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学科主题: 临床医学
题名:
Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease
作者: Zhong, Nanshan1; Zheng, Jinping1; Wen, Fuqiang2; Yang, Lan3; Chen, Ping4; Xiu, Qingyu5; Yao, Wanzhen6; Sun, Tieying7; Zhao, Ziwen8; Shen, Huahao9; Shi, Yi10; Lin, Jiangtao; Li, Qiang12
关键词: Budesonide/formoterol ; chronic obstructive pulmonary disease ; dry powder inhaler ; Lung function
刊名: CURRENT MEDICAL RESEARCH AND OPINION
发表日期: 2012-02-01
DOI: 10.1185/03007995.2011.636420
卷: 28, 期:2, 页:257-265
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal ; Medicine, Research & Experimental
研究领域[WOS]: General & Internal Medicine ; Research & Experimental Medicine
关键词[WOS]: RESPIRATORY QUESTIONNAIRE ; FLUTICASONE ; SALMETEROL ; THERAPY
英文摘要:

Objective:

To evaluate the efficacy and safety of budesonide (BUD)/formoterol (FORM) compared with BUD, both administered by way of a dry powder inhaler (Turbuhaler*).

Methods:

This was a 6-month, multicenter, randomized, parallel-group, double-blind, double-dummy design study (NCT 00421122). Patients were randomized to either BUD/FORM 160/4.5 mu g, two inhalations twice daily, or BUD 200 mg, two inhalations twice daily. Improvement of lung function, daily symptoms, reliever use and health-related quality-of-life (St George′s Respiratory Questionnaire [SGRQ] score) were compared between the two treatment groups.

Results:

A total of 308 patients with moderate to very severe COPD from 12 centers in China were randomized to BUD/FORM (n = 156) or BUD (n = 152). The primary endpoint, 1-hour post-dose forced expiratory volume in 1 second (FEV1), in the BUD/FORM group improved by 0.18 L (from 0.83 L at baseline to 1.01 L) and this was significantly better (p<0.001) than the small increase (0.03 L) observed in the BUD group after 24 weeks′ treatment. Increases in pre-dose and 15-min post-dose FEV1 together with 1-hour post-dose forced vital capacity were also significantly larger with BUD/FORM than BUD (p<0.001 for all). Compared with BUD alone, BUD/FORM improved COPD total symptom scores (-1.04 +/- 0.16 vs. -0.55 +/- 0.17; p = 0.03), reduced reliever use (-0.85 +/- 0.16 puffs/day vs. -0.31 +/- 0.16 puffs/day; p = 0.012) and improved health-related quality-of-life (mean change of total SGRQ score -4.5 points (p = 0.0182). Overall, both treatments were well tolerated.

Conclusions:

In Chinese patients with moderate to very severe COPD, fixed combination treatment with BUD/FORM resulted in clinically meaningful improvements in lung function, health-related quality-of-life, COPD symptoms and a reduction in reliever use, compared with BUD alone and both treatments were well tolerated. Treatment of BUD/FORM for milder patients with COPD and head to head comparison of Chinese and Caucasians in future studies will be helpful to expand upon the findings of the current clinical trial.

语种: 英语
项目资助者: AstraZeneca
WOS记录号: WOS:000299741900011
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/63473
Appears in Collections:北京大学第三临床医学院_期刊论文

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作者单位: 1.China Japan Friendship Hosp, Beijing, Peoples R China
2.Shanghai Changhai Hosp, Shanghai, Peoples R China
3.Sichuan Univ, W China Hosp, Chengdu 610064, Peoples R China
4.Shenyang Mil Command, Gen Hosp, Shenyang, Peoples R China
5.Shanghai Changzheng Hosp, Shanghai, Peoples R China
6.Peking Univ, Hosp 3, Beijing 100871, Peoples R China
7.Beijing Hosp, Beijing, Peoples R China
8.Guangzhou Med Coll, Affiliated Hosp 1, State Key Lab Resp Dis, Guangzhou 515120, Guangdong, Peoples R China
9.Xi An Jiao Tong Univ, Coll Med, Affiliated Hosp 1, Xian 710049, Peoples R China
10.Guang Zhou First Municipal Peoples Hosp, Guangzhou, Guangdong, Peoples R China
11.Zhejiang Univ, Coll Med, Affiliated Hosp 2, Hangzhou 310003, Zhejiang, Peoples R China
12.Nanjing Mil Command, Nanjing Gen Hosp, Nanjing, Jiangsu, Peoples R China

Recommended Citation:
Zhong, Nanshan,Zheng, Jinping,Wen, Fuqiang,et al. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease[J]. CURRENT MEDICAL RESEARCH AND OPINION,2012,28(2):257-265.
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