Boner A L, Spezia E, Piovesan P, Chiocca E, Maiocchi G
Pediatrics Department, University of Verona, Italy.
Am J Respir Crit Care Med. 1994 Apr;149(4 Pt 1):935-9. doi: 10.1164/ajrccm.149.4.7908246.
The duration and magnitude of the effect of inhaled formoterol (12 micrograms) against exercise-induced bronchoconstriction (EIB) was compared with that of inhaled salbutamol (200 micrograms) and that of placebo in 15 children with asthma and EIB in a double-blind, double-dummy, within-patient, placebo-controlled study. The treatments were given by metered dose aerosol on three different days. The exercise test was performed at the 3rd and the 12th hour after dosing. The magnitude of the blocking effect was assessed both by evaluating the lowest FEV1 reading obtained within an hour after each exercise test and by considering the percent decrease below the baseline FEV1 measured before drug administration. Comparison of the lowest values obtained during the hour after each exercise test shows that formoterol was significantly better than both salbutamol (p = 0.022), and placebo (p = 0.001) in limiting exercise-induced bronchoconstriction after the first exercise test (3 h after dosing), while no difference was observed between salbutamol and placebo (p = 0.198). After the second exercise test (12 h after dosing), formoterol again proved to be more effective than both salbutamol (p = 0.008) and placebo (p = 0.001), and no significant difference was observed between salbutamol and placebo (p = 0.391). The evaluation of the mean percentage decrease in FEV1 confirmed the results in favor of formoterol in both the exercise tests. No adverse effects were reported in any treatment group. The protection against EIB is significantly more prolonged after formoterol than after salbutamol, and persists for 12 h after dosing.
在一项针对15名患有哮喘和运动诱发性支气管收缩(EIB)的儿童的双盲、双模拟、患者自身对照、安慰剂对照研究中,比较了吸入福莫特罗(12微克)、吸入沙丁胺醇(200微克)和安慰剂对EIB的作用持续时间和强度。在三个不同的日子里通过定量气雾剂给予治疗。在给药后第3小时和第12小时进行运动试验。通过评估每次运动试验后一小时内获得的最低FEV1读数以及考虑给药前测量的基线FEV1以下的下降百分比来评估阻断作用的强度。对每次运动试验后一小时内获得的最低值进行比较表明,在第一次运动试验(给药后3小时)后,福莫特罗在限制运动诱发性支气管收缩方面明显优于沙丁胺醇(p = 0.022)和安慰剂(p = 0.001),而沙丁胺醇和安慰剂之间未观察到差异(p = 0.198)。在第二次运动试验(给药后12小时)后,福莫特罗再次被证明比沙丁胺醇(p = 0.008)和安慰剂(p = 0.001)更有效,沙丁胺醇和安慰剂之间未观察到显著差异(p = 0.391)。对FEV1平均下降百分比的评估证实了在两次运动试验中均有利于福莫特罗的结果。任何治疗组均未报告不良反应。福莫特罗对EIB的保护作用比沙丁胺醇显著延长,给药后持续12小时。