丙戊酸钠单药治疗新诊断儿童全面性癫痫失败原因分析

摘要

目的：探讨丙戊酸钠单药治疗新诊断儿童全面性癫痫失败原因、影响因素。方法前瞻性、开放性收集新诊断全面性癫痫病例，均接受丙戊酸钠单药治疗，随访到治疗2年以后。根据疗效分为对照组与疗效差2组,收集一般临床资料、脑电图等,采用Logistic回归分析治疗失败原因。结果231例患儿完成本研究，2年时有62例因疗效差而改用其他药物，169例患儿疗效可,3例依从性差，1例因副作用改药。两组脑电图异常率（疗效差组90.32%vs.对照组61.54%），头颅MRI异常率（疗效差组45.16%vs.对照组23.08%），首次发病年龄{疗效差组0.50（0.42,2.50）岁vs.对照组0.75（1.50,5.16）}岁等比较有统计学意义（P＜0.05）。单因素分析发现智能是否正常、出生窒息史、头颅MRI异常、首次发作年龄等有统计学意义（P＜0.05）。进一步多因素回归分析发现首发年龄低（OR=2.124，P=0.004）、智能障碍（OR=10.535，P=0.000）,头颅MRI异常（OR=1.603，P=0.020）,出生时有窒息（OR=1.913，P=0.027）为丙戊酸钠治疗全面性癫痫疗效差的独立危险因素。结论丙戊酸钠单药治疗全面性癫痫失败主要原因为疗效差，其次为依从性差、不良反应等。疗效差风险因素有首发年龄低、智能障碍、头颅MRI异常及出生时有窒息等。%Objectives To investigate the failure cause of valproate monotherapy for newly diagnosed generalized epilepsy in children and to investigate the factors related to the failure. Methods The newly diagnosed cases of general⁃ized epilepsy were recruited and given valproate monotherpy. After 2 years of treatment and regular follow-up, they were divided into control group and poor effect group.according to their response to the treatment. The clinic data and electro⁃encephalogram were collected. The reasons of treatment failure were studied using Logistic regression analysis. Results There were 231 patients who had completed this study in all. After 2 years, 62 cases had switched to other drugs because of poor efficacy. Efficacy of was satisfactory in 169 cases of children. There were 3 cases of poor compliance, and one case switched to other drug due to side effect. There were statistically significant (P<0.05) in the abnormal electroenceph⁃alogram (EEG) rate (poor effects group 90.32%vs. control group 61.54%), abnormal cranial magnetic resonance imaging (MRI) rate (poor effects group 45.16%vs. control grou p23.08%) and the first age of onset [poor effects group 0.50(0.42, 2.50)year vs. control group 0.75(1.50, 5.16)year] between the good effects group and poor effects group. Univariate anal⁃ysis showed that mental retardation,birth asphyxia,abnormal bain MRI,the first episode of age were statistically signifi⁃ cant different between these two groups (P<0.05). Further multivariate regression analysis showed that the low first onset age (OR=2.124 P=0.004)、mentalretardation (OR=10.535,P=0.000, abnormal brain MRI(OR=1.603,P=0.020), asphyxia at birth(OR=1.913 P=0.027)were independent risk factors for the poor efficacy of valproate. Conclusions The main rea⁃sons for the failure of valproate monotherpy in children with generalizedepilepsy are poor efficacy,bad compliance, ad⁃verse reactions. The risk factors of poor efficacy are the low first onset age, mental retardation, abnormal brain MRI and asphyxia at birth etc.