Devinsky Orrin, Elger Christian
Department of Neurology, New York University Comprehensive Epilepsy Center, New York, New York 10016, United States.
Epileptic Disord. 2003 May;5 Suppl 1:S27-31.
Controlled clinical trials and routine clinical practice demon-strate that levetiracetam is effective as add-on therapy and appears to allow for withdrawal to monotherapy in patients who respond well in the add-on setting. In pivotal clinical trials of adjunctive therapy with levetiracetam 1000 to 3000 mg/day (pooled data), 40% to 54% of patients experienced a 50% or greater reduction in seizure frequency, compared with 18% to 28% of patients treated with placebo. The median percent reduction from baseline in seizure frequency ranged from 36% to 68% for levetiracetam, versus 10% to 23% for placebo. Seizure freedom was achieved by 11% to 35% of those in the levetiracetam treatment group, compared with 3% to 18% of those in the placebo group. (All comparisons statistically significant versus placebo for simple partial, complex partial, and secondarily generalized seizures except for percentage of seizure-free patients with simple partial seizures.) Clinical obser-vations are consistent with these findings.
对照临床试验和常规临床实践表明，左乙拉西坦作为附加疗法是有效的，并且对于在附加治疗中反应良好的患者，似乎可以撤药至单药治疗。在左乙拉西坦每日1000至3000毫克（汇总数据）辅助治疗的关键临床试验中，40%至54%的患者癫痫发作频率降低了50%或更多，相比之下，接受安慰剂治疗的患者为18%至28%。左乙拉西坦组癫痫发作频率较基线降低的中位数为36%至68%，而安慰剂组为10%至23%。左乙拉西坦治疗组中11%至35%的患者实现了无癫痫发作，而安慰剂组为3%至18%。（除单纯部分性发作无癫痫发作患者的百分比外，所有比较与安慰剂相比，对于单纯部分性、复杂部分性和继发性全身性发作均具有统计学意义。）临床观察结果与这些发现一致。
