Botulinum Toxin Type A Neuromuscular Blockade in the Treatment of Equinus Foot Deformity in Cerebral Palsy: A Multicenter, Open-Label Clinical Trial

摘要: 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 dystonia, stroke, and CP. Objective. prospective, open-label, multicenter clinical trial evaluated long-term safety efficacy repeated intramuscular injections BTX-A on CP children. Methods. Nine centers enrolled 207 (4 U/Kg) were given approximately every 3 months (maximum dose 200 U per treatment). Outcome measures included Physician Rating Scale gait, ankle range motion measurements, incidence profile adverse events. Results. One hundred fifty-five (75%) completed at least 1 year total 302 patient years treatment. The mean duration exposure was 1.46 patient. Dynamic pattern improved 46% patients (86/185) first follow-up. response maintained 41% to 58% for 2 years. Both position visit. most common treatment-related events increased stumbling, leg cramps, weakness, calf atrophy 1% 11% patients. No serious reported. Only 6% (7/117) pre- postantibody samples had both detectable antibodies subsequent treatment failure. Conclusion. proved safe effective chronic management focal gait. Pediatrics 2001;108:1062-1071; BTX-A, palsy, foot deformity, blockade, pediatric patients, spasticity.