Daugbjerg P, Nielsen K G, Skov M, Bisgaard H
Department of Paediatrics, National University Hospital, Rigshospitalet, Copenhagen, Denmark.
Acta Paediatr. 1996 Jun;85(6):684-7. doi: 10.1111/j.1651-2227.1996.tb14125.x.
The aim of this study was to evaluate the effect and tolerability of formoterol 12 micrograms on exercise-induced asthma in children for 12 h as compared to the effect of salbutamol 400 micrograms and placebo. The drugs were inhaled as dry powder from a flow-dependent metered-dose inhaler (DP-MDI). Sixteen asthmatic children took part in a double-blind placebo-controlled within-patient single-centre trial. On each study day the patients were given one of the drugs or placebo in random order, and standardized exercise tests were performed after 3 and 12 h. At a pretrial test the children had demonstrated a median maximum percentage fall of 38% (range 22-79%) in forced expiratory volume in 1 s after exercise challenge. Formoterol showed a median percentage protection of 77% and 70% at 3 and 12 h postexercise, respectively, as compared to 46% and 13% with salbutamol. No side-effects were observed. Formoterol 12 micrograms administered as dry powder offers significantly better protection against exercise-induced asthma after 3 and 12 h as compared to salbutamol 400 micrograms and placebo.
本研究旨在评估与400微克沙丁胺醇及安慰剂相比,12微克福莫特罗对儿童运动诱发性哮喘12小时的疗效及耐受性。药物通过流量依赖型定量干粉吸入器(DP-MDI)吸入。16名哮喘儿童参与了一项双盲、安慰剂对照、患者自身单中心试验。在每个研究日,患者按随机顺序接受其中一种药物或安慰剂,在3小时和12小时后进行标准化运动试验。在预试验中,儿童在运动激发后1秒用力呼气量的最大下降百分比中位数为38%(范围22%-79%)。与沙丁胺醇在运动后3小时和12小时分别为46%和13%的保护率相比,福莫特罗在运动后3小时和12小时的保护率中位数分别为77%和70%。未观察到副作用。与400微克沙丁胺醇及安慰剂相比,以干粉形式给予12微克福莫特罗在3小时和12小时后对运动诱发性哮喘的保护作用显著更好。