Efficacy and Safety of Budesonide/Formoterol Combined with Tiotropium for Chinese Patients with COPD: A Meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 ZENGLin-miao ¹ , YUXiao-lian ² , ZHANGQing-hua ¹ , HANFang-duo ¹ , XIAOJian-hong ¹ , PENGQing-mei ³ , ZHOUZhi-jun ³

1. Department of Respiratory, Mindong Hospital Affiliated to Fujian Medical University, Fu'an 355000, China;
2. Fujian Mindong Medical School, Fu'an 355017, China;
3. Clinical Medical College, Jinggangshan University, Ji'an 343000, China;

Corresponding author：

Keywords：

Tiotropium; Budesonide/formoterol; Chronic obstructive pulmonary disease; COPD; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20160051

Video：

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Abstract Full text Figures/Tables Video References Cited by

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 WanFang 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 1123 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<0.00001), 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<0.00001), 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<0.00001), mMRC (MD=-0.43, 95%CI -0.52 to -0.33, P<0.00001), CAT (MD=-1.45, 95%CI -2.26 to -0.64, P=0.0005), SGRQ (MD=-7.05, 95%CI -9.16 to -4.94, P<0.00001) and 6MWT (MD=32.52, 95%CI 16.68 to 48.37, P<0.00001). 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.

Citation： ZENGLin-miao, YUXiao-lian, ZHANGQing-hua, HANFang-duo, XIAOJian-hong, PENGQing-mei, ZHOUZhi-jun. Efficacy and Safety of Budesonide/Formoterol Combined with Tiotropium for Chinese Patients with COPD: A Meta-analysis. Chinese Journal of Evidence-Based Medicine, 2016, 16(3): 325-333. doi: 10.7507/1672-2531.20160051 Copy

