Hoekx J C, Hedlin G, Pedersen W, Sorva R, Hollingworth K, Efthimiou J
Dept of Paediatrics, Groene Hart Ziekenhuis, Gouda, The Netherlands.
Eur Respir J. 1996 Nov;9(11):2263-72. doi: 10.1183/09031936.96.09112263.
The aim of this study was to compare fluticasone propionate (FP) with budesonide (BUD) at a dose of 400 microg x day(-1) in the treatment of children with asthma. Two hundred and twenty nine children with mild-to-moderate asthma, currently receiving 200-400 microg x day(-1) of inhaled corticosteroid, were randomized to receive either 400 microg x day(-1) of FP from the Diskhaler (registered trade mark of the Glaxo Group of Companies) or 400 microg x day(-1) of BUD from the Turbuhaler (registered trade mark of Astra Pharmaceuticals Ltd) for 8 weeks, in a parallel-group, double-blind, double-dummy study. Primary efficacy was assessed by measurement of daily peak expiratory flow (PEF). In addition, pulmonary function tests were performed at each clinic visit and a self-administered patient-centred questionnaire was completed by one parent of each patient at the start and end of study treatment. Mean morning PEF increased following treatment both with FP and BUD, but was significantly higher following treatment with FP during Weeks 1-4 (p=0.015) and Weeks 1-8 (p=0.019). Similar results were found for mean evening PEF and percentage predicted morning and evening PEF. Children receiving FP experienced significantly less disruption in their physical activities (i.e. sports, games) because of their asthma compared to children treated with BUD (p=0.03). Mean cortisol levels increased in both groups, but the increase was significantly higher in the FP group at 4 weeks (p=0.022). Serum and urine markers of bone formation and resorption changed very little and showed no consistent pattern of change. Fluticasone propionate at a dosage of 400 microg x day(-1) from the Diskhaler provided a more rapid and greater improvement in lung function in children with mild-to-moderate asthma than BUD 400 microg day(-1) from the Turbuhaler. Both treatments were well-tolerated, with a similar safety profile.
本研究旨在比较丙酸氟替卡松（FP）与布地奈德（BUD）在剂量为400微克/天的情况下治疗儿童哮喘的效果。229名患有轻至中度哮喘、目前正在接受200 - 400微克/天吸入性糖皮质激素治疗的儿童，被随机分为两组，在一项平行组、双盲、双模拟研究中，一组接受来自Diskhaler（葛兰素集团公司注册商标）的400微克/天的FP，另一组接受来自Turbuhaler（阿斯特拉制药有限公司注册商标）的400微克/天的BUD，为期8周。主要疗效通过每日呼气峰值流速（PEF）测量进行评估。此外，在每次门诊就诊时进行肺功能测试，并且在研究治疗开始和结束时，由每位患者的一位家长完成一份以患者为中心的自填式问卷。治疗后，FP和BUD组的平均早晨PEF均有所增加，但在第1 - 4周（p = 0.015）和第1 - 8周（p = 0.019）期间，FP治疗后的平均早晨PEF显著更高。平均夜间PEF以及预测的早晨和夜间PEF百分比也得到了类似结果。与接受BUD治疗的儿童相比，接受FP治疗的儿童因哮喘导致的身体活动（即运动、游戏）中断明显更少（p = 0.03）。两组的平均皮质醇水平均升高，但在第4周时，FP组的升高幅度显著更高（p = 0.022）。骨形成和吸收的血清及尿液标志物变化很小，且未显示出一致的变化模式。与来自Turbuhaler的400微克/天的BUD相比，来自Diskhaler的剂量为400微克/天的丙酸氟替卡松能使轻至中度哮喘儿童的肺功能得到更快、更大程度的改善。两种治疗的耐受性均良好，安全性相似。
