| Objective: According to epidemiological survey, the incidence of kidney disease in type 1 diabetic patients is 30 to 40 percent, while it's 20 to 60 percent in type 2 ones. The incidence of diabetic nephropathy (DN) is related to diabetic course closely. It's that the incidence of DN increases with the extension of diabetic course. With the increasing incidence of diabetes around the world, as well as the extension of survival time for patients, the ratio of DN patients in patients with diabetes also increases year by year. At present, the DN has become the main reason of the End-stage renal disease in the west. Clinical treatment is mainly with Low protein diet ,control of blood glucose, hypertension, Blood Lipid and application of rennin-angiotensin system blocker treatment, peroxisome proliferators-activated receptors ofγagonist treatment, protein kinase C inhibitors and renal replacement therapy. However, its course is still in progress and the treatments are often with toxic side– effects. Therefore, it plays an extremely important role in human treatment of DN to find treatment drugs whose curative effect is reliable and short of side effects.Herbal compound can get its efficacy through multi-channel and multi-target. It has fewer side effects, lower drug resistance rate and reliable therapeutic effect what had been confirmed by lots of clinical practice and experiment research institute. But now Chinese medicine - related researches of kidney diseases are basically single studies, and there's lack of large– scale, multi - center, and randomized study. It leads to such a situation that the exact clinical efficacy of many traditional Chinese medicine are failed to be fully confirmed by science. So it's especially necessary to carry out multi-center randomized study with stringent design, scientific and rational evaluation of curative effect. The study that is on the integrated scheme about diabetic nephropathy intervention by Chinese differential treatment, which is an"Eleventh Five-Year Program"National Science and Technology Plan Projects, is to evaluate the role of Chinese medicine in postponing the process of DN scientifically. The study which followed the spirit of epidemiological study and with a multi-center, prospective randomized study method, conducted a two-year observation of multi-course. Traditional Chinese Medicine Hospital of Hebei Medical University is one of the ten centers of the research group, and the author summarized the clinical trials of this center.Methods: Collected outpatients that have been diagnosed with DN of departments of nephrology and endocrine in the Chinese medicine Hospital of Hebei Medical University. In accordance the third and fourth Stage patients with the DN of the Mogensen staging diagnosis standards. And chose"the diabetes mellitus stages of Chinese medicine Syndrome Differentiation and Effect Evaluation of reference standard", which was passed by the Chinese School of diabetes mellitus Committee in the Third working Meeting in 1992, May, for TCM diagnostic basis. Selected patients who belonged to yin deficiency type, yang deficiency type or both Yin and Yang deficiency type .At the same time, patients should have performance of blood-stasis and turbid dampness syndrome. Using blind envelope method, divided patients into the treatment group and the control group randomly. All the patients were gave blood pressure, blood sugar and lipid-lowering therapy. Then the treatment group were gave experimental drugs a bag twice a day while the control group were gave irbesartan, which has exact effect on slowing the progression of DN , 0.15g oral once a day. In each group, it must be avoided that the use of ACEI and ARB types of anti-hypertensive drugs and drugs with function of renal protection, such as Chinese caterpillar fungus. The therapeutic duration is 12 months with re-assessing every 3 months . Observed patients of two groups with symptoms, urinary albumin excretion rate(UAER), 24h urine protein,serum creatinine(Scr), blood urea nitrogen(BUN) and glomerular filtration rate(GFR) which calculated by the latest evaluation of eGFR formula-simplification of MDRD equation. Results:①Two groups had no significant differences in the integration of syndrome pre-treatment with P>0.05.In each group there were significant differences between index before and after treatment with P<0.05.The differences between two groups after treatment had significant meaning with P<0.05.②Compared with UAEA in both group between before and after treatment, both had significant differences with P<0.05. Compared with UAEA in results after treatment between two groups, the differences was no meaning with P>0.05.③Compared with 24h urine protein in both group between before and after treatment, both had no significant differences with P>0.05. Compared with 24h urine protein in results after treatment between two groups, the differences was no meaning with P>0.05.④Compared with Scr in both group between before and after treatment, both had no significant differences with P>0.05. Compared with Scr in results after treatment between two groups, the differences was no meaning with P>0.05.⑤Compared with BUN in both group between before and after treatment, both had no significant differences with P>0.05. Compared with BUN in results after treatment between two groups, the differences was no meaning with P>0.05.⑥Compared with GFR in both group between before and after treatment, both had no significant differences with P>0.05. Compared with GFR in results after treatment between two groups, the differences was no meaning with P>0.05.Conclusion:①The diagnosis and treatment based on differentiation of symptoms and signs was superior to irbesartan on improving symptoms and the quality of life of patients with DN.②The diagnosis and treatment based on differentiation of symptoms and signs used on patients with DN had functions of lowing urinary albumin of the third Stage patients with DN.③The diagnosis and treatment based on differentiation of symptoms and signs used on patients with DN had functions of slowing the reducing of GFR and deterioration of renal function.
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