| Objective: In this study, the curative effect of Shen Xiao Tong Luo fang on diabetic nephropathy(DN) in stage ? or ? was investigated by prospective, stratified, random and controllable methods, which will provide valuable data in treatment DN with traditional Chinese medicine.Methods: One hundred and twenty patients with DN coming from two hospitals were divided into three levels according to the severity: stage ?level(Level A), ?proteinuria level(Level B), stage ?renal failure level(Level C), 40 cases were included in each level, and then these patients were divided randomly into control group and treatment group(20 cases in each group). During preparation period(from one to three months), all cases were treatment with western medicine including diabetes diet, sport and medicine, leading to their blood sugar, blood pressure and blood lipid were controlled in a stable and standard range. In the experimental process(six months), treatment and control groups were treated with Shen Xiao Tong Luo fang and ARB, respectively. We explored the changes of Traditional Chinese Medicine(TCM) syndrome after treatment, compared the differences between two groups and evaluated the efficacy of the treatment of DN in the stage ? or ? with Shen Xiao Tong Luo fang by statistical methods.Results:1 TCM syndromeAfter treatment, the three levels of TCM syndromes have improved, moreover, it was more obvious in treatment groups compared with control groups in each level, P value < 0.05, the difference was statistically significant.2 AlbuminuriaLevel A: Compared with pretreatment, 24 h microalbumin showed a significant decrease in both control and treatment groups(P<0.05, control vs pretreatment, P<0.01, treatment vs pretreatment). After treatment, compared with control group, the decrease of 24 h microalbumin was more obvious in treatment groups(P<0.01)Level B: Compared with pretreatment, we observed the decrease in 24 h urinary protein quantity in both groups, moreover, this decrease was more obvious in treatment group(P<0.05). After treatment, 24 h urinary protein quantity decreased markedly in treatment group than control group(P<0.05).Level C: Compared with pretreatment, 24 h urinary protein quantity decreased in both control and treatment group, this decrease was more obvious in treatment group(P<0.05, treatment vs pretreatment). After treatment, compared with control group, 24 h urinary protein quantity decreased apparently in treatment group(P<0.01).3 Renal functionBUN(Blood urea nitrogen): Compared with pretreatment, in control and treatment groups of Level A or B, the changes of BUN were not obvious(P>0.05, both groups vs pretreatment). However, BUN decreased obviously in both control and treatment groups in Level C(P<0.05 and P<0.01, compared with pretreatment). After treatment, compared with control group, the changes of BUN were not obvious in treatment group in Level A and B,(P>0.05). However, the BUN was significant decreased in treatment group in Level C(P<0.05, compared with control group).SCr(Serum creatinine): Compared with pretreatment, in control and treatment groups of Level A or B, the changes of SCr were not obvious(P>0.05). However, the change was obvious in treatment group compared with pretreatment in Level C(P<0.01). After treatment, compared with control group, the changes of SCr were also not obvious in Level A or B(P>0.05), the SCr had a marked drop after treatment in Level C(P<0.05, treatment vs control).GFR(Glomerular filtration rate): Comparing with pretreatment, in control and treatment groups of Level A or B, the changes of GFR were not obvious(P>0.05). In Level C P<0.01, this change was obvious between treatment and pretreatment. After treatment, in Level A or B, compared with control group, the changes of GFR were not obvious(P>0.05), but the value of GFR showed a obvious decline after treatment in Group C(P<0.01 treatment vs control).4 Incidence rate of endpoint event of renal functionThere was one case of renal end point events from DN stage ? to IV in treatment group of Level A, as well one case from DN stage IV to V in control group of Level B. Moreover, the incidence of renal endpoint was no change between treatment and control groups(P>0.05 by chi square test). Furthermore, there were no death events in both groups.Conclusions: Our results showed that Shen Xiao Tong Luo fang could effectively improve TCM syndromes and relieve clinical symptoms, leading to improving the life quality of patients. It may reduce 24 h microalbumin and 24 h urinary protein quantity, decline the level of BUN and SCr, raise the level of GFR, and protect renal function. So Chinese medicine Shen Xiao Tong Luo fang has a remarkable clinical efficacy on DN, and it should be put into clinical application. |
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