布地奈德/福莫特罗联合噻托溴铵治疗中国慢性阻塞性肺疾病患者有效性和安全性的Meta分析  

Efficacy and Safety of Budesonide/Formoterol Combined with Tiotropium for Chinese Patients with COPD: A Meta-analysis

作　　者：曾林淼[1] 俞晓莲 张清华[1] 韩芳朵[1] 肖建宏[1] 彭清妹[3] 周志军[3] 

机构地区：[1]福建医科大学附属闽东医院呼吸内科,福建福安355000 [2]福建省闽东卫生学校,福建福安355000 [3]井冈山大学临床医学院,江西吉安343000

出　　处：《中国循证医学杂志》2016年第3期325-333,共9页Chinese Journal of Evidence-based Medicine

摘　　要：目的系统评价布地奈德/福莫特罗联合噻托溴铵与单用布地奈德/福莫特罗比较治疗中国慢性阻塞性肺疾病(COPD)患者的有效性及安全性。方法计算机检索PubMed、EMbase、The Cochrane Library(2015年3期)、CNKI、VIP和WanFang Data数据库,搜集布地奈德/福莫特罗联合噻托溴铵与单用布地奈德/福莫特罗治疗中国COPD患者的相关随机对照试验(RCT),检索时限均为从建库至2015年3月。由2位评价者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果共纳入15个RCT,1 123例中国患者。Meta分析结果显示:在有效性方面,与单用布地奈德/福莫特罗比较,噻托溴铵联合布地奈德/福莫特罗能有效改善我国COPD患者的FEV_1[MD=0.19,95%CI(0.12,0.25),P<0.000 01]、FVC[MD=0.35,95%CI(0.14,0.57),P=0.001]、FEV_1%[MD=5.96,95%CI(4.48,7.43),P<0.000 01]、FEV_1占预测值%[MD=6.82,95%CI(2.21,11.43),P=0.004]、FEV_1/FVC[MD=7.72,95%CI(5.69,9.75),P<0.000 01]、m MRC[MD=–0.43,95%CI(–0.52,–0.33),P<0.000 01]、CAT[MD=–1.45,95%CI(–2.26,–0.64),P=0.000 5]、SGRQ[MD=–7.05,95%CI(–9.16,–4.94),P<0.000 01]及6MWT[MD=32.52,95%CI(16.68,48.37),P<0.000 01];在安全性方面,两组不良反应发生率无明显差异[OR=1.77,95%CI(0.79,3.98),P=0.16]。结论现有证据表明,应用噻托溴铵联合布地奈德/福莫特罗可改善中国COPD患者的肺功能和临床症状。受纳入研究数量和质量限制,上述结论尚需开展更多高质量研究予以验证。Objective To systematically evaluate the efficacy and safety of budesonide/formoterol combined with tiotropium versus budesonide/formoterol alone for Chinese patients with COPD. Methods We electronically searched databases including PubMed, EMbase, The Cochrane Library（Issue 3, 2015）, CNKI, VIP and Wan Fang Data to collect randomized controlled trials（RCTs） about budesonide/formoterol combined with tiotropium vs. budesonide/formoterol alone for Chinese COPD patients from inception to March 2015. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was conducted by RevMan 5.3 software. Results A total of 15 studies involving 1 123 Chinese patients were included. The results of meta-analysis showed that, compared with the budesonide/formoterol alone group, the budesonide/formoterol plus tiotropium group could significantly improve the levels of FEV1（MD=0.19, 95%CI 0.12 to 0.25, P〈0.000 01）, FVC（MD=0.35, 95%CI 0.14 to 0.57, P=0.001）, FEV1%（MD=5.96, 95%CI 4.48 to 7.43, P〈0.000 01）, FEV1% pred（MD=6.82, 95%CI 2.21 to 11.43, P=0.004）, FEV1/FVC（MD=7.72, 95%CI 5.69 to 9.75, P〈0.000 01）, m MRC（MD= –0.43, 95%CI –0.52 to –0.33, P〈0.000 01）, CAT（MD= –1.45, 95%CI –2.26 to –0.64, P=0.000 5）, SGRQ（MD= –7.05, 95%CI –9.16 to –4.94, P〈0.000 01） and 6MWT（MD=32.52, 95%CI 16.68 to 48.37, P〈0.000 01）. While there was no significant difference in adverse reaction rates between the two groups（OR=1.77, 95%CI 0.79 to 3.98, P=0.16）. Conclusion Current evidence shows that budesonide/formoterol plus tiotropium can improve lung function and clinical symptom in Chinese patients with COPD. Due to the limited quality and quantity of included studies, more high quality studies are needed to verify the above conclusion.

关 键 词：噻托溴铵 布地奈德/福莫特罗 慢性阻塞性肺疾病 COPD 系统评价 META分析 随机对照试验 

分 类 号：R563.9[医药卫生—呼吸系统]