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3.	Abdool-Gaff MS, Ambaram A, Ainslie GM, et al. Guideline for the management of chronic obstructive pulmonary disease-2011 update. SAMJ, 2011, 101(1):62-73.
4.	Lopez AD, Shibuya K, Rao C, et al. Chronic obstructive pulmonary disease:current burden and fiiture projections. Eur Respir J, 2006, 27(2):397-412.
5.	卓广英, 何庆. 2011 GOLD推荐3种方案治疗慢性阻塞性肺疾病稳定期的药物经济学分析. 四川医学, 2013, 34(1):28-30.
6.	Higgins JP, Green S. Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0).[cited 2012 Jan 5]. Available at:http://www.cochrane-handbook.org.
7.	魏亚强, 赵红. 布地奈德/福莫特罗粉剂联合噻托溴铵粉剂吸入治疗稳定期慢性阻塞性肺疾病临床研究. 陕西医学杂志, 2012, 41(7):880-881.
8.	刘鹏珍, 宋春钰, 刘艳芹. 噻托溴铵联合信必可都保吸入剂治疗COPD稳定期的疗效观察. 临床肺科杂志, 2013, 18(3):544.
9.	林卫涵, 吴卫锋. 噻托溴铵与布地奈德福莫特罗粉联合吸入在重度、极重度COPD稳定期中的疗效观察. 中国现代药物应用, 2013, 7(11):9-11.
10.	田玉恒, 马原, 陈书文. 布地奈德/福莫特罗粉剂联合噻托溴铵治疗稳定期慢性阻塞性肺疾病的疗效探究. 中国现代药物应用, 2014, 8(19):124-125.
11.	刘勇, 解玉东. 布地奈德/福莫特罗干粉吸入剂联合噻托溴铵治疗中重度稳定期COPD疗效评价. 中国实用医药, 2013, 8(16):165-166.
12.	叶青, 张立波, 范荣梅, 等. 布地奈德福莫特罗联合噻托溴铵对重度慢性阻塞性肺疾病稳定期患者的疗效分析. 中华肺部疾病杂志(电子版), 2014,7(3):45-48.
13.	张维杰, 李辉, 刘相海, 等. 联合吸入布地奈德/福莫特罗和噻托溴铵在治疗中重度稳定期慢性阻塞性肺疾病中的临床疗效研究. 中国医药指南, 2013, 11(36):148-149.
14.	李翠芬, 张华, 张增, 等. 联合吸入布地奈德/福莫特罗和噻托溴铵治疗老年慢性阻塞性肺疾病临床研究. 泰山医学院学报, 2010, 31(11):853-855.
15.	时迎俊, 赵玉良, 丁宁. 联合吸入噻托溴铵和布地奈德福莫特罗对中重度稳定期慢性阻塞性肺疾病疗效评价. 黑龙江医药, 2014, 27(4):817-819.
16.	王雪莹, 尚卫红, 张智伟. 联合应用布地奈德福莫特罗与噻托溴铵治疗COPD稳定期的临床观察. 中外健康文摘, 2013, 10(14):225-225.
17.	张红莉, 邓卫中, 宋文玲. 两种药物联合治疗稳定期COPD患者的临床疗效观察. 中国现代药物应用, 2014, 8(9):126-127.
18.	陈望月, 程德云, 李鹤, 等. 噻托溴铵、布地奈德/福莫特罗及联合方案对COPD稳定期D组患者的疗效观察. 四川大学学报(医学版), 2014, 45(5):876-879.
19.	张剑青, 刘凌, 方利洲, 等. 噻托溴铵和布地奈德/福莫特罗治疗慢性阻塞性肺疾病的疗效与安全性研究. 中国医师进修杂志, 2010, 33(22):12-15.
20.	张继贤, 姜益, 赵莺. 噻托溴铵联合布地奈德/福莫特罗吸入治疗慢性阻塞性肺疾病的临床分析. 中国医师进修杂志, 2014, 37(28):66-68.
21.	吴颖宇. 噻托溴铵联合布地奈德/福莫特罗治疗慢性阻塞性肺疾病稳定期的临床分析. 中国伤残医学, 2014, 22(15):99-101.
22.	Tonnesen P, Lauri H, Perfekt R, et al. Efficacy of a nicotine mouth spray in smoking cessation:a randomised, double-blind trial. Eur Respir J, 2012, 40(3):548-554.
23.	GOLD Executive Summary (revised 2014) Global strategy for the diagnosis, management and prevention of COPD.[Accessed November 5, 2014]. Available at:http://www.goldcopd.com/.
24.	Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD:a network meta-analysis. Cochrane Database Syst Rev, 2014, (3):CD010844.
25.	Puhan MA, Bachmann LM, Kleijnen J, et al. Inhaled drugs to reduce exacerbations in patients with chronic obstructive pulmonary disease:a network meta-analysis. BMC Med, 2009, 7:2.
26.	van der Meer RM, Wagena EJ, Ostelo RW, et al. Smoking cessation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev, 2003, (2):CD002999.
27.	许成芳, 朱建波, 梁芳. 沙美特罗/氟替卡松(50/500)吸入治疗缓解期慢性阻塞性肺疾病72例. 实用医学杂志, 2009, 25(23):4054-4056.
28.	Karner C, Cates CJ. The effect of adding inhaled corticosteroids to tiotropium and long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst, 2011, (9):CD009039.
29.	Welte T, Miravitlles M, Hernandez P, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med, 2009; 180(8):741-750.
30.	向利华. 噻托溴铵粉吸入治疗慢性阻塞性肺疾病稳定期的疗效. 中国实用医刊, 2015, 42(5):71-72.
31.	Keam SJ, Keating GM. Tiotropium bromide. A review of its use as maintenance therapy in patients with COPD. Treat Respir Med, 2004, 3(4):247-268.
32.	Gil Aldea I, Azanza JR, Palacios E, et al. Tiotropium. Rev Med Univ Navarra, 2003, 47(3):49-52.
33.	Barr RG, Bourbeau J, Camargo CA. Tiotropium for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev, 2005, (2):CD002876.
34.	李卫阳. 布地奈德/福莫特罗粉剂联合噻托溴铵治疗慢性阻塞性肺疾病稳定期的疗效分析. 中国实用医药, 2015, 10(7):184-185.
35.	程妮. 布地奈德福莫特罗粉剂联合噻托溴铵治疗稳定期慢性阻塞性肺疾病的疗效探究. 中国实用医药, 2015, 10(5):142-143.
36.	陈锐, 卢火俭. 噻托溴胺粉雾剂对稳定期老年慢性阻塞性肺病患者内皮细胞功能的影响及疗效. 中国老年学杂志, 2013, 33(20):5156-5157.
37.	林茂华, 唐雨晴, 王智辉, 等. 布地奈德福莫特罗粉吸入剂联合噻托溴铵治疗慢性阻塞性肺疾病的临床疗效和安全性. 中国现代药物应用, 2015, 9(6):3-4.

