Wu Xun-Yi, Hong Zhen, Wu Xun, Wu Li-Wen, Wang Xue-Feng, Zhou Dong, Zhao Zhong-Xin, Lv Chuan-Zhen
The Institute of Neurology, Huashan Hospital, Fudan University, Shanghai, China [corrected]
Epilepsia. 2009 Mar;50(3):398-405. doi: 10.1111/j.1528-1167.2008.01729.x. Epub 2008 Jul 24.
To evaluate efficacy and tolerability of levetiracetam (LEV; Keppra) as add-on therapy in Chinese patients with refractory partial-onset seizures.
In this multicenter, double-blind, randomized, placebo-controlled trial, 206 patients aged 16-70 years with uncontrolled partial-onset seizures were randomized to receive LEV (n =103) or placebo (n =103); 202 patients (LEV, n =102; placebo, n = 100) comprised the intent-to-treat population. An 8-week historical baseline period confirmed eligibility according to seizure count. The 16-week treatment period consisted of a 4-week up-titration period (LEV, 1,000-3,000 mg/day in two equal divided doses) followed by a 12-week maintenance period. Efficacy assessments were based on weekly frequency of partial-onset seizures during the 16-week treatment period.
LEV significantly decreased weekly partial-onset seizure frequency over placebo by 26.8% (p < 0.001). Median percentage reductions in weekly partial-onset seizure frequency from historical baseline were 55.9% for LEV and 13.7% for placebo (p < 0.001). The >or=50% responder rates were 55.9% for LEV, compared with 26.0% for placebo (p < 0.001). Freedom from partial-onset seizures during treatment period was achieved by 11 LEV patients (10.8%) and 2 placebo patients (2.0%) (p = 0.012). Adverse events were reported by 65 LEV-treated patients (63.1%) and 62 placebo-treated patients (60.2%); most were of mild-to-moderate intensity. The most common adverse events were somnolence (LEV, 17.5%; placebo, 17.5%), decreased platelet count (LEV, 9.7%; placebo, 9.7%), and dizziness (LEV, 7.8%; placebo, 13.6%).
Add-on LEV was effective and well-tolerated in Chinese patients with refractory partial-onset seizures.
评估左乙拉西坦（LEV；开浦兰）作为附加疗法治疗中国难治性部分性发作癫痫患者的疗效和耐受性。
在这项多中心、双盲、随机、安慰剂对照试验中，206例年龄在16至70岁、部分性发作未得到控制的患者被随机分为接受左乙拉西坦治疗组（n = 103）或安慰剂组（n = 103）；202例患者（左乙拉西坦组，n = 102；安慰剂组，n = 100）纳入意向性治疗人群。通过发作计数，8周的历史基线期确定入选资格。16周的治疗期包括4周的剂量递增期（左乙拉西坦，1000 - 3000毫克/天，分两次等量服用），随后是12周的维持期。疗效评估基于16周治疗期内部分性发作的每周发作频率。
与安慰剂相比，左乙拉西坦显著降低了每周部分性发作频率26.8%（p < 0.001）。与历史基线相比，左乙拉西坦组每周部分性发作频率的中位数降低百分比为55.9%，安慰剂组为13.7%（p < 0.001）。左乙拉西坦组发作频率降低≥50%的缓解率为55.9%，而安慰剂组为26.0%（p < 0.001）。在治疗期间，11例左乙拉西坦组患者（10.8%）和2例安慰剂组患者（2.0%）实现了无部分性发作（p = 0.012）。65例接受左乙拉西坦治疗的患者（63.1%）和62例接受安慰剂治疗的患者（60.2%）报告了不良事件；大多数为轻至中度。最常见的不良事件是嗜睡（左乙拉西坦组，17.5%；安慰剂组，17.5%）、血小板计数降低（左乙拉西坦组，9.7%；安慰剂组，9.7%）和头晕（左乙拉西坦组，7.8%；安慰剂组，13.6%）。
左乙拉西坦作为附加疗法治疗中国难治性部分性发作癫痫患者有效且耐受性良好。
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