Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma  

作　　者：LIN Jiang-tao CHEN Ping ZHOU Xin SUN Tie-ying XIE Can-mao XIU Qing-yu YAO Wan-zhen YANG Lan YIN Kai-sheng ZHANG Yong-ming 

机构地区：[1]Department of Respiratory Diseases, China-Japan Friendship Hospital, Beijing 100029, China [2]Department of Respiratory Diseases, General Hospital ot Shenyang Military Command, Shenyang, Liaoning I 10840, China Department of Respiratory Diseases, Shanghai First People's Hospital, Shanghai 200080, China [3]Department of Respiratory Diseases, Beijing Hospital, Beijing 100730, China [4]Department of Respiratory Diseases, Shanghai First People's Hospital, Shanghai 200080, China [5]Department of Respiratory Diseases, First Affiliated tlospital, Sun Yet-Sen University, Guangzhou, Guangdong 510080, China [6]Department of Respiratory Diseases, Shanghai Changzheng Hospital, Shanghai 200003, China [7]Department of Respiratory Diseases, Peking University Third Hospital, Beijing 100083, China [8]Department of Respiratory Diseases, First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, Shaanxi 710061, China [9]Department of Respratory Diseases, Jiangsu Provincial Hospital, Nanjing, Jiangsu 210029, China

出　　处：《Chinese Medical Journal》2012年第17期2994-3001,共8页中华医学杂志（英文版）

摘　　要：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 IB2-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 pg/inhalation） （640/18 pg/d; n=111 ）, or SALM/FP＋as-needed terbutaline （0.4 mg/inhalation） （100/1000 pg/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 reBackground 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 IB2-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 pg/inhalation） （640/18 pg/d; n=111 ）, or SALM/FP＋as-needed terbutaline （0.4 mg/inhalation） （100/1000 pg/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 re

关 键 词：ASTHMA BUDESONIDE/FORMOTEROL EXACERBATION salmeterol/iquticasone 

分 类 号：P[天文地球]