| Background:In recent years, with the gradual increase in the incidence of diabetes, diabetic nephropathy as the most common microvascular complications of diabetes, and its incidence is gradually increasing, which is Increasingly large proportion in resulting in the end-stage nephropathy and maintenance hemodialysis. It is the key to the development and progression of kidney disease delay that the early diabetic nephropathy intervene effectively. Western medicine, in the treatment of diabetic nephropathy, often has less obvious for clinical improvement and long-term use may be secondary failure. But TCM has a unique advantage in the fight against diabetic nephropathy. Therefore there is great significance developing effective prevention and treatment of early diabetic nephropathy medicine.Objective:Through observe the clinical efficacy of Sanhuangyishen granule for the case of early diabetic nephropathy qi yin and yang deficiency and blood stasis patients to evaluate the safety and effectiveness of drugs.Methods:57 patients with early diabetic nephropathy patients, were randomly divided into experimental group and control group. The experimental group,28 cases; the control group, 29 cases. Based on the basic treatment of hypoglycemic, lipid-lowering, nutritional therapy, the experimental group was given Sanhuangyishen granule,1 bag each time,2 times a day; the control group was given irbesartan,150mg,1 times a day, at the same time to take traditional Chinese medicine placebo, which consistents with the appearance of the sanhuangyishen granule. The course of treatment is 12 weeks. The observation items included: the syndrome integral, urinary albumin excretion rate (UAER), glycosylated hemoglobin (HbAlc), serum creatinine (SCr), estimated glomerular filtration rate (eGFR) and other therapeutic index, safety index, end point events.Results: ①The TCM curative effect:In the experimental group and the control group, the TCM syndrome total score decreased significantly than before treatment. Compared with two groups, the test group decreased significantly than that of the control group. The test group was 57.1%, efficiency of 25%, the total effective rate was 82.1%, the control group was 20.7%, efficiency was 20.7%, the total efficiency of 41.4%. Through the test of χ2, the data of the two groups had statistically significant difference, the experimental group were significantly better than the control group. ②In the western medicine treatment:After treatment, the test group UAER significantly decreased than before, the control group had no significant change compared with the former UAER. the test group was 25%, efficiency of 14.3%, the total effective rate was 39.9%, control group was 24.13%, efficiency was 10.34%, the total efficiency of 34.5%, the χ2 test, no significant difference between the experimental group and the control group. ③The indexes of renal function improvement:the eGFR of the two groups were higher than that before treatment, the comparison group, two groups of patients before and after treatment eGFR value had no significant difference; in SCr, the test group after treatment was lower than before the treatment, the control group had no significant difference before and after treatment. ④The decrease of HbAlc:two groups of patients before and after HbA1c treatment, the P value is greater than 0.05, no statistical differences. ⑤The end point events:2 cases in test group events, the incidence rate was 7.1%, the control group event occurred in 3 cases, the incidence rate was 10.3%, by statistical analysis, no obvious difference between the two groups. ⑥The two groups during the treatment, there was no any adverse reaction.Conclusion:the Sanhuangyishen granule can significantly improve the clinical symptoms in patients with early diabetic nephropathy, reduce UAER, and delay the progress of diabetic nephropathy, and drug safety is good, safe and reliable use dose. |
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