Verberne A A, Hop W C, Bos A B, Kerrebijn K F
Department of Pediatrics, Erasmus University, Rotterdam, The Netherlands.
J Allergy Clin Immunol. 1993 Jan;91(1 Pt 1):127-34. doi: 10.1016/0091-6749(93)90305-y.
Salmeterol is a new inhaled selective beta 2-adrenergic receptor agonist with a long duration of action. We studied the duration of the bronchodilation and the protective effect against methacholine-induced airway obstruction of a single dose of salmeterol in a double-blind, randomized, placebo-controlled, crossover design.
Seventeen boys and three girls with mild-to-moderate asthma participated in the study. On two separate days either 50 micrograms salmeterol or placebo was inhaled. FEV1 and PD20 methacholine were determined before and 1, 4, 8, 12, and 24 hours after inhalation.
Salmeterol resulted in a significant bronchodilation compared with placebo, up to 12 hours (p = 0.0001). At 24 hours there was a residual effect that approached significance; mean FEV1 being 8.3% +/- 2.4% above baseline (p = 0.06). Significant protection against airway sensitivity to methacholine after salmeterol inhalation was found at all time points (p < 0.005). Twenty-four hours after administration mean PD20 was still 1.22 +/- 0.29 doubling dose above baseline. No important adverse effects were noted.
We conclude that a single dose of 50 micrograms salmeterol in children with asthma gives a long-lasting bronchodilation, exceeding 12 hours, which is comparable to the results in adult studies. The duration of the protection against airway sensitivity to methacholine exceeds 24 hours.
沙美特罗是一种新型吸入性长效选择性β2肾上腺素能受体激动剂。我们采用双盲、随机、安慰剂对照、交叉设计,研究了单剂量沙美特罗的支气管扩张持续时间以及对乙酰甲胆碱诱导的气道阻塞的保护作用。
17名男孩和3名女孩患有轻度至中度哮喘,参与了本研究。在两个不同的日子里,分别吸入50微克沙美特罗或安慰剂。在吸入前以及吸入后1、4、8、12和24小时测定第一秒用力呼气容积(FEV1)和乙酰甲胆碱激发试验的PD20。
与安慰剂相比,沙美特罗可导致显著的支气管扩张,持续长达12小时(p = 0.0001)。在24小时时仍有残留效应,接近显著水平;平均FEV1比基线高8.3%±2.4%(p = 0.06)。在所有时间点均发现沙美特罗吸入后对气道对乙酰甲胆碱的敏感性有显著保护作用(p < 0.005)。给药24小时后,平均PD20仍比基线高1.22±0.29倍剂量。未观察到重要的不良反应。
我们得出结论,哮喘儿童单剂量50微克沙美特罗可产生超过12小时的持久支气管扩张,这与成人研究结果相当。对气道对乙酰甲胆碱敏感性的保护持续时间超过24小时。