中国实用儿科杂志 ›› 2012, Vol. 27 ›› Issue (3): 214-217.

• 论著 • 上一篇    下一篇

奥卡西平单药治疗儿童部分性癫痫
疗效和安全性观察

红梅,吴沪生,陈春红,肖    静,伍    妘,杨欣英,方    方   

  1. 首都医科大学附属北京儿童医院神经康复中心 儿科学国家重点学科,北京    100056
  • 出版日期:2012-03-06 发布日期:2012-04-16

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

  • Online:2012-03-06 Published:2012-04-16

摘要:

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。

关键词: 奥卡西平, 部分性癫痫, 儿童, 自身对照, 困倦, 皮疹

Abstract:

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.

Key words: oxcarbazepine, partial seizure, child, auto-control, skin rash, drowsiness