Abstract
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.
Highlights
Background: early treatment using botulinum toxin type A (BTA) postpones or even prevents contractures and osteoarticular deformations and, surgical interventions in children with cerebral palsy (CP)
Expansion of age groups and conditions to prescribe BTA is the primary trend of current studies
Single self-limited mild and moderate topical and systemic adverse reactions typical for botulinum toxin were reported in both groups
Summary
РЕЗЮМЕ Введение: раннее начало терапии с использованием ботулинического токсина типа А (БТА) способно отсрочить или вовсе предотвратить образование контрактур, костно-суставных деформаций, а значит, и оперативное лечение у детей с детским церебральным параличом (ДЦП). Цель исследования: оценить безопасность и эффективность препарата Релатокс® у детей со спастическими формами ДЦП в возрасте от 2 до 6 лет. В простом слепом рандомизированном сравнительном исследовании приняли участие 100 детей со спастической формой ДЦП в возрасте от 2 до 6 лет. В спастичные мышцы, согласно протоколу исследования, вводили препарат Релатокс® (n=51) или эталонный препарат БТА (n=49). Сразу после инъекции оценивали местные и системные реакции на введение препаратов. В обеих группах отмечались типичные для препаратов БТА местные и системные (в единичных случаях) реакции слабой и средней степени тяжести, которые купировались самостоятельно. Заключение: в ходе исследования установлены безопасность и эффективность препарата Релатокс® при введении детям с ДЦП в возрасте 2–6 лет, идентичные таковым эталонного препарата сравнения. Включение максимального количества спастичных мышц в протокол инъекционной сессии необходимо для полноценной двигательной абилитации/реабилитации детей с ДЦП.
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