Document Detail

Safety profile and efficacy of botulinum toxin A (Dysport) in children with muscle spasticity.
MedLine Citation:
PMID:  11305399     Owner:  NLM     Status:  MEDLINE    
Botulinum toxin A (BTX-A) is widely used in the management of muscle spasticity in children. However, at present the dose of BTX-A for a given patient is selected empirically. The aim of this study is to provide dosage guidelines that are based on risk/benefit assessment. This was a multicentre retrospective study of the safety profile and efficacy of BTX-A in children with chronic muscle spasticity. Data in 758 patients who received a total of 1594 treatments were analysed (mean age 7.2 years; 429 males, 329 females). Spastic cerebral palsy (CP) was the most common diagnosis (94% of the study sample). Of all treatments 7% resulted in adverse events; incidence was related to the total dose rather than the dose calculated on the basis of body weight. The highest incidence of adverse events was observed in patients who received >1000 IU of BTX-A per treatment session. The odds of an adverse event was 5.1 times greater for this group of patients than for those who had 250 IU or less (p<0.001). A good overall response to treatment was reported in 82% and treatment goals were fully or partially achieved in 3% and 94% of participants respectively. More patients in the highest dose group reported functional deterioration. Interestingly, multilevel treatments resulted in a better response than single-level treatments (odds ratio 1.7, 95% CI 1.3 to 2.2,p=0.001).
A M Bakheit; S Severa; A Cosgrove; R Morton; S H Roussounis; L Doderlein; J P Lin; S H Rousso
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Developmental medicine and child neurology     Volume:  43     ISSN:  0012-1622     ISO Abbreviation:  Dev Med Child Neurol     Publication Date:  2001 Apr 
Date Detail:
Created Date:  2001-04-17     Completed Date:  2001-05-10     Revised Date:  2009-11-11    
Medline Journal Info:
Nlm Unique ID:  0006761     Medline TA:  Dev Med Child Neurol     Country:  England    
Other Details:
Languages:  eng     Pagination:  234-8     Citation Subset:  IM    
University of Plymouth, Beauchamp Centre, Mount Gould Hospital, UK.
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MeSH Terms
Age Factors
Botulinum Toxin Type A / administration & dosage*,  adverse effects*
Child, Preschool
Chronic Disease
Dose-Response Relationship, Drug
Muscle Spasticity / drug therapy*
Neuromuscular Agents / administration & dosage*,  adverse effects*
Retrospective Studies
Risk Assessment
Reg. No./Substance:
0/Botulinum Toxin Type A; 0/Neuromuscular Agents
Erratum In:
Dev Med Child Neurol 2001 May;43(5):357
Note: Rousso SH [corrected to Roussounis SH]

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