Article

The aim of this study was to evaluate the efficacy and safety of a newly
manufactured botulinum toxin, Neuronox, compared with BOTOX for the treatment of
the spastic equinus gait in children with cerebral palsy. METHOD: A total of 127
children with cerebral palsy, aged 2 to 10 years, who presented at three
university hospitals with spastic equinus gait were assessed for eligibility to
participate in this double-blinded, randomized, controlled trial. Of the 119
eligible participants (mean age 4.33 y; SD 2.07; 76 males and 43 females; 79 with
diplegia and 40 with hemiplegia), 57 were classified as Gross Motor Function
Classification System level I, 29 as level II, and 33 as level III. Participants
were randomly assigned to receive an injection of Neuronox (n=60) or BOTOX (n=59)
to the calf muscles at a dose of 4U/kg for those with hemiplegia and 6U/kg for
those with diplegia. Assessments were performed at baseline (V1) and at 4 (V2),
12 (V3), and 24 (V4) weeks after the intervention. The primary outcome measure
was response rate at V3, with a positive response being defined as at least a
2-point increase in the Physicians' Rating Scale (PRS) score. The non-inferiority
margin was set as -20% for the difference in the response rate. The secondary
outcome measures included PRS score, passive range of motion (PROM) of the ankle
and knee, and Gross Motor Function Measure 88 (GMFM-88). Any adverse events were
investigated for safety implications. RESULTS: The response rate of the Neuronox
group at V3 was not inferior to that of the BOTOX group (90% lower
limit=-11.58%). There were significant improvements in PRS, PROM of ankle
dorsiflexion, and GMFM scores at V2, V3, and V4 in both groups. The changes in
PRS score were not statistically different between the two groups in serial
evaluation (p=0.96). PROM of the ankle dorsiflexion increased without any
significant difference between the two groups, either overall (p=0.56) or at each
visit (V2, p=0.32; V3, p=0.66; V4, p=0.90). The increase in GMFM score in serial
measurements were not significantly different between the two groups (p=0.16),
whereas it was larger in the BOTOX group than in the Neuronox group at V2 and V4
(p=0.03 and 0.05 respectively). The frequency of adverse events was not
significantly different between the two groups (p=0.97), and drug-related
complications of Neuronox treatment were not addressed. INTERPRETATION: The
outcomes of Neuronox, based on PRS, proved to be as effective and safe as those
of BOTOX for the treatment of spasticity in individuals with cerebral palsy.
CI - (c) The Authors. Journal compilation (c) Mac Keith Press 2010.

Langue : ANGLAIS