Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: Results of the German-Austrian open-label post-marketing surveillance prospective study

JOURNAL OF THE NEUROLOGICAL SCIENCES

卷:337

Article

Jost, Wolfgang H.¹  Hefter, Harald²  Reissig, Andrea³  Kollewe, Katja⁴  Wissel, Joerg⁵ 

[1] Univ Freiburg, Dept Neurol, D-79106 Freiburg, Germany

[2] Univ Dusseldorf, Dept Neurol, D-40225 Dusseldorf, Germany

[3] Ipsen Pharma, D-76275 Ettlingen, Germany

[4] Hannover Med Sch, Dept Neurol, D-30625 Hannover, Germany

[5] Vivantes Hosp Berlin Spandau, Dept Neurorehabil & Phys Therapy, D-13585 Berlin, Germany

关键词: Dysport;    AbobotulinumtoxinA;    Botulinum toxin type A;    Stroke;    Arm spasticity;    Post-stroke spasticity;   

DOI  :  10.1016/j.jns.2013.11.022

来源: Elsevier

【 摘 要 】

The current practice in Germany and Austria, and the safety and efficacy of botulinum toxin type A (BoNT-A; Dysport) in the treatment of patients with post-stroke arm spasticity (with no fixed upper-limb contractures), were assessed in this observational prospective non-interventional study. One treatment cycle was documented with assessments at baseline, approximately week 4 (optional), and approximately week 12. Pattern of spasticity, treatment goal, safety and efficacy were recorded. Overall response and goal achievement was rated on a 4-point scale ('no goal achievement', 'goal achievement', 'good goal achievement', 'best goal achievement). In total, 409 patients were included and 99% assigned to one of five arm-spasticity patterns. Therapy goals included reduced muscle tone (92.6%), physiotherapy or occupational therapy support (63.8%), increased range of motion (61.8%), pain reduction (58.9%), facilitation of care or hygiene (55.7%), and functional improvement (17.0%). Goals were achieved in 84% of patients. The following factors had the most potential as predictors of treatment outcome: pretreatment; time since onset of spasticity; pattern of arm spasticity. Mean Dysport dose was 728 U and an inverse dose-response relationship was observed. Treatment was well tolerated. 500-1000 U was a safe and effective treatment for post-stroke arm spasticity in this post-marketing evaluation. (C) 2014 The Authors. Published by Elsevier B.V. All rights reserved.

【 授权许可】

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