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Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma
Lin Jiang-tao1; Chen Ping2; Zhou Xin3; Sun Tie-ying4; Xie Can-mao5; Xiu Qing-yu6; Yao Wan-zhen7; Yang Lan8; Yin Kai-sheng9; Zhang Yong-ming1
关键词Asthma Budesonide/formoterol Exacerbation Salmeterol/fluticasone
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
资助者AstraZeneca ; AstraZeneca
研究领域[WOS]General & Internal Medicine

Background Many studies have shown the superior efficacy of budesonide (BUD)/formoterol (FORM) maintenance and reliever therapy, but still lack evidence of its efficacy in Chinese asthma patients in a relative large patient-group. We finished this research to compare BUD/FORM maintenance and reliever therapy and high-dose salmeterol (SALM)/fluticasone (FP) maintenance plus an as-needed short-acting beta(2)-agonist in Chinese patients with persistent uncontrolled asthma. This was a post hoc analysis based on a 6-month, multicenter, randomized, double-blind study (NCT00242775).

Methods A total of 222 eligible asthma patients from nine centers in China were randomized to either BUD/FORM+as-needed BUD/FORM (160/4.5 mu g/inhalation) (640/18 mu g/d; n=111), or SALM/FP+as-needed terbutaline (0.4 mg/inhalation) (100/1000 mu g/d; n=111). The primary endpoint was time to first severe exacerbation while secondary endpoints included various measures of pulmonary function, symptom control and quality-of-life.

Results Time to first severe exacerbation over six months was lower with the BUD/FORM than with the SALM/FP treatment (risk ratio=0.52, 95% CI 0.22-1.22), but the difference did not achieve statistical significance (P=0.13). The cumulative number of severe exacerbations in the BUD/FORM group was lower than in the SALM/FP group (7.2% vs. 13.5%; risk ratio=0.45, P=0.028). BUD/FORM produced significantly better improvements in reliever use, cumulative mild exacerbations, symptom-free days (%), and morning/evening peak expiratory flow (PEF) than SALM/FP (P <0.05 in all cases). The two groups achieved similar improvements in their time to first mild exacerbation, forced expiratory volume in one second (FEV1), asthma control questionnaire and asthma symptom scores, and percentage of nights with awakening(s). Both treatments were well tolerated.

Conclusions In Chinese patients with persistent asthma, BUD/FORM decreased severe and mild exacerbations, decreased reliever use, increased symptom-free days, and improved morning/evening PEF compared with SALM/FP. There were no significant differences in time to first severe exacerbation or other assessments regarding daily asthma control between BUD/FORM and SALM/FP. BUD/FORM was more effective in this Chinese sub-group than in the total cohort involved in the original study. (Clinical Trial Registry Number: NCT00242775) Chin Med J 2012;125(17):2994-3001

资助者AstraZeneca ; AstraZeneca
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Cited Times:5[WOS]   [WOS Record]     [Related Records in WOS]
作者单位1.Jiangsu Prov Hosp, Dept Resp Dis, Nanjing 210029, Jiangsu, Peoples R China
2.China Japan Friendship Hosp, Dept Resp Dis, Beijing 100029, Peoples R China
3.Shenyang Mil Command, Gen Hosp, Dept Resp Dis, Shenyang 110840, Liaoning, Peoples R China
4.Shanghai First Peoples Hosp, Dept Resp Dis, Shanghai 200080, Peoples R China
5.Beijing Hosp, Dept Resp Dis, Beijing 100730, Peoples R China
6.Sun Yat Sen Univ, Affiliated Hosp 1, Dept Resp Dis, Guangzhou 510080, Guangdong, Peoples R China
7.Shanghai Changzheng Hosp, Dept Resp Dis, Shanghai 200003, Peoples R China
8.Peking Univ Third Hosp, Dept Resp Dis, Beijing 100871, Peoples R China
9.Xi An Jiao Tong Univ, Affiliated Hosp 1, Coll Med, Dept Resp Dis, Xian 710061, Shaanxi, Peoples R China
Recommended Citation
GB/T 7714
Lin Jiang-tao,Chen Ping,Zhou Xin,et al. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma[J]. CHINESE MEDICAL JOURNAL,2012,125(17):2994-3001.
APA Lin Jiang-tao.,Chen Ping.,Zhou Xin.,Sun Tie-ying.,Xie Can-mao.,...&Zhang Yong-ming.(2012).Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma.CHINESE MEDICAL JOURNAL,125(17),2994-3001.
MLA Lin Jiang-tao,et al."Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma".CHINESE MEDICAL JOURNAL 125.17(2012):2994-3001.
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