北京大学医学部机构知识库
Advanced  
IR@PKUHSC  > 北京大学第一临床医学院  > 神经内科  > 期刊论文
学科主题: 临床医学
题名:
Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in Chinese patients with refractory partial-onset seizures
作者: Wu, Xun-Yi1; Hong, Zhen; Wu, Xun2; Wu, Li-Wen3; Wang, Xue-Feng4; Zhou, Dong5; Zhao, Zhong-Xin6; Lv, Chuan-Zhen
关键词: Levetiracetam ; Epilepsy ; Add-on therapy ; Partial-onset seizures ; Refractory seizures ; Chinese patients
刊名: EPILEPSIA
发表日期: 2009-03-01
DOI: 10.1111/j.1528-1167.2008.01729.x
卷: 50, 期:3, 页:398-405
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Clinical Neurology
研究领域[WOS]: Neurosciences & Neurology
关键词[WOS]: IDIOPATHIC GENERALIZED EPILEPSY ; PHARMACOKINETICS ; EFFICACY ; BINDING ; PROTEIN ; SV2A ; DRUG
英文摘要:

Purpose: To evaluate efficacy and tolerability of levetiracetam (LEV; Keppra (R)) 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.

语种: 英语
项目资助者: UCB Pharma SA
WOS记录号: WOS:000266198000013
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/65353
Appears in Collections:北京大学第一临床医学院_神经内科_期刊论文

Files in This Item:

There are no files associated with this item.


作者单位: 1.Fudan Univ, Inst Neurol, Huashan Hosp, Shanghai Med Coll, Shanghai 200433, Peoples R China
2.Peking Univ, Hosp 1, Dept Neurol, Beijing, Peoples R China
3.Peking Xiehe Hosp, Peking Union Med Coll, Dept Neurol, Beijing, Peoples R China
4.Chongqing Univ Med Sci, Affiliated Hosp, Dept Neurol, Chongqing, Peoples R China
5.Sichuan Univ, W China Hosp, Dept Neurol, Chengdu 610064, Peoples R China
6.Second Mil Med Univ, Dept Neurol, Shanghai Changzheng Hosp, Shanghai, Peoples R China

Recommended Citation:
Wu, Xun-Yi,Hong, Zhen,Wu, Xun,et al. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in Chinese patients with refractory partial-onset seizures[J]. EPILEPSIA,2009,50(3):398-405.
Service
Recommend this item
Sava as my favorate item
Show this item's statistics
Export Endnote File
Google Scholar
Similar articles in Google Scholar
[Wu, Xun-Yi]'s Articles
[Hong, Zhen]'s Articles
[Wu, Xun]'s Articles
CSDL cross search
Similar articles in CSDL Cross Search
[Wu, Xun-Yi]‘s Articles
[Hong, Zhen]‘s Articles
[Wu, Xun]‘s Articles
Related Copyright Policies
Null
Social Bookmarking
Add to CiteULike Add to Connotea Add to Del.icio.us Add to Digg Add to Reddit

Items in IR are protected by copyright, with all rights reserved, unless otherwise indicated.

 

 

Valid XHTML 1.0!
Copyright © 2007-2017  北京大学医学部 - Feedback
Powered by CSpace