多索茶碱与茶碱治疗中度稳定期慢性阻塞性肺疾病的临床疗效研究

A comparative clinical study of doxophylline and theophylline on chronic obstructive pulmonary disease

目的比较多索茶碱和茶碱治疗中度稳定期慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)的临床疗效。方法 107例稳定期COPD患者随机分为茶碱组56例和多索茶碱组51例。茶碱组给予茶碱缓释片,每次口服0.4g,每日1次;多索茶碱组给予多索茶碱片,每次口服0.4g,每日2次。治疗14d后检测用力肺活量(forced vital capacity,FVC)、第1秒用力呼气容积(forced expiratory volume in 1second,FEV_1)、FEV_1/FVC比值,观察肺功能改善情况,评价2组生活质量,监测不良反应发生情况。结果治疗后2组FVC、FEV_1、FEV_1/FVC均较治疗前明显上升,差异有统计学意义(P<0.05);但2组治疗后FVC、FEV_1、FEV_1/FVC比较,差异均无统计学意义(P>0.05)。2组治疗后COPD评估测试评分明显降低,差异有统计学意义(P<0.05)。治疗期间多索茶碱组不良反应发生率为9.8%(5/51),低于茶碱组的25.0%(14/56),差异有统计学意义(P<0.05)。结论多索茶碱与茶碱均可明显提高稳定期COPD患者的生活质量,改善其肺功能,且多索茶碱的治疗效果更好,安全性更高。

Objective To compare the clinical effect of theophylline and doxophylline on moderate stable chronic obstructive pulmonary disease(COPD).Methods A total of 107 patients with COPD in stable period were randomly divided into theophylline group with 56 cases and doxophylline group with 51 cases.Theophylline group was administered theophylline sustained release 400 mg once daily and Doxophylline group was administered doxophylline 400 mg twice a day orally.The forced vital capacity(FVC),forced expiratory volume in 1 second(FEV_1)and the ratio of FEV_1 and FVC were recorded after 14 days of the drug treatment to observe the pulmonary function.COPD assessment test was evaluated and adverse reactions were monitored of the two groups after 14 days of therapy.Results FVC,FEV_1 and FEV_1/FVC were improved after treatment in both groups,and that the improvement was statistically significant as compared to the pre-treatment values in each group(P<0.05).But the improvements in the theophylline and the doxofylline groups were not significantly different from each other(P>0.05).The score of COPD assessment test was decreased significantly after the drug treatment in both groups(P<0.05).The rate of adverse reactions was 9.8% during the treatment of doxofylline,which is significantly lower than 25.0% during the treatment of theophylline(P<0.05).Conclusion It is concluded that both theophylline and doxofylline can improve the quality of life and lung function of patients of COPD,and doxofylline has a better clinical effect and safety.