De Boeck Kris, De Baets Frans, Malfroot Anne, Desager Kristine, Mouchet Françoise, Proesmans Marijke
Department of Pediatric Pulmonology and Cystic Fibrosis Clinic, University Hospital of Leuven, Herestraat 49, 3000 Leuven, Belgium.
Eur J Pediatr. 2007 Jan;166(1):23-8. doi: 10.1007/s00431-006-0198-9. Epub 2006 Jun 24.
Despite absence of clear proof of efficacy, the use of inhaled corticosteroids (ICS) is widespread in cystic fibrosis (CF) patients. Therefore, the effect of ICS on lung function and other clinical variables was studied in 27 prepubertal CF children with mild to moderate lung disease. In a prospective double-blind case-controlled study, fluticasone propionate 500 microg or placebo were administered twice daily during 12 months. The mean (standard error of the mean, SEM) patient age was 8.2 (0.6) years in the placebo group and 9.0 (0.5) years in the fluticasone group. The mean (SEM) forced expiratory volume in 1 s (FEV(1)) was 91% (4%) in the placebo group and 86% (4%) in the fluticasone group. There was no statistically significant difference in the evolution of lung function and the number of respiratory exacerbations between groups. However, longitudinal growth in fluticasone patients was significantly slower than in placebo patients: 3.96 (0.29) cm versus 5.49 (0.38) cm [p<0.005, analysis of variance (ANOVA)] over the 12-month study duration. This resulted in a significant change in height standard deviation score (SDS) of -0.38 (0.09) in the fluticasone group versus -0.01 (0.07) in the placebo group (p<0.003, ANOVA). No catch-up growth was noted 1-2 years after discontinuation of inhaled steroids. The use of high-dose ICS in CF patients with mild lung disease may lead to persistent growth impairment.
尽管缺乏明确的疗效证据，但吸入性糖皮质激素（ICS）在囊性纤维化（CF）患者中仍被广泛使用。因此，研究人员对27名患有轻度至中度肺部疾病的青春期前CF儿童进行了ICS对肺功能和其他临床变量影响的研究。在一项前瞻性双盲病例对照研究中，丙酸氟替卡松500微克或安慰剂每天给药两次，持续12个月。安慰剂组患者的平均（平均标准误差，SEM）年龄为8.2（0.6）岁，氟替卡松组为9.0（0.5）岁。安慰剂组1秒用力呼气量（FEV₁）的平均（SEM）值为91%（4%），氟替卡松组为86%（4%）。两组之间肺功能的变化和呼吸道加重的次数没有统计学上的显著差异。然而，氟替卡松组患者的纵向生长明显慢于安慰剂组患者：在为期12个月的研究期间，分别为3.96（0.29）厘米和5.49（0.38）厘米[p<0.005，方差分析（ANOVA）]。这导致氟替卡松组的身高标准差评分（SDS）显著变化为-0.38（0.09），而安慰剂组为-0.01（0.07）（p<0.003，ANOVA）。停用吸入性类固醇1至2年后未观察到追赶生长。在患有轻度肺部疾病的CF患者中使用高剂量ICS可能会导致持续的生长障碍。
