小于 2 岁儿童应用 A 型肉毒毒素的安全性。

Safety of botulinum toxin type A in children younger than 2 years.

机构信息

Pediatric Neurology Service, University Hospital La Paz, Paseo de la Castellana 261, 28046 Madrid, Spain.

出版信息

Eur J Paediatr Neurol. 2009 Nov;13(6):511-5. doi: 10.1016/j.ejpn.2008.10.006. Epub 2008 Nov 25.

DOI:10.1016/j.ejpn.2008.10.006

PMID:19036619

Abstract

BACKGROUND

Botulinum toxin type A (BoNT-A) has been used in many indications and is licensed for the treatment of spasticity in children older than 2 years. However, there are few reports of BoNT-A treatment in patients younger than 2 years of age.

AIMS

To review retrospectively the safety data from all infants treated with botulinum toxin type A (BoNT-A) before 2 years of age in a paediatric neurology unit.

METHODS

There were 74 infants: 28 received the first dose before 1 year of age, and 46 between the ages of 1 and 2 years.

RESULTS

In the first year of life, the most frequent indication was obstetric brachial palsy (OBP) (71.4% of cases) and in the second year, cerebral palsy (CP) (73.9%). Both Botox and Dysport, the two commercially-available BoNT-A products in Spain, were used. The average starting dose by session was 6.55 U/kg body weight Botox in infants in their first year of life, and 8.4 U/kg body weight Botox and 21.1 U/kg body weight Dysport in the second year of life. Only 3.6% of cases treated in the first year and 6.5% of those treated in the second experienced adverse events (AEs), which consisted of mild weakness or tiredness lasting 1-4 days.

CONCLUSIONS

BoNT-A has a good safety profile in infants younger than 2 years old. AEs are similar to those found in older children.

摘要

背景

A型肉毒毒素（BoNT-A）已被用于多种适应症，且被批准用于治疗 2 岁以上儿童的痉挛。然而，在 2 岁以下的患者中使用 BoNT-A 治疗的报道较少。

目的

回顾性审查在小儿神经病学单元接受 BoNT-A 治疗的所有 2 岁以下婴儿的安全性数据。

方法

共有 74 名婴儿：28 名在 1 岁之前接受首剂治疗，46 名在 1 至 2 岁之间接受治疗。

结果

在生命的第一年，最常见的指征是产伤性臂丛神经麻痹（OBP）（71.4%的病例），第二年是脑瘫（CP）（73.9%）。两种市售的 BoNT-A 产品 Botox 和 Dysport 都有使用。首剂治疗时，1 岁以下婴儿每次治疗的平均起始剂量为 6.55 U/kg 体重的 Botox，2 岁以下婴儿每次治疗的平均起始剂量为 8.4 U/kg 体重的 Botox 和 21.1 U/kg 体重的 Dysport。首年治疗的 3.6%和次年治疗的 6.5%的病例出现不良反应（AE），包括持续 1-4 天的轻度无力或疲劳。