To observe the efficacy and safety of integrated traditional Chinese medicine(TCM) with western medicine in treating diabetic nephropathy(DN) as well as its treating mechanism.Methods:Eighty cases of patients with DN were randomly divided into treatment group and control group. The control group received conventional western medicine and the treatment group western medicine and Chinese medicine. The treatment course lasted for 8 weeks. Indexes including urinary albumin excretionrate(UAER), fasting blood glucose(FBG), glycosylated hemoglobin(HbA1c), β2-microglobulin(β2-MG), and plasminogen activator inhibitor 1(PAI-1) were observed.Results:The FBG, HbA1c, β2-MG, PAI-1 indexes and clinical symptoms of the treatment groups were improved obviously with the total effective rate of 80.00%. Compared to that of the control group(57.50%), the difference was significant.Conclusion:Chinese medicine combined with western medicine to treat DN could reduce the levels of SBP, DBP, FBG, HbA1c, β2-MG, and PAI-1 with high safety.