Selroos Olof, Ekström Tommy
AstraZeneca R&D, S-221 87, Lund, Sweden.
Pulm Pharmacol Ther. 2002;15(2):175-83. doi: 10.1006/pupt.2001.0335.
Clinical trials show that formoterol (Oxis) Turbuhaler 4.5 microg delivered dose (6 microg metered dose) has a rapid onset of bronchodilation similar to that of salbutamol and a 12-h duration of action. Maximum increase in FEV(1) and duration of bronchodilation are dose-dependent, the 4.5 microg dose being the lowest dose tested giving both effects. Clinical studies investigating onset of bronchodilation show a significant increase in specific airway conductance occurring within 1 min after inhalation of formoterol Turbuhaler 4.5 microg. When measured from 3-20 min after inhalation, formoterol Turbuhaler 4.5 microg showed similar increases in FEV(1) to salbutamol administered via pMDI. No difference in onset of bronchodilation was observed between the formoterol Turbuhaler 4.5 and 9 microg doses.Single-dose studies and studies of 1-12 weeks' duration show that formoterol Turbuhaler 4.5 microg produces a significant and clinically important mean bronchodilating effect for > or =12 h after inhalation. In the cited studies no significant differences in duration of bronchodilation were observed between the formoterol Turbuhaler 4.5 and 9 microg doses.
clinical data show that formoterol Turbuhaler 4.5 microg is an effective dose in patients with asthma, with a rapid onset of bronchodilation and a duration of at least 12 h.
临床试验表明,福莫特罗(奥克斯)都保4.5微克递送剂量(6微克计量剂量)起效迅速,支气管扩张作用与沙丁胺醇相似,作用持续时间达12小时。第一秒用力呼气量(FEV₁)的最大增加量和支气管扩张持续时间呈剂量依赖性,4.5微克剂量是产生这两种效应的最低测试剂量。研究支气管扩张起效的临床研究显示,吸入4.5微克福莫特罗都保后1分钟内,比气道传导率显著增加。从吸入后3至20分钟测量,4.5微克福莫特罗都保的FEV₁增加量与通过压力定量吸入器给药的沙丁胺醇相似。4.5微克和9微克剂量的福莫特罗都保在支气管扩张起效方面未观察到差异。单剂量研究和为期1至12周的研究表明,吸入4.5微克福莫特罗都保后≥12小时可产生显著且具有临床意义的平均支气管扩张作用。在引用的研究中,4.5微克和9微克剂量的福莫特罗都保在支气管扩张持续时间上未观察到显著差异。
临床数据表明,4.5微克福莫特罗都保对哮喘患者是有效剂量起,支气管扩张起效迅速,持续时间至少12小时。