Lamotrigine versus valproic acid as first-line monotherapy in newly diagnosed typical absence seizures: An open-label, randomized, parallel-group study
Lamotrigine versus valproic acid as first-line monotherapy in newly diagnosed typical absence seizures: An open-label, randomized, parallel-group study
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DOI：
10.1111/j.0013-9580.2004.40903.x
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发表时间：
2004-09-01
期刊：
影响因子：
5.6
通讯作者：
Pascotto, A
中科院分区：
文献类型：
--
作者：
Coppola, G;Auricchio, G;Pascotto, A
目的：比较拉莫三嗪（LTG）与丙戊酸（VPA）治疗初诊儿童青少年典型失神发作的疗效。方法：采用随机、开放标签平行组设计。在接受清醒视频-脑电图记录后，包括一到两次3分钟过度通气和间歇性光刺激的试验，符合条件的患者随机接受LTG或VPA。LTG开始时每日剂量为0.5 mg/kg，分两次给药，持续2周，随后1.0 mg/kg/天，再持续2周。此后，每5天增加1 mg/kg/天的剂量，直到癫痫发作得到控制，出现无法忍受的不良反应，或达到12 mg/kg/天的最大剂量。根据临床反应，VPA同样增加，从10mg /kg开始，如果需要，每3天增加5mg /kg/24小时，最大剂量为30mg /kg/天，分3次给药。患者每月在诊所就诊少于或等于12个月。每次就诊的主要疗效终点是癫痫发作自由，定义为自上次就诊以来没有临床观察到的癫痫发作，以及在动态24小时脑电图测试和过度通气的视频脑电图期间没有电临床癫痫发作。结果：38名儿童（17名男孩，21名女孩），年龄3 ~ 13岁（平均7.5岁），均为新诊断的儿童或青少年典型失神发作。治疗1个月后，VPA组19例患儿中10例（52.6%）无癫痫发作，LTG组19例患儿中1例（5.3%）无癫痫发作（p = 0.004）。随访3个月，对照组VPA患儿12例（63.1%），LTG患儿7例（36.8%）（p = 0.19）。12个月后，13例患儿服用VPA（剂量范围20 ~ 30 mg/kg/d，平均血清水平76.8 mg/L，范围51.4 ~ 91 mg/L）， 10例患儿服用LTG（剂量范围2 ~ 11 mg/kg/d，平均血清水平8.1 mg/L，范围1.1 ~ 18 mg/L）无癫痫发作（p = 0.51）。副作用大多是轻微和短暂的，在2例（10.6%）VPA治疗的儿童和6例（31.8%）LTG治疗的儿童中记录了副作用。结论：VPA和LTG对失神性癫痫都有效，尽管VPA的起效要快得多，至少部分原因是其滴定时间较短。
Purpose: To compare the efficacy of lamotrigine (LTG) and valproic acid (VPA) in newly diagnosed children and adolescents with typical absence seizures.Methods: A randomized, open-label parallel-group design was used. After undergoing an awake video-EEG recording, which included one to two trials of 3 min of hyperventilation and intermittent photic stimulation, eligible patients were randomized to receive LTG or VPA. LTG was initiated at a daily dose of 0.5 mg/kg for 2 weeks in two divided doses, followed by 1.0 mg/kg/day for an additional 2 weeks. Thereafter, doses were increased in 1-mg/kg/day increments every 5 days until seizures were controlled, intolerable adverse effects occurred, or a maximum dose of 12 mg/kg/day had been reached. VPA was equally uptitrated according to clinical response, starting at 10 mg/kg and increasing by 5 mg/kg/24 h every 3 days, if required, to a maximum of 30 mg/kg/day in three divided doses. Patients were seen in the clinic every month for less than or equal to12 months. The primary efficacy end point at each visit was seizure freedom, defined as lack of clinically observed seizures since the previous visit and lack of electroclinical seizures during ambulatory 24-h EEG testing and a video-EEG session with hyperventilation.Results: Thirty-eight children (17 boys, 21 girls), aged from 3 to 13 years (mean, 7.5 years), all newly diagnosed with childhood or juvenile typical absence seizures, were enrolled. After I month of treatment, 10 (52.6%) of 19 children taking VPA and one (5.3%) of 19 taking LTG were seizure free (p = 0.004). By the 3-month follow-up, 12 (63.1%) children taking VPA and seven (36.8%) taking LTG were controlled (p = 0.19). After 12 months, 13 children taking VPA (dose range, 20-30 mg/kg/day; mean serum level, 76.8 mg/L; range, 51.4-91 mg/L) and 10 taking LTG (dose range, 2-11 mg/kg/day; mean serum level, 8.1 mg/L; range, 1.1-18 mg/L) were seizure free (p = 0.51). Side effects were mostly mild and transient and were recorded in two (10.6%) children treated with VPA and in six (31.8%) treated with LTG.Conclusions: Both VPA and LTG can be efficacious against absence seizures, although VPA shows a much faster onset of action, at least in part because of its shorter titration schedule.