Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
J Allergy Clin Immunol. 2010 Feb;125(2):374-80. doi: 10.1016/j.jaci.2009.11.015.
Current treatments for acute asthma provide inadequate benefit for some patients. Intravenous montelukast may complement existent therapies.
To evaluate efficacy of intravenous montelukast as adjunctive therapy for acute asthma.
A total of 583 adults with acute asthma were treated with standard care during a < or = 60-minute screening period. Patients with FEV(1) < or =50% predicted were randomly allocated to intravenous montelukast 7 mg (n = 291) or placebo (n = 292) in addition to standard care. This double-blind treatment period lasted until a decision for discharge, hospital admission, or discontinuation from the study. The primary efficacy endpoint was the time-weighted average change in FEV(1) during 60 minutes after drug administration. Secondary endpoints included the time-weighted average change in FEV(1) at various intervals (10-120 minutes) and percentage of patients with treatment failure (defined as hospitalization or lack of decision to discharge by 3 hours postadministration).
Montelukast significantly increased FEV(1) at 60 minutes postdose; the difference between change from baseline for placebo (least-squares mean of 0.22 L; 95% CI, 0.17, 0.27) and montelukast (0.32 L; 95% CI, 0.27, 0.37) was 0.10 L (95% CI, 0.04, 0.16). Similar improvements in FEV(1)-related variables were seen at all time points (all P <.05). Although treatment failure did not differ between groups (OR 0.92; 95% CI, 0.63, 1.34), a prespecified subgroup analysis suggests likely benefit for intravenous montelukast at US sites.
Intravenous montelukast added to standard care in adults with acute asthma produced significant relief of airway obstruction throughout the 2 hours after administration, with an onset of action as early as 10 minutes.
目前的急性哮喘治疗方法对某些患者效果不佳。静脉用孟鲁司特可能会补充现有的治疗方法。
评估静脉用孟鲁司特作为急性哮喘辅助治疗的疗效。
共有 583 名急性哮喘成人患者在 < 或 = 60 分钟的筛选期内接受标准治疗。FEV(1) < 或 = 50%预测值的患者被随机分配至静脉用孟鲁司特 7 mg（n = 291）或安慰剂（n = 292），并接受标准治疗。双盲治疗期持续至出院、住院或退出研究决定。主要疗效终点是给药后 60 分钟时的时间加权平均 FEV(1)变化。次要终点包括不同时间（10-120 分钟）的时间加权平均 FEV(1)变化和治疗失败患者的百分比（定义为给药后 3 小时内住院或未决定出院）。
孟鲁司特治疗组在给药后 60 分钟时显著增加了 FEV(1)；与安慰剂（从基线的最小二乘均值为 0.22 L；95%CI，0.17，0.27）相比，孟鲁司特组（0.32 L；95%CI，0.27，0.37）的差异为 0.10 L（95%CI，0.04，0.16）。所有时间点的 FEV(1)相关变量均有类似的改善（均 P <.05）。尽管两组之间的治疗失败率没有差异（OR 0.92；95%CI，0.63，1.34），但一项预先指定的亚组分析表明，美国研究地点的静脉用孟鲁司特可能会带来益处。
在急性哮喘成人患者中，静脉用孟鲁司特联合标准治疗可显著缓解气道阻塞，在给药后 2 小时内持续起效，作用起始时间早至 10 分钟。
