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目的通过随机对照研究,评估生酮饮食治疗难治性癫癎的疗效。方法回顾性分析145例难治性癫癎儿童的临床资料。年龄2～16岁;癫癎每天均发作(或每周至少发作7次);使用两种或两种以上抗癫癎药物治疗无效,前期未采用生酮饮食。2001年12月-2006年7月,在治疗年轻癫癎病人的医疗中心进行研究。实验组病儿随机接受生酮饮食,立即或者每隔3个月进行评估;对照组不接受治疗。家属和调查者均了解分组情况。与对照组相比,3个月后记录早期放弃情况,评估治疗中癫癎发作频率。主要的评价指标是发作减少,分析治疗方法。治疗耐受性可通过3个月后调查问卷评估。研究注册于ClinicalTrials.gov网站,编号:NCT00564915。结果实验组73例,对照组72例。103例病儿数据可用于分析,其中54例接受生酮饮食,49例不接受治疗。未完成观察的病例中,16例不接受治疗,16例未能提供有效数据,10例在3个月观察期内放弃治疗(其中6例不耐受)。3个月后,实验组基线癫癎平均发作率(62%)低于对照组(136.9%),降低75%(95%CI为42.4%～107.4%,P<0.0001)。与对照组4例(6%)病儿相比,实验组28例(38%)癫癎发作减少50%以上(P<0.0001),5例(7%)癫癎发作减少90%以上(P=0.0582)。两组在缓解全身症状或局部症状方面无差别。最常见的副作用为便秘、呕吐、无力、饥饿。结论研究表明:生酮饮食适用于难治性癫癎儿童的治疗。
Objective To evaluate the efficacy of ketogenic diet in the treatment of refractory epilepsy by a randomized controlled study. Methods The clinical data of 145 children with refractory epilepsy were retrospectively analyzed. Age 2 to 16 years old; epilepsy episodes every day (or at least 7 episodes per week); the use of two or more anti-epileptic drugs ineffective, did not use ketogenic diet. December 2001 - July 2006, in the treatment of young patients with epilepsy medical center for research. Children in the experimental group were randomized to ketogenic diet and evaluated immediately or at 3-month intervals; the control group did not receive treatment. Family members and investigators are aware of grouping. Compared with the control group, three months later record the early abandonment, evaluation of the treatment of epileptic seizures frequency. The main evaluation index is reduced seizures, analysis of treatment. Treatment tolerance can be assessed by questionnaire 3 months later. Research is registered on the ClinicalTrials.gov website, number NCT00564915. Results The experimental group of 73 cases, control group of 72 cases. 103 cases of sick children data can be used for analysis, of which 54 cases received ketogenic diet, 49 cases did not receive treatment. Of the unfinished cases, 16 were not treated, 16 failed to provide valid data, and 10 discontinued treatment during the 3-month observation period (6 were intolerant). After 3 months, the mean seizure rate (62%) of baseline epilepsy was lower in the experimental group than in the control group (136.9%) and 75% (95% CI, 42.4% -107.4%, P <0.0001). In 28 (38%) patients in the experimental group, seizures were reduced by more than 50% (P <0.0001) and in 5 (7%) epileptic seizures by 90% or more compared with 4 (6% = 0.0582). There was no difference between the two groups in relieving systemic symptoms or local symptoms. The most common side effects are constipation, vomiting, weakness, hunger. Conclusions Studies have shown that ketogenic diet is suitable for the treatment of children with refractory epilepsy.