观察芪葵颗粒联合火把花根片对G3A3期糖尿病肾病（DKD）患者的疗效及其对血清miRNA-21的影响。

随机、平行对照临床试验。纳入2020年7月至2022年6月南京中医药大学附属医院内分泌科门诊或住院的98例G3A3期DKD患者。将患者按照2∶1比例随机分为中药组和对照组，对照组给予常规西药治疗，中药组加用芪葵颗粒和火把花根片治疗，均治疗12周。观察两组患者治疗前后中医证候积分、血压、糖化血红蛋白、血脂、尿白蛋白肌酐比值（UACR）、估算肾小球滤过率（eGFR）、尿液转化生长因子β1、黏连蛋白（LN）和Ⅳ型胶原，以及血清miRNA-21等的变化情况。

最终98例G3A3期DKD患者完成研究，其中对照组32例，中药组66例。与治疗前比较，两组患者治疗12周后中医证候积分、血压、糖化血红蛋白、UACR均显著降低（P<0.05）。治疗12周后，中药组患者中医证候积分、胱抑素C和UACR较对照组降低更明显[4.60±2.09比6.75±2.14，（1.70±0.46）mg/L比（2.03±0.58）mg/L，625(426, 1 306) mg/g比781(560, 1 462) mg/g，均P<0.05]。治疗12周后，两组患者的血压、糖化血红蛋白、血脂和eGFR比较，差异无统计学意义（P>0.05）。中药组患者治疗12周后尿液转化生长因子β1（TGF-β1）、黏连蛋白（LN）和Ⅳ型胶原（Ⅳ-Col）均较治疗前显著降低（P<0.05），且中药组患者治疗12周后尿液TGF-β1和LN与同期对照组比较明显降低[(139±46) μg/L比(172±51) μg/L，(20.5±9.4)比(28.7±11.5) μg/L，均P<0.05）。治疗12周后，两组患者血清miRNA-21均较治疗前显著升高（P<0.05），且中药组患者治疗后血清miRNA-21较对照组升高更明显（76.5%±10.6%比65.2%±8.3%，P<0.05）。

芪葵颗粒联合火把花根片可改善G3A3期DKD患者临床症状和肾功能，降低尿蛋白排泄水平，其治疗作用可能为通过上调miRNA-21表达和抑制TGF-β1表达，降低肾小球系膜细胞外基质成分LN和Ⅳ型胶原而实现。

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.

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.

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, HbA_1c, 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).

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.