The Efficacy and Safety of Tiotropium Plus Budesonide/Formoterol Compared with Tiotropium in Chinese Patients with Chronic Obstructive Pulmonary Disease:<i>A</i>Meta-analysis_Chinese Journal of Respiratory and Critical Care Medicine

Authors：

 ZengLinmiao ¹ , YuXiaolian ² , ZhangQinghua ¹ , PengQingmei ³ , ZhouZhijun ³ , HanFangduo ¹ , XiaoJianhong ¹

1. Department of Respiratory Diseases, Mindong Hospital Affiliated to Fujian Medical University, Fu'an, Fujian, 355000, China;
2. ;
3. ;

Corresponding?author：

ZengLinmiao, Email: zenglinmiao@126.com

Keywords：

Tiotropium; Budesonide/formoterol; Chronic obstructive pulmonary disease; Systematic review; Meta-analysis

DOI：

10.7507/1671-6205.2016030

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Objective To systematically evaluate the efficacy and safety of tiotropium plus budesonide/formoterol compared with tiotropium in Chinese patients with chronic obstructive pulmonary disease (COPD). Methods PubMed (from 1980 to March, 2015), Wiley Online Library (from 1990 to March, 2015), Elsevier (from 1990 to March, 2015), CNKI(from 1990 to March, 2015), VIP(from 1990 to March, 2015) and WanFang Data(from 1990 to March, 2015) were searched for randomized controlled trials (RCTs) of tiotropium plus budesonide/formoterol compared with tiotropium in treating Chinese patients with COPD from the establishment of the database to March 2015. The quality of included studies was assessed according to Cochrane Methods 5.1 for Systematic Review, and Meta-analysis was conducted by RevMan 5.3 software. Results Atotal of 9 studies involving 503 patients were included. Compared with the tiotropium therapy group, tiotropium plus budesonide/formoterol in treating Chinese patients with COPD can more significantly improve FEV₁ (MD=0.10, 95%CI 0.05 to 0.15, P<0.000 01), FEV₁%pred (MD=4.27, 95%CI 2.44 to 6.09, P<0.000 01), FEV₁/FVC (MD=3.48, 95%CI 3.21 to 3.74, P<0.000 01), mMRC (MD=-0.27, 95%CI -0.38 to -0.17, P<0.000 01), CAT (MD=-0.91, 95%CI -1.74 to -0.08, P=0.03), 6MWT (MD=27.64, 95%CI 11.76 to 37.53, P<0.000 01) and the frequency of repeated exacerbations (OR=0.25, 95%CI 0.08 to 0.76, P=0.01) while no significant difference was found between two groups in SGRQ (MD=-5.11, 95%CI -11.57 to 1.36, P=0.12). There was no significant differences in adverse reaction rates (OR=1.33, 95%CI 0.65 to 2.73, P=0.44) between the tiotropium plus budesonide/formoterol group and the control group. Conclusions Tiotropium plus budesonide/formoterol is effective in treating Chinese patients with COPD. It can effectively improve treatment efficiency and does not increase the incidence of adverse drug reactions. However, due to the limitation of both quantity and quality of included studies, this conclusion should be further confirmed by more high quality and large sample studies.

Citation： ZengLinmiao, YuXiaolian, ZhangQinghua, PengQingmei, ZhouZhijun, HanFangduo, XiaoJianhong. The Efficacy and Safety of Tiotropium Plus Budesonide/Formoterol Compared with Tiotropium in Chinese Patients with Chronic Obstructive Pulmonary Disease:AMeta-analysis. Chinese Journal of Respiratory and Critical Care Medicine, 2016, 15(2): 119-126. doi: 10.7507/1671-6205.2016030 Copy

