目的：观察在西药治疗基础上，中药芪葵颗粒对2型糖尿病肾病（Diabetic Nephropathy，DN）患者蛋白尿及炎症因子的影响。方法：采用随机、平行对照方法，将符合2型DN诊断标准的患者随机分为中药组和对照组。两组均给予血管紧张素Ⅱ受体拮抗剂为基础的常规西药治疗，中药组加用芪葵颗粒口服。患者每4周复诊1次，治疗12周。观察两组患者治疗前后尿白蛋白/肌酐比值（Urinary Albumin-Creatinine Ratio，UACR）、尿白蛋白排泄率（Urinary Albumin Excretion Rate，UAER）以及炎症因子水平的变化。结果：共纳入研究病例72例，最终完成有效病例对照组32例，中药组31例。两组患者治疗12周后UACR、UAER均显著降低（P<0.01）；且中药组疗效优于对照组（P<0.05）；治疗12周后，中药组患者血清白介素-6（Interleukin-6，IL-6）、肿瘤坏死因子α（Tumor Necrosis Factor α，TNF-α）、转化生长因子β₁（Transforming Growth Factor，TGF-β₁）和尿单核细胞趋化蛋白-1（Monocyte Chemoattractant Protein，MCP-1）/Cr较对照组显著降低（P<0.01）。结论：中药芪葵颗粒可显著降低2型DN患者尿蛋白，其作用机制可能为通过改善肾小球炎症状态而发挥肾脏保护作用。

This study aimed at investigating the effects of Chinese herbal compound Qi Kui granules on urine protein and inflammatory markers in patients with type 2 diabetic nephropathy(DN)based on the treatment of regular western medication.A randomized,parallel controlled method was involved in the present trial,and patients diagnosed with type 2 DN were randomly divided into the Chinese herb group and the control group.Regular treatment of angiotensin II receptor blocker(ARB)in western medicine was administered in the two groups with the additional treatment of Qi Kui granules for the Chinese herb group.All the patients revisited the doctor every 4 weeks during the observation period within a 12-week course of the observation.Urinary albumin to creatinine ratio(UACR),urinary albumin excretion rate(UAER)and inflammatory cytokines in the two groups were determined.As a result,seventy-two patients in aggregate were included in the study,while 32 patients of the control group and 31 patients of the Chinese herb group effectively accomplished the observation.After the 12-week treatments,UACR and UAER were significantly decreased in the two groups(P<0.01),while the efficacy of the Chinese herb group was better than that of the control group(P<0.05).Compared with the control group,the levels of serum IL-6,tumor necrosis factor α(TNF-α),transforming growth factor β₁(TGF-β₁)and urinary monocyte chemoattractant protein (MCP-1)/Cr significantly decreased after the 12-week treatment(P<0.01).It was concluded that the Chinese herbal compound Qi Kui granules successfully mitigated proteinuria in DN patients.The improvement of glomerular inflammation for renoprotection should be the mechanism behind this.

江苏省卫生计生委预防医学科研项目（2015053）：糖尿病肾脏病监测及社区早期防治综合研究，负责人：黄莉吉；南京市科学技术委员会科技发展计划项目（201402012）：糖尿病肾脏病中西医结合综合诊治方案的临床研究，负责人：余江毅。