天津医药 ›› 2026, Vol. 54 ›› Issue (5): 528-532.doi: 10.11958/20253253

• 药物临床观察 • 上一篇    下一篇

生酮饮食联合吡仑帕奈对癫痫性脑病伴睡眠期棘慢波激活患儿的疗效观察

陈曼(), 郑诺, 张冬丽, 陈娇, 刘晓鸣()   

  1. 徐州医科大学附属徐州儿童医院神经内科(邮编 221000)
  • 收稿日期:2025-10-29 修回日期:2026-01-21 出版日期:2026-05-15 发布日期:2026-05-13
  • 通讯作者: E-mail:xzlrlxm@163.com
  • 作者简介:陈曼(1990),女,主治医师,主要从事小儿神经疾病方面研究。E-mail:592873772@qq.com
  • 基金资助:
    徐州市卫生健康委科技项目(XWKYHT20230013);徐州医科大学附属儿童医院2023年度科研立项项目(23040416)

Observation on the therapeutic efficacy of ketogenic diet combined with perampanel in children with epileptic encephalopathy accompanied by sharp-slow wave activation during sleep period

CHEN Man(), ZHENG Nuo, ZHANG Dongli, CHEN Jiao, LIU Xiaoming()   

  1. Department of Neurology, Affiliated Xuzhou Children's Hospital of Xuzhou Medical University, Xuzhou 221000, China
  • Received:2025-10-29 Revised:2026-01-21 Published:2026-05-15 Online:2026-05-13
  • Contact: E-mail:xzlrlxm@163.com

摘要:

目的 探究生酮饮食(KD)联合吡仑帕奈(PER)治疗对癫痫性脑病伴睡眠期棘慢波激活(EE-SWAS)患儿睡眠期棘慢波指数(SWI)、中枢神经特异性蛋白S-100β水平及智力发育等的影响。方法 前瞻性选取99例EE-SWAS患儿,随机分为对照组49例(PER治疗)和试验组50例(KD+PER治疗)。比较2组患儿治疗6个月后的临床疗效、SWI、血清S-100β蛋白、神经元特异性烯醇化酶(NSE)、脑源性神经营养因子(BDNF)水平;采用韦氏儿童智力量表(WISC-V)评估智力发育情况;监测不良反应。结果 治疗后,2组SWI、S-100β、NSE水平均较治疗前下降,BDNF水平、WISC-V评分较治疗前升高,且试验组的SWI、S-100β、NSE水平低于对照组,BDNF水平、WISC-V评分高于对照组(P<0.05)。治疗后,试验组总有效率高于对照组(96.00% vs. 79.59%,P<0.05)。2组在治疗期间的不良反应发生率差异无统计学意义(12.00% vs. 16.32%,P>0.05)。结论 KD联合PER对EE-SWAS患儿的疗效突出,能够降低SWI、调节神经因子水平,维护患儿智力发育,且安全性良好。

关键词: 癫痫, S100钙结合蛋白β亚基, 韦氏智力量表, 生酮饮食, 吡仑帕奈, 癫痫性脑病伴睡眠期棘慢波激活, 睡眠期棘慢波指数

Abstract:

Objective To evaluate the therapeutic effects of ketogenic diet (KD) combined with perampanel (PER) on sleep-related spike-and-wave activity index (SWI), serum levels of central nervous system-specific protein S-100β and intellectual development in children diagnosed with epileptic encephalopathy with sleep-related spike-and-wave activation (EE-SWAS). Methods A prospective randomized controlled trial was conducted involving 99 children with EE-SWAS, and they were randomly assigned to the control group (n = 49, receiving PER monotherapy) and the experimental group (n = 50, receiving KD combined with PER). After six months of treatment, clinical efficacy, SWI, serum biomarkers including S-100β, neuron-specific enolase (NSE) and brain-derived neurotrophic factor (BDNF) were assessed and compared between groups. Cognitive function was evaluated using the Wechsler Intelligence Scale for Children—Fifth Edition (WISC-V). Adverse events were systematically monitored throughout the study period. Results After treatment, SWI, S-100β and NSE levels were significant reduced in both groups, and BDNF level and WISC-V scores were higher compared to those of the control group (P<0.05). SWI, S-100β and NSE levels were lower in the experimental group than those of the control group, and BDNF level and WISC-V scores were higher in the control group (P<0.05). After treatment, the total effective rate was hiter in the experimental group (96.00%) than that in the control group (79.59%, P<0.05). There was no significant difference in the incidence of adverse events during the treatment period between the two groups (12.00% vs. 16.32%,P>0.05). Conclusion The combination of KD and PER demonstrates superior therapeutic efficacy in children with EE-SWAS, effectively reducing abnormal electroencephalographic activity, modulating key neurochemical markers, supporting cognitive development and exhibiting a favorable safety.

Key words: epilepsy, S100 calcium binding protein beta subunit, Wechsler scales, ketogenic diet, perampanel, epileptic encephalopathy with sleep-wake-activated spikes, spike-wave index

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