【摘要】 目的:观察糖肾祛湿方治疗糖尿病肾病（DKD）的临床疗效和安全性。方法:采用单臂探索性临床研究方法，所有病例来自于2020年05月—2021年08月广东省中医院肾内科就诊的DKD患者，符合纳入排除标准的受试者按入组先后予糖肾祛湿方中药饮片汤剂一天一次，联合西医基础治疗6个月，每月随访1次，每3个月收集血液、尿液标本进行检测，通过对比肾小球滤过率（eGFR）年下降速率、尿蛋白/肌酐比值（PCR）、糖化血红蛋白（HbA1C）、血脂、血清白蛋白、血常规、肾功能（BUN、Scr）等指标在治疗前后的变化来评估糖肾祛湿方治疗DKD的疗效与安全性。结果:最终纳入本临床研究的病例共有79例，进入统计分析共59例（剔除5例，脱落11例，中止1例，进入透析终点3例）。患者平均年龄（62.42±9.65）岁，女性患者23人占总体的39%,平均病程（14.52±7.16）年，平均体重指数为（24.30±3.48）,eGFR的中位数为39.42 ml·min^-1·1.73 m^-2,PCR的中位数为1.10 g/g, HbA1c%的中位数为7%。接受糖肾祛湿方干预3个月后，患者的eGFR由基线的（46.39±24.91）ml·min^-1·1.73 m^-2升至（50.00±27.05）ml·min^-1·1.73 m^-2,差异具有统计学意义（P<0.05）;干预6个月后，eGFR为（47.96±29.98）ml·min^-1·1.73 m^-2,较第3个月轻微下降，但仍高于基线；经分析，eGFR的年下降速率为（-2.61±2.58）ml·min^-1·1.73 m^-2,差异具有统计学意义（P<0.05）;PCR较前升高（P>0.05）,糖化血红蛋白（HbA1c%）较治疗前下降（P>0.05）,高密度脂蛋白（HDL-C）较治疗前升高（P<0.05）,中性粒细胞比值（NEUT%）与单核细胞比值（MONO%）较前升高（P<0.05）。患者未出现其他安全性指标异常，亦无不良事件及严重不良事件发生。结论:（1）糖肾祛湿方能够有效延缓DKD患者肾功能下降；（2）糖肾祛湿方可能通过改善糖脂代谢、调控免疫途径改善DKD患者的肾功能；（3）糖肾祛湿方治疗DKD的安全性良好，但其疗效和潜在机制有待进一步高质量的随机对照临床研究的验证。更多还原

【Abstract】 Objective:To observe the clinical efficacy and safety of Tangshen Qushi Formula（TQF） in treating patients with diabetic kidney disease（DKD）. Methods:An open-label, single-arm, exploratory study was conducted. Eligible patients with DKD in Guangdong Provincial Hospital of Chinese Medicine were included from May, 2020 to August, 2021, all receiving TQF once a day combined with conventional therapy according to guidelines for 6 months. Participants were followed up every month and their blood and urine samples were collected every three months. Outcomes included the change of mean decline of estimated glomerular filtration rate（eGFR）, proteinuria to creatinine rate（PCR）, HbA1c, serum lipid, serum albumin and other safety outcomes. Results:79 patients were included and 59 were completed（five cases were excluded, eleven were lost-to-follow-up, one was discontinued, three reached the endpoint of dialysis）. The average age was（62.42±9.65） years. Twenty-three of them were female（counted for 39%）. The average course of the disease was（14.52±7.16） years and their mean BMI was（24.30±3.48）. The median of eGFR was 39.42 ml·min^-1·1.73 m^-2, PCR was 1.10 g/g and HbA1c% was 7%. With the treatment of TQF, eGFR increased to（50.00±27.05） ml·min^-1·1.73 m^-2 at month 3 with the difference statistically significant（P<0.05）. It slightly declined to（47.96±29.98） ml·min^-1·1.73 m^-2 at month 6（P>0.05） from month 3, but still increased from baseline. The eGFR slope was（-2.61±2.58） ml·min^-1·1.73 m^-2 over the entire period, meaning that eGFR increased on the whole. PCR increased after 6 months（P>0.05） but HbA1c decreased from baseline（P>0.05）, and high-density lipoprotein-cholesterol（HDL-C） increased（P<0.05）. Besides, neutrophil ratio（NEUT%） and monocyte ratio（MONO%） increased after treatment（P<0.05）.There was no significant difference in the change of liver function and kidney function after 6 months（P>0.05）, neither was the other safety parameters. No adverse events or serious adverse events occurred in the study. Conclusion:（1）TQF may delay the progression of DKD by slowing the decline of renal function;（2）TQF may improve renal function of patients with DKD by improving glucolipid metabolism and regulating immunity;（3）TQF is safe in treating DKD, but its efficacy and potential mechanism need to be further verified by high-quality randomized controlled trials.更多还原