Experimental And Clinical Study On The Effect Of Tangshen Powder In The Treatment Of Diabetes Nephropathy

Background: Diabetes nephropathy (DN) is part of blood capillary disease in diabetes mellitus. It is the major cause of the chronic renal failure, and it is also the major cause of death in type 1 diabetes mellitus. So far, simple western medicine can't prevent the course of disease in diabetes mellitus. We have accumulated many traditional Chinese medicine and treatment experience to prevent and treat the diabetes nephropathy. So, it has very important medical and social value to know the pathogenesis of diabetes nephropathy all around and systematically and select effective traditional Chinese medicine to prevent and treat the disease.TangShen Powder is one of the achievements from Administration of Traditional Chinese Medicine in Shandong. We find the powder also has the protection and treatment effect to diabetes nephropathy in recent years. The study is plan to explore the pathogenesis and curative effect of TangShen Powder in protect and treat diabetes nephropathy by animal experiment and clinical study, thus we can find an effective way to cure diabetes nephropathy in clinical.EXPERIMENTAL PARTObjective: To observe preventive and curative effect of TangShen Powder on the renal damage of diabetic rats, and explore the best dosage of Astragalus membranaceus in TangShen Powder by animal experiment.Methods: Tangshen Powder were made and divided into three species: Tangshen-1, Tangshen-2 and Tangshen-3 according to the different dosage of Astragalus membranaceus in them. 70 male and healthy mature Wistar rats were chosen, weight 180～210g, urine glucose is negative. All the rats were fasted for 12 hours. 13 rats were chosen randomly as a control group (NC). Streptozotocin (STZ, bought from American Sigma) were dissolved in newly-made O.lmmol/L citrate buffer (pH=4.5) to make into lOmg/ml STZ solution, then injected into the rest rats (60mg/kg body weight). The blood glucose were determined 72 hours later after the injection of STZ, and rats with blood glucose levels≥13.5mmol/L were used as diabetic rats model. Diabetic model rats were divided into 4 groups: diabetic model group (DM), High-dose treatment group (HDT group), Low-dose treatment group (LDT group). Tangshen Powder was dissolved in distilled water to make into 0.12g/mL solution. The solution was injected to the rats by intragastric administration (per kilogram of rats were converted by 6.25 times as adult). HDT group:13 rats were injected with Tangshen-1, qd, 8 weeks; MDT group:13 rats were injected with Tangshen-2, qd, 8 weeks; LDT group:13 rats were injected with Tangshen-3, qd, 8 weeks; DM group(12 rats) and NC group (13 rats): each group were injected with the same dosage of distilled water, qd,8 weeks. All rats were allowed free access to food and water with 12 hours illumination. All rats were executed after 8 weeks' treatment. Fasting 12 hours, to measure the body weight before the death of the rats. The following items were determined: the rats' serum creatinine (Scr), urine albumin (UAlb), sorbitol content in red blood cell (RBCS), fasting blood glucose (FBG), fructosamine (FIM), triglyceride (TG), cholesterol (CHO) and kidney/body weight were determined respectively. The histology morphological change of the rats' kidney was observed with microscope after HE and PAS staining.Results:①Compared with DM group, HDT group has a lower Scr, higher Ccr (P<0.01); HDT, MDT and LDT group have a lower UAlb, RBCS, FBG, FIM, kidney /body weight (P<0.05).②Compared with DM group, HDT group has a lower CHO(P<0.05), but come short of normal level. MDT and LDT group has a lower CHO, TG compared with DM group, but the differencehasn't statistical significance.③Compared with MDT, LDT group, HDTgroup has the best effect.Conclusions:①HDT group can improve the Scr and Ccr of the diabeticrats', but MDT and LDT haven't the significant improvement.②All threegroups can protect the kidney damage, to ameliorate UAlb of diabetic rats,and HDT group has the best effect.③All three groups can ameliorate RBCS.④All three groups can improve the sugar metabolism, ameliorate BG, TIM, butcan't control BG effectively.⑤All three groups can improve lipoids metabolismof the diabetic rats, but come short of normal level.⑥The optimal dosage ofAstragalus Membranaceus in Tangshen Powder is 120g per powder.CLINICAL PARTObjective: To evaluate the clinical effect of Tangshen Powder in treatmentof DN.Methods: 65 DN patients were divided into three groups as A (24 cases), B(21 cases) and C (20 cases) according to the staging of criteria of Mogensen. Whilekeeping taking the original medicine, all patients were given Tangshen Powder. Theexperimental indexes and the score of CTM symptoms and signs were comparedbefore and after 30 days' treatment of Tangshen Powder.Results: The effective rate of the three groups is 91.67%, 80.95%, 70.00%respectively. Tangshen Powder can also improve the blood rheology (P<0.01), reducethe score of TCM symptoms and signs (P<0.05). Among the three groups, group Ahas the best curative effect.Conclusions: Tangshen Powder is effective for every level of DN and the earliertreatment, the better curative effect.