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Evaluation of the safety and efficacy of the Russian botulinum toxin-A relatox versus botox in treating arm and hand spasticity after ischemic stroke: A multicenter randomized trial

https://doi.org/10.14412/2074-2711-2017-1-71-77

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Abstract

Objective: to evaluate the safety and efficacy of the first Russian botulinum toxin-A relatox versus botox in treating arm and hand spasticity after ischemic stroke.

Patients and methods. A multicenter randomized clinical trial was conducted in 6 centers of the Russian Federation, which covered 160 patients with prior ischemic stroke and upper limb spasticity (an Ashworth scale score of at least 2). Not earlier than 3 months after stroke, a single injection of relatox or botox was made, followed by the evaluation of changes in muscle tone and the presence and severity of adverse events (local and systemic reactions).

Results. After relatox injection, all the patients had significantly decreased upper limb muscle tone according to the Ashworth scale (p<0.05), which was recorded at all visits as compared to that at the baseline visit. The greatest muscle tone reduction was observed at 1 and 2 months after injection, and that in the pattern of fingers was seen at 3 months. The effect persisted within 3 months following the injection, which was confirmed by the Ashworth scale scores during the last visit as compared to the baseline one (p<0.05). No significant differences were found in muscle tone reductions between the relatox and botox groups (p>0.05). Relatox showed the good tolerability and safety that was comparable to those of the comparison drug. The number of registered local and systemic reactions was low and was not significantly different in both groups (p>0.05). There were no considerable differences in laboratory parameters and electrocardiographic findings in both patient groups (p>0.05). Serious adverse events were not detected during the study either.

Conclusion. The findings suggest that relatox is safe and efficient in decreasing upper limb muscle tone in patients after ischemic stroke, which is an important component in the structure of rehabilitation (first of all, functional recovery) of patients with spastic paresis of the upper limb.

About the Authors

S. E. Khatkova
Treatment and Rehabilitation Center, Ministry of Health of Russia
Russian Federation
3, Ivankovskoe Shosse, Moscow 125367


E. V. Kostenko
Moscow Research and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine, Moscow Healthcare Department
Russian Federation
53, Zemlyanoi Val, Moscow 105120


D. V. Pokhabov
Prof. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia
Russian Federation
1, Partisan Zheleznyak St., Krasnoyarsk 660022


A. V. Gustov
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
Russian Federation
190, Rodionov St., Nizhny Novgorod 603126;


A. N. Kalyagin
Irkutsk State Medical University, Ministry of Health of Russia
Russian Federation
1, Krasnoe Vosstanie St., Irkutsk 664003


N. G. Zhukova
6Siberian State Medical University, Ministry of Health of Russia
Russian Federation
2, Moskovsky Road, Tomsk 634050


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For citation:


Khatkova S.E., Kostenko E.V., Pokhabov D.V., Gustov A.V., Kalyagin A.N., Zhukova N.G. Evaluation of the safety and efficacy of the Russian botulinum toxin-A relatox versus botox in treating arm and hand spasticity after ischemic stroke: A multicenter randomized trial. Neurology, Neuropsychiatry, Psychosomatics. 2017;9(1):71-77. (In Russ.) https://doi.org/10.14412/2074-2711-2017-1-71-77

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ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)