成人急性重度哮喘加重期治疗中左旋沙丁胺醇与消旋沙丁胺醇的比较。

A comparison of levalbuterol with racemic albuterol in the treatment of acute severe asthma exacerbations in adults.

作者信息

Nowak Richard, Emerman Charles, Hanrahan John P, Parsey Merdad V, Hanania Nicola A, Claus Raymond, Schaefer Kendyl, Baumgartner Rudolf A

机构信息

Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.

出版信息

Am J Emerg Med. 2006 May;24(3):259-67. doi: 10.1016/j.ajem.2006.01.027.

DOI:10.1016/j.ajem.2006.01.027

PMID:16635694

Abstract

UNLABELLED

This multicenter, randomized, double-blind trial compared nebulized levalbuterol (Lev) and racemic albuterol (Rac) in the treatment of acute asthma.

METHODS

Adults with acute asthma exacerbations (FEV(1) 20%-55% predicted) received prednisone and either Lev (1.25 mg, n = 315) or Rac (2.5 mg, n = 312). Nebulized treatments were administered every 20 minutes in the first hour, then every 40 minutes for 3 additional doses, then as necessary for up to 24 hours. The primary end point was time to meet discharge criteria. Secondary end points included changes in lung function and hospitalization rates. A subset of 160 patients had plasma (S)-albuterol concentrations determined at study entry.

RESULTS

Time to meet discharge criteria did not differ between the 2 treatments. FEV(1) improvement was greater following Lev compared with Rac, both after dose 1 and cumulatively over the entire treatment period (dose 1 in intent to treat [ITT] group: Lev 0.50 +/- 0.43 L, Rac 0.43 +/- 0.37 L; P = .02), particularly among the 60% of patients not on recent steroid therapy (dose 1: Lev 0.58 +/- 0.47 L, Rac 0.44 +/- 0.37 L; P < .01), and patients whose entry (S)-albuterol concentrations were in the highest quartile of those measured. A small and similar proportion of Lev-treated (7.0%) and Rac-treated (9.3%) patients required hospitalization (P = .28). Among patients not on steroids, fewer Lev- than Rac-treated patients required admission (3.8% vs 9.3%, P = .03), as was also the case for patients with high plasma (S)-albuterol concentrations. Asthma relapses (5% in 30 days) were lower than in previous reports and did not differ between groups.

CONCLUSIONS

This study suggests that early, regular nebulized beta(2)-agonist and systemic corticosteroid therapy may reduce hospitalization and relapse rates in patients with acute severe asthma. Lev was well tolerated and compared favorably with Rac in improving airway function, particularly in those who were not on inhaled or oral corticosteroids and in those who had high plasma (S)-albuterol concentrations at presentation.

摘要

未标注

这项多中心、随机、双盲试验比较了雾化吸入左沙丁胺醇（Lev）和消旋沙丁胺醇（Rac）治疗急性哮喘的效果。

方法

急性哮喘加重期的成年人（预计第一秒用力呼气容积[FEV(1)]为20%-55%）接受泼尼松治疗，并随机分为两组，一组接受Lev（1.25毫克，n = 315）治疗，另一组接受Rac（2.5毫克，n = 312）治疗。在最初的1小时内，每20分钟进行一次雾化治疗，随后再进行3次额外剂量的治疗，每次间隔40分钟，之后根据需要进行治疗，最长持续24小时。主要终点是达到出院标准的时间。次要终点包括肺功能变化和住院率。160名患者的亚组在研究开始时测定了血浆（S）-沙丁胺醇浓度。

结果

两种治疗方法达到出院标准的时间没有差异。与Rac相比，Lev治疗后FEV(1)的改善更大，无论是在第1剂后还是在整个治疗期间累计改善情况（意向性治疗[ITT]组第1剂：Lev为0.50±0.43升，Rac为0.43±0.37升；P = 0.02），特别是在60%近期未接受类固醇治疗的患者中（第1剂：Lev为0.58±0.47升，Rac为0.44±0.37升；P < 0.01），以及那些血浆（S）-沙丁胺醇浓度在测量值最高四分位数的患者中。接受Lev治疗的患者（7.0%）和接受Rac治疗的患者（9.3%）需要住院治疗的比例较小且相似（P = 0.28）。在未使用类固醇的患者中，接受Lev治疗的患者需要住院的人数少于接受Rac治疗的患者（3.8%对9.3%，P = 0.03），血浆（S）-沙丁胺醇浓度高的患者也是如此。哮喘复发率（30天内为5%）低于以往报告，且两组之间无差异。