Objective To observe the effect of TCM intervention on the evolution regularity of syndrome factors in the patients with diabetic nephropathy（DN）.Methods Totally 152 cases of early DN were randomized into treatment group of 78 cases and control group of 74 cases.The treatment group was given Chinese medication on the basis of syndrome identification.The control group was given 150mg of Irbesartan tablet orally

once daily.One treatment course lasted for 3 months and the observation lasted for 3 courses.The syndrome data was collected before treatment and in the 4th

8th and 12th week of treatment.The syndromes were indentified and the syndrome factors were extracted.The evolution regularities of syndrome factors in the syndromes of yin deficiency

qi deficiency

yang deficiency

blood deficiency

blood stasis

phlegm damp and damp turbidity were analyzed.Then the quadratic curve of the evolution trend was fitted and evolution trend graph was drawn.Results The syndrome factors of yin deficiency

qi deficiency

yang deficiency

blood deficiency

blood stasis

phlegm damp and damp turbidity changed over time in both groups（P<0.05）.The difference between groups was statistically significant in the evolution of syndrome factors in qi deficiency syndrome（P<0.05）.There was no significant difference between groups in the evolution of syndrome factors in other syndromes（P>0.05）.Comparing with the control group

the syndrome factor of qi deficiency syndrome in the treatment group was improved obviously as the curve slope of syndrome factor score in the treatment group was higher than that in the control group.Conclusion Both Chinese formulas and Irbesartan could improve the syndrome factors of early ND.Chinese formulas are more effective in syndrome factors of qi deficiency syndrome as compared with Irbesartan.