UMC Utrecht, Division of Heart and Lungs, 3584 CX Utrecht, The Netherlands.
J Aerosol Med Pulm Drug Deliv. 2009 Dec;22(4):317-21. doi: 10.1089/jamp.2008.0723.
Monodisperse salbutamol inhalers were compared to select the optimal mass median aerodynamic diameter: 4.0, 5.0 or 6.0 microm.
Fifteen mild asthmatic patients participated. In all a FEV(1)-response of >12% (vs. baseline) or >200 mL after inhalation of 200 microg salbutamol was measured. Each patient was studied four times with intervals of 1 week (three active and one placebo inhaler). First, 10 microg salbutamol was administered, followed by 10, 20, and 40 microg, resulting in cumulative doses of 10, 20, 40, and 80 microg salbutamol. The FEV(1) and other lung function parameters were assessed at baseline and 30 min after inhalation of each consecutive dose. Five minutes later a next inhalation was given.
The 4.0- and 5.0-microm droplets did not differ from placebo (p = 0.502, p = 0.127), but the 6.0-microm droplets differed significantly (p = 0.003). The difference between 6.0-4.0 microm droplets was significant (p = 0.020), but not between the 6.0-5.0 microm droplets (p = 0.129). The FEV(1) increase after 80-microg salbutamol for the 6.0-microm droplets was 243 +/- 144 mL.
The study showed that the 6.0-microm droplets differed from the others in terms of FEV(1)-improvement, and hence, are the most efficacious of the three evaluated.
单分散沙丁胺醇吸入器被比较以选择最佳的质量中值空气动力学直径：4.0、5.0 或 6.0 微米。
15 名轻度哮喘患者参与了这项研究。所有患者均在吸入 200 微克沙丁胺醇后，FEV(1) 增加了>12%（与基线相比）或增加了>200 毫升。每位患者均进行了四次研究，间隔为 1 周（三次活性吸入器和一次安慰剂吸入器）。首先，给予 10 微克沙丁胺醇，然后给予 10、20 和 40 微克，从而给予 10、20、40 和 80 微克沙丁胺醇的累积剂量。在每次连续剂量吸入后 30 分钟评估 FEV(1) 和其他肺功能参数。5 分钟后进行下一次吸入。
4.0 和 5.0 微米的液滴与安慰剂无差异（p = 0.502，p = 0.127），但 6.0 微米的液滴差异显著（p = 0.003）。6.0-4.0 微米液滴之间的差异具有统计学意义（p = 0.020），但 6.0-5.0 微米液滴之间的差异无统计学意义（p = 0.129）。6.0 微米液滴吸入 80 微克沙丁胺醇后，FEV(1) 增加了 243 ± 144 毫升。
该研究表明，6.0 微米的液滴在 FEV(1) 改善方面与其他液滴不同，因此是三种评估中最有效的。
