Article

The aim of the present study was to evaluate the efficacy and safety of three
doses of botulinum toxin type B (BoNT-B) in reducing persistent sialorrhoea in
children with cerebral palsy (CP). Method Children with CP and refractory
sialorrhoea were randomized to one of four groups: a control group and three
experimental groups receiving a low (1500 mouse units [MU]), medium (3000MU), or
high (5000MU) dose of BoNT-B respectively, into bilateral salivary glands.
Drooling was measured using the Thomas-Stonell rating scale, and the weight and
the number of bibs used per day were counted in all children at baseline, 4, and
12 weeks after BoNT-B injection. Results Twenty-seven children (15 males, 12
females; mean age 7y 10mo, SD 1y 6mo; range 5-15y) were randomized into a control
(seven children: four males, three females) and experimental groups receiving low
(six children: four males, two females), medium (seven children: four males,
three females), and high (seven children: three males, four females) doses of
BoNT-B respectively. All children had mixed neurological disorders consisting of
spastic paraparesis, tetraparesis, dystonic movements, and ataxia. Gross Motor
Function Classification System levels ranged from III to V, and all children had
moderate or severe intellectual disability. Estimated means with their standard
errors (SEM) of drooling were at baseline, 4, and 12 weeks respectively, as
follows: control group, 12.1 (2.1), 11.9 (2.1), 11.8 (2.2), p for trend 0.992;
low dose group, 13.8 (2.3), 11.4 (2.3), 13.9 (2.3), p for trend 0.952; medium
dose group, 13.9 (2.1), 6.7 (2.1), 7.1 (2.1) p for trend 0.008; and for the high
dose group 14.4 (2.1), 5.0 (2.1), 5.6 (2.1), p for trend 0.002. Side effects
included dense saliva, xerostomia, and difficulty in swallowing, and were more
frequent in the high-dose group. Interpretation A 3000MU injection of BoNT-B into
the salivary glands significantly improved the frequency and severity of
sialorrhoea in children with CP. The lower dose was ineffective, and the higher
dose produced no greater benefit and more side effects.
CI - (c) The Authors. Developmental Medicine & Child Neurology (c) 2011 Mac Keith
Press.

Langue : ANGLAIS