1.	GOLD Executive Summary (revised 2014) Global strategy for the diagnosis, management and prevention of COPD. [Accessed November 5, 2014]. Available from: http://www.goldcopd.com/.
2.	Lopez AD, Shibuya K, Rao C, et al. Chronic obstructive pulmonary disease: current burden and fiiture projections. Eur Respir J, 2006, 27:397-412.
3.	陳亞紅(摘譯), 王辰(點評).2015年更新版GOLD慢性阻塞性肺疾病診斷、治療和預防的全球策略簡介.中國醫學前沿雜志(電子版), 2015, (2):34-39.
4.	卓廣英, 何慶.2011GOLD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, 34:28-30.
5.	Barnes PJ. How corticosteroids control inflammation: Quintiles Prize Lecture 2005. Br J Pharmacol, 2006, 148:245-254.
6.	Bourbeau J, Christodoulopoulos P, Maltais F, et al. Effect of salmeterol/fluticasone propionate on airway inflammation in COPD: a randomised controlled trial. Thorax, 2007, 62:938-943.
7.	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(2007年修訂版).中華結核和呼吸雜志, 2007, 30:8-17.
8.	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, 36:255-264.
9.	Higgins JP, Green S. Cochrane handbook for systematic reviews of interventions (Version 5.1.0). [cited 2012 Jan 5]. Available from: http://www.cochrane-handbook.org.
10.	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, 7:9-11.
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, 8:165-166.
12.	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, 35:853-855.
13.	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, 8:126-127.
14.	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, 45:876-879.
15.	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, 33:12-15.
16.	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: 66-68.
17.	林劍東, 阮琰, 陳力舟, 等.信必可都保聯合噻托溴銨治療緩解期COPD的療效分析.中國衛生產業, 2011, (25):21-22.
18.	張衛東, 李榜龍.噻托溴銨及噻托溴銨聯合布地奈德福莫特羅治療COPD療效分析.現代生物醫學進展, 2010, 10:302-304.
19.	Vijayan VK. Chronic obstructive pulmonary disease. Indian J Med Res, 2013, 137:251-269.
20.	Ohta K, Ichinose M, Tohda Y, et al.Long-term once-daily tiotropium Respimat? is well tolerated and maintains efficacy over 52 weeks in patients with symptomatic asthma in Japan: a randomised, placebo-controlled study.PLoS One, 2015, 10:e0124109.
21.	Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med, 2008, 359:1543-1554.
22.	Mathioudakis AG, Kanavidis P, Chatzimavridou-Grigoriadou V, et al. Tiotropium HandiHaler improves the survival of patients with COPD: a systematic review and meta-analysis.J Aerosol Med Pulm Drug Deliv, 2014, 27:43-50.
23.	Jahnz-Róyk K, Szepiel P. Early impact of treatment with tiotropium, long-acting anticholinergic preparation, in patients with COPD - real-life experience from an observational study. Int J Chron Obstruct Pulmon Dis, 2015, 10:613-623.
24.	Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD.Thorax, 2003, 58:399-404.
25.	Cramer JA, Bradley-Kennedy C, Scalera A. Treatment persistence and compliance with medications for chronic obstructive pulmonary disease. Can Respir J, 2007, 14:25-29.
26.	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, 10:184-185.
27.	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, 10:142-143.
28.	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, 33:5156-5157.
29.	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, (6):3-4.
30.	Kerstjens HA, Disse B, Schr?der-Babo W, et al. Tiotropium improves lung function in patients with severe uncontrolled asthma: a randomized controlled trial. J Allergy Clin Immunol, 2011, 128:308-314.
31.	Szafranski W, Cukier A, Ramirez A, et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J, 2003, 21:74-81.
32.	Cazzola M, Hanania NA. The role of combination therapy with corticosteroids and long-acting β₂-agonists in the prevention of exacerbations in COPD. Int J Chron Obstruct Pulmon Dis, 2006, 1:345-354.
33.	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, 180:741-750.

