Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy.
Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy.
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DOI：
10.1056/nejmoa0902014
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发表时间：
2010-03-04
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影响因子：
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通讯作者：
Childhood Absence Epilepsy Study Group
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作者：
Glauser TA;Cnaan A;Shinnar S;Hirtz DG;Dlugos D;Masur D;Clark PO;Capparelli EV;Adamson PC;Childhood Absence Epilepsy Study Group
儿童失神癫痫是最常见的小儿癫痫综合征，通常用乙舒酰亚胺、丙戊酸或拉莫三嗪治疗。最有效和最耐受的初始经验治疗尚未确定。在一项双盲、随机、对照临床试验中，我们比较了乙舒酰亚胺、丙戊酸和拉莫三嗪对新诊断的儿童失神性癫痫儿童的疗效、耐受性和神经心理学作用。逐渐增加药物剂量，直到儿童不再出现癫痫发作、达到最大允许或最高耐受剂量，或达到治疗失败的标准。主要结局是治疗 16 周后没有出现治疗失败；次要结果是注意力功能障碍。通过成对比较来确定不同的药物作用。 453 名儿童被随机分配接受乙磺酰亚胺 (156)、拉莫三嗪 (149) 或丙戊酸 (148) 治疗，其人口统计学特征相似。治疗 16 周后，乙舒酰亚胺和丙戊酸的无失败率相似（分别为 53% 和 58%；丙戊酸与乙舒酰亚胺的比值比为 1.26；95% 置信区间 [CI]，0.80 至 1.98；P = 0.35），并且高于拉莫三嗪的无失败率（29%；比值比）与乙舒酰亚胺的比例 与拉莫三嗪相比，2.66； 95% CI，1.65 至 4.28；丙戊酸与拉莫三嗪的比值比，3.34； 95% CI，2.06 至 5.42；两次比较 P<0.001）。三种药物因不良事件而停药的情况没有显着差异。丙戊酸组的注意力功能障碍比乙舒酰亚胺组更常见（49% 的儿童 vs. 33%；比值比，1.95；95% CI，1.12 至 3.41；P = 0.03）。乙舒酰亚胺和丙戊酸在治疗儿童失神性癫痫方面比拉莫三嗪更有效。乙舒酰亚胺与较少的不良注意力影响相关。 （ClinicalTrials.gov 编号，NCT00088452。）
Childhood absence epilepsy, the most common pediatric epilepsy syndrome, is usually treated with ethosuximide, valproic acid, or lamotrigine. The most efficacious and tolerable initial empirical treatment has not been defined. In a double-blind, randomized, controlled clinical trial, we compared the efficacy, tolerability, and neuropsychological effects of ethosuximide, valproic acid, and lamotrigine in children with newly diagnosed childhood absence epilepsy. Drug doses were incrementally increased until the child was free of seizures, the maximal allowable or highest tolerable dose was reached, or a criterion indicating treatment failure was met. The primary outcome was freedom from treatment failure after 16 weeks of therapy; the secondary outcome was attentional dysfunction. Differential drug effects were determined by means of pairwise comparisons. The 453 children who were randomly assigned to treatment with ethosuximide (156), lamotrigine (149), or valproic acid (148) were similar with respect to their demographic characteristics. After 16 weeks of therapy, the freedom-from-failure rates for ethosuximide and valproic acid were similar (53% and 58%, respectively; odds ratio with valproic acid vs. ethosuximide, 1.26; 95% confidence interval [CI], 0.80 to 1.98; P = 0.35) and were higher than the rate for lamotrigine (29%; odds ratio with ethosuximide vs. lamotrigine, 2.66; 95% CI, 1.65 to 4.28; odds ratio with valproic acid vs. lamotrigine, 3.34; 95% CI, 2.06 to 5.42; P<0.001 for both comparisons). There were no significant differences among the three drugs with regard to discontinuation because of adverse events. Attentional dysfunction was more common with valproic acid than with ethosuximide (in 49% of the children vs. 33%; odds ratio, 1.95; 95% CI, 1.12 to 3.41; P = 0.03). Ethosuximide and valproic acid are more effective than lamotrigine in the treatment of childhood absence epilepsy. Ethosuximide is associated with fewer adverse attentional effects. (ClinicalTrials.gov number, NCT00088452.)