Qikui granules combined with Huobahuagen tablets for treatment of stage G3A3 diabetic kidney disease: clinical efficacy and impact on serum microRNA-21
Objective:To evaluate the clinical efficacy of Qikui granules combined with Huobahuagen tablets in treating patients with stage G3A3 diabetic kidney disease (DKD) and to observe the effect on serum microRNA-21 (miRNA-21) level.Methods:A randomized, parallel controlled clinical trial was conducted, in which patients diagnosed with stage G3A3 DKD were randomly divided into either a Chinese herb group or a control group in a 2:1 ratio. Routine western medicine was administered in both groups, and the Chinese herb group was additionally given Qikui granules combined with Huohuagen tablets . The treatment lasted 12 weeks for all patients. Traditional Chinese medicine (TCM) symptom scores, blood pressure, blood lipids, glycosylated hemoglobin (HbA1c), estimated glomerular filtration rate (eGFR), urinary albumin to creatinine ratio (UACR), urinary transforming growth factor beta 1 (TGF-β1), laminin, and type Ⅳ collagen (Ⅳ-Col), and serum miRNA were observed in both groups.Results:Ninety-eight stage G3A3 DKD patients completed the study, including 32 patients in the control group and 66 in the Chinese herb group. After treatment, TCM syndrome scores, blood pressure, HbA1c, blood lipids, and UACR were significantly decreased in both groups (P<0.05). TCM syndrome scores, cystatin C, and UACR in the Chinese herb group were significantly lower than those in the control group after treatment (4.60±2.09 vs 6.75±2.14, (1.70±0.46) mg/L vs (2.03±0.58) mg/L, 625(426, 1 306) mg/g vs 781(560, 1 462) mg/g, respectively; P<0.05 for all). There was no significant difference in blood pressure, HbA1c, blood lipids, or GFR between the two groups after treatment (P>0.05 for all). After treatment, urinary TGF-β1, laminin, and Ⅳ-Col in the Chinese herb group decreased significantly compared with those before treatment (P<0.05 for all). Notably, urinary TGF-β1 and laminin in the Chinese herb group decreased significantly compared with those in the control group after 12-week treatment [(139±46) μg/L vs (172±51) μg/L and (20.5±9.4) μg/L vs (28.7±11.5) μg/L, respectively; P<0.05 for both). After treatment, serum level of miRNA-21 increased significantly than that before treatment in both groups (P<0.05), and the increase in the Chinese herb group was superior to that in the control group (76.5%±10.6% vs 65.2%±8.3%, P<0.05).Conclusion:Qikui granules combined with Huobahuagen tablets can ameliorate clinical symptoms, improve renal function, and alleviate urinary protein excretion in patients with stage G3A3 DKD. The therapeutic effect may be achieved by up-regulating the expression of miRNA-21 and inhibiting the expression of TGF-β1, which further reduces the production of laminin and Ⅳ-Col, components of glomerular mesangial extracellular matrix.
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