| To explore the clinical efficacy and safety of Qishen Buqi Capsule in the treatment of pulmonary qi deficiency syndrome of chronic obstructive pulmonary disease(COPD)in stable stage.Methods:By using the method of randomized controlled trial,a total of 480 cases of COPD patients with lung qi deficiency in stable stage were randomly divided into 2 groups,240 cases in each group,and observed for 52 weeks.Both groups were given basic treatment such as health guidance,family oxygen therapy,salmeterol and ticasone powder inhalation,Zhuli Capsule,etc.; the control group was given Yupingfeng Capsule orally,2 a time,3 times a day; the observation group was given Qishen Buqi Capsule orally,3 a time,3 times a day,on the basis of basic treatment.The main endpoint was the number of acute exacerbations in the 2 groups.The secondary indexes included:the CAT score and the respiratory function(FEV1、FVC、FEV1/FVC%)at the baseline,the 3rd,the 6th and the 12th month of treatment; immune function indexes(IGA,IgG,complement C3,CD4,CD8,CD4/CD8)and inflammatory reaction indexes(TNF-α,IL-6,IL-8)were measured at baseline and at the end of treatment in the first 96 patients; occurrence of adverse events in 2 groups.Results:There was no significant difference in drop off rate and lost visit rate between the 2 groups(P> 0.05).There was no significant difference in baseline between the 2 groups(P> 0.05).The average number of acute exacerbations in the observation group was 1.62±0.93 times,while that in the control group was 1.83±0.97 times.The frequency of seizures in the observation group was significantly reduced(t=2.262,P=0.012).The risk of acute exacerbation in the observation group was reduced by 13.1%,RR=0.869(0.763～0.988),P=0.032,compared with the control group.Qishen Buqi Capsule helped patients with cough,wheeze,constipation or smoking at baseline,with a lower risk of acute exacerbation(P<0.05).The CAT score and FEV1 in the observation group were significantly better than those in the control group(P<0.05).There were no significant differences in FVC,FEV1/FVC% and immune function indexes(IgA,complement C3,CD4,CD8,CD4/CD8)between the 2 groups(P> 0.05).The improvement of inflammatory response indicators(TNF-a,IL-6,IL-8)in the observation group was significantly better than that in the control group.The incidence of adverse events in the observation group was significantly lower than that in the control group.Conclusion:Both Qishen Buqi Capsule and Yupingfeng Powder have good effects on improving immune function and improving cough,expectoration and wheezing symptoms in COPD patients with lung qi deficiency syndrome.Among them,Qishen Buqi Capsule can significantly reduce the risk of acute exacerbation compared with Yupingfeng Capsule.Especially for patients with cough,wheeze,constipation and other symptoms and smoking history,Qishen Buqi Capsule significantly reduces the risk of acute exacerbation,and has good safety,which is worthy of popularization. |
