Short Term Clinical Observation Of Oral Low-dose, Slow-release Theophylline On Patients With COPD

ObjectiveTo observe the effect and safety of low-dose, slow release oral theophylline in the treatment of patient with moderate chronic obstructive pulmonary disease (COPD).MethodsThis was a randomized,double-blind, placebo-controlled trial. Fifty-six patient with COPD were randomly divided into two group:theophylline group (n=35)was treated with slow-release theophylline (100mg,twice daily),control group(n=21)was given with placebo. The trial lasted for 3months.Efficacy measures include lung function, quality of life scores, BODE index score, exercise tolerance, exacerbations, satisfaction with treatments and adverse effects.Results42 patients completed the study, including theophylline group 25 subjects and control group 17 subjects. No statistical differences were found of theophylline group in lung function, though there was slightly improvement in FEV1 and FVC (P>0.05). Significant Statistical improvements were observed on quality of life scores such as the activity section score, the impacts section score,and the total score (P<0.01), but the symptom score was slightly raised with no statistical difference. The BODE index scores was significantly reduced after the treatment in the theophylline group (P=0.001).The changes of 6MWT before and after the treatment was insignificant (P>0.05) in two group. Patients treated with theophylline were less likely than the control group to experience exacerbations(x2= 4.748, P=0.029). The differences in satisfaction with treatments between the two groups were statistics significance (Z=-2.579, P=0.01).3 patients in the theophylline group were suffered drug-related adverse events such as insomnia, stomach discomforts and headache. No one in the control group was observed adverse event.ConclusionLow dose, slow-release oral theophylline is efficient in improving the quality of life scores and BODE index score, but has no significant effect on lung function.