Cazzola Mario, Di Marco Fabiano, Santus Pierachille, Boveri Barbara, Verga Massimo, Matera Maria Gabriella, Centanni Stefano
Unit of Pneumology and Allergology, Department of Respiratory Medicine, A. Cardarelli Hospital, Via del Parco Margherita 24, Naples 80121, Italy.
Pulm Pharmacol Ther. 2004;17(1):35-9. doi: 10.1016/j.pupt.2003.09.001.
The aim of this double-blind, double-dummy, cross-over, randomized, pilot study was to compare the acute bronchodilator efficacy of a single dose of formoterol with that of tiotropium in patients with stable chronic obstructive pulmonary disease (COPD). Because the potential of tiotropium for additive effects is yet unknown, the acute effects of adding this anticholinergic agent to formoterol were also explored. A total of 20 outpatients with stable COPD were enrolled. Single doses of 12 microg formoterol, 18 microg tiotropium, and 12 microg formoterol+18 microg tiotropium were given. Serial measurements of FEV1 were performed over 24 h. Formoterol, either alone or in combination with tiotropium, elicited a significantly faster onset of action and showed a trend for a greater maximum bronchodilation than tiotropium alone. At 24 h, mean FEV1 continued to be significantly higher than pre-dosing value following tiotropium and formoterol+tiotropium. These findings indicate that formoterol and tiotropium have different profiles that make both agents attractive alternatives in the treatment of stable COPD. Since tiotropium ensures prolonged bronchodilation, whereas formoterol adds fast onset and a greater peak effect, the two drugs appear complementary.
这项双盲、双模拟、交叉、随机的试点研究旨在比较单剂量福莫特罗与噻托溴铵对稳定期慢性阻塞性肺疾病（COPD）患者的急性支气管扩张疗效。由于噻托溴铵的叠加效应潜力尚不清楚，因此还探讨了将这种抗胆碱能药物与福莫特罗联合使用的急性效应。总共招募了20名稳定期COPD门诊患者。分别给予单剂量的12微克福莫特罗、18微克噻托溴铵以及12微克福莫特罗+18微克噻托溴铵。在24小时内对第一秒用力呼气容积（FEV1）进行连续测量。单独使用福莫特罗或与噻托溴铵联合使用时，起效明显更快，且最大支气管扩张程度比单独使用噻托溴铵时有增大趋势。在24小时时，使用噻托溴铵以及福莫特罗+噻托溴铵后，FEV1的平均值仍显著高于给药前的值。这些发现表明，福莫特罗和噻托溴铵具有不同的特点，这使得两种药物在稳定期COPD的治疗中都是有吸引力的选择。由于噻托溴铵可确保支气管扩张作用持续时间延长，而福莫特罗起效快且峰值效应更大，这两种药物似乎具有互补性。
