Clinical efficacy and safety evaluation of diabetic nephropathy treatment with Yishen Huashi Granule combined with Tripterygium wilfordii polyglycosides Tablet / 中草药

ABSTRACT

Objective: To study the clinical efficacy and safety of Yishen Huashi Granule (YHG) combined with Tripterygium wilfordii polyglycosides tablet (TWP) in the treatment of diabetic kidney disease (DKD). Methods: A total of 92 DKD patients in the stage of III-IV were selected from the department of nephropathy of the Jiujiang Hospital of Chinese Medicine. These patients were randomly divided into the observation group (46 cases) and the control group(46 cases). The observation group was treated with conventional therapy combined with TWP, and the control group was treated with TWP combined with YHG based on conventional therapy, both groups were continuously treated for three months. The urinary microprotein, serum albumin, urea nitrogen, creatinine, triglyceride, total cholesterol, urine IgG4, and urinary retinol binding protein were detected before and after treatment. The TCM syndrome score was evaluated and recorded. Blood routine, liver function, cellular immunity were detected after treatment. The recurrence and metastasis events were followed up and recorded. Results: After treatment, the total effective rate of the control group and the treatment group were 73.91% and 86.96% respectively, and the difference between the two groups was statistically significant (P < 0.05). Moreover, the levels of urinary microprotein, urea nitrogen and creatinine were (178.65 ± 31.72) mmol/L, (7.63 ± 2.15) mmol/L and (85.68 ± 14.74) μmol/L, respectively, which were significantly lower in the treatment group when compared with control group (P < 0.05). After treatment, the levels of serum albumin, triglyceride, and total cholesterol in the treatment and control groups were significantly improved (P < 0.05). The serum albumin level in the treatment group was significantly higher than that in the control group (P < 0.05), and the TG and TC levels were significantly lower than that in the control group (P < 0.05). The urine IgG4, and urinary retinol binding protein in the observation group were significantly reduced than those in the control group (P < 0.05). The white blood cell, and CD4+ in the observation group were higher than those in the control group (P < 0.05). The AST, ALT, and CD8+ in the observation group were significantly reduced than those in the control group (P < 0.05). TCM syndrome score in the observation group were lower than that in the control group (P < 0.05). The incidence of adverse reactions in the observation group was significantly lower than that in the control group (P < 0.05). Conclusion: YHG combined with TWP have the effect of increasing the efficacy and reducing the toxicity in the treatment of DKD.