Acta neurologica Scandinavica · 2010
Efficacy and safety of NT 201 for upper limb spasticity of various etiologies--a randomized parallel-group study.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Barnes M, Schnitzler A, Medeiros L, Aguilar M, Lehnert-Batar A, Minnasch P
Аннотация
OBJECTIVE: To assess efficacy and safety of two dilutions of botulinum neurotoxin type A NT 201 (Xeomin®) 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.
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.