍儿童的睡眠障碍很常见，并且通常难以用传统的药物和行为方法进行治疗。褪黑素是一种松果体激素，已知在昼夜节律的调节中起着重要作用，包括睡眠-觉醒周期。这项对随机临床试验现有证据的系统评价评估了褪黑素在这些儿童中是否发挥有益作用，特别是其对总睡眠时间、入睡时间（睡眠潜伏期）和觉醒次数的影响。我们还考察了家长对其效果的看法。确定了将口服褪黑素与安慰剂在患有任何类型神经发育障碍及相关睡眠障碍的儿童中进行比较的随机临床试验。只有三项研究（共报告了35名儿童）符合纳入标准。两项报告了入睡时间的研究表明，在将褪黑素与安慰剂进行比较的这一特定结果中，入睡时间显著缩短（p<0.05）。与安慰剂相比，褪黑素在总睡眠时间、夜间觉醒次数和家长意见等其他结果指标上没有显著效果。尽管随机临床试验数据极其有限，但褪黑素似乎仍然是治疗神经发育异常儿童睡眠障碍的常用处方药。
