| Objective:To observe the clinical efficacy and safety of Danshen Bufei Decoction combined with Tiotropium bromide in the treatment of lung and kidney qi deficiency and blood stasis type chronic obstructive pulmonary disease,and to preliminary explore the mechanism of action of Danshen Bufei Decoction.Methods:A total of 70 patients who met the inclusion criteria in pulmonary disease department of Shijiazhuang City hospital of traditional chinese medicine from October 2019 to June 2020 were chosen as the research subjects.The patients were divided into therapeutic group(35cases)and control group(35 cases)by random number table according to the chronological order of treatment.The therapeutic group was given Danshen Bufei Decoction combined with Tiotropium Bromide,and the control group was given Tiotropium Bromide.Both groups were cured for12 weeks and followed up for 12 weeks after therapy.The changes of FEV1/FVC,FEV1%pred,TCM syndrome integral,SOD,MDA,whole blood low-cut viscosity,plasma viscosity and whole blood high-cut viscosity before and after treatment were recorded in the two groups,respectively.The frequency and severity of acute exacerbations during treatment and follow-up were recorded in the two groups,and the abscess and adverse events were also recorded.SPSS 25.0 software was used to conduct statistical analysis on the collected data.Results:(1)Comparison of lung function:There were statistically significant differences in FEV1/FVC and FEV1%pred between the two groups(P<0.01).There was no significant difference in FEV1/FVC and FEV1%pred between the two groups after therapy(P>0.05).(2)Comparison of TCM syndrome scores:The differences of single TCM syndrome scores in the therapeutic group were statistically significant(P<0.01).In the control group,there was no significant difference in fatigue and bluish lips(P>0.05).There were statistically significant differences among the other groups(P<0.01).After therapy,there were significant differences in fatigue item and lip purple item between the two groups(P<0.01).There were statistically significant differences in all the other groups(P<0.05).There was statistical significance in the total scores of TCM syndromes between the two groups(P<0.01).The total score of TCM syndromes in the two groups after therapy showed statistically significant difference between the two groups(P<0.01).(3)Acute aggravation:The frequency and severity of acute exacerbation were significantly different between the two groups(P<0.05).(4)Oxidative stress index:The differences of SOD and MDA in the therapeutic group were statistically significant(P<0.01).There was no significant difference in SOD and MDA in the control group(P>0.05).After therapy,there were statistically significant differences in SOD and MDA between the two groups(P<0.01).(5)Hemorheological indexes:The differences of whole blood low-cut viscosity,plasma viscosity and whole blood high-cut viscosity between the two groups were statistically significant(P<0.01).After therapy,there were statistically significant differences in whole blood low-cut viscosity,plasma viscosity and whole blood high-cut viscosity between the two groups(P<0.01).(6)Comparison of the efficacy of TCM syndromes:The total effective rate of the treatment group was 87.50%,and the total effective rate of the control group was 66.67%,and the difference between the two groups was statistically significant(P<0.01).Conclusion:(1)Danshen Bufei Decoction combined with Tiotropium Bromide in the treatment of lung and kidney qi deficiency and blood stasis type chronic obstructive pulmonary disease patients,can improve the clinical symptoms,can improve lung function indicators,reduce the frequency and severity of acute aggravation,has a good long-term effect,clinical efficacy is definite.(2)In this clinical trial,Danshen Bufei Decoction did not have any adverse reactions,which is safe and reliable,and has clinical promotion value.(3)Danshen Bufei Decoction can improve the antioxidant capacity and reduce the blood viscosity.Therefore,it can be inferred that the mechanism of Danshen Bufei Decoction is to regulate the balance of oxidation and anti-oxidation system and improve the microcirculation barrier. |