目的 探讨益肾化湿颗粒联合雷公藤多苷片治疗糖尿病肾病（diabetic kidney disease，DKD）的疗效与安全性。方法 筛选九江市中医院Ⅲ～IV期DKD患者，随机分配入对照组（46例）及治疗组（46例）。在常规治疗基础上，对照组给予雷公藤多苷片，治疗组在对照组基础上施予益肾化湿颗粒，治疗持续3个月。检测并比较各组治疗前后尿微量蛋白、血清白蛋白、尿素氮、肌酐、血脂、尿IgG4、尿视黄醇结合蛋白改变。评估并记录中医证候积分。检测治疗后血常规、肝功能、细胞免疫，记录不良反应发生情况。结果 治疗后，对照组和治疗组的总有效率分别是73.91%、86.96%，两组比较差异具有统计学意义（P<0.05）。治疗后，对照组和治疗组尿微量蛋白、尿素氮、血肌酐水平较治疗前明显降低。治疗后，治疗组尿微量蛋白为（178.65±31.72）mmol/L、尿素氮为（7.63±2.15）mmol/L、血肌酐水平为（85.68±14.74）μmol/L，较对照组明显降低（P<0.05）。治疗后，治疗组和对照组血清白蛋白、三酰甘油、总胆固醇水平均明显改善（P<0.05）。且治疗组血清白蛋白水平显著高于对照组（P<0.05），三酰甘油、总胆固醇水平显著低于对照组（P<0.05）。治疗后，治疗组尿IgG4、尿视黄醇结合蛋白水平较对照组显著降低（P<0.05）；治疗组白细胞、CD4⁺、CD4⁺/CD8⁺水平显著高于对照组（P<0.05），谷氨酸氨基转移酶、天门冬氨酸氨基转移酶及CD8⁺水平显著低于对照组（P<0.05）。治疗后，治疗组中医证候积分显著低于对照组（P<0.05）。治疗组不良反应发生率低于对照组（P<0.05）。结论 益肾化湿颗粒联合雷公藤多苷片治疗DKD具有增效减毒作用。

Obejective 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.

R28

江西省科技厅一般项目（S2016SFYBG0294）；江西省卫生健康委科技计划（20204305）；江西省中医药科研计划（2019A395）