| This paper was divided into two parts. The first part is about theoretical discussion and the following contents were reported such as basic theory and treatment development of diabetic nephropathy of traditional Chinese medicine, pathology and therapeutic situation of western medicine, and sum up our teacher-professor Lee Delin's academic ideology, which provided theoretical foundation for clinical study. In the second part, 78 patients with incipient DN were observed with random control study on the basis of clinical epidemiological survey and DME method. The result: l.Qizhi Shenxiao fomular has function of improving clinical symptoms and the effect was better than the control group treated with western medicine through statistics analysis. 2. Qizhi Shenxiao fomular has effect of reducing blood sugar, serum advanced glycation end products (AGEs), regulating sugar and lipid metabolism. 3. Qizhi Shenxiao fomular could reduce urinary albumin excretion rate in DN early stage, improve glomerular filtration rate, protect kidney function, and defer DN development. 4. Qizhi Shenxiao fomular has effect of reducing plasma homocysteine (Hey), regulating protein metabolism, decrease the hyperhomocysteinemia (Hhcy) occurremce of incipient DN. 5. Qizhi Shenxiao fomular could reducd TXB2 and increase 6-Keto-PGF1a, reduce blood viscosity, pack cell volume, RBC aggregation index, fibrinogen concentration, blood platelet adhesion and aggregation rate, all above were better than control group treated with western medicine (P<0.01). 6. Qizhi Shenxiao fomular probably has good effect on treating retina disorders and peripheral nerve diseases caused by diabetes.
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