马来酸茚达特罗治疗慢性阻塞性肺疾病的Meta分析

Meta-Analysis of the Treatment of Chronic Obstructive Pulmonary Diseases with Indacaterol Maleate

目的系统评价马来酸茚达特罗治疗慢性阻塞性肺疾病(COPD)的安全性和有效性。方法计算机检索截至2013年12月Pubmed、Embase、中国期刊全文数据库(CNKI)、万方数据库、维普数据库和中国生物医学文献数据库中关于茚达特罗与安慰剂、沙美特罗、噻托溴铵、福莫特罗治疗慢性阻塞性肺疾病的随机对照文献,对符合纳入标准的文献进行质量评价及筛选,采用Rev Man 5.1软件对最终纳入文献的研究结果进行Meta分析。结果共纳入14项随机对照试验,共计8 594例患者。Meta分析结果显示,茚达特罗对慢性阻塞性肺疾病患者给药后24 h谷一秒用力呼气容积的改善显著高于安慰剂[OR平均=0.16,95%CI(0.15,0.18),P<0.01]、沙美特罗[MD=0.08,95%CI(0.08,0.09),P<0.01]、福莫特罗[MD=0.10,95%CI(0.08,0.12),P<0.01]和噻托溴铵[MD=0.02,95%CI(0.01,0.04),P<0.01];不良反应发生与对照组比较无统计学差异,主要的不良反应为慢性阻塞性肺疾病加重、鼻咽炎、咳嗽和头痛。结论茚达特罗在治疗慢性阻塞性肺疾病中的临床有效性和安全性均优于其他支气管舒张剂。

OBJECTIVE To evaluate the efficacy and safety of indacaterol in the treatment of chronic obstructive pulmonary dis- eases （COPD）. METHODS The randomized controlled trials （RCTs） about indacaterol, placebo, salmeterol, tiotropium and formeterol in the treatment of CDPD were collected from Pubmed, Embase, CNKI, Wangfang database, VIP and CBM. The quality of the trials was evaluated and selected, and the results of the studies were reviewed and analyzed using Rev Man 5.1 software. RESULT Fourteen RCTs were included, involving 8 594 patients. Meta-analysis showed that effective rate of improving trough forced expirato- ry volume in one second was higher than that of placebo[ mean OR = 0. 16,95% CI（0. 15,0. 18 ） ,P 〈 0. 01, salmeterol [ MD = 0. 08, 95 % CI （0. 08,0. 09 ）, P 〈 0. 01 ], formeterol [ MD = 0. 10,95% CI （ 0. 08,0. 12 ）, P 〈 0. 01]and tiotropium [ MD = 0. 02,95% CI （0. 01,0. 04） ,P 〈0. 01 ] in the treatment of COPD. In terms of ADR, indacaterol showed no statistical difference with control group. Main ADR include COPD worsening, nasopharyngitis, cough and headache. CONCLUSION Indacaterol is more effective and safer than other bronchodilators in the treatment of COPD.