Calverley Peter M, Eriksson Göran, Jenkins Christine R, Anzueto Antonio R, Make Barry J, Persson Anders, Fagerås Malin, Postma Dirkje S
Pulmonary and Rehabilitation Research Group, University Hospital Aintree, Liverpool, UK.
Department of Respiratory Medicine and Allergology, University Hospital, Lund, Sweden.
Int J Chron Obstruct Pulmon Dis. 2016 Dec 19;12:13-25. doi: 10.2147/COPD.S114209. eCollection 2017.
Large clinical trials have confirmed the long-term efficacy of inhaled corticosteroid/long-acting β-agonist combinations in patients with chronic obstructive pulmonary disease (COPD). It was hypothesized that significant treatment effects would already be present within 3 months after the initiation of treatment across a range of clinical outcomes, irrespective of COPD severity.
Post hoc analysis of 3-month post-randomization outcomes, including exacerbation rates, dropouts, symptoms, reliever use, and lung function, from three studies with similar inclusion criteria of moderate-to-very-severe COPD. Patients (n=1,571) were treated with budesonide/formoterol (B/F) 320/9 μg or placebo, twice daily; in one study, tiotropium 18 μg once daily was also given.
Over the first 3 months of treatment, fewer patients randomized to B/F experienced exacerbations versus the placebo group (111 and 196 patients with ≥1 exacerbation, respectively). This was true in each COPD severity group. Compared with placebo, B/F treatment led to significantly lower 3-month exacerbation rates in the moderate and severe COPD severity groups (46% and 57% reduction, respectively), with a nonsignificant reduction (29%) in very severe COPD. Fewer dropouts occurred among patients treated with B/F versus placebo, this effect being greater with increasing COPD severity. B/F was associated with improved forced expiratory volume in 1 s, morning peak expiratory flow rate, total reliever use, and total symptom score versus placebo.
Treatment with B/F decreased exacerbations in patients with moderate-to-very-severe COPD within 3 months of commencing treatment. This effect was paralleled by improved lung function, less reliever medication use, and fewer symptoms, irrespective of disease severity.
大型临床试验已证实吸入性糖皮质激素/长效β受体激动剂联合用药对慢性阻塞性肺疾病（COPD）患者的长期疗效。研究假设，无论COPD严重程度如何，在治疗开始后的3个月内，一系列临床结局中均会出现显著的治疗效果。
对三项纳入标准相似的中重度至极重度COPD研究进行事后分析，这些研究的随机分组后3个月结局包括急性加重率、退出研究情况、症状、缓解药物使用情况及肺功能。1571例患者每日两次接受布地奈德/福莫特罗（B/F）320/9μg或安慰剂治疗；在一项研究中，还每日一次给予18μg噻托溴铵。
在治疗的前3个月，随机接受B/F治疗的患者急性加重次数少于安慰剂组（分别有111例和196例患者发生≥1次急性加重）。各COPD严重程度组均如此。与安慰剂相比，B/F治疗使中重度和重度COPD严重程度组的3个月急性加重率显著降低（分别降低46%和57%），而在极重度COPD组降低不显著（29%）。与安慰剂相比，接受B/F治疗的患者退出研究的情况较少，且COPD严重程度越高，这一效果越明显。与安慰剂相比，B/F可改善1秒用力呼气容积、早晨呼气峰流速、缓解药物总使用量及总症状评分。
在开始治疗的3个月内，B/F治疗可减少中重度至极重度COPD患者的急性加重次数。无论疾病严重程度如何，这一效果伴随着肺功能改善、缓解药物使用减少及症状减轻。
