奥卡西平单药治疗儿童部分性癫痫 疗效和安全性观察

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5.0～10.0 mg/（kg·d），维持剂量为12.7～40.0 mg/（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.