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Safety profile and efficacy of botulinum toxin A (Dysport a ) in children with muscle spasticity
Author(s) -
Bakheit A M O,
Severa S,
Cosgrove A,
Morton R,
Roussounis S H,
Doderlein L,
Lin JP
Publication year - 2001
Publication title -
developmental medicine and child neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.658
H-Index - 143
eISSN - 1469-8749
pISSN - 0012-1622
DOI - 10.1111/j.1469-8749.2001.tb00195.x
Subject(s) - spasticity , medicine , adverse effect , incidence (geometry) , odds ratio , cerebral palsy , botulinum toxin , retrospective cohort study , spastic cerebral palsy , spastic , anesthesia , physical therapy , physics , optics
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).