Comparative Study on the Efficacy of Tiotropium Bromide Inhalation and Oral Doxofylline Treatment of Moderate to Severe Stable Chronic Obstructive Pulmonary Disease  

作　　者：汪涛 罗光伟 胡轶 李发久 马静 王坚苗 左鹏 熊维宁 刘先胜 赵建平 熊盛道 张珍祥 李承红 赵苏 孙洁民 徐永健 

机构地区：[1]Department of Respiratory Medicine, Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University [2]Department of Respiratory Medicine, Wuhan First Hospital [3]Department of Respiratory Medicine, Wuhan Second Hospital [4]Department of Respiratory Medicine, Wuhan Sixth Hospital

出　　处：《Journal of Huazhong University of Science and Technology(Medical Sciences)》2011年第5期614-618,共5页华中科技大学学报（医学英德文版）

基　　金：supported by grants from the Clinical Chronic Respiratory Diseases Research Foundation of Chinese Medical Association (No. 07010030011);Key Research Program of the Ministry of Health of China (No. 2007353);the Special Funds for Scientific Research on Public Causes of Ministry of Health of China (No. 201002008)

摘　　要：This study compared the efficacy and safety of tiotropium bromide inhalation powder （spiriva） and doxofylline oral tablet （doxofylline） in the treatment of chronic obstructive pulmonary disease （COPD）. A multi-center, randomized, double-blind, double-dummy, parallel-controlled study involved 127 eligible stable moderate to severe COPD patients treated with inhaled tiotropium dry powder （18 μg/day） or oral doxofylline tablets （0.2 g/time, 2 times a day） for 12 and 24 weeks. Before and after treatment for 12 weeks and 24 weeks, respectively, pulmonary function, 6-min walking distance and dyspnea index were recorded. The results showed that in both tiotropium group and doxofylline groups, after 12-week treatment, FEV1, FEV1/FVC% and 6-min walk distance were sig-nificantly higher than those before the medication, while dyspnea index decreased as compared with that before treatment. After 24-week treatment, a slight improvement in the measures was observed as compared with that of 12-weeks treatment, but the difference was not statistically significant. With both 12-week and 24-week treatment, the effect of tiotropium was slightly better than that of doxofylline tablets, with the difference being statistically insignificant. The major adverse events in the tiotropium group and doxofylline group were observed in 9 cases （9.9%） and 12 cases （12.9%）, respectively, and no statistically significant difference was found between them. We are led to conclude that both tiotropium at 18 μg a day and doxofylline tablets at 0.2 g/day （two times a day） are effective and safe for the treatment of COPD.This study compared the efficacy and safety of tiotropium bromide inhalation powder （spiriva） and doxofylline oral tablet （doxofylline） in the treatment of chronic obstructive pulmonary disease （COPD）. A multi-center, randomized, double-blind, double-dummy, parallel-controlled study involved 127 eligible stable moderate to severe COPD patients treated with inhaled tiotropium dry powder （18 μg/day） or oral doxofylline tablets （0.2 g/time, 2 times a day） for 12 and 24 weeks. Before and after treatment for 12 weeks and 24 weeks, respectively, pulmonary function, 6-min walking distance and dyspnea index were recorded. The results showed that in both tiotropium group and doxofylline groups, after 12-week treatment, FEV1, FEV1/FVC% and 6-min walk distance were sig-nificantly higher than those before the medication, while dyspnea index decreased as compared with that before treatment. After 24-week treatment, a slight improvement in the measures was observed as compared with that of 12-weeks treatment, but the difference was not statistically significant. With both 12-week and 24-week treatment, the effect of tiotropium was slightly better than that of doxofylline tablets, with the difference being statistically insignificant. The major adverse events in the tiotropium group and doxofylline group were observed in 9 cases （9.9%） and 12 cases （12.9%）, respectively, and no statistically significant difference was found between them. We are led to conclude that both tiotropium at 18 μg a day and doxofylline tablets at 0.2 g/day （two times a day） are effective and safe for the treatment of COPD.

关 键 词：chronic obstructive pulmonary disease （COPD） TIOTROPIUM DOXOFYLLINE 6-min walk distance safety 

分 类 号：R563.9[医药卫生—呼吸系统]