van Essen-Zandvliet E E, Hop W C, de Jong H, Ferwerda A, Kerrebijn K F
Dept of Paediatrics, Erasmus University of Rotterdam, The Netherlands.
Eur Respir J. 1993 Mar;6(3):383-6.
Several studies have shown that long-term administration of inhaled corticosteroid reduces airway hyperresponsiveness. This study was performed in order to exclude an acute effect of inhaled corticosteroid. In a double-blind, randomized, cross-over study, children with asthma, who had never used inhaled or oral corticosteroid, received a single dose of 0.8 mg budesonide or placebo on two separate days, with an interval of at least 48 h. On each test day, baseline forced expiratory volume in one second (FEV1) and methacholine responsiveness (expressed as provocative dose producing a 20% fall in FEV1 (PD20) to methacholine, in doubling dose) were measured. Both measurements were repeated 2 and 5 h after administration of the drug. Twenty children were included in the study. FEV1 showed a mean increase of 1% at 5 h on the budesonide day, and a decrease of 2% on the placebo day (p = 0.01). PD20 increased by 0.1 doubling dose on the budesonide day, and decreased by 0.4 doubling dose on the placebo day. These changes are within the measurement variation (p = 0.06). We conclude that a single dose of 0.8 mg budesonide has a minor effect on methacholine responsiveness 5 h after administration in children with asthma. It is unlikely that such an effect interferes with the interpretation of data collected in long-term studies.
多项研究表明，长期吸入糖皮质激素可降低气道高反应性。进行本研究是为了排除吸入糖皮质激素的急性效应。在一项双盲、随机、交叉研究中，从未使用过吸入或口服糖皮质激素的哮喘患儿在两个不同日期分别接受单次剂量的0.8 mg布地奈德或安慰剂，间隔至少48小时。在每个测试日，测量基线一秒用力呼气容积（FEV1）和乙酰甲胆碱反应性（以使FEV1下降20%的激发剂量（PD20）表示，以加倍剂量计算）。在给药后2小时和5小时重复这两项测量。20名儿童纳入本研究。在布地奈德日，FEV1在5小时时平均增加1%，在安慰剂日下降2%（p = 0.01）。PD20在布地奈德日增加0.1个加倍剂量，在安慰剂日下降0.4个加倍剂量。这些变化在测量误差范围内（p = 0.06）。我们得出结论，单次剂量的0.8 mg布地奈德在给药5小时后对哮喘患儿的乙酰甲胆碱反应性有轻微影响。这种效应不太可能干扰长期研究中收集的数据的解释。
