奥卡西平治疗4岁以下儿童症状性癫痫长程保留率的临床研究

Retention rate of Oxcabazepine in children under the age of four with symptomatic epilepsy

目的分析奥卡西平(Oxcabazepine,OXC)治疗4岁以下儿童症状性癫痫的疗效、耐受性及长程保留率,以期为儿童症状性癫痫提供更多的思路与方案,以指导临床用药。方法选取2009年1月-2015年6月就诊于重庆医科大学附属儿童医院神经内科门诊的89例儿童症状性癫痫患者,给予OXC首用或添加用药治疗。OXC的起始剂量为10 mg/(kg·d),经3~4周加至目标剂量,最大剂量≤60 mg/(kg·d),平均剂量为(34.00±8.59)mg/(kg·d)。分别于3、6、12个月,2、3年随访患儿的服药情况、发作频率、药物不良反应及脑电图(EEG)情况。结果 89例患儿服用OXC后6、12个月,2、3年总有效率(发作频率较基线期减少≥50%)分别为56.5%、55.3%、44.7%、24.7%,完全缓解率(发作频率较基线期减少≥100%)分别为36.5%、34.1%、29.4%、16.5%。在服药期间,16例(18.0%)患儿至少出现了一种不良反应,主要不良反应有嗜睡8例(42.1%)、皮疹3例(15.8%)。大部分不良反应轻微,其中8例因不能耐受不良反应而停药。3、6、12个月,2、3年的保留率分别为95.5%、87.6%、75.3%、56.2%、25.8%。主要停药原因有缺乏疗效36例(54.5%)、时间终点10例(15.2%)、不能耐受8例(12.1%)、控制可5例(7.6%)、失访3例(4.5%)。COX回归分析示患儿起病年龄与停药具有相关性(P<0.05)。结论 OXC作为一种新型的抗癫痫药物在治疗4岁以下症状性癫痫患儿的过程中不良反应轻微,具有较好的耐受性,但远期有效性和长期保留率较低。症状性癫痫患儿使用OXC后若疗效欠佳,需综合考虑各方面因素,及时调整用药,以提高远期的效果及保留率。

Objective To investigate the long-term retention rate of Oxcabazepine( OXC) in Chinese young children with symptomatic epilepsy and to evaluate the withdrawal causes of OXC. Methods Clinical features of 89 cases( male/female: 48/41) from January. 2009 to June. 2015 were collected.Patients with symptomatic epilepsy who received mono-or adjunctive therapy with OXC. The initial dose was10mg/kg/d twice a daily,3 ~ 4weeks to increased to the target dose. OXC doses ranged between 12 ~ 53mg/( kg·d)( mean dose: 34. 0 ± 8. 59 mg/( kg · d). An investigator recorded the antiepileptic drugs,seizure frequency,electroencephalogram and side effects for 3,6,12,24 and 36 months during follow-up.Results A total of 89 patients were enrolled in this investigation. patients with 50% reduction in seizure frequency in 6,12,24 and 36 months were 56. 5%,55. 3%,44. 7%,24. 7%,and with seizure-free were36. 5%,34. 1%,29. 4%,16. 5%. In this research,16( 18. 0%) patients experienced at least one side effect. The most common side effects observed were drowsiness 8( 42. 1%),rash 3( 15. 8%),and most were mild in severity. The retention rate of OXC in 3,6,12,24,and 36 months were 95. 5%,87. 6%,75. 3%,56. 2%,25. 8%,respectively. The predominant causes of withdrawal were lack of efficacy 36( 54. 5%),end point 10( 15. 2%),adverse effects 8( 12. 1%),seizure-free 5( 7. 6%),follow-up loss 3( 4. 5%). COX analysis reveals that the age of onset was associated with treatment failure. Conclusion Our study demonstrates that OXC is safe and well tolerated in infants and very young children with symptomatic epilepsy,but the long-term retention rate is low. Whereas,for the purpose of better retention rate and therapeutic benefits,we should treat discretely depending on the complicated etiology and clinical features.