A prospective cohort study on “Ye’s benefit Qi and soften hardness Decoction” in the treatment of stage-IV diabetic nephropathy GAI yun ZHANG tong YANG xiao-ping Department of TCM, The People’s Hospital of Seventh Abstract: Objective To observe the therapeutic effect of “Ye’s benefit Qi and soften hardness Decoction” in the treatment of stage2Ⅳ diabetic nephropathy. Methods A prospective cohort study method was utilized in this clinical trial. A total of 60 cases were divided into groups, treatment group 30 cases and control group 30 cases.The subjects in the control group 30 cases were given the standard treatment by following the clinical guide of diabetic nephropathy, while the subjects in the treatment group was orally given “ye’s benefit Qi and soften hardness decoction” plus the standard treatment, with a course of 12 weeks. 24 hours urinary protein , serum creatinine. blood urea nitrogen, triglyceride, cholesterol were analyzed for evaluation before and after treatment. Results Before the treatment, the difference of the mean total score of symptom and the score of every main symptoms between two groups is inappreciable. After the treatment, compared with the control group, the mean total score of symptom of treatment group is obviously lower than control group(P<0.01). The total effective rates for western medicine were 81.2 % and 51.6% in the treatment group and control group, with significant differences between the two groups (P<0.05);and there were great differences in 24 hour urinary protein About creatinine and BUN, there was no significant change in the two groups (P>0.05).Conclusion Ye’s benefit Qi and soften hardness Decoction can effectively decrease the urinary protein. Key words: Stage-Ⅳ diabetic nephropathy; integrative Chinese and western medicine; “Ye’s benefit Qi and soften hardness Decoction”