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静脉注射孟鲁司特治疗急性哮喘的随机对照试验。

A randomized controlled trial of intravenous montelukast in acute asthma.

作者信息

Camargo Carlos A, Smithline Howard A, Malice Marie-Pierre, Green Stuart A, Reiss Theodore F

机构信息

Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, USA.

出版信息

Am J Respir Crit Care Med. 2003 Feb 15;167(4):528-33. doi: 10.1164/rccm.200208-802OC. Epub 2002 Nov 27.

DOI:10.1164/rccm.200208-802OC
PMID:12456380
Abstract

Many patients with acute asthma do not respond adequately to currently accepted therapy, including oxygen, beta-agonists, and corticosteroids. Leukotriene receptor antagonists such as montelukast have demonstrated efficacy in chronic asthma, but their efficacy in acute asthma is unknown. In this randomized, double-blind, parallel-group pilot study, adults with moderate to severe acute asthma received standard therapy plus either intravenous montelukast (7 or 14 mg) or matching placebo. A total of 201 patients were randomized, and 194 had complete data available for analysis. There was no difference in FEV1 response between the 7- and 14-mg montelukast groups. Montelukast improved FEV1 over the first 20 minutes after intravenous administration (mean percentage change from prerandomization baseline, 14.8% versus 3.6% for the pooled montelukast and placebo treatment groups, respectively; p = 0.007). This benefit was observed at 10 minutes and over 2 hours after intravenous therapy. Patients treated with montelukast tended to receive less beta-agonists and have fewer treatment failures than patients receiving placebo. The tolerability profile for montelukast was similar to that observed for placebo, and no unexpected adverse experiences were observed. We conclude that intravenous montelukast in addition to standard therapy causes rapid benefit and is well tolerated in adults with acute asthma.

摘要

许多急性哮喘患者对目前公认的治疗方法,包括吸氧、使用β受体激动剂和皮质类固醇,反应并不充分。白三烯受体拮抗剂,如孟鲁司特,已在慢性哮喘中显示出疗效,但其在急性哮喘中的疗效尚不清楚。在这项随机、双盲、平行组的试点研究中,中重度急性哮喘成人患者接受标准治疗加静脉注射孟鲁司特(7毫克或14毫克)或匹配的安慰剂。共有201名患者被随机分组,194名患者有完整数据可供分析。7毫克和14毫克孟鲁司特组之间的第一秒用力呼气量(FEV1)反应没有差异。静脉注射孟鲁司特后最初20分钟内FEV1有所改善(联合孟鲁司特和安慰剂治疗组从随机分组前基线的平均百分比变化分别为14.8%和3.6%;p = 0.007)。在静脉治疗后10分钟和2小时以上观察到了这种益处。与接受安慰剂的患者相比,接受孟鲁司特治疗的患者使用的β受体激动剂较少,治疗失败的情况也较少。孟鲁司特的耐受性与安慰剂相似,未观察到意外的不良事件。我们得出结论,对于急性哮喘成人患者,在标准治疗的基础上加用静脉注射孟鲁司特可迅速起效,且耐受性良好。

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