Besag F M, Wallace S J, Dulac O, Alving J, Spencer S C, Hosking G
Centre for Epilepsy, London, England, United Kingdom.
J Pediatr. 1995 Dec;127(6):991-7. doi: 10.1016/s0022-3476(95)70047-1.
In this multicenter study, the efficacy and tolerability of lamotrigine were assessed in 285 children less than 13 years of age, recruited from 37 centers in 11 countries.
Pooled data from five open add-on studies have been analyzed. All the children had treatment-resistant epilepsy and most had two or more seizure types. Seizure frequency and global evaluation were assessed at the end of four successive 12-week periods of therapy.
Seizure frequency was reduced by 50% or more in one third of the patients. Lamotrigine was effective in all seizure types examined, particularly for typical and atypical absence seizures. Atonic seizures also responded well. Improvement was well maintained during the treatment period. The maintenance dose had to be adjusted according to concomitant medication; dose ranges were 1 to 5 mg/kg per day for children taking valproate and 5 to 15 mg/kg per day for those not taking valproate. The commonest reported adverse experiences were somnolence, rash, vomiting, and seizure exacerbations. Adverse experiences led to withdrawal of treatment from 36 patients (12.6%).
These results indicate that lamotrigine is well tolerated and is effective for a broad range of seizure types, especially absence seizures and atonic seizures.
在这项多中心研究中，对从11个国家37个中心招募的285名13岁以下儿童评估了拉莫三嗪的疗效和耐受性。
分析了五项开放性附加研究的汇总数据。所有儿童均患有难治性癫痫，大多数有两种或更多种发作类型。在连续四个12周治疗期结束时评估发作频率和整体评估。
三分之一的患者发作频率降低了50%或更多。拉莫三嗪对所有检查的发作类型均有效，尤其对典型和非典型失神发作有效。失张力发作反应也良好。在治疗期间改善情况得到很好维持。维持剂量必须根据合并用药进行调整；服用丙戊酸盐的儿童剂量范围为每日1至5毫克/千克，未服用丙戊酸盐的儿童为每日5至15毫克/千克。报告的最常见不良事件为嗜睡、皮疹、呕吐和发作加剧。不良事件导致36名患者（12.6%）退出治疗。
这些结果表明，拉莫三嗪耐受性良好，对广泛的发作类型有效，尤其是失神发作和失张力发作。
