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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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

1.	中華醫學會呼吸病學分會慢性阻塞性肺疾病學組. 慢性阻塞性肺疾病診治指南(2013年修訂版). 中華結核和呼吸雜志, 2013, 36(4):255-264.
2.	中華人民共和國衛生部醫政司.慢性阻塞性肺疾病診療規范(2011版), 衛辦醫政發108號. 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.	卓廣英, 何慶. 2011 GOLD推薦3種方案治療慢性阻塞性肺疾病穩定期的藥物經濟學分析. 四川醫學, 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.	魏亞強, 趙紅. 布地奈德/福莫特羅粉劑聯合噻托溴銨粉劑吸入治療穩定期慢性阻塞性肺疾病臨床研究. 陜西醫學雜志, 2012, 41(7):880-881.
8.	劉鵬珍, 宋春鈺, 劉艷芹. 噻托溴銨聯合信必可都保吸入劑治療COPD穩定期的療效觀察. 臨床肺科雜志, 2013, 18(3):544.
9.	林衛涵, 吳衛鋒. 噻托溴銨與布地奈德福莫特羅粉聯合吸入在重度、極重度COPD穩定期中的療效觀察. 中國現代藥物應用, 2013, 7(11):9-11.
10.	田玉恒, 馬原, 陳書文. 布地奈德/福莫特羅粉劑聯合噻托溴銨治療穩定期慢性阻塞性肺疾病的療效探究. 中國現代藥物應用, 2014, 8(19):124-125.
11.	劉勇, 解玉東. 布地奈德/福莫特羅干粉吸入劑聯合噻托溴銨治療中重度穩定期COPD療效評價. 中國實用醫藥, 2013, 8(16):165-166.
12.	葉青, 張立波, 范榮梅, 等. 布地奈德福莫特羅聯合噻托溴銨對重度慢性阻塞性肺疾病穩定期患者的療效分析. 中華肺部疾病雜志(電子版), 2014,7(3):45-48.
13.	張維杰, 李輝, 劉相海, 等. 聯合吸入布地奈德/福莫特羅和噻托溴銨在治療中重度穩定期慢性阻塞性肺疾病中的臨床療效研究. 中國醫藥指南, 2013, 11(36):148-149.
14.	李翠芬, 張華, 張增, 等. 聯合吸入布地奈德/福莫特羅和噻托溴銨治療老年慢性阻塞性肺疾病臨床研究. 泰山醫學院學報, 2010, 31(11):853-855.
15.	時迎俊, 趙玉良, 丁寧. 聯合吸入噻托溴銨和布地奈德福莫特羅對中重度穩定期慢性阻塞性肺疾病療效評價. 黑龍江醫藥, 2014, 27(4):817-819.
16.	王雪瑩, 尚衛紅, 張智偉. 聯合應用布地奈德福莫特羅與噻托溴銨治療COPD穩定期的臨床觀察. 中外健康文摘, 2013, 10(14):225-225.
17.	張紅莉, 鄧衛中, 宋文玲. 兩種藥物聯合治療穩定期COPD患者的臨床療效觀察. 中國現代藥物應用, 2014, 8(9):126-127.
18.	陳望月, 程德云, 李鶴, 等. 噻托溴銨、布地奈德/福莫特羅及聯合方案對COPD穩定期D組患者的療效觀察. 四川大學學報(醫學版), 2014, 45(5):876-879.
19.	張劍青, 劉凌, 方利洲, 等. 噻托溴銨和布地奈德/福莫特羅治療慢性阻塞性肺疾病的療效與安全性研究. 中國醫師進修雜志, 2010, 33(22):12-15.
20.	張繼賢, 姜益, 趙鶯. 噻托溴銨聯合布地奈德/福莫特羅吸入治療慢性阻塞性肺疾病的臨床分析. 中國醫師進修雜志, 2014, 37(28):66-68.
21.	吳穎宇. 噻托溴銨聯合布地奈德/福莫特羅治療慢性阻塞性肺疾病穩定期的臨床分析. 中國傷殘醫學, 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.	許成芳, 朱建波, 梁芳. 沙美特羅/氟替卡松(50/500)吸入治療緩解期慢性阻塞性肺疾病72例. 實用醫學雜志, 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.	向利華. 噻托溴銨粉吸入治療慢性阻塞性肺疾病穩定期的療效. 中國實用醫刊, 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.	李衛陽. 布地奈德/福莫特羅粉劑聯合噻托溴銨治療慢性阻塞性肺疾病穩定期的療效分析. 中國實用醫藥, 2015, 10(7):184-185.
35.	程妮. 布地奈德福莫特羅粉劑聯合噻托溴銨治療穩定期慢性阻塞性肺疾病的療效探究. 中國實用醫藥, 2015, 10(5):142-143.
36.	陳銳, 盧火儉. 噻托溴胺粉霧劑對穩定期老年慢性阻塞性肺病患者內皮細胞功能的影響及療效. 中國老年學雜志, 2013, 33(20):5156-5157.
37.	林茂華, 唐雨晴, 王智輝, 等. 布地奈德福莫特羅粉吸入劑聯合噻托溴銨治療慢性阻塞性肺疾病的臨床療效和安全性. 中國現代藥物應用, 2015, 9(6):3-4.

