Objective: This research comprehensively evaluates the clinical efficacy and with different medical treatment, in order to provide a basis for amending and improving the criteria of TCM clinical efficacy through the observation of multi-dimensional evaluation indicators such as the acute exacerbation times and degree, lung function, clinical symptom scores and BODE index within the stability of chronic obstructive pulmonary disease(COPD) of syndrome of qi deficiency of lung and kidney. Meanwhile, the study is to analyze the economic impact of different medical treatment projects using several evaluation indexes of health economics, in order to provide the reference to clinical physician about how to select the economical and effective projects from the aspect of health economics, provide the evidence to the decision-makers to allocate health resources reasonably.Methods: A randomized, double-blind, double-dummy, parallel-controlled clinical trial. Select 120 cases with the stability of COPD of syndrome of qi deficiency of lung and kidney and divide them into two groups at random, sixty cases in each group. In carrying out health education, the experimental group takes orally of simulated sustained-release theophylline , Chinese medicine and plastering therapy. while the control group takes orally of sustained-release theophylline, simulated Chinese medicine and plastering therapy of simulated application. The course of treatment is four months. The two groups are observed in the improvements of acute exacerbation times and degree, lung function, 6MWD, clinical symptom scores, the BODE index and health economic indicators.Results:Remove the information was incomplete, not taking the cases provided for in line with the requirements of the case study a total of 110 cases. fifty-six patients of the experimental group and fifty-four of the control group. The clinical evaluation and cost-effectiveness Analysis with Bufei Yishen prescription alliance application treatment are observed in two aspects as follows:1 The clinical evaluation1.1 Acute exacerbation times and degree There were no significant difference of the two groups in acute exacerbation times and degree of nearly a year before treatment(P>0.05). After treatment, the acute exacerbation times of experimental group are lower than those of control group(P<0.05), and the acute exacerbation degree have more significantly improved than those of control group(P<0.01).1.2 Lung function FVC, FEV1 and FEV1% had no significant difference before treatment(P>0.05). Each item of the experimental group improves remarkably after treatment(P<0.05), while in the control group each item decreases after treatment(P<0.05).1.3 BODE index There was no significant difference between the two groups before (P>0.05). The two groups improve more significantly after treatment(P<0.01), and the experimental group has more significantly improved than the control group(P<0.01).1.4 Grades of decompensation There were no statistical differences of the two groups in grades of decompensation before treatment(P>0.05); The experimental group have more significant differences than control group in Grades of decompensation after treatment of two months and four months(P<0.01).1.5 6MWD There were no statistical differences of the two groups in 6MWD before treatment(P>0.05); Repeated measure analysis of variance shows that the two groups have significant time effects in 6MWD(P<0.01). Each group has a continuing upward trend with the time of treatment prolonged (P<0.01), and the experimental group has improved more in 6MWD than the control group (P<0.01).1.6 Clinical symptom scores There were no statistical differences of the two groups in clinical symptom scores before treatment(P>0.05); Repeated measure analysis of variance shows that the two groups have significant time effects in clinical symptom scores(P<0.01); Each group has a continuing downward trend with the time of treatment prolonged (P<0.01), and the experimental group lower significantly than the control group in clinical symptoms scores(P<0.01).2 Health economic indicators2.1 Cost of each group The average treatment cost of experimental group(2332.90yuan) is higher than control group(1924.90yuan), and there are significant differences between two groups(P<0.01).2.2 Effect of each group The acute exacerbation times of experimental group(0.21times) are lower than control group(0.85times), and there are significant differences between two groups(P<0.05).2.3 CEA of each group The cost of experimental group(489.91yuan) are lower than control group(1636.17yuan) in reducing one time of acute exacerbation. Compared with experimental group, control group need to increase the cost per -261.12 yuan as decreasing by 1 unit for every effect. The cost effectiveness rate is less than 0. In the incremental analysis, experimental group is better than control group. It showes that the result of this study was more stable and reliable by sensitivity analysis.Conclusion: Based on health education, two groups of patients with 6MWD, clinical symptoms scores, BODE index and so on. Compared with the control group, Group Bufei Yishen prescriptions alliance application can be more significant improvement in clinical symptoms, the reduce of acute exacerbation times and degree, the increase of lung function and the decrease of BODE index of patients,which is in the stability of chronic obstructive pulmonary disease(COPD) of syndrome of qi deficiency of lung and kidney. Also it is a more economical, reasonable and effective option from the economical indicators.
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