消旋沙丁胺醇和左旋沙丁胺醇持续雾化吸入治疗急性哮喘恶化的疗效:随机、双盲、临床试验
2011/05/12
摘要
目的:比较急诊消旋沙丁胺醇(RAC)和左旋沙丁(LEV)胺醇持续应用治疗儿童急性哮喘恶化的疗效。
研究设计:入选患者年龄6~17岁,有哮喘史,因急性哮喘恶化而入急诊治疗,初始第1秒用力呼气体积<70%预测值。患者随机分为采用7.5 mg RAC 或3.75 mg LEV 治疗组,雾化吸入时间为1h。此外,两组患者同时采用标准哮喘治疗。首次治疗1h后对患者进行肺活量检测和哮喘评分,必要时重复上述治疗。治疗后再次检测肺活量和进行哮喘评分,记录最后结果。此外,收集部分患者血液,检测血液基线状态(治疗前)下的沙丁胺醇水平。
结果:共计99名患者完成本研究(44名采用RAC,55名采用LEV)。除了RAC组患者具有较高的基线哮喘评分外,其他特征基本相似。与LEV组相比,首次治疗后,RAC组FEV1(p =0.043)和哮喘评分(p =0.01)显著改善。再次采用相同治疗方案,RAC组哮喘评分(p =0.008)进一步显著改善,但FEV1无显著变化。心率、呼吸频率、氧饱和度和入院率在两组间无显著差异。
结论:基于本研究所选剂量,RAC在改善FEV1和哮喘评分上优于LEV。两者在入院率和副作用方面无显著差异。
(林江涛 审校)
J Asthma. 2011 Mar;48(2):188-93. Epub 2011 Jan 29.
Efficacy of Racemic Albuterol versus Levalbuterol Used as a Continuous Nebulization for the Treatment of Acute Asthma Exacerbations: A Randomized, Double-Blind, Clinical Trial.
Wilkinson M, Bulloch B, Garcia-Filion P, Keahey L.
Department of Emergency Medicine, Dell Children’s Medical Center of Central Texas, Austin, TX, USA.
Abstract
Objective. To compare racemic albuterol (RAC) with levalbuterol (LEV) in continuous form for the treatment of acute pediatric asthma exacerbations in the emergency department.
Study design. Children between the ages of 6 and 17 inclusive were enrolled if they had a history of asthma, presented to the emergency department with an acute asthma exacerbation, and had an initial forced expiratory volume in 1 second (FEV1) <70% predicted. Patients were then randomized to receive either 7.5 mg of RAC or 3.75 mg of LEV over 1 hour, in addition to standard asthma therapies. Spirometry and asthma scoring were performed at the end of the first hour, and a second hour-long nebulization with the same drug was administered if deemed necessary. Spirometry and asthma scoring were again performed and the final disposition was recorded. As a second, optional part of the study, baseline serum albuterol levels were collected on some patients before treatment.
Results. A total of 99 patients completed the study (44 RAC and 55 LEV). Baseline characteristics were similar except that the RAC group had a higher baseline asthma score. Children in the RAC group had a greater improvement in their FEV1 (p = .043) as well as in their asthma scores (p = .01) after 1 hour of continuous treatment compared to the LEV group. The greater improvement in asthma scores was maintained after the second hour of continuous therapy in the RAC group (p = .008) but not for FEV1 measurements (p = .57). There were no differences between groups for changes in heart rate, respiratory rate, oxygen saturation, or rates of admission.
Conclusions. At the doses used, RAC appears to be superior to LEV with respect to changes in FEV1 and asthma score. There was no significant difference between the drugs with respect to admission rates or side-effect profile.
J Asthma. 2011 Mar;48(2):188-93. Epub 2011 Jan 29.
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城区哮喘儿童奥玛珠单抗(IgE抗体)治疗的随机试验
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