1. 中華醫學會呼吸病學分會慢性阻塞性肺疾病學組. 慢性阻塞性肺疾病診治指南(2013年修訂版). 中華結核和呼吸雜志, 2013, 36(4):255-264.
2. 中華人民共和國衛生部醫政司.慢性阻塞性肺疾病診療規范(2011版), 衛辦醫政發108號. 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. 卓廣英, 何慶. 2011 GOLD推薦3種方案治療慢性阻塞性肺疾病穩定期的藥物經濟學分析. 四川醫學, 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. 魏亞強, 趙紅. 布地奈德/福莫特羅粉劑聯合噻托溴銨粉劑吸入治療穩定期慢性阻塞性肺疾病臨床研究. 陜西醫學雜志, 2012, 41(7):880-881.
8. 劉鵬珍, 宋春鈺, 劉艷芹. 噻托溴銨聯合信必可都保吸入劑治療COPD穩定期的療效觀察. 臨床肺科雜志, 2013, 18(3):544.
9. 林衛涵, 吳衛鋒. 噻托溴銨與布地奈德福莫特羅粉聯合吸入在重度、極重度COPD穩定期中的療效觀察. 中國現代藥物應用, 2013, 7(11):9-11.
10. 田玉恒, 馬原, 陳書文. 布地奈德/福莫特羅粉劑聯合噻托溴銨治療穩定期慢性阻塞性肺疾病的療效探究. 中國現代藥物應用, 2014, 8(19):124-125.
11. 劉勇, 解玉東. 布地奈德/福莫特羅干粉吸入劑聯合噻托溴銨治療中重度穩定期COPD療效評價. 中國實用醫藥, 2013, 8(16):165-166.
12. 葉青, 張立波, 范榮梅, 等. 布地奈德福莫特羅聯合噻托溴銨對重度慢性阻塞性肺疾病穩定期患者的療效分析. 中華肺部疾病雜志(電子版), 2014,7(3):45-48.
13. 張維杰, 李輝, 劉相海, 等. 聯合吸入布地奈德/福莫特羅和噻托溴銨在治療中重度穩定期慢性阻塞性肺疾病中的臨床療效研究. 中國醫藥指南, 2013, 11(36):148-149.
14. 李翠芬, 張華, 張增, 等. 聯合吸入布地奈德/福莫特羅和噻托溴銨治療老年慢性阻塞性肺疾病臨床研究. 泰山醫學院學報, 2010, 31(11):853-855.
15. 時迎俊, 趙玉良, 丁寧. 聯合吸入噻托溴銨和布地奈德福莫特羅對中重度穩定期慢性阻塞性肺疾病療效評價. 黑龍江醫藥, 2014, 27(4):817-819.
16. 王雪瑩, 尚衛紅, 張智偉. 聯合應用布地奈德福莫特羅與噻托溴銨治療COPD穩定期的臨床觀察. 中外健康文摘, 2013, 10(14):225-225.
17. 張紅莉, 鄧衛中, 宋文玲. 兩種藥物聯合治療穩定期COPD患者的臨床療效觀察. 中國現代藥物應用, 2014, 8(9):126-127.
18. 陳望月, 程德云, 李鶴, 等. 噻托溴銨、布地奈德/福莫特羅及聯合方案對COPD穩定期D組患者的療效觀察. 四川大學學報(醫學版), 2014, 45(5):876-879.
19. 張劍青, 劉凌, 方利洲, 等. 噻托溴銨和布地奈德/福莫特羅治療慢性阻塞性肺疾病的療效與安全性研究. 中國醫師進修雜志, 2010, 33(22):12-15.
20. 張繼賢, 姜益, 趙鶯. 噻托溴銨聯合布地奈德/福莫特羅吸入治療慢性阻塞性肺疾病的臨床分析. 中國醫師進修雜志, 2014, 37(28):66-68.
21. 吳穎宇. 噻托溴銨聯合布地奈德/福莫特羅治療慢性阻塞性肺疾病穩定期的臨床分析. 中國傷殘醫學, 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. 許成芳, 朱建波, 梁芳. 沙美特羅/氟替卡松(50/500)吸入治療緩解期慢性阻塞性肺疾病72例. 實用醫學雜志, 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. 向利華. 噻托溴銨粉吸入治療慢性阻塞性肺疾病穩定期的療效. 中國實用醫刊, 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. 李衛陽. 布地奈德/福莫特羅粉劑聯合噻托溴銨治療慢性阻塞性肺疾病穩定期的療效分析. 中國實用醫藥, 2015, 10(7):184-185.
35. 程妮. 布地奈德福莫特羅粉劑聯合噻托溴銨治療穩定期慢性阻塞性肺疾病的療效探究. 中國實用醫藥, 2015, 10(5):142-143.
36. 陳銳, 盧火儉. 噻托溴胺粉霧劑對穩定期老年慢性阻塞性肺病患者內皮細胞功能的影響及療效. 中國老年學雜志, 2013, 33(20):5156-5157.
37. 林茂華, 唐雨晴, 王智輝, 等. 布地奈德福莫特羅粉吸入劑聯合噻托溴銨治療慢性阻塞性肺疾病的臨床療效和安全性. 中國現代藥物應用, 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

Abstract Full text Figures/Tables Video References Cited by

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