Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double-blind, placebo-controlled, dose-ranging study

被引:111
作者
Baker, R
Jasinski, M
Maciag-Tymecka, I
Michalowska-Mrozek, J
Bonikowski, M
Carr, L
MacLean, J
Lin, JP
Lynch, B
Theologis, T
Wendorff, J
Eunson, P
Cosgrove, A
机构
[1] Queens Univ Belfast, Musgrave Pk Hosp, Belfast BT9 7JB, Antrim, North Ireland
[2] Dzieciecy Szpital Klin AM W Lublinie, Lublin, Poland
[3] Wojewodzki Oddzial Rehabil Dzieci & Mlodziezy, Gdansk, Poland
[4] Ctr Zdrowia Dziecka, Inst Pomnik, Warsaw, Poland
[5] Dzial Neurol Dzieciecy Swzpznoz, Zagorze, Poland
[6] Great Ormond St Hosp Sick Children NHS Trust, Wolfson Ctr, London, England
[7] Dundee Teaching Hosp NHS Trust Hosp, Dundee, Scotland
[8] Guys & St Thomas Hosp Trust, Newcomen Ctr, London, England
[9] Cent Remedial Clin, Dublin, Ireland
[10] Nuffield Orthopaed NHS Trust, Oxford, England
[11] Ctr Zdrowia Matki Polki, Lodz, Poland
[12] Edinburgh Sick Childrens NHS Trust, Edinburgh, Midlothian, Scotland
关键词
D O I
10.1111/j.1469-8749.2002.tb00268.x
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
This study evaluated the efficacy and safety of three doses of botulinum toxin A (BTX-A; Dysport(R)) in 125 patients (mean age 5.2 years, SD 2; 54% male) with dynamic equinus spasticity during walking. Participants were randomized to receive Dysport (10, 20, or 30 units/kg) or placebo to the gastrocnemius muscle of both legs. Muscle length was calculated from electrogoniometric measurements and the change in the dynamic component of gastrocnemius shortening at four weeks was prospectively identified as the primary outcome measure. All treatment groups showed statistically significant decreases in dynamic component compared with placebo at 4 weeks. Mean improvement in dynamic component was most pronounced in the 20 units/kg group, being equivalent to an increase in dorsiflexion with the knee extended at 19degrees, and was still present at 16 weeks. The safety profile of the toxin appears satisfactory.
引用
收藏
页码:666 / 675
页数:10
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