Objective To explore the effect of Wuwei Xiaoke Formula on intestinal flora and inflammatory factors in patients with type 2 diabetes mellitus.Methods A total of 92 cases of type 2 diabetes patients with Qi-Yin deficiency syndrome were selected and randomly divided into treatment group(n=46)and control group(n=46).The control group was treated with basic treatment + metformin,and the treatment group was treated with Wuwei Xiaoke formula on the basis of the control group.The clinical efficacy,intestinal flora and inflammatory factor levels of the two groups were observed and compared.Results The two groups of patients were evenly distributed,with good baseline status and strong comparability.After treatment,the total effective rate of 91.30%in the treatment group was higher than that of 78.26%in the control group(P<0.05).After treatment,the number of Bacteroides,Lactobacillus and bifidobacterium groups in treatment group was higher than that in control group(P<0.05).The numbers of enterococcus,enterobacter and yeast were lower than those in control group(P<0.05).After treatment,the levels of tumor necrosis factor-α(TNF-α),interleukin-6(IL-6)and C-reactive protein(CRP)in the treatment group were decreased more significantly than those in the control group(P<0.05).Conclusion Wuwei Xiaoke formula is helpful to improve the clinical symptoms of type 2 diabetes patients,regulate the disorder of intestinal flora in patients,reduce the level of inflammatory factors,and has good safety.