We are grateful for A.R.L. Medford's interest in our study1。The patients in our trial had relatively severe chronic obstructive pulmonary disease (COPD; mean forced expiratory volume in one second (FEV1) 36% predicted), as did those in a companion study of the same treatment that used a different trial design2。在这两个试验中,布德索德viaa dry powder reservoir delivery system was less effective in preventing exacerbations than fluticisone delivered in a slightly higher dose in the TRial of Inhaled STeroids ANd long-acting β-agonists (TRISTAN) of patients with a mean FEV144% pred3。这些差异可能反映了给定剂量,输送系统或吸入皮质类固醇在更严重疾病中的有效性的差异,我们的数据无法解决这一点。但是,目前正在准备发表的Tristan数据集的最新分析表明,在患有更严重疾病的患者中,吸入的皮质类固醇对加重数量的影响较低,这与该人保持一致,这与该人保持一致我们研究的结果。我们放心地看到,尽管单独给出了吸入的皮质类固醇的影响相对有限,但在两种试验中,布德索尼二烯型形式的组合显着降低了加重数。当前有关在COPD中使用吸入皮质类固醇的指南建议应将其添加到维护支气管扩张剂疗法中,理想情况下应通过长效吸入的支气管扩张剂提供。4,不建议将吸入的皮质类固醇作为单一疗法来预防加重。
Our statement about the benefits of combining treatment ina single inhaler was strictly factual, as we were not in a position to conduct the proposed comparison of fixed dosesversus相同的药物在不同的吸入器。很明显,this isof practical relevance, but, unfortunately, calculating the statistical power of a study that could conclusively establish a difference between such treatment interventions suggests that it would have to be a substantially larger study than any that have been reported so far. We agree that there are good reasons for combining long-acting β-agonists and an inhaled corticosteroid, but the data about dose flexibility in chronic obstructive pulmonary disease has not been explored. There may be some utility in delivering the drugs together in a fixed dose combination at the site of action, rather than potentially allowing for different patterns of airway deposition on individual inhaler actuations. Such concerns remain of theoretical interest, but are hard to test with our existing techniques and in representative populations of chronic obstructive pulmonary disease patients. There are certainly advantages of convenience and, potentially, of treatment adherence by giving both drugs together, but this will need to be established in future studies.
- 已收到July 27, 2004.
- AcceptedAugust 6, 2004.
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