Laurikainen K, Silvasti M, Calderon P, Lins R, Rosillon D
Orion Pharma, Kuopio, Finland.
Arzneimittelforschung. 1997 Jan;47(1):44-6.
In an open, randomized crossover study two different types of dry powder inhalers (DPIs) were compared. Twenty-five adult asthmatic patients inhaled a single dose of 200 micrograms of salbutamol (CAS 18559-94-9) on two separate days. Salbutamol was administered either from a novel multidose DPI (Easyhaler, test DPI) or from another type of DPI (reference DPI). On both study days lung function, blood pressure and heart rate were measured during a 4-h follow-up period. Both powder inhalers caused a clear increase in lung function parameters. The mean (SD) maximum forced expiratory volume in 1 s (FEV1) after the test DPI was 3.25 (1.30) 1 and after the reference DPI 3.28 (1.29) 1. The mean relative change from the baseline in FEV1 was similar after administration of both preparations. The mean area under the curve (AUC0-4h) of the absolute FEV1 values was 729 (316) and 731 (309) 1 x min after test and reference DPIs, respectively. The salbutamol doses had no clinically significant effects on blood pressure or heart rate and were equally well tolerated. Furthermore, 41% of patients preferred the test DPI and 19% the reference DPI, while 40% felt there was no difference between the devices. In conclusion, the results of this study show that the test DPI, a novel multidose powder inhaler, is an effective, safe and convenient alternative when an inhaled bronchodilator treatment is considered for an obstructive patient.
在一项开放、随机交叉研究中,对两种不同类型的干粉吸入器(DPI)进行了比较。25名成年哮喘患者在两个不同的日子吸入了单剂量200微克的沙丁胺醇(CAS 18559-94-9)。沙丁胺醇分别通过一种新型多剂量DPI(易吸乐,试验DPI)或另一种类型的DPI(对照DPI)给药。在两个研究日的4小时随访期间测量肺功能、血压和心率。两种干粉吸入器均使肺功能参数明显增加。试验DPI后1秒用力呼气量(FEV1)的平均值(标准差)为3.25(1.30)升,对照DPI后为3.28(1.29)升。两种制剂给药后FEV1相对于基线的平均变化相似。试验DPI和对照DPI后绝对FEV1值的曲线下平均面积(AUC0-4h)分别为729(316)和731(309)升·分钟。沙丁胺醇剂量对血压或心率无临床显著影响,耐受性良好。此外,41%的患者更喜欢试验DPI,19%的患者更喜欢对照DPI,而40%的患者认为两种装置没有差异。总之,本研究结果表明,试验DPI,一种新型多剂量干粉吸入器,在考虑对阻塞性患者进行吸入支气管扩张剂治疗时是一种有效、安全且方便的替代方案。