Seppälä O P, Kari E, Elo J, Löyttyniemi E, Kunkel G
Leiras Oy, Turku, Finland.
Arzneimittelforschung. 1998 Sep;48(9):919-23.
In a two-day, randomised, double-blind, double-dummy, cross-over multicenter study, the bronchodilating effect of 100 micrograms of salbutamol (CAS 18559-94-9) inhaled from a new metered dose powder inhaler (MDPI; Taifun) was compared with that of an identical dose of salbutamol inhaled from a conventional pressurised metered dose inhaler connected to a spacer (pMDI + S). Thirty-six non-smoking, adult asthmatic outpatients with a baseline forced expiratory volume in 1 s (FEV1) between 35 and 70% of the predicted value participated in the study. After inhalation of the study medication pulmonary function, FEV1 and airway resistance (R(aw)), blood pressure (BP), and heart rate (HR) were measured up to 6 h. Area under the FEV1 vs. time curve (AUCFEV1) was used as the primary efficacy parameter, and the 90% confidence intervals (CI) were used to judge clinical equivalence. Other efficacy parameters were used in supportive analyses as secondary parameters. Both treatments produced a clear improvement in pulmonary function. The mean +/- SD AUCFEV1 were 893 +/- 281 and 889 +/- 2761.min after MDPI and pMDI + S, respectively. The 90% CI for the relative efficacy of the MDPI is from 98 to 103% of that of the pMDI + S. Also the other efficacy parameters gave similar results without significant differences: the mean +/- SD values of percent increase in FEV1 were 47.2 +/- 19.3 and 44.7 +/- 20.8, the maximum absolute value of FEV1 were 2.87 +/- 0.77 and 2.86 +/- 0.77, the maximum percent decrease in R(aw) 53.2 +/- 20.5 and 55.0 +/- 19.1, and the minimum absolute value of R(aw) 0.27 +/- 0.11 and 0.30 +/- 0.12 kPa.s.l-1 for the MDPI and pMDI + S, respectively. The salbutamol doses had no significant effect on BP or HR, and were equally well tolerated. Furthermore, 57.5% of the patients preferred the MDPI, 35% the pMDI + S, and 7.5% considered that there was no difference between the devices. In conclusion, this study demonstrates that the new MDPI is as effective and safe a device as a conventional pMDI connected to a spacer in administering inhaled salbutamol for asthmatic patients. Further, most patients considered the MDPI easier to handle, and preferred it over the pMDI + S.
在一项为期两天的随机、双盲、双模拟、交叉多中心研究中，比较了从新型定量干粉吸入器（MDPI；Taifun）吸入100微克沙丁胺醇（CAS 18559-94-9）与从连接储雾罐的传统压力定量吸入器（pMDI + S）吸入相同剂量沙丁胺醇的支气管扩张效果。36名非吸烟成年哮喘门诊患者参与了该研究，其基线第1秒用力呼气量（FEV1）为预测值的35%至70%。吸入研究药物后，测量长达6小时的肺功能、FEV1和气道阻力（R(aw)）、血压（BP）及心率（HR）。FEV1随时间变化曲线下面积（AUCFEV1）用作主要疗效参数，采用90%置信区间（CI）判断临床等效性。其他疗效参数用于支持性分析作为次要参数。两种治疗均使肺功能明显改善。MDPI和pMDI + S吸入后，平均±标准差AUCFEV1分别为893±281和889±276 1·min。MDPI相对疗效的90%CI为pMDI + S的98%至103%。其他疗效参数也得出类似结果，无显著差异：MDPI和pMDI + S的FEV1增加百分比的平均±标准差分别为47.2±19.3和44.7±20.8，FEV1的最大绝对值分别为2.87±0.77和2.86±0.77，R(aw)的最大下降百分比分别为53.2±20.5和55.0±19.1，R(aw)的最小绝对值分别为0.27±0.11和0.30±0.12 kPa·s·l-1。沙丁胺醇剂量对BP或HR无显著影响，耐受性相当。此外，57.5%的患者更喜欢MDPI，35%更喜欢pMDI + S，7.5%认为两种装置无差异。总之，本研究表明，对于哮喘患者，新型MDPI在吸入沙丁胺醇给药方面与连接储雾罐的传统pMDI一样有效且安全。此外，大多数患者认为MDPI更易于操作，且比pMDI + S更受青睐。
