Medical Investigation of Neurodevelopmental Disorders (M.I.N.D.) Institute, University of California Davis Health System, Sacramento, CA 95817, USA.
J Clin Sleep Med. 2009 Apr 15;5(2):145-50.
To determine the efficacy of melatonin on sleep problems in children with autistic spectrum disorder (ASD) and fragile X syndrome (FXS).
A 4-week, randomized, double blind, placebo-controlled, crossover design was conducted following a 1-week baseline period. Either melatonin, 3 mg, or placebo was given to participants for 2 weeks and then alternated for another 2 weeks. Sleep variables, including sleep duration, sleep-onset time, sleep-onset latency time, and the number of night awakenings, were recorded using an Actiwatch and from sleep diaries completed by parents. All participants had been thoroughly assessed for ASD and also had DNA testing for the diagnosis of FXS.
Data were successfully obtained from the 12 of 18 subjects who completed the study (11 males, age range 2 to 15.25 years, mean 5.47, SD 3.6). Five participants met diagnostic criteria for ASD, 3 for FXS alone, 3 for FXS and ASD, and 1 for fragile X premutation. Eight out of 12 had melatonin first. The conclusions from a nonparametric repeated-measures technique indicate that mean night sleep duration was longer on melatonin than placebo by 21 minutes (p = .02), mean sleep-onset latency was shorter by 28 minutes (p = .0001), and mean sleep-onset time was earlier by 42 minutes (p = .02).
The results of this study support the efficacy and tolerability of melatonin treatment for sleep problems in children with ASD and FXS.
确定褪黑素治疗自闭症谱系障碍（ASD）和脆性 X 综合征（FXS）儿童睡眠问题的疗效。
采用 4 周随机、双盲、安慰剂对照、交叉设计，在基线期 1 周后进行。参与者接受 3 毫克褪黑素或安慰剂治疗 2 周，然后交替治疗 2 周。使用 Actiwatch 和父母填写的睡眠日记记录睡眠变量，包括睡眠时间、入睡时间、入睡潜伏期和夜间觉醒次数。所有参与者均经过彻底的 ASD 评估，并且还进行了 DNA 测试以诊断 FXS。
完成研究的 18 名受试者中的 12 名（11 名男性，年龄 2 至 15.25 岁，平均 5.47，标准差 3.6）成功获得数据。5 名参与者符合 ASD 的诊断标准，3 名符合 FXS 单独的诊断标准，3 名符合 FXS 和 ASD 的诊断标准，1 名符合脆性 X 前突变的诊断标准。12 名中有 8 名先服用褪黑素。非参数重复测量技术的结论表明，褪黑素组的夜间平均睡眠时间比安慰剂组长 21 分钟（p =.02），平均入睡潜伏期缩短 28 分钟（p =.0001），平均入睡时间提前 42 分钟（p =.02）。
本研究结果支持褪黑素治疗 ASD 和 FXS 儿童睡眠问题的疗效和耐受性。
