| Objective: To explore and provide the evidence on efficacy and safety of diabetes nephropathy prescription in treating early(stage?) Diabetic nephropathy(deficiency of both qi and yin and collateral obstruction by blood stasis syndrome) by randomized controlled trial with the empirical formula created by professor Gao Jining, and to demonstrate the micro-mechanism of diabetes nephropathy prescription with multiapproach and multi-target regarding oxidative stress and renal fibrosis as cutting points, so as to provide new ideas and inspiration for TCM treating DN.Methods: 66 cases of patients with stage ? DN were numbered by consulting order and divided into treatment group and control group with 33 cases randomly. The treatment group and control group were both given conventional western medicine therapy including health education, diet, exercise and good control of blood glucose,blood pressure and blood fat. In addition, the treatment group was given Diabetes nephropathy prescription orally. The related efficacy and safety indexes which including the symptoms, signs, symptom scores of TCM, the level of urine routines,urinary nag enzyme, 24-hour proteinuria, blood glucose, glycosylated hemoglobin,serum creatinine, urea nitrogen and cystatin C were observed, and the MDA content and activity level of SOD were detected to reflect the oxidative stress, and the levels of TGF-?1 and collagen IV were measured to assess the degree of renal fibrosis. All the indexes mentioned above were measured respectively before treatment, during treatment of the 12 th and 24 th week to evaluate the clinic effects of diabetes nephropathy prescription objectively.Results:(1) Total effective rate: During the treatment of the 12 th week, the total effective rate of treatment group was 83.33% while the control group was 59.38%, showing statistical significance(P<0.05); During the treatment of the 24 th week, the total effective rate of treatment group was 93.33% while the control group was 62.50%,also showing statistical significance(P<0.05).(2) TCM symptom scores: During the treatment of the 12 th week, the symptoms of treatment group were improved obviously compared to control group(P<0.05),(3) and during the treatment of the 24 th week, the symptoms of treatment group were improved significantly compared to control group(P<0.01).(4) Blood glucose and glycosylated hemoglobin: the comparison of FPG among two groups before treatment, during treatment of the 12 th and 24 th week showing no statistical significance(P>0.05). However, the comparison of postprandial blood glucose and glycosylated hemoglobin showing statistical significance(P<0.05).The effect of treatment group was superior to that of control group, and the result was significant during treatment of the 24 th week.(5) Proteinuria and renal protective effect: the levels of urine protein, urinary NAG enzyme and Cys-C were lowered obviously(P<0.01)during treatment of the 12 th and 24 th week. Furthermore, the effects of treatment group on reducing the levels of urinary NAG enzyme and Cys-C in 24 th week were superior to those in 12 th week(P<0.01). However, the levels of Scr and BUN showing no statistical significance(P>0.05).(6) Anti-oxidative stress and anti-fibrosis: the MDA content was reduced(P<0.01) and SOD activity(P<0.01)was raised in both two groups before treatment, during treatment of the 12 th and 24 th week. Compared to control group, the levels of TGF-?1 and ?-C were decreased obviously(P<0.01). Furthermore, the effects in24 th week were surperior to those in 12 th week(P<0.01).Conclusion:(1) Compared to conventional western medicine therapy, diabetes nephropathy prescription could improve the 2h PG and glycosylated hemoglobin level,decrease the UAER and the levels of urinary NAG enzyme and Cys-C, which shows renal protective effect and certain value for popularization.(2) Diabetes nephropathy prescription could regulate the levels of MDA and SOD,resist oxidative stress reaction, so as to reduce renal damage and exert preventive and curative effects. This formula could lower the levels of TGF-?1and ?-C, which demonstrate its effects of anti-fibrosis and delay of progress of DN. |
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