| Objective:Observe the impact on quality of life,and the effectiveness and safety of Bufei Jiawei Decoction in the treatment of chronic obstructive pulmonary disease(COPD)at Stable Period and Lung-kidney Qi Deficiency Syndrome through clinical research.Material and method:This study adopts a randomized,double-blind,controlled research method,in strict accordance with the inclusion and exclusion criteria designed in this study,from February 2021 to February 2022,a total of 72 patients with lung and kidney qi deficiency syndrome in stable phase of chronic obstructive pulmonary disease were selected from the outpatients of the Department of Pulmonary Disease,Affiliated Hospital of Liaoning University of Traditional Chinese Medicine.They were randomly divided into treatment and control groups on a 1:1 basis,with 36 cases in each group.Both groups were treated with conventional Western medicine,based on the patients’actual condition.On top of routine treatment,the treatment group was treated with Bufei Jiawei Decoction while the control group was treated with placebo.Bufei Jiawei Decoction was treated for six weeks and followed for 12 weeks.To observe the changes of TCM syndrome score,CAT score,m MRC score,6MWD,SGRQ,number of acute exacerbations,lung function,blood gas analysis and immune function before and after treatment,to evaluate the effect and effectiveness of Bufei Jiawei Decoction on the quality of life of COPD in stable stage,and to record the adverse events during the whole study,and to observe the safety of drugs.Results:1.Comparison of efficacy indexes before and after treatment between the two groups1.1 Comparison of the efficacy of TCM syndromes before and after treatment in the two groups of patientsAfter treatment,6 cases(18.18%)were clinically controlled in the treatment group,16 cases(48.48%)were markedly effective,9 cases(27.27%)were effective,and 2 cases(6.06%)were ineffective.In the control group,2 cases(6.06%)were clinically controlled,16 cases(48.48%)were markedly effective,9 cases(27.27%)were effective,and 6 cases(18.18%)were ineffective.The total effective rate of TCM syndromes in the treatment group(93.94%)was better than that in the control group(81.82%),and the difference was statistically significant(P<0.05).1.2 Comparison of total scores of TCM syndromes before and after treatment between the two groups of patientsThere was no significant difference in TCM syndrome scores between the two groups before treatment(P>0.05).After treatment,the two groups were improved compared with before treatment,and the treatment group was better than the control group at the same time,the difference was statistically significant(P<0.05).There was no significant difference between the 12th week and the 6th week(P>0.05).1.3 Comparison of single symptom scores between the two groups before and after treatmentBefore treatment,there was no significant difference in the scores of shortness of breath,fatigue,or spontaneous sweating,lumbar and knee weakness between the two groups after activity(P>0.05),which was comparable.After treatment,the scores of symptoms such as shortness of breath,fatigue,or spontaneous sweating,soreness and weakness of waist and knees in the two groups were significantly improved compared with those before treatment,and the scores of the treatment group were better than those of the control group at the same time,the difference was statistically significant(P<0.05).There was no significant difference between the 12th week and the 6th week(P>0.05).1.4 Comparison of pulmonary function between the two groups before and after treatmentThere was no significant difference in FEV1%pred and FEV1/FVC between the two groups before treatment(P>0.05).After treatment,the pulmonary ventilation function of the two groups was improved compared with that before treatment,and the difference was statistically significant(P<0.05).1.5 Comparison of blood gas analysis between the two groups before and after treatmentThere was no significant difference in blood gas analysis(Pa O2,Sa O2,Pa CO2)between the two groups before treatment(P>0.05).After treatment,the blood gas indexes of the two groups were improved compared with those before treatment,and the treatment group was better than the control group,the difference was statistically significant(P<0.05).2.Comparison of quality of life assessment results between the two groups before and after treatmentThere was no significant difference in CAT score,m MRC score,6MWD,SGRQ symptoms,activity ability.After treatment,the CAT score,m MRC score and 6 MWD of the two groups were significantly improved compared with those before treatment,and the treatment group was better than the control group at the same time(P<0.05).There was no significant difference between the 12th week and the 6th week(P>0.05).After treatment,the scores of each part and total score of SGRQ in the two groups were improved,and the difference was statistically significant(P<0.05).There was no significant difference between the second week and the control group(P>0.05).There was no significant difference between the 12th week and the 6th week(P>0.05).After treatment,the number of acute exacerbations decreased in both groups within 1 year,and the treatment group was significantly better than the control group,the difference was statistically significant(P<0.05).3.Comparison of immune indexes between the two groups before and after treatmentThere was no significant difference in the levels of CD4+,CD8+,CD4+/CD8+,Ig A,Ig G and Ig M between the two groups before treatment(P>0.05).After treatment,the levels of CD4+,CD8+,CD4+/CD8+,Ig A,Ig G and Ig M in the two groups were significantly improved,and those in the treatment group were better than the control group,the differences were statistically significant(P<0.05).4.Safety indicatorsThere were no abnormalities in blood routine,urine routine,liver function,renal function and electrocardiogram between the two groups;there were no toxic,side effects,nausea,allergic reactions and other adverse reactions in the two groups.No adverse events occurred in both groups.Conclusion:Bufei Jiawei Decoction can improve the clinical symptoms of patients with stable COPD of lung and kidney qi deficiency type,such as shortness of breath,fatigue or spontaneous sweating,aggravation of movement,susceptibility to cold,soreness and weakness of waist and knees,reduce the number of acute exacerbations within 1 year,improve lung function and blood gas,increase exercise tolerance and improve patients’quality of life.The possible mechanism is related to delaying the decline of lung function,correcting the body’s hypoxic state and improving the body’s immune function,and has good clinical safety. |