Li Wei, Hao Xiaoyan, Gu Wei, Liang Chao, Tu Fulai, Ding Le, Lu Xiaopeng, Liao Jianxiang, Guo Hu, Zheng Guo, Wu Chunfeng
Department of Quality Management, Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Department of Neurology, Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Front Neurol. 2023 Apr 27;14:1146349. doi: 10.3389/fneur.2023.1146349. eCollection 2023.
To compare the efficacy and safety of inpatient and outpatient initiation ketogenic diet (KD) protocol of pediatric refractory epilepsy.
Eligible children with refractory epilepsy were randomly assigned to receive KD with inpatient and outpatient initiation. The generalized estimation equation (GEE) model was used to analyze the longitudinal variables of seizure reduction, ketone body, weight, height, body mass index (BMI), and BMI Z-score at different follow-up times between the two groups.
Between January 2013 and December 2021, 78 and 112 patients were assigned to outpatient and inpatient KD initiation groups, respectively. There were no statistical differences between the two groups based on baseline demographics and clinical characteristics (all s > 0.05). The GEE model indicated that the rate of reduction of seizures≥50% in the outpatient initiation group was higher than that of the inpatient initiation group ( = 0.049). A negative correlation was observed between the seizure reduction and blood ketone body at 1, 6, and 12 months (all < 0.05). There were no significant differences in height, weight, BMI, and BMI Z-score between the two groups over the 12-month period by the GEE models (all s > 0.05). Adverse events were reported by 31 patients (43.05%) in the outpatient KD initiation group and 46 patients (42.20%) in the inpatient KD initiation group, but these differences were not statistically significant ( = 0.909).
Our study shows that outpatient KD initiation is a safe and effective treatment for children with refractory epilepsy.
比较小儿难治性癫痫住院起始和门诊起始生酮饮食（KD）方案的疗效和安全性。
将符合条件的难治性癫痫患儿随机分配接受住院起始和门诊起始的KD治疗。采用广义估计方程（GEE）模型分析两组在不同随访时间癫痫发作减少、酮体、体重、身高、体重指数（BMI）和BMI Z评分的纵向变量。
2013年1月至2021年12月期间，分别有78例和112例患者被分配到门诊起始KD组和住院起始KD组。两组在基线人口统计学和临床特征方面无统计学差异（均P>0.05）。GEE模型表明，门诊起始组癫痫发作减少≥50%的比例高于住院起始组（P=0.049）。在1、6和12个月时，癫痫发作减少与血酮体之间呈负相关（均P<0.05）。GEE模型显示，在12个月期间，两组在身高、体重、BMI和BMI Z评分方面无显著差异（均P>0.05）。门诊起始KD组有31例患者（43.05%）报告了不良事件，住院起始KD组有46例患者（42.20%）报告了不良事件，但这些差异无统计学意义（P=0.909）。
我们的研究表明，门诊起始KD治疗小儿难治性癫痫是一种安全有效的治疗方法。
