Repeat injection of botulinum toxin A is safe and effective for upper limb movement and function in children with cerebral palsy

摘要

The efficacy of repeated botulinum toxin A (BTX-A) injections in two and three dose regimes, together with occupational therapy, on upper limb movement and function, was studied using an evaluator blinded, randomized, controlled two-group trial. Forty-two children (31 males, 11 females; range 2–8y, mean 4y [SD 1y 7mo]) with hemiplegic cerebral palsy (Gross Motor Function Classification System Level I) longitudinally participated for 30 months, with the first 6 months reported earlier (Lowe et al. 2006). The BTX-A group (n=21) received three injections (0, 6, and 18mo), while the delayed group had two (6 and 18mo; dose 0.5-2.1 units/kg, mean 1.5 [SD 0.18]; dilution 100 units/0.5ml). At 30 months, no difference existed between groups on any standardized measures. First and second injections showed significant treatment effect sizes, on Quality of Upper Extremity Skills Test (5.5 p=0.01: 4.5 p=0.03); parent Goal Attainment Scaling (GAS; 3.5 p=0.02: 3.9 p=0.01; therapist GAS 7.8 p=0.00: 4.0 p=0.03); Canadian Occupational Performance Measure (performance 0.4 p=0.05: 0.4 p=0.02; satisfaction 0.4 p=0.05: 0.37 p=0.08); and Pediatric Evaluation of Disability Inventory functional skills (1.8 p=0.00: 2.3 p=0.04). BTX-A was not linked to adverse events, suggesting repeated upper limb injections in children with hemiplegia receiving occupational therapy were safe and effective for improvement of movement and function.