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【Epilepsy】多中心双盲、随机、安慰剂对照评价左
*Xun-Yi Wu, *Zhen Hong, †Xun Wu, ‡Li-Wen Wu, §Xue-Feng Wang, ¶Dong Zhou, #Zhong-Xin Zhao, and *Chuan-Zhen Lv
*The Institute of Neurology, Huashan Hospital, Fudan University, Shanghai, China ; †Department of Neurology, Peking University First Hospital, Peking University, Peking, China ; ‡Department of Neurology, Peking Xiehe Hospital, Peking Union Medical College, Peking, China ; §Department of Neurology, The Affiliated Hospital of Chongqing University of Medical Sciences, Chongqing University of Medical Sciences, Chongqing, China ; ¶Department of Neurology, West China Hospital, Sichuan University, Chengdu, China ; and #Department of Neurology, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China
Address correspondence to Xun-Yi Wu, The Institute of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China. E-mail: dr.xunyiwu@hotmail.com
Copyright © 2008 by the International League Against Epilepsy
KEYWORDS
Levetiracetam • Epilepsy • Add-on therapy • Partial-onset seizures • Refractory seizures • Chinese patients
ABSTRACT
Purpose: To evaluate efficacy and tolerability of levetiracetam (LEV; Keppra® as add-on therapy in Chinese patients with refractory partial-onset seizures.
Methods: 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.
Results: 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 ≥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%).
Discussion: Add-on LEV was effective and well-tolerated in Chinese patients with refractory partial-onset seizures.
Accepted May 29, 2008; Online Early publication xxxxxx xx xxxx.
http://www3.interscience.wiley.com/journal/120848567/abstract 这好像是2006年完成的一个国际多中心的实验，参考《中华神经科杂志》2007年3期：
多中心双盲、随机、安慰剂对照评价左乙拉西坦添加治疗难治性部分性癫痫发作的疗效及安全性
吴洵昳[1] 洪震[1] 吴逊[2] 吴立文[3] 赵忠新[4] 王学峰[5] 周东[6] 吕传真[1] [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-06-23 19:15
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