Ullman A, Löfdahl C G, Melander B, Svedmyr N
Department of Clinical Pharmacology, Sahlgrenska Hospital, Göteborg, Sweden.
Allergy. 1996 Oct;51(10):745-8. doi: 10.1111/j.1398-9995.1996.tb02120.x.
Formoterol administered by a dry-powder (DP) capsule inhaler was compared with a pressurized metered-dose inhaler (pMDI) with regard to bronchodilating and systemic effects. The study used a double-blind, crossover, double-dummy technique. Twelve patients with moderate reversible asthma in a stable phase were examined on two separate study days, and the inhalers were given in randomized order. After baseline measurements, increasing doses of formoterol were given at intervals of 75 min. FEV1 and heart rate and tremor measurements were repeated after each dose, and the doses were 12 + 12 + 24 + 48 micrograms, giving a total dose of 96 micrograms. The peak expiratory flow rate (PEFR) was recorded in the morning before the first dose, after the last dose, and then repeatedly at home until 19 h after the last dose. There was an equal increase in ventilatory capacity at each dose level, independent of inhaler device. Repeated PEFR measurements after the last dose did not reveal any differences in duration of effect. There was a slight but statistically significant increase in heart rate and tremor after the highest doses of the DP formulation compared to the pMDI. These systemic effects can probably be explained by the reduced oral deposition of the aerosol caused by using a spacer. This study indicates that the DP and pMDI formulations of formoterol are equipotent in bronchodilation.
对使用干粉（DP）胶囊吸入器给药的福莫特罗与压力定量吸入器（pMDI）的支气管扩张作用和全身效应进行了比较。该研究采用双盲、交叉、双模拟技术。在两个不同的研究日对12名处于稳定期的中度可逆性哮喘患者进行检查，吸入器按随机顺序给药。在进行基线测量后，每隔75分钟给予递增剂量的福莫特罗。每次给药后重复测量第一秒用力呼气量（FEV1）、心率和震颤，剂量分别为12 + 12 + 24 + 48微克，总剂量为96微克。在首次给药前的早晨、最后一次给药后以及随后在家中直到最后一次给药后19小时，记录最大呼气流量（PEFR）。在每个剂量水平，通气能力的增加相同，与吸入器装置无关。最后一次给药后重复测量PEFR未发现作用持续时间有任何差异。与pMDI相比，DP制剂最高剂量给药后心率和震颤有轻微但具有统计学意义的增加。这些全身效应可能是由于使用储雾罐导致气溶胶经口沉积减少所致。本研究表明，福莫特罗的DP和pMDI制剂在支气管扩张方面具有同等效力。
