Effects of montelukast and beclomethasone on airway function and asthma control
Effects of montelukast and beclomethasone on airway function and asthma control
复制标题
DOI：
10.1067/mai.2002.129413
复制
发表时间：
2002-12-01
影响因子：
14.2
通讯作者：
Edelman, JM
中科院分区：
文献类型：
--
作者：
Israel, E;Chervinsky, PS;Edelman, JM
背景：维持哮喘控制是治疗的主要目标。传统上，哮喘治疗的有效性主要通过其对气道功能的影响来判断，而不是通过对多方面哮喘控制的影响来判断。目的：比较吸入性皮质类固醇和白三烯受体拮抗剂，以确定它们是否提供等效的效果，通过哮喘控制天数来判断。方法：在一项随机、多中心、双盲、安慰剂对照、平行组研究中，782例FEV 1百分比预测值在50%-85%之间，每周平均β激动剂使用超过2喷/天的哮喘患者随机接受孟鲁司特治疗（10毫克，每天），倍氯米松（200微克，每天两次），或安慰剂治疗6周的双模拟方式。我们检查了主要终点的分布：哮喘控制天数的百分比。次要终点包括FEV 1，沙丁胺醇的使用，发生哮喘发作，哮喘发作，抢救皮质类固醇的使用，持续哮喘控制，和不良experiences.Results：哮喘控制天数的百分比之间的孟鲁司特和倍氯米松组几乎相同（98%的分布重叠）。孟鲁司特至少与倍氯米松相当，并且在哮喘发作、哮喘发作和补救皮质类固醇使用频率的基础上，两者均大于安慰剂。在改善FEV 1方面，倍氯米松优于孟鲁司特，两种治疗均优于安慰剂。结论：从除FEV 1以外的临床控制指标判断，孟鲁司特与倍氯米松同样有效。在评价孟鲁司特治疗的结果时，FEV 1可能低估了临床疗效。
Background: Maintaining asthma control is a major objective of therapy. Traditionally, the effectiveness of asthma therapy has been judged primarily by its effect on airway function rather than on multiaspect asthma control.Objective: An inhaled corticosteroid and a leukotriene receptor antagonist were compared to determine whether they provided equivalent effects, as judged by days of asthma control.Methods: In a randomized, multicenter, double-blind, placebocontrolled, parallel-group study, asthmatic patients (n = 782) with FEV1 percent predicted values of between 50% and 85% and a weekly average beta-agonist use of more than 2 puffs per day were randomized to receive montelukast (10 mg daily), beclomethasone (200 mug twice daily), or placebo treatment for 6 weeks in a double-dummy fashion. We examined the distribution of the primary end point: percentage of days of asthma control. Secondary end points included FEV1, albuterol use, occurrence of an asthma attack, asthma flare-up, rescue corticosteroid use, sustained asthma control, and adverse experiences.Results: The percentage of days of asthma control was almost identical between the montelukast and beclomethasone groups (98% overlap in the distribution). Montelukast was at least equal to beclomethasone, and both were greater than placebo on the basis of frequency of asthma attacks, asthma flare-ups, and rescue corticosteroid use. Beclomethasone had a greater effect than montelukast and both treatments were better than placebo at improving FEV1.Conclusions: Montelukast was as effective as beclomethasone, as judged by indices of clinical control other than FEV1. When evaluating the outcome of montelukast therapy, FEV1 might underestimate clinical effectiveness.