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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 safety and efficacy of indacaterol maleate in the treatment of chronic obstructive pulmonary disease (COPD). Methods The computer-based searches of Pubmed, Embase, Chinese Journal Full-text Database (CNKI), Wanfang Database, VIP Database and Chinese Biomedical Literature Database were performed on computer for the analysis of indacaterol versus placebo, salmeterol, tiotropium , And formoterol in the treatment of chronic obstructive pulmonary disease (RCT). The quality of the eligible literature was evaluated and screened. RevMan 5.1 software was used to perform meta-analysis of the results of the final inclusion studies. Results A total of 14 RCTs were enrolled in a total of 8 594 patients. Meta-analysis showed that indacaterol had significantly higher forced expiratory volume expiratory volume at 24 h post-treatment in patients with chronic obstructive pulmonary disease than placebo [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] Tiotropium bromide [MD = 0.02,95% CI (0.01,0.04), P <0.01]. Adverse reactions were not statistically different from the control group. The main adverse reactions were chronic obstructive pulmonary disease (COPD), nasopharyngitis, Cough and headache. Conclusion Indacaterol is superior to other bronchodilators in the clinical efficacy and safety in the treatment of chronic obstructive pulmonary disease.