Objective

2

To observe the clinical efficacy of modified

Jinwei Guben Decoction

（金卫固本汤， MJGD） combined with

Bailing Capsule

（百令胶囊， BC） in the treatment of chronic obstructive pulmonary disease （COPD） patients in the stable stage with

qi

deficiency， blood stasis and phlegm obstruction syndrome， in addition to conventional western medicine treatment.

Methods

2

A total of 102 patients with stable COPD and

qi

deficiency， blood stasis， and phlegm obstruction syndrome were included in the study. According to the patients'preferences， they were divided into treatment group （49 cases） and control group （53 cases）. The control group received conventional western medicine treatment， while the treatment group was given MJGD （1 dose daily） combined with BC （2.0 g each time， three times a day） additionally. The treatment period was 3 months， and the patients were followed up for 1 year after the treatment. The acute exacerbation frequency （mild， moderate， severe） before treatment， during treatment， at 6-month follow-up， and at 1-year follow-up was compared between groups. Additionally， the lung function indicators such as FEV

1

， FEV

1

%pred， FVC， and FEV

1

/FVC ratio， traditional Chinese medicine （TCM） syndrome scores， modified British Medical Research Council （mMRC） dyspnea scale， and the COPD Assessment Test （CAT） scores before and after treatment were compared. A logistic regression model was constructed to analyze the impact of MJGD combined with BC on clinical efficacy.

Results

2

Four patients dropped out

from the treatment group and eight from the control group， leaving 45 patients of each group for statistical analysis. The number of mild and moderate acute exacerbations in the treatment group was lower than that in the control group during the treatment period， at 6-month follow-up and within 1 year of follow-up （

P

＜0.05） .The number of severe acute exacerbations was only lower in the treatment group than in the control group at 6-month follow-up （

P

＜0.05）. Compared with that before treatment， the number of acute exacerbations of all degrees in the treatment group was significantly reduced within 1 year of follow-up （

P

＜0.05），while only the number of mild acute exacerbations in the control group was significantly reduced within 1 year of follow-up （

P

＜0.05）. The treatment group showed significant improvement in FEV

1

and FEV

1

%pred and FEV

1

/FEV， while the control group showed a significant decline in FEV

1

and FVC （

P

＜0.05）. After treatment， both groups showed significant reductions in TCM syndrome scores， including coughing， sputum， wheezing， chest tightness， shortness of breath， and fatigue， as well as mMRC and CAT scores （

P

＜0.05）， with the treatment group having significantly lower scores than the control group （

P

＜0.05）. The overall clinical effective rate of in the treatment group was 93.33% （42/45）， significantly higher than that of the control group， 75.56% （34/45，

P

＜0.05）. Multivariate logistic regression analysis showed that the use of MJGD combined with BC （

OR

= 4.68， 95%

CI

： 1.15 - 19.09，

P

= 0.03） was positively correlated with clinical efficacy.

Conclusions

2

In addition to conventional western medicine treatment， the combination of MJGD and BC can reduce the frequency of acute exacerbations， delay the decline of lung function， improve clinical symptom

s， and significantly enhance the clinical efficacy in patients with stable COPD and

qi

deficiency， blood stasis， and phlegm obstruction syndrome.