1. 中华医学会呼吸病学分会慢性阻塞性肺疾病学组. 慢性阻塞性肺疾病诊治指南(2013年修订版). 中华结核和呼吸杂志, 2013, 36(4):255-264.
2. 中华人民共和国卫生部医政司.慢性阻塞性肺疾病诊疗规范(2011版), 卫办医政发108号. Available at:http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohyzs/s3586/201108/52675.htm.
3. Abdool-Gaff MS, Ambaram A, Ainslie GM, et al. Guideline for the management of chronic obstructive pulmonary disease-2011 update. SAMJ, 2011, 101(1):62-73.
4. Lopez AD, Shibuya K, Rao C, et al. Chronic obstructive pulmonary disease:current burden and fiiture projections. Eur Respir J, 2006, 27(2):397-412.
5. 卓广英, 何庆. 2011 GOLD推荐3种方案治疗慢性阻塞性肺疾病稳定期的药物经济学分析. 四川医学, 2013, 34(1):28-30.
6. Higgins JP, Green S. Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0).[cited 2012 Jan 5]. Available at:http://www.cochrane-handbook.org.
7. 魏亚强, 赵红. 布地奈德/福莫特罗粉剂联合噻托溴铵粉剂吸入治疗稳定期慢性阻塞性肺疾病临床研究. 陕西医学杂志, 2012, 41(7):880-881.
8. 刘鹏珍, 宋春钰, 刘艳芹. 噻托溴铵联合信必可都保吸入剂治疗COPD稳定期的疗效观察. 临床肺科杂志, 2013, 18(3):544.
9. 林卫涵, 吴卫锋. 噻托溴铵与布地奈德福莫特罗粉联合吸入在重度、极重度COPD稳定期中的疗效观察. 中国现代药物应用, 2013, 7(11):9-11.
10. 田玉恒, 马原, 陈书文. 布地奈德/福莫特罗粉剂联合噻托溴铵治疗稳定期慢性阻塞性肺疾病的疗效探究. 中国现代药物应用, 2014, 8(19):124-125.
11. 刘勇, 解玉东. 布地奈德/福莫特罗干粉吸入剂联合噻托溴铵治疗中重度稳定期COPD疗效评价. 中国实用医药, 2013, 8(16):165-166.
12. 叶青, 张立波, 范荣梅, 等. 布地奈德福莫特罗联合噻托溴铵对重度慢性阻塞性肺疾病稳定期患者的疗效分析. 中华肺部疾病杂志(电子版), 2014,7(3):45-48.
13. 张维杰, 李辉, 刘相海, 等. 联合吸入布地奈德/福莫特罗和噻托溴铵在治疗中重度稳定期慢性阻塞性肺疾病中的临床疗效研究. 中国医药指南, 2013, 11(36):148-149.
14. 李翠芬, 张华, 张增, 等. 联合吸入布地奈德/福莫特罗和噻托溴铵治疗老年慢性阻塞性肺疾病临床研究. 泰山医学院学报, 2010, 31(11):853-855.
15. 时迎俊, 赵玉良, 丁宁. 联合吸入噻托溴铵和布地奈德福莫特罗对中重度稳定期慢性阻塞性肺疾病疗效评价. 黑龙江医药, 2014, 27(4):817-819.
16. 王雪莹, 尚卫红, 张智伟. 联合应用布地奈德福莫特罗与噻托溴铵治疗COPD稳定期的临床观察. 中外健康文摘, 2013, 10(14):225-225.
17. 张红莉, 邓卫中, 宋文玲. 两种药物联合治疗稳定期COPD患者的临床疗效观察. 中国现代药物应用, 2014, 8(9):126-127.
18. 陈望月, 程德云, 李鹤, 等. 噻托溴铵、布地奈德/福莫特罗及联合方案对COPD稳定期D组患者的疗效观察. 四川大学学报(医学版), 2014, 45(5):876-879.
19. 张剑青, 刘凌, 方利洲, 等. 噻托溴铵和布地奈德/福莫特罗治疗慢性阻塞性肺疾病的疗效与安全性研究. 中国医师进修杂志, 2010, 33(22):12-15.
20. 张继贤, 姜益, 赵莺. 噻托溴铵联合布地奈德/福莫特罗吸入治疗慢性阻塞性肺疾病的临床分析. 中国医师进修杂志, 2014, 37(28):66-68.
21. 吴颖宇. 噻托溴铵联合布地奈德/福莫特罗治疗慢性阻塞性肺疾病稳定期的临床分析. 中国伤残医学, 2014, 22(15):99-101.
