Lamotrigine monotherapy for newly diagnosed typical absence seizures in children.
Lamotrigine monotherapy for newly diagnosed typical absence seizures in children.
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DOI：
10.1016/j.eplepsyres.2008.07.016
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发表时间：
2008-12
影响因子：
2.2
通讯作者：
Messenheimer, John
中科院分区：
文献类型：
--
作者：
Holmes, Gregory L.;Frank, L. Matthew;Sheth, Raj D.;Philbrook, Bryan;Wooten, John D.;Vuong, Alain;Kerls, Susan;Hammer, Anne E.;Messenheimer, John
评价拉莫三嗪单药治疗新诊断的典型失神发作儿童的疗效、耐受性以及对行为和心理社会功能的影响。符合入组标准的儿童（n = 54）接受确证性24小时动态脑电图（EEG）检查，然后进入长达20周的递增期，在此期间滴定拉莫三嗪，直至癫痫发作得到控制或达到最大剂量（10.2 mg/kg）。通过日记审查和临床过度通气（clinic HV）评估癫痫发作自由度，然后通过EEG伴过度通气（HV/EEG）确认。连续两次每周访视保持无癫痫发作的患者进入维持期（n = 30）。在基线以及递增和维持阶段结束时，使用24小时动态EEG补充日记、诊所HV和HV/EEG数据。在筛选和维持阶段结束时完成健康结局评估。到递增期结束时，根据癫痫发作日记（n = 51）、HV/EEG（n = 54）（主要终点）和24小时动态EEG（n = 49），无癫痫发生率（应答者）分别为59%、56%和49%。在维持阶段，89%（第24周）和86%（第32周）通过日记（n = 28）、78%通过门诊HV（n = 27）和81%通过24小时动态EEG（n = 26）保持无癫痫发作。从递增阶段第5周开始首次观察到无癫痫发作。最常见的不良事件是头痛和咳嗽。在维持期结束时，健康结局评分改善或不变。拉莫三嗪单药治疗可使大量典型失神发作的儿童完全无癫痫发作。拉莫三嗪在本研究中耐受性良好。
To evaluate the efficacy, tolerability, and effects on behavior and psychosocial functioning of lamotrigine monotherapy in children with newly diagnosed typical absence seizures. Children meeting enrollment criteria (n = 54) received a confirmatory 24-h ambulatory electroencephalogram (EEG) and then entered a Escalation Phase of up to 20-weeks during which lamotrigine was titrated until seizures were controlled or maximum dose (10.2 mg/kg) was reached. Seizure freedom was assessed by diary review and clinic hyperventilation (clinic HV) and then confirmed by EEG with hyperventilation (HV/EEG). Patients who maintained seizure freedom for two consecutive weekly visits were entered into the Maintenance Phase (n = 30). Diary, clinic HV, and HV/EEG data were supplemented with 24-h ambulatory EEG at baseline and the ends of the Escalation and Maintenance Phases. Health outcome assessments were completed at screening and at the end of the Maintenance Phase. By the end of the Escalation Phase, seizure-free rates (responders) were 59% by seizure diary (n = 51), 56% by HV/EEG (n = 54) (primary endpoint), and 49% by 24-h ambulatory EEG (n = 49). During the Maintenance Phase, 89% (week 24) and 86% (week 32) remained seizure free by diary (n = 28), 78% by clinic HV (n = 27), and 81% by 24-h ambulatory EEG (n = 26). Seizure freedom was first observed beginning at the fifth week of the Escalation Phase. The most frequent adverse events were headache and cough. Health outcome scores were either improved or unchanged at the end of the Maintenance Phase. Lamotrigine monotherapy results in complete seizure freedom in a substantial number of children with typical absence seizures. Lamotrigine was well tolerated in this study.
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