| Objective:Through prospective clinical observation and animal experiments,to evaluate the equivalence of TCM formula granules and TCM Decoction Pieces in the treatment of COPD,and to provide the basis for the clinical application of TCM formula granules in the future.Method:1.Clinical study: From December 2019 to December 2020,100 hospitalized patients with COPD at the First Affiliated Hospital of Anhui University of Chinese medicine,Bozhou Hospital of Traditional Chinese Medicine,Taihe Hospital of Traditional Chinese Medicine and Jieshou Hospital of Traditional Chinese Medicine were divided into granule group(n = 50)and docoction group(n = 50)at random.The clinical efficacy,cat score,TCM syndrome score and serum inflammatory index(hs-CRP,SAA)were observed before and after treatment.Among them,60 patients(30cases in granule group and 30 cases in decoction group)were measured for lung function at the beginning and end of therapy.2.Animal experiment: 32 healthy male SD rats were assigned into normal group,model group,granule group and decoction group at random,with 8 rats in each group.In addition to the normal group,the other groups were treated with intratracheal instillation of LPS and smoking to establish COPD rat models.The dosage of each group was as follows: normal group and model group were given normal saline 10 ml /kg / D;granule group was given Liuwei Buqi granule 0.5g/kg/d;Decoction group was given Liuwei Buqi Decoction 0.5g/kg/d for 14 days.Result:1.Clinical study: In this clinical study,100 patients were included,4 cases of shedding,96 cases of effective research cases,including 46 cases in granule group and 50 cases in decoction group.The general information of the two groups,including gender,smoking history,age,course of disease,and distribution of TCM syndrome types,was comparable(P > 0.05).There was no significant difference in cat scores between granule and decoction groups before therapy(P > 0.05);cat scores of the two groups were improved after therapy,and the dissimilarity was statistically obvious(P < 0.01),but there was no obvious dissimilarity in the improvement of cat scores between the two groups(P >0.05).Before treatment,there was little disparity in TCM syndrome scores between granule and decoction groups(P > 0.05);after therapy,TCM syndrome scores of the two groups were improved,and dissimilarity was quite obvious(P < 0.01),while there was no significant difference in the improvement of TCM syndrome scores between the two groups(P > 0.05).The FEV1(L),FVC(L)and FEV1 / FVC(%)of the two groups before treatment had no statistical difference(P > 0.05);the FEV1(L),FVC(L)and FEV1 / FVC(%)of the two groups after therapy were rised,the difference was quite obvious(P < 0.01),while the FEV1(L),FVC(L)and FEV1 / FVC(%)of granule and decoction groups after therapy had no statistical difference(P > 0.05).Before treatment,there was no obvious divergence in hs-CRP and SAA between the two groups(P > 0.05);after treatment,the levels of hs-CRP and SAA in the two groups were significantly decreased(P < 0.01),but there was no obvious divergence in the standard of hs-CRP and SAA between granule and decoction groups(P > 0.05).2.Animal experiment At the end of the modeling cycle,the pathological state,lung function and general physiological state of the lung in model group varied greatly from those in the normal group,suggesting that the construction of model was completed successful.After intragastric administration,there was no inflammatory cell infiltration in and around the lung tissue of the normal group,the structure of bronchioles and alveoli was intact,there was no exudate in the alveolar cavity,and the alveolar septum was not damaged.In the COPD model group,the trachea mucosa epithelium was partly necrotic and exfoliated,the shell of pipe became thicker,duct cavity was constricted,lots of inflammatory plastids were exuded and fibrotic,the alveolar septum was broken and expanded,fused,and presented bullous emphysema.The lung tissue of rats in the granule group and decoction group were improved in varying degrees,with a small amount of inflammatory cells infiltration and mild destruction of alveolar septum;the levels of fev0.3,FVC and fev0.3/fvc in the model group were significantly decreased(P < 0.01),and the indexes of lung function were improved after the intervention of TCM granule and decoction,with statistical difference(P < 0.01),but there was no obvious dissimilarity between granule group and docoction group(P > 0.05);In comparison with the normal group,the levels of IFN-γ,IL-23 and TNF-αin the model group were significantly increased(P < 0.01),and the levels of IL-4 were obviously lower(P < 0.01);In comparison with model group,the standards of IFN-γ,IL-23 and TNF-α in granule group and docoction group were significantly decreased(P < 0.01),and the standards of IL-4 were significantly increased(P < 0.01);the levels of IFN-γ,IL-23 and TNF-αin Liuwei Buqi granule group and Heyin group were significantly decreased(P < 0.01)There was no significant difference between the two groups(P > 0.05).Coclusion:1.On the basis of conventional treatment of Western Medicine,both TCM granules and decoction could effectively relieve the symptoms and signs of COPD patients,improve their lung function,inhibit inflammatory reaction,and there was no significant difference between the two groups.2.In the application of COPD model rats,TCM granules and decoction can reduce the pathological injury of lung tissue,improve lung function,regulate immune function and inhibit inflammatory reaction.3.In this study,the effect of TCM granules and decoction in the treatment of COPD is equivalent.Bue to the granules are easy to take and carry,it is conducive to clinical application and promotion. |