BACKGROUND:This is a meta-analysis of the safety and efficacy of indacaterol in chronic obstructive pulmonary disease (COPD) with treatment duration of ≥12 weeks. METHODS:Randomized controlled trials (RCTs) reported in English (to September 30, 2012) were identified from PubMed, the Cochrane Library, Embase, websites, reference lists, and manual searches. Two reviewers independently assessed the quality of the trials and extracted information. RESULTS:Five RCTs were eligible. Five involved indacaterol, two salmeterol, one formoterol, and one tiotropium. Four studies had placebos. Using trough forced expiratory volume in 1 s as a measure of therapeutic effect, indacaterol was superior to the other β2-agonists, tiotropium, and placebo at weeks 12, 26, and 52. Indacaterol had a greater effect on the transition dyspnoea index compared with placebo, formoterol, and salmeterol, but not open-label tiotropium. In reducing the as-needed use of salbutamol, indacaterol were superior to placebo, tiotropium, and formoterol, but not salmeterol (5, 95 % confidence interval (CI), -2.15, 12.15). Indacaterol improved St George's Respiratory Questionnaire scores more than placebo and open-label tiotropium, but not formoterol. Indacaterol seemed to cause more adverse events than placebo only at a dose of 600 μg daily and a duration of 52 weeks (risk ratio 1.15; 95 % CI, 1.04, 1.26). The total and serious adverse events and adverse events leading to discontinuation were comparable with open-label tiotropium and the β2-agonists. CONCLUSIONS:Indacaterol is effective and well-tolerated as a bronchodilator for the maintenance of moderate to severe COPD.

译文

背景:这是茚达特罗在治疗持续时间≥12周的慢性阻塞性肺疾病(COPD)中的安全性和有效性的荟萃分析。
方法:从PubMed,Cochrane图书馆,Embase,网站,参考文献列表和手册搜索中识别以英语报告的随机对照试验(RCT)(至2012年9月30日)。两名审稿人独立评估了试验的质量并提取了信息。
结果:五项RCT符合条件。其中五种涉及茚达特罗,两种沙美特罗,一种福莫特罗和一种噻托铵。有四项研究有安慰剂。用低谷强迫呼气量作为治疗效果的指标,茚达特罗在第12、26和52周时优于其他β2受体激动剂,噻托溴铵和安慰剂。相比之下,茚达特罗对过渡呼吸困难指数的影响更大。安慰剂,福莫特罗和沙美特罗,但不包括开放标签的噻托铵。在减少按需使用沙丁胺醇时,茚达特罗优于安慰剂,噻托溴铵和福莫特罗,但不比沙美特罗(5,95%置信区间(CI),-2.15,12.15)。茚达特罗比安慰剂和开放标签的噻托溴铵改善了圣乔治呼吸问卷的得分,但福莫特罗没有。仅在每天600μg的剂量和52周的持续时间内,茚达特罗似乎比安慰剂引起更多的不良事件(风险比1.15; 95%CI,1.04,1.26)。总的和严重的不良事件以及导致停药的不良事件与开放标签的噻托铵和β2-激动剂相当。
结论:茚达特罗作为支气管扩张剂有效且耐受性良好,可维持中度至重度COPD。

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