每日一次固定剂量的格隆溴铵和茚达特罗双重支气管扩张治疗对慢性阻塞性肺疾病患者的临床获益：系统评价。
Clinical benefit of fixed-dose dual bronchodilation with glycopyrronium and indacaterol once daily in patients with chronic obstructive pulmonary disease: a systematic review.
机构信息
Department of Respiratory Medicine, Hvidovre Hospital and University of Copenhagen, Hvidovre, Denmark.
出版信息
Int J Chron Obstruct Pulmon Dis. 2014 Apr 1;9:331-8. doi: 10.2147/COPD.S60362. eCollection 2014.
BACKGROUND AND AIM
Long-acting bronchodilators are the preferred option for maintenance therapy of patients with chronic obstructive pulmonary disease (COPD). The aim of this review is to provide an overview of the clinical studies evaluating the clinical efficacy of the once-daily fixed-dose dual bronchodilator combination of indacaterol and glycopyrronium bromide in patients suffering from COPD.
METHODS
This study comprised a systematic review of randomized controlled trials identified through systematic searches of different databases of published trials.
RESULTS
Nine trials (6,166 participants) were included. Fixed-dose once-daily indacaterol/glycopyrronium seems to be safe and well tolerated in patients with COPD. Compared with single therapy with other long-acting bronchodilators (indacaterol, glycopyrronium, and tiotropium) and fixed-combination long-acting β2-agonist/inhaled corticosteroid (salmeterol/fluticasone twice daily), once-daily fixed-dose indacaterol/glycopyrronium has clinically important effects on symptoms, including dyspnea score, health status, level of lung function, and rate of moderate or severe exacerbations in patients with moderate-to-very severe COPD (Global initiative for chronic Obstructive Lung Disease [GOLD] spirometric criteria). Furthermore, a very recent study has shown that fixed-dose indacaterol/glycopyrronium improves exercise endurance time compared with placebo, although no significant difference was observed between fixed-dose indacaterol/glycopyrronium and tiotropium.
CONCLUSION
Fixed-dose indacaterol/glycopyrronium has clinically relevant effects on important COPD outcome measures and is, in general, superior to therapy with a single long-acting bronchodilator (with or without inhaled corticosteroid) indicating long-acting dual bronchodilation as a potential important maintenance therapeutic option for patients with symptomatic COPD, possibly also for the treatment of naïve patients.
背景和目的
长效支气管扩张剂是慢性阻塞性肺疾病（COPD）患者维持治疗的首选。本综述的目的是提供对评估每日一次固定剂量联合应用茚达特罗和格隆溴铵治疗 COPD 患者的临床研究的概述。
方法
本研究包括对通过系统检索不同已发表试验数据库而确定的随机对照试验进行的系统综述。
结果
纳入了 9 项试验（6166 名参与者）。每日一次固定剂量的茚达特罗/格隆溴铵在 COPD 患者中似乎是安全且耐受良好的。与其他长效支气管扩张剂（茚达特罗、格隆溴铵和噻托溴铵）的单药治疗以及长效β2-激动剂/吸入性皮质激素（沙美特罗/氟替卡松每日 2 次）固定剂量联合治疗相比，每日一次固定剂量的茚达特罗/格隆溴铵在症状（包括呼吸困难评分、健康状况、肺功能水平以及中重度 COPD 患者中度或重度恶化的发生率[全球慢性阻塞性肺疾病倡议（GOLD）肺功能标准]）方面具有重要的临床疗效。此外，一项最近的研究表明，与安慰剂相比，固定剂量的茚达特罗/格隆溴铵可改善运动耐力时间，尽管固定剂量的茚达特罗/格隆溴铵与噻托溴铵之间未观察到显著差异。
结论
固定剂量的茚达特罗/格隆溴铵对重要的 COPD 结局指标具有显著的临床疗效，总体上优于单药长效支气管扩张剂（有或无吸入性皮质激素）治疗，表明长效双重支气管扩张可能是有症状的 COPD 患者的一种潜在重要维持治疗选择，也可能适用于初治患者。
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