奥卡西平单药治疗儿童部分性癫痫疗效和安全性观察

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

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。

Objective To evaluate the long-term efficacy,tolerability and safety of oxcarbazepine（OXC）monotherapyf or 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 upf rom 3-month to 2 years.Results Of the 56 patients,50 cases were followed up for over 6-month,45 cases over1 2-month,and 42 cases over 24 months.The seizure frequencies reduced significantly after therapy（P0.01）.The3 -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 lostd uring the study.The withdraw rate was 19.6%（n=11）with a follow-up of 24-month,1 because of skin rash,10 be？c ause of incomplete seizure control.Patients’retention of OXC monotherapy was 80.4%for one year,and 75.0%for 2y ears.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 monotherapyh as satisfactory effects in treating pediatric patients with partial seizures.It is well tolerated and safe,and may have ag reat clinical application value with slight side effects.