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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 analyze the efficacy, tolerability and long-term retention rate of Oxcabazepine (OXC) in children under 4 years of age with symptomatic epilepsy, in order to provide more ideas and solutions for children with symptomatic epilepsy, to guide clinical medication. Methods From January 2009 to June 2015, 89 children with symptomatic epilepsy were enrolled in Department of Neurology, Children’s Hospital Affiliated to Chongqing Medical University, and were given OXC first or added medication. The initial dose of OXC was 10 mg / (kg · d). The maximum dose of OXC was ≤60 mg / (kg · d) and the average dose was (34.00 ± 8.59) mg / (kg · d). The medication, frequency of seizure, adverse drug reactions and electroencephalogram (EEG) in children were followed up at 3, 6, 12 months, 2 and 3 years respectively. Results The total effective rate at 6, 12, and 2, 3 years after the OXC administration in 89 children was 56.5%, 55.3%, 44.7% and 24.7%, respectively. The complete response rate The frequency of seizures was reduced by 100% or more than baseline) were 36.5%, 34.1%, 29.4% and 16.5% respectively. During medication, 16 patients (18.0%) had at least one adverse reaction. The main side effects were drowsiness in 8 (42.1%) and rash in 3 (15.8%). Most of the minor adverse reactions, including 8 cases because they can not tolerate adverse reactions and withdrawal. The retention rates at 3, 6, 12 months and 2 and 3 years were 95.5%, 87.6%, 75.3%, 56.2% and 25.8% respectively. The main reasons for discontinuation were 36 patients (54.5%), 10 patients (15.2%) at the end of time, 8 patients (12.1%) unable to tolerate, 5 (7.6%) controls and 3 patients (4.5% . COX regression analysis showed that the onset age of children was correlated with withdrawal (P <0.05). Conclusion OXC, as a novel antiepileptic drug, has mild side effects and good tolerance in the treatment of symptomatic epilepsy children under 4 years of age, but its long-term efficacy and long-term retention rate are low. Symptomatic epilepsy in children with OXC if the poor efficacy, we must take into account all aspects of factors, timely adjustment of medication to improve the long-term effects and retention rates.