1. GOLD Executive Summary (revised 2014) Global strategy for the diagnosis, management and prevention of COPD. [Accessed November 5, 2014]. Available from: http://www.goldcopd.com/.
2. Lopez AD, Shibuya K, Rao C, et al. Chronic obstructive pulmonary disease: current burden and fiiture projections. Eur Respir J, 2006, 27:397-412.
3. 陳亞紅(摘譯), 王辰(點評).2015年更新版GOLD慢性阻塞性肺疾病診斷、治療和預防的全球策略簡介.中國醫學前沿雜志(電子版), 2015, (2):34-39.
4. 卓廣英, 何慶.2011GOLD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, 34:28-30.
5. Barnes PJ. How corticosteroids control inflammation: Quintiles Prize Lecture 2005. Br J Pharmacol, 2006, 148:245-254.
6. Bourbeau J, Christodoulopoulos P, Maltais F, et al. Effect of salmeterol/fluticasone propionate on airway inflammation in COPD: a randomised controlled trial. Thorax, 2007, 62:938-943.
7. 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(2007年修訂版).中華結核和呼吸雜志, 2007, 30:8-17.
8. 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, 36:255-264.
9. Higgins JP, Green S. Cochrane handbook for systematic reviews of interventions (Version 5.1.0). [cited 2012 Jan 5]. Available from: http://www.cochrane-handbook.org.
10. 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, 7:9-11.
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, 8:165-166.
12. 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, 35:853-855.
13. 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, 8:126-127.
14. 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, 45:876-879.
15. 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, 33:12-15.
16. 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: 66-68.
17. 林劍東, 阮琰, 陳力舟, 等.信必可都保聯合噻托溴銨治療緩解期COPD的療效分析.中國衛生產業, 2011, (25):21-22.
18. 張衛東, 李榜龍.噻托溴銨及噻托溴銨聯合布地奈德福莫特羅治療COPD療效分析.現代生物醫學進展, 2010, 10:302-304.
19. Vijayan VK. Chronic obstructive pulmonary disease. Indian J Med Res, 2013, 137:251-269.
20. Ohta K, Ichinose M, Tohda Y, et al.Long-term once-daily tiotropium Respimat? is well tolerated and maintains efficacy over 52 weeks in patients with symptomatic asthma in Japan: a randomised, placebo-controlled study.PLoS One, 2015, 10:e0124109.
21. Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med, 2008, 359:1543-1554.
22. Mathioudakis AG, Kanavidis P, Chatzimavridou-Grigoriadou V, et al. Tiotropium HandiHaler improves the survival of patients with COPD: a systematic review and meta-analysis.J Aerosol Med Pulm Drug Deliv, 2014, 27:43-50.
23. Jahnz-Róyk K, Szepiel P. Early impact of treatment with tiotropium, long-acting anticholinergic preparation, in patients with COPD - real-life experience from an observational study. Int J Chron Obstruct Pulmon Dis, 2015, 10:613-623.
24. Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD.Thorax, 2003, 58:399-404.
25. Cramer JA, Bradley-Kennedy C, Scalera A. Treatment persistence and compliance with medications for chronic obstructive pulmonary disease. Can Respir J, 2007, 14:25-29.
26. 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, 10:184-185.
27. 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, 10:142-143.
28. 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, 33:5156-5157.
29. 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, (6):3-4.
30. Kerstjens HA, Disse B, Schr?der-Babo W, et al. Tiotropium improves lung function in patients with severe uncontrolled asthma: a randomized controlled trial. J Allergy Clin Immunol, 2011, 128:308-314.
31. Szafranski W, Cukier A, Ramirez A, et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J, 2003, 21:74-81.
32. Cazzola M, Hanania NA. The role of combination therapy with corticosteroids and long-acting β₂-agonists in the prevention of exacerbations in COPD. Int J Chron Obstruct Pulmon Dis, 2006, 1:345-354.
33. 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, 180:741-750.

Chinese Journal of Respiratory and Critical Care Medicine

The Efficacy and Safety of Tiotropium Plus Budesonide/Formoterol Compared with Tiotropium in Chinese Patients with Chronic Obstructive Pulmonary Disease:AMeta-analysis

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