Efficacy and safety of NT 201 for upper limb spasticity of various etiologies - a randomized parallel-group study

被引：38
作者：
Barnes, M. [1 ]
Schnitzler, A. [2 ]
Medeiros, L. [3 ]
Aguilar, M. [4 ]
Lehnert-Batar, A. [5 ]
Minnasch, P. [5 ]
机构：
[1] 14 Rake House Farm, N Shields, England
[2] Hop Raymond Poincare, Serv Med Phys & Readaptat, Garches, France
[3] Ctr Hosp Lisboa Cent, Unidade Neurol & Neurofisiol, Lisbon, Portugal
[4] Hosp Mutua Terrassa, Terrassa, Spain
[5] Merz Pharmaceut GmbH, Frankfurt, Germany
来源：
ACTA NEUROLOGICA SCANDINAVICA | 2010年 / 122卷 / 04期
关键词：
botulinum neurotoxin type A; etiology; functional disability; muscle tone; NT; 201; upper limb spasticity; Xeomin; TOXIN TYPE-A; BOTULINUM TOXIN; POSTSTROKE SPASTICITY; COMPLEXING PROTEINS; DOUBLE-BLIND; NEUROTOXIN; TRIAL; DYSTONIA; DILUTION;
D O I：
10.1111/j.1600-0404.2010.01354.x
中图分类号：
R74 [神经病学与精神病学];
学科分类号：
摘要：
Objective - To assess efficacy and safety of two dilutions of botulinum neurotoxin type A NT 201 (Xeomin (R)) in patients with upper limb spasticity of diverse etiology. Methods - Changes in functional disability and muscle tone from baseline to week 4 after NT 201 treatment. Results - One hundred ninety-two patients with stroke, brain injury, multiple sclerosis, or cerebral palsy were randomized to either 50 or 20 U/ml NT 201 dilutions. The maximum total NT 201 dose was 495 units. Four weeks post-injection, a >= 1-point reduction was observed on the Disability Assessment Scale in 57.1%, and on the Ashworth scale in >= 62.2% of patients. The 20 U/ml NT 201 dilution was non-inferior to the 50 U/ml NT 201 dilution. Global improvement was rated high by patients (80.2%) and investigators (89.0%). Conclusions - NT 201 improved functional disability and muscle tone and was well tolerated in patients with upper limb spasticity of diverse etiology in both dilutions.
引用
收藏
页码：295 / 302
页数：8
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