联合吸入芜地澳镀与糖皮质激素/长效β2受体激动剂治疗慢性阻塞性肺疾病有效性和安全性的系统评价

摘要

Objective To evaluate the effectiveness and safety of umeclidinium/ inhaled corticosteroid/ longacting?z-agonist (UMEC/ICS/LABA) in the treatment of chronic obstructive pulmonary disease(COPD). Meth叫SPubMed , Embase, Cochrane Central Register of Controlled Trials(CENTRAL) , ClinicalTrail. gov. CBM. VIP, CNKIand WanFang Data were electronically searched for randomized controlled trials (RCTs)about UMEC/ICS/LABA forCOPD from inception to May 28 , 2018. Two reviewers independently screened literatures, extracted data and assessedthe risk of bias of included studies. Then. meta-analysis was performed using RevMan 5.3 and R software. ResultsSeven RCTs involving 13 219 patients were included. UMEC 62. 5μg/ICS/LABA vs PBO/ICS/LABA: UMEC 62.5μg/ICS/LABA ∞uld sigIùficantly improve the lung function (trough FEV. [MD = O. 13, 95 % Cl = O. 10 to O. 15, P <0.00001] , 0-6 h wmFEV,[MD =0.16 , 95% Cl 0.14 to 0.17 , P <0.00001] , Peak FEV, [MD =0.16 , 95% ClO. 14 to O. 18. P <0. 00001J , Trough FVC [ MD =0.21, 95 % CI O. 19 to O. 23 , P <0. 00001J) and the'quality of life(SGRQ score[ MD = -1. 83 , 95% CI -2.31 to 1. 34. P <0. 00001J. TDI score[ MD = 0.54 , 95% CI 0.29 to0.78 , P <0. 00001] , CAT score[ MD = -0.93 , 95% CI 一1. 29 t。一0.57 ， P <0. 00001J). reduce the use of rescuedrugs(salbutamoJ) and the rate of COPD acute exacerbation (RR =0.84 ,95% CI [0.79 , 0. 89J , P <0.00001) whilenot increase the drug-relating adverse events ( RR = 1. 00 ,95 % CI [0. 90 ,1. 12]， P =0. 99. (2) UMEC 125μg/ICS/LABA vs PBO/ICS/LABA : UMEC 125μg/ICS/LABA could significantly improve the lung function and the qualityof life, reduce the use of rescue drugs (salbutamol). However there is no difference in the rate of COPD acuteexacerbation [RR =0.57 ,95% CI (0.24 ,1. 37), P =0.21J and a hígher drug-relating adverse events rate than thecontrol group [RR = 1. 44 , 95 % CI (1. 00, 2. 08) , P = O. 05 J . Conclusion Both UMEC 62. 5μg and 125μg incombination with ICS/LABA are superior to PBO/ICS/LABA in the treatment of COPD patients, which cansignificantly improve lung function and the quality of life. UMEC 62. 5μg is preferred because of the lower adverseevents rate. However, due to the limitation of quantity of inc1uded studies, this conc1usion should be further confirmedby more high quality studies.%目的 系统评价芜地涣镑(Umedidinium. UMEC)与糖皮质激素/长效。β2受体激动剂(UMEC/ICS/LABA)三联吸入治疗慢性阻塞性肺疾病(COPD>的有效性和安全性.方法 检索PubMed、Embase、Cochrane Central Register of Controlled Trials (CENTRAL)、ClinicalTrail.gov、CBM、VIP、CNKL WanFang Data等数据库，搜集合UMEC与ICS/LABA三联治疗COPD的随机对照试验，检余时限均从建库至2018年5月28日。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用RevMan5.3和R软件进行数据处理分析。结果 纳入7个RCT.共132191列患者。UMEC 62.5μg/ICS/LABA vs安慰剂(PBO)/ICS/LABA， UMEC 62.5μg试验组能显著改善1秒用力呼气量谷值(Trough FEV,)[MD=0.13, 95% Cl (0.10.0.15). P<0.00001]、0-6小时加权平均1秒用力呼气量(0-6 h wmFEV,)[MD =0.16.95% Cl (0.14,0.17), P <0.00001]、1秒用力呼气量峰值(Peak FEV,)[MD=0.16,95% Cl (0.14.0.1肘，P<0.00001]、用力肺活量谷值(Trough FVC) [MD=0.21, 95% Cl (0.19,0.23), P<0.00001]等肺功能评价指标:并能改善生存质量评价指标，如圣乔治呼吸问卷(SGRQ)评分[MD=-1.83,95% Cl (-2.31,-1.34), P<0. 00001]、过度呼吸困难指数(TDl)评分[MD=0.54,95% Cl (0.29，0.7肘，P<0.00001]、COPD评估测试(CAT)评分[MD=-0.93,95% Cl (-1.29, -0.57), P <0.00001];同时，减少救援药物(沙丁麟碎〉的使用、降低COPD急性加重率[RR=0.84,95%Cl (0.79, 0.89), P