| Objective:Based on the theory of "Spleen deficiency causes elimination,treating the spleen will lead to elimination",and combined with the supervisor’ s many years of clinical experience,this study was conducted from the perspective of "nourishing the spleen and kidney",and formulated the experimental formula of Tangshen Zisheng Decoction to treat patients with Diabetic Kidney Disease stage(DKD)Ⅲ-Ⅳ(spleen and kidney deficiency).The clinical efficacy of the formula was analyzed by observing the changes of the laboratory indexes and TCM symptom points in the two groups before and after the treatment,and exploring the mechanism of the effect of the formula in the treatment of DKD.Methods:Sixty patients with DKD stage Ⅲ-Ⅳ who met the inclusion criteria and were identified by Chinese medicine as having deficiency of both spleen and kidney were selected.The control group was given conventional western medical treatment,and the experimental group was given Tangshen Zisheng Decoction plus reduction on the basis of the control group,with water decoction,one dose per day,for 8 weeks.Fasting blood glucose(FBG),glycated hemoglobin(HbA1c),serum creatinine(Scr),blood urea nitrogen(BUN),24h urinary protein quantity(24hUPr),hypersensitive C-reactive protein(hs-CRP)and changes in TCM symptom points were observed and recorded before and after treatment,to analyze their clinical efficacy and safety.Results:(1)Total clinical efficacy:the total clinical efficacy of the test group and the control group were 89.66%and 68.97%,respectively,and the test group was better than the control group(P<0.01).(2)Total TCM efficacy:the total TCM efficacy of the test group and the control group were 93.1%and 75.86%,respectively,and the test group was better than the control group(P<0.05).(3)Blood glucose:FBG and HbAlc in the test group decreased significantly before and after treatment(P<0.01);FBG decreased before and after treatment in the control group(P<0.05),and HbA1c decreased significantly(P<0.01).When comparing the two groups after treatment,the improvement of HbAlc in the test group was better than that in the control group(P<0.05),and the improvement of FBG in the test group was significantly better than that in the control group(P<0.01),indicating that the test group had more advantages in improving blood glucose.(4)Renal function:Scr,BUN and 24hUPr were significantly decreased in the test group before and after treatment(P<0.01);BUN was decreased in the control group before and after treatment(P<0.05),and Scr and 24hUPr were significantly decreased(P<0.01).When comparing the two groups after treatment,the improvement of 24hUPr in the test group was better than that in the control group(P<0.05),and the improvement of Scr and BUN in the test group was significantly better than that in the control group(P<0.01).It showed that the test group could improve the renal function better.(5)Inflammatory factors:There was a significant decrease in hs-CRP in both groups before and after treatment(P<0.01);after treatment,the improvement in hs-CRP in the test group was significantly better than that in the control group(P<0.01),indicating that the test group was more advantageous in improving the inflammatory response.(6)Safety indexes:No abnormalities were found in the safety indexes of the subjects.Conclusion:Treating patients with DKD in stage Ⅲ-Ⅳ(spleen and kidney deficiency syndrome)with Tangshen Zisheng Decoction can improve patients’ clinical symptoms,reduce blood glucose and proteinuria levels,mitigate renal function damage and reduce inflammatory response,suggesting that its mechanism of action may be related to the improvement of inflammatory response. |
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