Dose selection of Incobotulinumtoxin A for the treatment of spasticity and sialorrhea in cerebral palsy: results of a retrospective multicenter study

Author:

Kurenkov Alexey L.1ORCID,Agranovich Oleg V.2ORCID,Kuzenkova Lyudmila M.3ORCID,Khachatryan Lusine G.4ORCID,Kenis Vladimir M.5ORCID,Zherebtsova Valentina A.6ORCID,Sarzhina Marina N.7ORCID,Odinaeva Niso D.8ORCID,Artemenko Ada R.9ORCID,Popova Galina A.10ORCID,Moroshek Ekaterina A.11ORCID,Bursagova Bella I.3ORCID,Chernikov Vladislav V.3ORCID,Tabe Evgeniya E.3ORCID,Nezhelskaya Alexandra A.3ORCID,Maksimenko Anna A.6ORCID,Akhadova Leila Ya.7ORCID,Indereykin Mikhail V.12ORCID,Duibanova Nina V.13ORCID,Tikhonova Lyudmila V.10ORCID,Sapogovsky Andrey V.5ORCID,Gadzhialieva Zumrut M.7ORCID,Grigorieva Antonina V.14ORCID,Perminov Vladislav S.14ORCID,Fedonyuk Inessa D.15ORCID,Kolpakchi Larisa M.15ORCID,Kursakova Yulia A.15ORCID,Tsurina Natalia A.16ORCID

Affiliation:

1. National Medical Research Center for Children’s Health; Center for Interdisciplinary Dentistry and Neurology

2. The Stavropol Regional Children Clinical Hospital

3. National Medical Research Center for Children’s Health

4. First Moscow State Medical University (Sechenov University)

5. Turner National Medical Research Center for Сhildren’s Orthopedics and Trauma Surgery

6. Center of Child Psychoneurology

7. Scientific and Practical Center of Child Psychoneurology

8. Research Clinical Institute of Childhood; Moscow Regional Research Clinical Institute named after M.F. Vladimirsky

9. First Moscow State Medical University (Sechenov University); Center for Interdisciplinary Dentistry and Neurology

10. City Children’s Clinical Hospital of Emergency Medical Care

11. Dr. Balbert Clinic

12. Scientific and Practical Center of Specialized Medical Care for Children named after V.F. Voino-Yasenetsky

13. Children’s Republican Clinical Hospital

14. The Research and Clinical Institute for Pediatrics named after Ye.E. Veltischev of the Pirogov Russian National Research Medical University Moscow

15. Russian Children’s Clinical Hospital of the N.I. Pirogov Russian National Research Medical University

16. Research Clinical Institute of Childhood

Abstract

Introduction. In patients with infantile cerebral palsy (CP), botulinum therapy is used to treat both muscle tone disorders and sialorrhea. Therefore, it is logical to use one preparation of botulinum toxin type A to treat spasticity and sialorrhea in one injection procedure. The aim of the work is to conduct a retrospective analysis of data from 15 centres that treat patients with cerebral palsy and use the botulinum therapy method to determine the optimal doses of IncobotulinumtoxinA (IBTA) for the treatment of spasticity and chronic sialorrhea in real clinical practice. Materials and methods. The treatment results of 389 children with cerebral palsy (including 211 (54.2%) boys) with IBTA were analyzed. The majority were children with bilateral forms of cerebral palsy - 312 (80.2%). The average age of the patients was 5.27 ± 3.71 years, the average weight of the patients was 18.8 ± 10.9 kg. Results. The total dose of IBTA in the group of 389 patients with cerebral palsy for the treatment of spasticity was 163.74 ± 80.65 U (25-550; 95% CI 155.7-171.7) and 10.4 ± 5.4 U/kg body weight (1,25-29.7; 95% CI 9.8-10.9). The total dose of IBTA in the group of patients with cerebral palsy with simultaneous treatment of spasticity and chronic sialorrhea (n = 16) was significantly higher: 267.18 ± 124.57 U (115-570; 95% CI 200.8-333.6) and 13, 0 ± 7.1 U/kg (5.8-24.6; 95% CI 9.2-16.8). In the lower extremities, the most frequent target muscles were the gastrocnemius (55.0% of cases; 95% CI 49.9-60.0) and semitendinosus / semimembranous muscle (46.3% of cases; 95% CI 41.2-51.4 ), and in the upper limbs - pronator teres (48.6% of cases; 95% CI 43.5-53.7) and biceps brachii (28.8% of cases; 95% CI 24.3-33.6). Limitations of the study. The limitations of our work are the use of an open retrospective study format, a relatively small sample of patients with chronic sialorrhea, the absence of long-term follow-up of patients and the results of repeated IBTA injections. Conclusion. If it is necessary to use botulinum therapy for the treatment of spasticity and sialorrhea in a child with CP, it is optimal to use the product IncobotulinumtoxinA, which will allow correction of two pathological manifestations in one procedure and can shorten the intervals between repeated injection cycles.

Publisher

National Medical Research Center for Childrens Health

Subject

General Medicine

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