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首页> 外文期刊>Lancet Neurology >The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial.
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The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial.

机译：治疗儿童癫痫的生酮饮食：一项随机对照试验。

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BACKGROUND: The ketogenic diet has been widely and successfully used to treat children with drug-resistant epilepsy since the 1920s. The aim of this study was to test the efficacy of the ketogenic diet in a randomised controlled trial. METHODS: 145 children aged between 2 and 16 years who had at least daily seizures (or more than seven seizures per week), had failed to respond to at least two antiepileptic drugs, and had not been treated previously with the ketogenic diet participated in a randomised controlled trial of its efficacy to control seizures. Enrolment for the trial ran between December, 2001, and July, 2006. Children were seen at one of two hospital centres or a residential centre for young people with epilepsy. Children were randomly assigned to receive a ketogenic diet, either immediately or after a 3-month delay, with no other changes to treatment (control group). Neither the family nor investigators were blinded to the group assignment. Early withdrawals were recorded, and seizure frequency on the diet was assessed after 3 months and compared with that of the controls. The primary endpoint was a reduction in seizures; analysis was intention to treat. Tolerability of the diet was assessed by questionnaire at 3 months. The trial is registered with ClinicalTrials.gov, number NCT00564915. FINDINGS: 73 children were assigned to the ketogenic diet and 72 children to the control group. Data from 103 children were available for analysis: 54 on the ketogenic diet and 49 controls. Of those who did not complete the trial, 16 children did not receive their intervention, 16 did not provide adequate data, and ten withdrew from the treatment before the 3-month review, six because of intolerance. After 3 months, the mean percentage of baseline seizures was significantly lower in the diet group than in the controls (62.0%vs 136.9%, 75% decrease, 95% CI 42.4-107.4%; p<0.0001). 28 children (38%) in the diet group had greater than 50% seizure reduction compared with four (6%) controls (p<0.0001), and fivechildren (7%) in the diet group had greater than 90% seizure reduction compared with no controls (p=0.0582). There was no significant difference in the efficacy of the treatment between symptomatic generalised or symptomatic focal syndromes. The most frequent side-effects reported at 3-month review were constipation, vomiting, lack of energy, and hunger. INTERPRETATION: The results from this trial of the ketogenic diet support its use in children with treatment-intractable epilepsy. FUNDING: HSA Charitable Trust; Smiths Charity; Scientific Hospital Supplies; Milk Development Council.
机译：背景：自1920年代以来，生酮饮食已被广泛成功地用于治疗患有耐药性癫痫的儿童。这项研究的目的是在一项随机对照试验中测试生酮饮食的功效。方法：145名2至16岁的儿童每天至少发作一次（或每周发作7次以上），对至少两种抗癫痫药没有反应，并且以前未使用生酮饮食进行过治疗，控制癫痫发作疗效的随机对照试验。该试验的入组时间为2001年12月至2006年7月。儿童在两个医院中心之一或一个患有癫痫的年轻人的住所中被看到。随机分配儿童立即或在3个月延迟后接受生酮饮食，治疗无其他变化（对照组）。家庭和调查人员都没有对小组任务视而不见。记录提早退出，并在3个月后评估饮食中的癫痫发作频率，并与对照组进行比较。主要终点是癫痫发作减少。分析是有意治疗的。 3个月时通过问卷调查评估饮食的耐受性。该试验已在ClinicalTrials.gov上注册，编号为NCT00564915。结果：73名儿童被分配为生酮饮食，72名儿童被分配为对照组。来自103名儿童的数据可供分析：54名生酮饮食和49名对照。在未完成试验的那些人中，有16名儿童没有接受干预，有16名儿童没有提供足够的数据，还有10名儿童在3个月的审查之前退出治疗，其中6名是由于不宽容。 3个月后，饮食组基线癫痫发作的平均百分比显着低于对照组（62.0％vs. 136.9％，下降75％，95％CI 42.4-107.4％; p <0.0001）。饮食组中有28名儿童（38％）的癫痫发作减少量大于50％，而四名对照组（6％）（p <0.0001），饮食组中有五名儿童（7％）的癫痫发作减少率大于90％无对照（p ＝ 0.0582）。有症状的全身性或有症状的局灶性综合症之间的疗效没有显着差异。在3个月的复查中报告的最常见的副作用是便秘，呕吐，精力不足和饥饿。解释：这项生酮饮食试验的结果支持将其用于治疗难治性癫痫的儿童。资金：HSA慈善信托基金;史密斯慈善机构;科学医院用品;牛奶发展委员会。

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