Objective The patients were treated with external application of topical Chinese medicine(acupoint sticking and ion introduction)combined with oral administration of Liuwei Buqi Granules for the treatment of lung-kidney Qi deficiency in the stable stage of COPD.Recorded the number of acute exacerbations,pulmonary function,TCM syndrome score,quality of life assessment test(CAT score),dyspnea grading(m MRC scale),6-minute walking distance(6MWD)and related immune indexes at multiple time points,and initially evaluated and discussed the near and long-term efficacy of the external application of topical Chinese herbal medicine(acupoint sticking and ion introduction)and oral administration of Liuwei Buqi Granules in the treatment of lung-kidney Qi deficiency in the stable stage of COPD,and provided a basis for its further application in clinical practice.Methods1.This study was conducted by a randomized,parallel-controlled method.Seventy-three patients who met the diagnostic criteria of pulmonary and renal qi deficiency in the stable phase of COPD were randomly divided into 37 patients in the treatment group and 36 patients in the control group.The control group inhaled a combination of β2-agonist and hormone(salmeterol ticapone powder inhalation50ug/250ug),while the treatment group was given external application of topical Chinese medicine(acupoint sticking and ion introduction)combined with oral administration of Liuwei Buqi Granules.The total duration of treatment was 6months,and a multi-point follow-up was performed up to 4 years after the end of treatment.2.The changes in pulmonary function,TCM evidence score,m MRC score,CAT score,6MWD and number of acute exacerbations were observed in both groups before,after and 1,2 and 4 years after treatment.The expression levels of CD3+,CD4+,CD8+,CD4+/CD8+ were measured by flow cytometry technique before,after and 4 years after treatment,and the expression levels of complement C3 and C4 were measured by ELISA.Results1.Comparison of number of exacerbations.The number of exacerbations was significantly lower in the treatment group after 1 year than before treatment and after2 years than in the control group(P<0.05),and remained lower after 3 and 4 years than before treatment and in the control group,but was not statistically different(P>0.05).In the control group,the number of exacerbations was significantly lower after 1 year than before treatment(P<0.05),and the number of exacerbations was lower after 2 years than before treatment,after 3 years than before treatment,and after 4 years than before treatment.2.Comparison of overall effective rate and TCM evidence score.In the treatment group The overall effective rate in the treatment group(86.7%)was higher than the control group(70%),and the effective rate was higher than the control group(Z=-2.189,P<0.05);the TCM evidence score in the treatment group after 1,2,and 4years was significantly lower than the control group before treatment(P<0.05).The control group was lower than pre-treatment at 1 year(P<0.05),2 years(P<0.05),and4 years(P>0.05),but not statistically different from pre-treatment.3.Comparison of lung function FEV1 and FEV1/FVC.The treatment group were slightly higher than pre-treatment at 1 and 2 years post-treatment and slightly lower than pre-treatment at 4 years post-treatment,all higher than the control group but not statistically different(P>0.05),and in the control group they were higher than pre-treatment at 1 year post-treatment and lower at 2 and 3 years post-treatment but not statistically different(P>0.05).In the control group,it was higher than pre-treatment at 1 year post-treatment and lower than pre-treatment at 2 and 4 years post-treatment,but there was no statistical difference(P>0.05).4.Comparison of quality of life.CAT scores were significantly lower in the treatment group at 1,2,and 4 years post-treatment than before treatment and in the control group(P<0.05),1 year post-treatment was significantly lower in the control group than before treatment(P<0.05),2 years post-treatment was lower than before treatment,and 4 years post-treatment was higher than the control group,but there was no statistical difference(P>0.05).There was no statistical difference(P>0.05).5.Comparison of dyspnea ratings.The m MRC rating of the treatment group was significantly lower than that of the pretreatment and control group at 1 year after treatment(P<0.05),lower than that of the pretreatment group at 2 years after treatment,and slightly higher than that of the pretreatment group at 4 years after treatment,but still lower than that of the control group,with no statistical difference(P>0.05).In the control group,m MRC scores were significantly lower than in the pretreatment group 1 year after treatment(P<0.05)and lower than in the control group 2 years after treatment.There was no statistical difference(P>0.05).6.Comparison of physical endurance The treatment group’s 6MWD was significantly higher than the pre-treatment group and 1 year after treatment(P<0.05),higher than the 2-year post-treatment group,slightly lower than the 4-year post-treatment group,still higher than the control group and not statistically different(P>0.05).In the control group,TM6 was significantly higher at 1 year after treatment(P<0.05),higher at 2 years after treatment and lower at 4 years after treatment,but not statistically different(P>0.05).There was no statistical difference(P>0.05).7.Comparison of immunity indices: CD3+,CD4+,CD4+/CD8+,C3 and C4 complement expression levels were significantly higher in the treatment group than in the pre-and post-treatment control groups,CD8+ was significantly lower than in the pre-and post-treatment groups(P<0.05),and 4 years after treatment,CD3+,CD4+,CD4+/CD8+,C3 and C4 complement expression levels were slightly higher than in the pre-and post-treatment groups and CD8+ slightly lower than in the pre-and post-treatment groups,with all differences not being statistically significant(P>0.05).In the pre-treatment and control groups,CD8+ levels were slightly lower than in the pre-treatment and control groups,with all differences not being statistically significant(P>0.05).In controls,CD8+ was significantly lower after treatment(P<0.05)and CD3+,CD4+,CD4+/CD8+ and complement C3 and C4 were higher than before treatment.Four years after treatment,CD3+,CD8+ and complement C3 and C4 were lower than before treatment and CD4+ and CD4+/CD8+ were higher than before treatment,although not all differences were statistically significant(P>0.05).Conclusion1.External application of topical Chinese medicine(acupoint sticking and ion introduction)combined with oral administration of Liuwei Buqi Granules for the treatment of lung-kidney Qi deficiency in the stable stage of COPD can reduce clinical symptoms,decrease the number of acute exacerbations,delay the decline of lung function,improve exercise tolerance and survival quality,and have efficacy in the near and long term.2.External application of topical Chinese medicine(acupoint sticking and ion introduction)combined with oral administration of Liuwei Buqi Granules for the treatment of lung-kidney Qi deficiency in the stable stage of COPD can increase serum CD3+,CD4+,CD4+/CD8+,complement C3 and C4 levels and lower CD8+levels,and enhance immune function in stable COPD patients with lung-kidney qi deficiency,with recent efficacy better than long-term efficacy.3.External application of topical Chinese medicine(acupoint sticking and ion introduction)combined with oral administration of Liuwei Buqi Granules for the treatment of lung-kidney Qi deficiency in the stable stage of COPD has not shown any significant adverse effects and can be promoted in the treatment of COPD. |