Effect Of Banxia Xiexin Decoction On Intestinal Flora And Cellular Immunity In Patients With T2DM Based On The Method Of "Helping Spleen And Dispersing Essence"

Objective:To observe the changes of intestinal flora and cellular immune function in patients with type 2 diabetes mellitus,and to explore the effect of helping the spleen and dispersing essence method represented by Banxia Xiexin Decoction on intestinal flora and cellular immune function,and to expound the possible mechanism ofhelping the spleen and dispersing essence method in correcting T2DM.Methods:In this study,a randomized controlled trial was conducted to collect 66patients with type 2 diabetes who met the inclusion criteria.They were randomly divided into the experimental group?n=33?and the control group?n=33?.The cases were detached and rejected?1 in the experimental group and 3 in the control group?.The actual number of completed cases was 62,including 32 in the experimental group and 30 in the control group.The experimental group was treated with Banxia Xiexin Granules group,and the control group was treated with Banxia Xiexin Granule Simulator.Both groups received basic treatment such as diabetic diet,exercise adjustment and insulin subcutaneous injection.The 12-week course of treatment was used to evaluate the changes in clinical symptoms and signs and related indicators(including FPG,2hPG,HbA1c,HOMA-?,HOMA-IR,CD3⁺,CD4⁺,CD8^+,CD4⁺/CD8⁺,Intestinal flora)before and after treatment,and to record the occurrence of treatment adverse reactions.All data were statistically analyzed using SPSS 23.0 software.Results:?1?Comparison of TCM syndrome scores:After treatment,both groups of syndrome scores decreased,but the symptoms of the treatment group were significantly improved,the total effective rate was 90.63%;the total effective rate of the control group was 16.67%;The total effective rate of the treatment group compared with the control group,the difference was statistically significant?P<0.01?.?2?Comparison of blood glucose indexes:Compared with before treatment,the FPG,2hPG and HbA1c of the two groups were significantly lower than those before treatment,the difference was statistically significant?P<0.01?;There was a statistically significant difference in FPG and 2hPG between the two groups after treatment?P<0.01?,and the difference in HbA1c was statistical?P<0.05?.?3?Comparison of islet function:Compared with before treatment,HOMA-?and HOMA-IR were significantly improved after treatment in the treatment group,the difference was statistically significant?P<0.01?,and HOMA-?and HOMA-IR after treatment in the control group,the improvement was not obvious,and the difference was not statistical?P>0.05?.Compared with the control group,the HOMA-IR of the treatment group was significantly improved,the difference was statistically significant?P<0.01?,and the difference of HOMA-?was statistical.?P<0.05?.?4?Cellular immunity:Compared with before treatment,CD3⁺,CD4⁺,CD4⁺/CD8⁺increased and CD8⁺decreased after treatment,and the difference was statistically significant?P<0.01?.Compared with the control group,the treatment group CD4⁺was significantly improved,and the difference was statistically significant?P<0.01?.The difference of CD3⁺and CD4⁺/CD8⁺was statistical?P<0.05?.There was no significant improvement in CD8⁺,and the difference was not statistical?P>0.05?.?5?Intestinal flora:The experiment found that,from the perspective of bacterial diversity,the diversity of intestinal flora was significantly increased in the treatment group compared with the before treatment and the control group;From the level of flora abundance:At the level of the door,the treatment group can increase the proportion of Firmicutes and Bacteroidetes,and reduce the proportion of Proteobacteria;At the target level,the treatment group can make Bacteroides,Lactobacillales increased in proportion,and the proportion of Enterobacteriales and Bifidobacteriales decreased;At the genus level,the treatment group increased Bacteroides,Ruminococcaceae UCG-002 and Lactobacillus,and the proportion of Eschenchia-shigella decreased.?6?Safety evaluation:The three routine indexes,liver and kidney function,electrocardiogram and other indicators of the two groups before and after treatment were all within the normal range,and there were no adverse reactions or adverse events during the whole research process,indicating that the use of Banxia Xiexin Decoction for the treatment of type 2 diabetes is safe and reliable.Conclusions:?1?Spleen and weak stomach is the key to the pathogenesis of type 2 diabetes,and it is also an important pathogenesis for diabetic patients with low immunity and intestinal flora disorder;?2?The treatment of type 2 diabetes with helping the spleen and dispersing essence method represented by Banxia Xiexin Decoction can significantly alleviate the clinical symptoms of patients.Besides lowering blood sugar,it can also improve islet function and insulin resistance,improve immune function and regulate intestinal flora of patients.It has more advantages than insulin alone;?3?Improving the immune function of patients and regulating the intestinal flora of patients may be the new mechanism of action of Banxia Xiexin Decoction in the treatment of type 2 diabetes,which is worthy of further study;?4?Banxia Xiexin Decoction is safe and has no toxic side effects in the treatment of type 2 diabetes.