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一项随机试验研究了使用新型干粉吸入器吸入布地奈德治疗哮喘的儿童下肢和身高增长情况。

A randomized trial of lower leg and height growth in children with asthma treated with inhaled budesonide from a new dry powder inhaler.

机构信息

Children's Clinic Randers, Randers, Denmark.

出版信息

Pediatr Allergy Immunol. 2010 Feb;21(1 Pt 2):e206-12. doi: 10.1111/j.1399-3038.2009.00875.x. Epub 2009 Mar 3.

DOI:10.1111/j.1399-3038.2009.00875.x
PMID:19298635
Abstract

Short-term knemometry is a highly sensitive and accurate method for non-invasive assessment of systemic activity of inhaled corticosteroids in children with asthma. However, there are no randomized data available to elucidate the relation between inhaled corticosteroid suppressed short-term lower leg and height growth. The aim of the present study was to assess the relation between short-term lower leg and 1-yr height growth in children with asthma treated with inhaled budesonide from the new Pulairmax inhaler 200 μg once daily in the morning or montelukast 5 mg once daily. A total of 52 pre-pubertal children with asthma were included in a randomized open-label parallel group study. Length of the lower leg and height were measured by knemometry and stadiometry, respectively, at study entry and after 2, 4, 12, 20, 28, 36, 44 and 52 wks. Lower leg and height growth rates were significantly lower in the budesonide than in the montelukast group (p < 0.0001). Mean 2-wks lower leg growth rate was 0.17 mm/wk in the budesonide and 0.39 mm/wk in the montelukast treated children (p = 0.02). Mean 1-yr height growth rate was 5.51 cm/yr in the budesonide and 6.51 cm/yr in the montelukast group [95% CI: (0.20; 1.79)]. There was a strong linear correlation between lower leg and height growth in both groups, rho = 0.96 (budesonide) and 0.98 (montelukast). In conclusion, 1-yr height growth suppression of budesonide 200 μg administered via the Pulairmax inhaler once daily in the morning was indicated from suppressed short-term lower leg growth providing evidence that short-term knemometry is able to predict 1-yr height growth suppression of inhaled corticosteroids. Short-term knemometry should be performed as part of the safety assessments of new inhaled corticosteroids and inhalation devices in children with asthma before long-term height growth evaluations are initiated.

摘要

短期肢体测量是一种高度敏感和准确的方法,可用于非侵入性评估哮喘儿童吸入皮质类固醇的全身活性。然而,目前尚无随机数据阐明吸入皮质类固醇抑制短期小腿和身高生长之间的关系。本研究的目的是评估接受新的 Pulairmax 吸入器 200μg 布地奈德每日一次早晨或孟鲁司特 5mg 每日一次治疗的哮喘儿童短期小腿和 1 年身高生长之间的关系。共有 52 名青春期前哮喘患儿参与了一项随机、开放标签、平行组研究。在研究开始时和 2、4、12、20、28、36、44 和 52 周时,分别通过肢体测量和身高计测量小腿长度和身高。与孟鲁司特组相比,布地奈德组的小腿和身高生长速度明显较低(p < 0.0001)。布地奈德组的 2 周小腿生长率为 0.17mm/周,孟鲁司特组为 0.39mm/周(p = 0.02)。布地奈德组的 1 年身高生长率为 5.51cm/年,孟鲁司特组为 6.51cm/年[95%CI:(0.20;1.79)]。两组的小腿和身高生长之间存在很强的线性相关性,rho = 0.96(布地奈德)和 0.98(孟鲁司特)。总之,通过 Pulairmax 吸入器每日早晨给予布地奈德 200μg,可从短期抑制小腿生长中推断出 1 年身高生长抑制,这表明短期肢体测量能够预测吸入皮质类固醇的 1 年身高生长抑制。在开始进行长期身高生长评估之前,应将短期肢体测量作为儿童哮喘新吸入皮质类固醇和吸入装置安全性评估的一部分。

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