Matsuo F, Bergen D, Faught E, Messenheimer J A, Dren A T, Rudd G D, Lineberry C G
Department of Neurology, University of Utah, Salt Lake City 84132.
Neurology. 1993 Nov;43(11):2284-91. doi: 10.1212/wnl.43.11.2284.
We evaluated the efficacy and safety of lamotrigine (300 and 500 mg/day) as add-on therapy in a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of 216 patients with refractory partial seizures. During 6 months of treatment, median seizure frequency decreased by 8% with placebo, 20% with 300 mg lamotrigine, and 36% with 500 mg lamotrigine. Seizure frequency decreased by > or = 50% in one-third of the 500-mg group and one-fifth of the 300-mg group. Reductions in seizure frequency and seizure days were statistically significant, compared with placebo, for the 500-mg group but not the 300-mg group. Most adverse events were minor and resolved over time. Nine percent of patients on lamotrigine withdrew because of adverse experiences. Lamotrigine plasma concentrations appeared to be a linear function of dose, and the drug did not affect plasma concentrations of concomitant antiepileptic drugs. Lamotrigine was safe, effective, and well tolerated as add-on therapy for refractory partial seizures.
在一项针对216例难治性部分性癫痫患者的多中心、随机、双盲、平行组、安慰剂对照研究中，我们评估了拉莫三嗪（300毫克/天和500毫克/天）作为附加疗法的疗效和安全性。在6个月的治疗期间，安慰剂组的癫痫发作频率中位数下降了8%，300毫克拉莫三嗪组下降了20%，500毫克拉莫三嗪组下降了36%。在500毫克组中有三分之一的患者以及300毫克组中有五分之一的患者癫痫发作频率下降了≥50%。与安慰剂相比，500毫克组癫痫发作频率和发作天数的降低具有统计学意义，而300毫克组则无。大多数不良事件较轻，且会随着时间的推移而缓解。服用拉莫三嗪的患者中有9%因不良经历而退出。拉莫三嗪的血浆浓度似乎是剂量的线性函数，且该药物不影响同时服用的抗癫痫药物的血浆浓度。拉莫三嗪作为难治性部分性癫痫的附加疗法是安全、有效且耐受性良好的。
