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目的观察奥卡西平(OXC)单药治疗儿童部分性癫痫的长期疗效、耐受性和安全性。方法 2004年3月至2008年11月首都医科大学附属北京儿童医院神经内科新诊断的56例部分性癫痫患儿,应用OXC单药治疗,起始剂量为5.0～10.0mg(/kg·d),维持剂量为12.7～40.0mg(/kg·d),以治疗前3个月癫痫发作频度为对照,对治疗后3～24个月内的疗效、副反应、耐受性及安全性进行自身对照观察。结果应用OXC单药治疗后,50例(89.3%)观察至6个月以上,45例(80.4%)观察至12个月以上,42例(75.0%)观察至24个月以上,与治疗前自身对照,癫痫发作频率均明显减少,用药前后差异有统计学意义(P<0.01);治疗3～6个月后与治疗前自身对照,癫痫发作频率明显减少,用药前后差异有统计学意义(P<0.01),在治疗3、6、12、18、24个月时无发作率分别达到64.3%、62.5%、53.6%、55.4%、64.3%,总有效率分别为78.6%、73.2%、75.0%、67.9%、67.9%。OXC单药治疗24个月内,3例(5.4%)失访,11例(19.6%)陆续退出,包括1例因皮疹、10例(17.9%)因疗效差加用其他抗癫痫药物治疗。患儿保留率≥1年为80.4%,≥2年为75.0%。发生副反应16例(28.6%),副反应为困倦、皮疹、性情暴躁、头晕、头痛、无症状性低钠血症、纳差、乏力等,多数副反应持续短暂。结论 OXC单药治疗儿童部分性癫痫疗效明显。

The clinical efficacy and safety of oxcarbazepine monotherapy for children with newly diagnosed partial epilepsy

??Objective To evaluate the long-term efficacy?? tolerability and safety of oxcarbazepine ??OXC?? monotherapy for pediatric patients with partial epilepsy. Methods A total of 56 newly diagnosed pediatric patients with partial epilepsy were enrolled. The initial dose of OXC was 5??10 mg/??kg·d???? and the maintenance dose was 12.7??40.0 mg/??kg·d??.With the open-label auto-control method?? the efficacy?? tolerability and safety of OXC monotherapy were followed up from 3- month to 2 years. Results Of the 56 patients?? 50 cases were followed up for over 6-month??45 cases over 12-month?? and 42 cases over 24 months. The seizure frequencies reduced significantly after therapy ??P ?? 0.01??. The 3-month??6-month??12-month??18-month??24-month seizure free rates were 64.3%??62.5%??53.6%??55.4% and 64.3% respectively??and total effective rates were 78.6%??73.2%??75.0%??67.9% and 67.9% respectively.Three patients were lost during the study. The withdraw rate was 19.6% ??n=11?? with a follow-up of 24-month??1 because of skin rash??10 because of incomplete seizure control. Patients’retention of OXC monotherapy was 80.4% for one year?? and 75.0% for 2 years. Adverse events tended to be transient and were reported in 16 patients ??28.6%????such as drowsiness?? rash?? irascible??dizziness??headache??asymptomatic hyponatremia??anorexia and fatigue. Conclusion Oxcarbazepine monotherapy has satisfactory effects in treating pediatric patients with partial seizures. It is well tolerated and safe?? and may have a great clinical application value with slight side effects.