Ekström T, Ringdal N, Sobradillo V, Runnerström E, Soliman S
Department of Respiratory Disease, University Hospital, Linköping, Sweden.
Respir Med. 1998 Aug;92(8):1040-5. doi: 10.1016/s0954-6111(98)90352-3.
This study compared the efficacy of a low dose of formoterol Turbuhaler 6 micrograms b.i.d. (F) with that of terbutaline 0.5 mg q.i.d. (T), and placebo (P) from Turbuhaler. After a 2-week run-in, 397 adults with mild to moderate asthma were randomly allocated to one of the treatments for 12 weeks. During run-in, the mean morning peak expiratory flow (PEF) was 360 (F), 368 (T) and 367 1 min-1 (P). F was better than T (P = 0.014) and P (P = 0.0001) in improving morning PEF [mean changes from run-in: 20 (F), 9 (T), and 21 min-1 (P)]. F was statistically significantly more effective than either T or P in reducing asthma symptoms. F gave also statistically significantly higher evening PEF and less use of rescue medication than P. Bronchodilator response to study drugs and additional 1.25 mg terbutaline was similar before and after the 12-week treatment period. There were no adverse effects of clinical relevance. In conclusion, formoterol Turbuhaler, 6 micrograms b.i.d. was more effective in improving PEF and offered better asthma control than either terbutaline Turbuhaler, 0.5 mg q.i.d. or placebo. Regular use of formoterol did not reduce the bronchodilator response to additional terbutaline. There were no clinically relevant adverse effects.
本研究比较了低剂量福莫特罗都保（每日两次，每次6微克）（F）与特布他林（每日四次，每次0.5毫克）（T）以及都保安慰剂（P）的疗效。经过2周的导入期后，397名轻至中度哮喘成年患者被随机分配至其中一种治疗方案，为期12周。在导入期，早晨平均呼气峰值流速（PEF）分别为：福莫特罗组360、特布他林组368、安慰剂组367升/分钟。在改善早晨PEF方面，福莫特罗优于特布他林（P = 0.014）和安慰剂（P = 0.0001）[与导入期相比的平均变化：福莫特罗组20、特布他林组9、安慰剂组21升/分钟]。在减轻哮喘症状方面，福莫特罗在统计学上显著优于特布他林或安慰剂。与安慰剂相比，福莫特罗在夜间PEF方面也有统计学显著提高，且急救药物使用更少。在12周治疗期前后，研究药物和额外1.25毫克特布他林的支气管扩张反应相似。未出现具有临床相关性的不良反应。总之，每日两次、每次6微克的福莫特罗都保在改善PEF方面更有效，并且比每日四次、每次0.5毫克的特布他林都保或安慰剂能更好地控制哮喘。规律使用福莫特罗并未降低对额外特布他林的支气管扩张反应。未出现具有临床相关性的不良反应。
