Abstract: OBJECTIVE To observe therapeutic effects of Yiqi Yangyin Tongluo Formula in treating early diabetic nephropathy， so as to provide a safe and effective method for clinical treatment of early diabetic nephropathy. METHODS Eighty early DN patients were randomly assigned to the treatment group(42 cases) who treated by Yiqi Yangyin Tongluo Formula combined with conventional treatment and the control group(38 cases) treated by conventional treatment. The urine microalbumin， 24-hour urinary protein quantity， fasting blood glucose， glycosylated hemoglobin urine， β2 microglobulin and clinical effective rate of both groups were observed. RESULTS The effective rate was 68.42% in the control group and 85.71% in the treatment group with statistical differences when compared with each other(P<0.05). There experienced an evident decrease in urine microalbumin， 24-hour urinary protein quantity and β2 microglobulin after treatment of the two groups(P<0.05~0.01). And the treatment group was superior to the control group(P<0.05~0.01). CONCLUSION Yiqi Yangyin Tongluo Formula has obvious therapeutic effects on early diabetic nephropathy by improving sugar metabolism， kidney function and prolong its progress.