Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy.

Pediatrics 2015 Vol.136(5) p. 895-904

Edwards P, Sakzewski L, Copeland L, Gascoigne-Pees L, McLennan K, Thorley M, Kentish M, Ware R, Boyd RN

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Abstract

[OBJECTIVE] To determine safety of intramuscular botulinum toxin A (BoNT-A) injections to reduce spasticity and improve care and comfort of nonambulatory children with cerebral palsy (CP).

[METHODS] Nonambulatory children with CP were randomly allocated to receive either BoNT-A (n = 23) or sham procedure (n = 18) in Cycle 1. In Cycle 2, the BoNT-A group received a second episode of BoNT-A (n = 20) and sham group received their first episode of BoNT-A (n = 17). A pediatric rehabilitation specialist masked to group allocation graded each adverse event (AE) according to system, severity (mild, moderate, serious, sentinel) and causality (unlikely/unrelated; possible; probable/definite).

[RESULTS] There was no difference for all moderate/serious AEs between the BoNT-A and sham/control groups in either Cycle 1 (incident rate ratio = 1.30, 95% confidence interval = 0.43-4.00; P = .64) or Cycle 2 (incident rate ratio = 0.72, 95% confidence interval = 0.30-1.75; P = .47). In Cycle 2, 1 serious, 3 moderate (single-episode group), and 24 mild (single-episode group n = 10; 2 episode group n = 14) AEs were probably/definitely related to BoNT-A.

[CONCLUSIONS] Children receiving BoNT-A were at no greater risk of moderate/serious AEs compared with a sham control procedure. There was no increased risk of moderate/serious AEs between one and two episodes of BoNT-A.

추출된 의학 개체 (NER)

유형영어 표현한국어 / 풀이UMLS CUI출처등장
시술 botulinum toxin 보툴리눔독소 주사 dict 2

MeSH Terms

Botulinum Toxins, Type A; Cerebral Palsy; Child; Child, Preschool; Double-Blind Method; Female; Humans; Injections, Intramuscular; Male; Mobility Limitation; Neuromuscular Agents

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