Novel therapeutic modalities for children with spasticity
DOI: 10.32364/2587-6821-2021-5-10-630-635
D.A. Krasavina1,2, Yu.I. Ivanov2
1St. Petersburg Institute of the Advanced Training of Experts, St. Petersburg, Russian Federation
2St. Petersburg State Pediatric Medical University, St. Petersburg, Russian Federation
Background: early treatment using botulinum toxin type A (BTA) postpones or even prevents contractures and osteoarticular deformations and, therefore, surgical interventions in children with cerebral palsy (CP). Expansion of age groups and conditions to prescribe BTA is the primary trend of current studies.
Aim: to assess the safety and efficacy of Relatox® in children aged 2–6 years with spastic CP.
Patients and Methods: this simple blind randomized comparative study (2018–2019) enrolled 100 children aged 2–6 years with spastic CP. According to the study protocol, Relatox® (n=51) or reference preparation (n=49) was injected into spastic muscles. Each group included two subgroups (predominant involvement of the muscles of the upper or lower extremities). Topical and systemic reactions were evaluated immediately after injection. Over the follow-up (after 2, 4, 8, and 12 weeks after injections), muscle tonus using Modified Ashworth Scale (MAS) and pain severity using a 10-point visual analogue scale were assessed.
Results: maximum total doses of botulinum toxin per injection session for both preparations were 60 to 200 units. The efficacy of both preparations was similar (p>0.05). Single self-limited mild and moderate topical and systemic adverse reactions typical for botulinum toxin were reported in both groups.
Conclusions: the safety and efficacy of Relatox® are similar to these of reference preparation. Antispastic effect for muscles of the upper extremities was demonstrated, thereby allowing for expanding indications for Relatox®. Inclusion of the maximum number of spastic muscles in the protocol of injection session provided a full motor habilitation/rehabilitation of children.
Keywords: botulinum toxin type A, cerebral palsy, spasticity, efficacy, safety.
For citation: Krasavina D.A., Ivanov Yu.I. Novel therapeutic modalities for children with spasticity. Russian Medical Inquiry. 2021;5(10):630–635 (in Russ.). DOI: 10.32364/2587-6821-2021-5-10-630-635.
About the authors:
Diana A. Krasavina — Dr. Sc. (Med.), Head of the Department of Traumatology, Orthopedics, Medical Social Expertise, Prosthetics, and Rehabilitation, St. Petersburg Institute of the Advanced Training of Experts; 11/12, Bolshoy Sampsonievskiy lane, St. Petersburg, 194044, Russian Federation; professor of the Department of Surgical Diseases of Children,
St. Petersburg State Pediatric Medical University; 2, Litovskaya str., St. Petersburg, 194100, Russian Federation; ORCID iD 0000-0003-4255-7029.
Yuriy I. Ivanov — senior lab assistant, postgraduate student of the Department of Traumatology, Orthopedics, Medical Social Expertise, Prosthetics, and Rehabilitation, St. Petersburg Institute of the Advanced Training of Experts; 11/12, Bolshoy Sampsonievskiy lane, St. Petersburg, 194044, Russian Federation; ORCID iD 0000-0002-6832-1711.
Contact information: Diana A. Krasavina, e-mail: krasa-diana@yandex.ru.
The study was supported by "Microgen".
Financial Disclosure: no authors have a financial or property interest in any material or method mentioned.
There is no conflict of interests.
Received 26.08.2021.
Revised 17.09.2021.
Accepted 29.09.2021.
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