Safety of Botulinum Toxin A in Children and Adolescents with Cerebral Palsy in a Pragmatic Setting

Toxins

Antigone S. Papavasiliou¹  Irene Nikaina¹  Katerina Foska¹  Panagiotis Bouros¹  George Mitsou¹ 

[1] Department of Neurology, Pendeli Children’s Hospital, 8 Hippokrates street, Palaia Penteli 15236, Athens, Greece; E-Mails:

关键词: cerebral palsy;    spasticity;    treatment;    botulinum toxin A;    onabotulinumtoxin A;    abobotulinumtoxin A;    adverse events;    safety;   

DOI  :  10.3390/toxins5030524

来源: mdpi

【 摘 要 】

This retrospective study aimed to examine the safety of botulinum toxin A (BoNT-A) treatment in a paediatric multidisciplinary cerebral palsy clinic. In a sample of 454 patients who had 1515 BoNT-A sessions, data on adverse events were available in 356 patients and 1382 sessions; 51 non-fatal adverse events were reported (3.3% of the total injections number, 8.7% of the patients). On five occasions, the adverse reactions observed in GMFCS V children were attributed to the sedation used (rectal midazolam plus pethidine; buccal midazolam) and resulted in prolongation of hospitalization. Of the reactions attributed to the toxin, 23 involved an excessive reduction of the muscle tone either of the injected limb(s) or generalized; others included local pain, restlessness, lethargy with pallor, disturbance in swallowing and speech production, seizures, strabismus, excessive sweating, constipation, vomiting, a flu-like syndrome and emerging hypertonus in adjacent muscles. Their incidence was associated with GMFCS level and with the presence of epilepsy (Odds ratio (OR) = 2.74 − p = 0.016 and OR = 2.35 − p = 0.046, respectively) but not with BoNT-A dose (either total or per kilogram). In conclusion, treatment with BoNT-A was safe; adverse reactions were mostly mild even for severely affected patients. Their appearance did not necessitate major changes in our practice.

【 授权许可】

CC BY   
© 2013 by the authors; licensee MDPI, Basel, Switzerland.