目的 探究小儿抗痫胶囊联合丙戊酸钠缓释片（I）治疗儿童原发性全身强直–阵挛发作型癫痫的临床疗效及其对胶质纤维酸性蛋白（GFAP）、S100β蛋白水平的影响。方法 选取2018年2月—2020年2月在开封市儿童医院就诊的120例原发性全身强直–阵挛发作型癫痫患儿为研究对象，按照随机数字表法将全部患儿分为对照组和治疗组，每组各60例。对照组患儿口服丙戊酸钠缓释片（I），30 mg/(kg∙d)。治疗组在对照组用药基础上口服小儿抗痫胶囊，5粒/次，3次/d。2个月为1个疗程，两组患儿均连续治疗3个疗程。观察两组患儿的临床疗效，并比较两组患儿治疗前后脑电图特征、癫痫发作持续时间、癫痫发作频率、GFAP、S100β蛋白水平情况。结果 治疗后，治疗组总有效率（93.33%）明显高于对照组（80.00%）（P<0.05）。治疗后，两组患儿θ功率均较治疗前增加（P<0.05），且治疗组θ功率显著高于对照组（P<0.05）。治疗后，两组患儿癫痫发作持续时间、发作频率均明显降低（P<0.05）；且与对照组比较，治疗组癫痫发作持续时间、发作频率明显降低（P<0.05）。治疗后，两组GFAP、S100β水平均降低（P<0.05），且治疗组GFAP、S100β水平较对照组低（P<0.05）。结论 小儿抗痫胶囊联合丙戊酸钠缓释片（I）治疗儿童原发性全身强直–阵挛发作型癫痫疗效显著，能够有效改善患儿临床症状、脑电图特征、θ功率和GFAP、S100β水平，且不会增加不良反应。

Objective To investigate the clinical effect of Xiao’er Kangxian Capsules combined with Sodium Valproate Sustained-release Tablets (I) in treatment of primary systemic tonic-clonic seizure epilepsy in children and its effect on the levels of GFAP and S-100β.Methods Children (120 cases) with primary systemic tonic-clonic seizure epilepsy in Kaifeng Children’s Hospital from February 2018 to February 2020 were randomly divided into control and treatment groups, and each group had 60 cases. Children in the control group were po administered with Sodium Valproate Sustained-release Tablets (I), 30 mg/(kg∙d). Children in the treatment group were po administered with Xiao’er Kangxian Capsules on the basis of the control group, 5 grains/time, three times daily. A course had 2 months, and children in two groups were treated for 3 courses. After treatment, the clinical efficacies were evaluated, and the EEG characteristics, the duration and frequency of seizure, the levels of serum GFAP and S100β in two groups were compared.Results After treatment, the total effective rate of the treatment group (93.33%) was significantly higher than that of the control group (80.00%) (P<0.05). After treatment, the θ power of two groups were increased compared with that before treatment (P<0.05), and the θ power of the treatment group was significantly higher than that of the control group (P<0.05). After treatment, the duration and frequency of seizures in two groups were significantly decreased (P<0.05), and the duration and frequency of seizures in the treatment group were significantly lower than those in the control group (P<0.05). After treatment, the levels of GFAP and S100β in two groups were decreased (P<0.05), and the levels of GFAP and S100β in the treatment group were lower than those in the control group (P<0.05).Conclusion Xiao’er Kangxian Capsules combined with Sodium Valproate Sustained-release Tablets (I) has a significant effect on children with primary generalized tonic-clonic seizure epilepsy, can effectively improve the EEG, θ power, GFAP and S100β levels and clinical symptoms, with less adverse reactions.

R985

河南省医学科技攻关计划联合共建项目（2018020531）