Peake D, Mordekar S, Gosalakkal J, Mukhtyar B, Buch S, Crane J, Wheway R, Rittey C, Donnelly J, Whitehouse W P, Philip S
Department of Paediatric Neurology, Birmingham Children's Hospital, and Nottingham University Hospitals, UK.
Seizure. 2007 Mar;16(2):185-9. doi: 10.1016/j.seizure.2006.12.001. Epub 2007 Jan 26.
Levetiracetam (LEV) is a novel antiepileptic drug (AED) that has recently obtained marketing authorisation for use in children. The purpose of this study was to assess the efficacy, tolerability and retention rate of LEV in children with refractory epilepsies. It is a retrospective multicentre observational study reporting the use of LEV in 200 children, aged 0.3-19 years (median 9-years-old) over a 4-year period. All of the patients included in the study had refractory epilepsy with a median age of onset of epilepsy of 3 years (range 0-13 years). The 38% had failed and withdrawn 3 or more AEDs previously and 24% were taking at least 2 other AEDs in addition to LEV. The 47% had focal, and 58% had symptomatic epilepsies. The LEV dose ranged from 8 to 100 mg/kg/day (mean 39 mg/kg). The study comprised 215 person years of LEV exposure.
LEV was well tolerated with a retention rate of 49% at 1 year. No serious adverse events were reported with possibly related adverse events reported in only 24% of patients (mainly emotional or behavioural changes). At more than 2, 6 and 12 months, worthwhile improvement (>50% seizure reduction) was noted in 60, 40 and 32%, including seizure freedom in 14, 14 and 5%, respectively.
Our results confirm the efficacy and tolerability of LEV in children with refractory epilepsies and demonstrate good response and retention rates at 12 months. It represents the largest cohort of paediatric patients published so far on LEV with a 1-year follow-up.
左乙拉西坦(LEV)是一种新型抗癫痫药物(AED),最近已获得用于儿童的上市许可。本研究的目的是评估左乙拉西坦在难治性癫痫患儿中的疗效、耐受性和保留率。这是一项回顾性多中心观察性研究,报告了在4年期间200名年龄在0.3 - 19岁(中位数9岁)儿童中使用左乙拉西坦的情况。纳入研究的所有患者均为难治性癫痫,癫痫发病年龄中位数为3岁(范围0 - 13岁)。38%的患者先前使用3种或更多抗癫痫药物治疗失败并停药,24%的患者除左乙拉西坦外还服用至少2种其他抗癫痫药物。47%的患者患有局灶性癫痫,58%的患者患有症状性癫痫。左乙拉西坦剂量范围为8至100毫克/千克/天(平均39毫克/千克)。该研究包括215人年的左乙拉西坦暴露时间。
左乙拉西坦耐受性良好,1年时保留率为49%。未报告严重不良事件,仅24%的患者报告了可能相关的不良事件(主要是情绪或行为改变)。在2个月以上、6个月和12个月时,分别有60%、40%和32%的患者有显著改善(癫痫发作减少>50%),其中癫痫发作完全缓解的患者分别为14%、14%和5%。
我们的结果证实了左乙拉西坦在难治性癫痫患儿中的疗效和耐受性,并显示出12个月时良好的反应率和保留率。这是迄今为止发表的关于左乙拉西坦的最大规模儿科患者队列,随访时间为1年。