Objective: To observe clinical effect and mechanism of Tangshenbao granules combined with enalapril maleate tablets in treating early diabetic nephropathy (DN). Method: Eighty patients with DN were randomly divided into Contrast group (40 cases) and joint group (40 cases) by random number table. Blood glucose of patients in both groups was controlled strictly and blood pressure was controlled by oral 5-10 mg amlodipine tablets once daily. Patients in Contrast group received enalapril maleate tablets

10 mg/time

1time/day. Based on the treatment of Contrast group

patients in joint group received 1 dose formula granules of Tangshenbao granules in twice daily. Patients in two groups received a 12-week period of treatment. The ratio of microalbuminuria and creatinine (mALB/Ucr)

urine albumin excretion ratio(UAER)

fasting blood-glucose (FBG)

glycosylated hemoglobin (HbAlc)

serous cystatin-c (Cys-C)

haematic β2 microglobulin (β2-MG)

N-acetyl-β-D-glucosaminidase (NAG) and kidney injury molecule-1(KIM-1) were detected before and after treatment. Result: After treatment

UAER and mALB/Ucr in joint group were lower than those in Contrast group (P<0.01). Compared with the time before treatment

levels of FPG and HbAlc in both groups were decreased(P<0.01) and level of HbAlc in joint group was lower than that in Contrast group (P<0.05). Compared with the time before treatment

levels of Cys-C

β2-MG

NAG and KIM-1 in Contrast group were decreased and thay were lower than those in joint group (P<0.01). The curative efficacy in Contrast group was superior to that in joint group according to Ridit analysis (P<0.05). Conclusion: Tangshenbao granules combined with enalapril maleate tablets has a good protection in treating early DN and its curative efficacy is superior to enalapril maleate tablets therapy alone.