Long-term tolerability and efficacy of lamotrigine in pediatric patients with epilepsy
Long-term tolerability and efficacy of lamotrigine in pediatric patients with epilepsy
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DOI：
10.1177/088307380201700408
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发表时间：
2002-04-01
影响因子：
1.9
通讯作者：
Risner, M
中科院分区：
文献类型：
--
作者：
Duchowny, M;Gilman, J;Risner, M
越来越多的数据表明，抗癫痫药物拉莫三嗪已可供成人使用十多年，也可以对儿童癫痫进行广谱、耐受性良好的控制。目前的研究是几项短期临床试验的开放标签持续阶段，旨在评估拉莫三嗪作为开放标签辅助疗法或单一疗法对各种癫痫类型和综合征（包括部分性癫痫发作、失神发作和 Lennox-Gastaut 综合征）儿科患者的长期耐受性和疗效。在整个治疗期间，每 24 周进行一次临床就诊。共有 252 名 16 岁以下患者参与了该研究。接受拉莫三嗪治疗至少 48 周、96 周和 144 周的患者人数分别为 185 例（73.4%）、119 例（47.2%）和 60 例（23.8%），平均暴露时间为 96.7 周。研究者认为与药物相关的最常见不良事件是头晕（9.1%）、嗜睡（7.9%）、恶心（6.3%）、呕吐（5.2%）和头痛（5.2%）。最常见的严重不良事件（无论可疑原因如何）包括肺炎（3.0%）和感染（1.9%）。研究人员判断，四分之三的患者的总体临床状况在治疗第 48 周和第 96 周时相对于普拉莫三嗪的临床状况有所改善。拉莫三嗪作为单一疗法或辅助疗法平均 2 年（96.7 周）对部分或全身性癫痫儿童患者具有良好的耐受性和有效性。这些结果补充和扩展了证明拉莫三嗪在成人短期和长期使用的耐受性和有效性的大量数据。
Accumulating data suggest that, the antiepilepsy drug lamotrigine, which has been available for adult use for more than a decade, also confers broad-spectrum, well-tolerated control of epilepsy in children. The current study-the open-label continuation phase of several short-term clinical trials-was conducted to assess the long-term tolerability and efficacy of lamotrigine as open-label adjunctive therapy or monotherapy in pediatric patients for a variety of seizure types and syndromes including partial seizures, absence seizures, and Lennox-Gastaut syndrome. Clinic visits occurred every 24 weeks throughout the treatment period. A total of 252 patients under 16 years of age were enrolled in the study. The numbers of patients exposed to at least 48 weeks, 96 weeks, and 144 weeks of treatment with lamotrigine were 185 (73.4%), 119 (47.2%), and 60 (23.8%), respectively, for an average duration of exposure of 96.7 weeks. The most common adverse events considered by the investigator to be drug related were dizziness (9.1%), somnolence (7.9%), nausea (6.3%), vomiting (5.2%), and headache (5.2%). The most common serious adverse events (regardless of suspected cause) included pneumonia (3.0%) and infection (1.9%). Investigators judged that the overall clinical status of three-fourths of the patients had improved at treatment weeks 48 and 96 relative to prelamotrigine clinical status. Lamotrigine administered as monotherapy or adjunctive therapy for an average of 2 years (96.7 weeks) was well tolerated and effective in pediatric patients with partial or generalized epilepsy. These results complement and extend the large body of data demonstrating the tolerability and efficacy of lamotrigine with short- and long-term use in adults.