ABSTRACT
Objective To evaluate the efficacy of integrated traditional Chinese medicine(TCM)and western medicine in treatment of acute exacerbations of chronic obstructive pulmonary disease(AECOPD)combined with respiratory failure,TCM syndromes of spleen-kidney-yang deficiency and phlegm-dampness by comparison between the integrated therapy and simple western therapy in treatment of the disease. Methods 160 patients with AECOPD combined with respiratory failure,spleen-kidney-yang deficiency and phlegm-dampness syndrome in the intensive care units(ICU)of Affiliated Hospital of Chengdu University of TCM and other four hospitals were randomly allocated into two groups in this double-blinded,multicenter,prospective,randomized,controlled trial. In the control group (78 cases),western medicine and placebo were given to the patients,and in the treatment group(82 cases), conventional western medicine plus fei-shuai mistura 25 mL were administered,four times per day,the therapeutic course lasting for 2 weeks in both groups. The all-cause mortality,respiratory failure-cause mortality,improvement of modified Medical Research Council(mMRC)Dyspnea Scale grades,6 minutes walk distance(6MWD),the forced expiratory volume in 1 second/forced vital capacity(FEV1/FVC)were observed in the 28 days after the end of treatment. Results In the comparisons between the control and treatment groups,there were no statistical significant differences in the all-cause mortality〔54.87%(45/82)vs. 64.10%(50/78)〕and the cases of FEV1/FVC(both P>0.05)in the 28 days after the end of treatment;the 28 day respiratory failure-cause mortality was significantly decreased〔19.51%(16/82)vs. 33.33%(26/78),P<0.05〕,the number of patients with mMRC Dyspnea Scale grades (1-2)was obviously increased(22 cases vs. 7 cases,P<0.05),and the number of patients with 6 MWD grades (4-6)was markedly enhanced in the treatment group(21 cases vs. 8 cases,P<0.05). Conclusions The integrated TCM and western medicine has better therapeutic results in improvement of the patients' degree of dyspnea, 6 MWD and respiratory failure mortality than simple treatment with western therapy for treatment of patients with AECOPD combined with respiratory failure, spleen-kidney-yang deficiency and phlegm-dampness syndrome. However,in regard to the effect on pulmonary function and all cause mortality,the integrated therapy for treatment of such patients in short term has no significant effect.