22. Tonnesen P, Lauri H, Perfekt R, et al. Efficacy of a nicotine mouth spray in smoking cessation:a randomised, double-blind trial. Eur Respir J, 2012, 40(3):548-554.
23. GOLD Executive Summary (revised 2014) Global strategy for the diagnosis, management and prevention of COPD.[Accessed November 5, 2014]. Available at:http://www.goldcopd.com/.
24. Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD:a network meta-analysis. Cochrane Database Syst Rev, 2014, (3):CD010844.
25. Puhan MA, Bachmann LM, Kleijnen J, et al. Inhaled drugs to reduce exacerbations in patients with chronic obstructive pulmonary disease:a network meta-analysis. BMC Med, 2009, 7:2.
26. van der Meer RM, Wagena EJ, Ostelo RW, et al. Smoking cessation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev, 2003, (2):CD002999.
27. 许成芳, 朱建波, 梁芳. 沙美特罗/氟替卡松(50/500)吸入治疗缓解期慢性阻塞性肺疾病72例. 实用医学杂志, 2009, 25(23):4054-4056.
28. Karner C, Cates CJ. The effect of adding inhaled corticosteroids to tiotropium and long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst, 2011, (9):CD009039.
29. Welte T, Miravitlles M, Hernandez P, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med, 2009; 180(8):741-750.
30. 向利华. 噻托溴铵粉吸入治疗慢性阻塞性肺疾病稳定期的疗效. 中国实用医刊, 2015, 42(5):71-72.
31. Keam SJ, Keating GM. Tiotropium bromide. A review of its use as maintenance therapy in patients with COPD. Treat Respir Med, 2004, 3(4):247-268.
32. Gil Aldea I, Azanza JR, Palacios E, et al. Tiotropium. Rev Med Univ Navarra, 2003, 47(3):49-52.
33. Barr RG, Bourbeau J, Camargo CA. Tiotropium for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev, 2005, (2):CD002876.
34. 李卫阳. 布地奈德/福莫特罗粉剂联合噻托溴铵治疗慢性阻塞性肺疾病稳定期的疗效分析. 中国实用医药, 2015, 10(7):184-185.
35. 程妮. 布地奈德福莫特罗粉剂联合噻托溴铵治疗稳定期慢性阻塞性肺疾病的疗效探究. 中国实用医药, 2015, 10(5):142-143.
36. 陈锐, 卢火俭. 噻托溴胺粉雾剂对稳定期老年慢性阻塞性肺病患者内皮细胞功能的影响及疗效. 中国老年学杂志, 2013, 33(20):5156-5157.
37. 林茂华, 唐雨晴, 王智辉, 等. 布地奈德福莫特罗粉吸入剂联合噻托溴铵治疗慢性阻塞性肺疾病的临床疗效和安全性. 中国现代药物应用, 2015, 9(6):3-4.

Chinese Journal of Evidence-Based Medicine

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

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