Eficacia clínica de la aplicación de toxina botulínica tipo A en las glándulas submaxilares para el tratamiento de la sialorrea profusa en pacientes pediátricos con parálisis cerebral

Abstract

Cerebral palsy (CP) is the most common cause of motor disability in childhood. The prevalence of profuse drooling in children with cerebral palsy ranges from 10 to 37%. This can cause choking, repeated respiratory infections, bronchial aspiration and skin lesions and the negative impact on the psychosocial field with an impact on quality of life of patients and their families. Overall objective. To evaluate the clinical efficacy of botulinum toxin type A in the management of drooling in children with cerebral palsy treated at the Unit for Children's Rehabilitation Hospital. Material and methods: A longitudinal, prospective, experimental, double-blind, case control, randomized controlled clinical trial in pediatric patients 4 to 15 years of age diagnosed with cerebral palsy or severe with profuse salivation assigned, were formed two groups A (Experimental botulinum toxin type A 500 U) and B (Control Sodium Chloride 0.9%) was applied at the beginning and end of treatment the scales of intensity and frequency of drooling and functional independence (WeeFIM ) every 4 weeks for 3 times. Results During the period January to August 2011, 20 patients included 12 children (60%) and 8 girls (40%) with mean age of 6.9 and an average of 7.0 (range 4-15 years). The groups were comparable in the range of functional independence (WeeFIM) and the intensity and frequency scales at baseline. The dose of botulinum toxin type A in each submandibular gland was 15 to 25 U (mean dose of 20 U / gland). Analysis was performed with the STATA statistical package using the Mann Whitney U test, the measurement system of functional independence in children (WeeFIM) and the intensity and frequency scale at 8 weeks with a p <0.05 which is statistically significant. Conclusion. Botulinum toxin type A is useful and safe for the treatment of profuse drooling in pediatric patients with cerebral palsy.