摘要
目的系统评价茚达特罗与噻托溴铵比较治疗慢性阻塞性肺疾病(COPD)的有效性和安全性。方法计算机检索PubMed、EMbase、The Cochrane Library、CNKI、VIP和WanFang Data数据库,搜集茚达特罗与噻托溴铵比较治疗COPD的随机对照试验(RCT),检索时限从建库至2016年11月。由两位研究者独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man 5.1软件进行Meta分析。结果共纳入10个RCT,包括10 415例患者,其中茚达特罗组5 686例,对照组4 729例。Meta分析结果显示:(1)在改善治疗后一秒用力呼气容积(FEV1)方面,两组差异无统计学意义[MD=0.00,95%CI(–0.03,0.03),P=0.79]。亚组分析结果显示,仅在随访2周时茚达特罗优于噻托溴铵[MD=–0.05,95%CI(–0.10,0.00),P=0.03]。(2)在改善短暂呼吸困难指数(TDI)方面,茚达特罗优于噻托溴铵[RR=1.09,95%CI(1.05,1.14),P<0.000 1]。(3)虽然在改善圣乔治呼吸问卷评分(SGRQ)方面,两组差异无统计学意义[MD=–0.48,95%CI(–1.42,0.47),P=0.32],但茚达特罗在改善SGRQ≥4分患者方面优于噻托溴铵[RR=1.13,95%CI(1.05,1.22),P=0.002]。(4)在总体不良反应发生率[RR=1.05,95%CI(1.01,1.09),P=0.01]方面,茚达特罗优于噻托溴铵。但在严重不良反应发生率方面,两组差异无统计学意义[RR=1.02,95%CI(0.89,1.16),P=0.81]。结论茚达特罗与噻托溴铵在改善COPD患者的肺功能方面效果相似,而在TDI及SGRQ方面优于噻托溴铵。两组的严重不良反应相当。受纳入研究质量和数量限制,上述结论尚需开展更多高质量研究予以验证。
Objective To systematically review the efficacy and safety of indacaterol compared with tiotropium in the treatment of chronic obstructive pulmonary disease (COPD). Methods We electronically searched databases including PubMed, EMbase, The Cochrane Library, CNKI, VIP and WanFang Data to collect randomized controlled trims (RCTs) about indacaterol versus tiotropium for COPD patients from inception to November 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.1 software. Results A total of 10 RCTs involving 10 415 patients were included, 5 686 patients were in tiotropium group and 4 729 patients in tiotropium group. The results ofmeta-analysis showed that there was no significant difference between both groups for improving trough forced expiratory volume in one second pulmonary function (FEV,) (MD=0.00, 95%CI -0.03 to 0.03, P=0.79). In the subgroup analysis, it was found that indacaterol had a significant advantage over tiotropium in improving FEV1 over the first 2 weeks (MD=-0.05, 95%CI -0.10 to 0.00, P=0.03). As to the transition dyspnoea index, indoruterol was superior to tiotropium (RR= 1.09, 95%CI 1.05 to 1.14, P〈0.000 1). Although there was no significant difference of two groups in the St George's respiratory questionnaire score (SGRQ) (MD=-0.48, 95%CI -1.42 to 0.47, P=0.32), indoruterol could significantly improve it among patients whose SGRQ score was greater than or equal 4 than tiotropium (RR=1.13, 95%CI 1.05 to 1.22, P=0.002). Indoruterol had lower overall incidence of adverse reactions (RR=I.05, 95%CI 1.01 to 1.09, P=0.01), but there was no significant difference between two groups in severe adverse events (RR=1.02, 95%CI 0.89 to 1.16, P=0.81). Conclusion Indacaterol and tiotropium are similar in improving lung function in COPD patients, however, the indacaterol is better than tiotropium in TDI and SGRQ. There is no significant differ
作者
江训盛
张艳霞
董必文
周娜
焦深山
JIANG Xunsheng ZHANG Yanxia DONG Biwen ZHOU Na JIAO Shenshan(Department of Respiratory Medicine, Nanchang Third Hospital, Nanchang, 330006, P.R.Chin)
出处
《中国循证医学杂志》
CSCD
2017年第7期783-791,共9页
Chinese Journal of Evidence-based Medicine
关键词
茚达特罗
噻托溴铵
慢性阻塞性肺疾病
META分析
系统评价
随机对照试验
Indacaterol
Tiotropium
Chronic obstructive pulmonary disease
Systematic review
Meta-analysis
Randomized controlled trial