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首页> 外文期刊>BMJ: British medical journal >Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial
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Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial

机译：褪黑激素对睡眠问题儿童神经发育障碍:随机双戴面具的安慰剂对照试验

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摘要

Is melatonin effective and tolerable in treating severe sleep problems in children with neurodevelopmental disorders?Children fell asleep significantly faster but woke earlier and gained little additional sleep on melatonin.Melatonin is widely prescribed within this population with inconsistent conclusions about its effectiveness. This study shows that children given an instant release preparation of melatonin fall asleep earlier but also wake earlier. Doses as low as low as 0.5 mg might be effective.This was a randomised, parallel group, double masked, multicentre, placebo controlled, phase III trial. At registration, parents/carers were provided with an advice booklet on standardised sleep behaviour therapy for a one month run-in period. Randomisation lists were generated witha 1:1 ratio with block randomisation. At randomisation, each child was given 0.5 mg immediate release melatonin or placebo. Every four weeks, we reviewed the child's sleep pattern and increased drug dose according to required criteria. There was a maximum of three dose increments from 0.5 mg to 2 mg, 6 mg, and a maximum of 12 mg.
机译：是褪黑激素治疗有效和可容忍的严重的儿童睡眠问题神经发育障碍?并获得早些时候明显快但醒来小额外睡眠的褪黑激素。在这个人口与广泛的规定对其有效性不一致的结论。这项研究表明,儿童给定的瞬间褪黑激素的释放制备入睡早些时候还早醒来。低至0.5毫克可能是有效的。随机、平行组双屏蔽,多中心、安慰剂对照、III期试验。在登记、父母/护理人员提供小册子在标准化睡眠的建议行为治疗一个月的磨合过程。随机列表生成1:1买下比块随机。每个孩子被立即释放0.5毫克褪黑素或安慰剂。回顾了孩子的睡眠模式和增加药物剂量根据所需的标准。是一个最大的三个剂量增加从0.5吗mg 2毫克,6毫克,最多12毫克。

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