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.	陈亚红(摘译), 王辰(点评).2015年更新版GOLD慢性阻塞性肺疾病诊断、治疗和预防的全球策略简介.中国医学前沿杂志(电子版), 2015, (2):34-39.
4.	卓广英, 何庆.2011GOLD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, 34:28-30.
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(2007年修订版).中华结核和呼吸杂志, 2007, 30:8-17.
8.	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, 36:255-264.
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, 7:9-11.
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, 8:165-166.
12.	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, 35:853-855.
13.	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, 8:126-127.
14.	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, 45:876-879.
15.	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, 33:12-15.
16.	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: 66-68.
17.	林剑东, 阮琰, 陈力舟, 等.信必可都保联合噻托溴铵治疗缓解期COPD的疗效分析.中国卫生产业, 2011, (25):21-22.
18.	张卫东, 李榜龙.噻托溴铵及噻托溴铵联合布地奈德福莫特罗治疗COPD疗效分析.现代生物医学进展, 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, 10:184-185.
27.	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, 10:142-143.
28.	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, 33:5156-5157.
29.	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, (6):3-4.
30.	Kerstjens HA, Disse B, Schröder-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. 陈亚红(摘译), 王辰(点评).2015年更新版GOLD慢性阻塞性肺疾病诊断、治疗和预防的全球策略简介.中国医学前沿杂志(电子版), 2015, (2):34-39.
4. 卓广英, 何庆.2011GOLD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, 34:28-30.
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(2007年修订版).中华结核和呼吸杂志, 2007, 30:8-17.
8. 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, 36:255-264.
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, 7:9-11.
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, 8:165-166.
12. 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, 35:853-855.
13. 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, 8:126-127.
14. 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, 45:876-879.
15. 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, 33:12-15.
16. 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: 66-68.
17. 林剑东, 阮琰, 陈力舟, 等.信必可都保联合噻托溴铵治疗缓解期COPD的疗效分析.中国卫生产业, 2011, (25):21-22.
18. 张卫东, 李榜龙.噻托溴铵及噻托溴铵联合布地奈德福莫特罗治疗COPD疗效分析.现代生物医学进展, 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, 10:184-185.
27. 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, 10:142-143.
28. 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, 33:5156-5157.
29. 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, (6):3-4.
30. Kerstjens HA, Disse B, Schröder-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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