Botulinum toxin type a neuromuscular blockade in the treatment of equinus foot deformity in cerebral palsy: a multicenter, open-label clinical trial
| Autor: | J. Garcia de Yebenes Prous, Allison Brashear, Henry G. Chambers, Mercer Rang, L. Andrew Koman, Beth P. Smith, Leon Root, Barry S. Russman, Catherine C. Turkel, Jennifer M. Walcott, Eugenio Ferrari, Samuel R. Rosenfeld, Patricia T. Molloy |
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| Rok vydání: | 2001 |
| Předmět: |
Male
Adolescent Cerebral palsy Muscle tone medicine Humans Spasticity Prospective Studies Botulinum Toxins Type A Foot deformity Stroke Gait Dystonia business.industry Cerebral Palsy Equinus Deformity medicine.disease medicine.anatomical_structure Neuromuscular Agents Anesthesia Pediatrics Perinatology and Child Health Neuromuscular Blockade Female medicine.symptom Ankle business |
| Zdroj: | Pediatrics. 108(5) |
| ISSN: | 1098-4275 |
| Popis: | Background. Focal spasticity of the gastrocnemius-soleus muscles causes equinus gait in children with cerebral palsy (CP). Botulinum toxin type A (BTX-A), a neuromuscular blocking agent, reduces muscle tone/overactivity in dystonia, stroke, and CP. Objective. A prospective, open-label, multicenter clinical trial evaluated the long-term safety and efficacy of repeated intramuscular injections of BTX-A on equinus gait in CP children. Methods. Nine centers enrolled 207 children. BTX-A injections (4 U/Kg) were given approximately every 3 months (maximum dose 200 U per treatment). Outcome measures included a Physician Rating Scale of gait, ankle range of motion measurements, and the incidence and profile of adverse events. Results. One hundred fifty-five (75%) of 207 children completed at least 1 year with a total of 302 patient years of BTX-A treatment. The mean duration of BTX-A exposure was 1.46 years per patient. Dynamic gait pattern on the Physician Rating Scale improved in 46% of patients (86/185) at first follow-up. The response was maintained in 41% to 58% of patients for 2 years. Both gait pattern and ankle position improved at every visit. The most common treatment-related adverse events included increased stumbling, leg cramps, leg weakness, and calf atrophy in 1% to 11% of patients. No treatment-related serious adverse events were reported. Only 6% (7/117) of patients with pre- and postantibody samples had both detectable antibodies and a subsequent treatment failure. Conclusion. BTX-A proved both safe and effective in the chronic management of focal muscle spasticity in children with equinus gait. |
| Databáze: | OpenAIRE |
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