Abstract: Background　Diabetic kidney disease（DKD） is one of the major complications of diabetes，which endangers nearly one third of the diabetic patients in China，a country owning the largest number of diabetics.However，there is lack of effective interventions for DKD，and it is necessary to explore relevant treatments with Chinese medicine.Objective　To investigate the clinical effect of Tongluo Digui decoction in patients with stage 4 type 2 DKD.Methods　From June 2018 to February 2019，70 stage 4 type 2 DKD outpatients and inpatients with Yin deficiency and blood stasis syndrome from Departments of Nephrology and Endocrinology，Henan Province Hospital of TCM（the Second Affiliated Hospital of Henan University of Chinese Medicine） were enrolled，and randomized into the observation group（n=36） and control group（n=34）.Both groups received primary Western medicine treatments，the observation group additionally received 8-week oral administration of Tongluo Digui decoction.Pre- and post-treatment TCM Symptom Scale score，24-hour quantitative proteinuria，serum creatinine（Scr），blood urea nitrogen（BUN），estimated glomerular filtration rate（eGFR），HbA1c，fasting blood glucose，hemoglobin，albumin，serum uric acid，inflammatory cytokines in the serum and urine were compared between the two groups.The adverse reactions of the two groups were counted.Results　After treatment，the average levels of 24-hour quantitative proteinuria，Scr，BUN，HbA1c，fasting blood glucose and serum uric acid decreased and average levels of eGFR and albumin increased in both groups（P<0.05）.Intergroup comparisons revealed that there were no significant differences in post-treatment fasting blood glucose，hemoglobin，albumin and serum uric acid after treatment（P>0.05），however the observation group showed lower average levels of 24-hour quantitative proteinuria，Scr，BUN and HbA1c but higher eGFR than the control group（P<0.05）.The average each item of TCM Syndrome Scale score，serum IL-6 and TNF-α，and urine IL-1β and IL-18 showed a decrease after treatment in both groups（P<0.05），and they decreased more significantly in the observation group（P<0.05）.During the treatment，2 patients in the observation group had mild diarrhea.Conclusion　Tongluo Digui decoction helps to improve the clinical symptoms，renal functions and inflammation，and reduce the 24-hour quantitative proteinuria in stage 4 type 2 DKD patients with satisfactory safety.

Key words: Diabetic nephropathies；Diabetes mellitus, type 2；Tongluo Digui decoction；Traditional Chinese Medicine；Treatment outcome

摘要： 背景　糖尿病肾病是糖尿病的主要并发症之一。我国已成为全球糖尿病患者数量最多的国家，且近1/3的糖尿病患者面临糖尿病肾病的威胁，但目前针对糖尿病肾病尚缺乏有效的干预手段，中医药治疗方法需要进一步探讨。目的　观察通络地龟汤治疗2型糖尿病肾病Ⅳ期患者的临床疗效。方法　筛选2018年6月—2019年2月在河南省中医院（河南中医药大学第二附属医院）肾内科、内分泌科门诊就诊及住院的70例2型糖尿病肾病Ⅳ期患者为研究对象，中医辨证为阴虚血瘀。采用单盲随机数字表法将所有患者分为观察组（n=36）和对照组（n=34），对照组给予西医基础方案治疗，观察组在对照组基础上服用通络地龟汤8周。比较两组患者治疗前后中医症状积分、24 h尿蛋白定量、血肌酐（Scr）、尿素氮（BUN）、估算肾小球滤过率（eGFR）、糖化血红蛋白（HbA1c）、空腹血糖、血红蛋白、白蛋白、血尿酸、血清炎性因子与尿液炎性因子水平。统计两组不良反应发生情况。结果　治疗后，两组患者24 h尿蛋白定量、Scr、BUN、HbA1c、空腹血糖及血尿酸较治疗前降低，eGFR、白蛋白较治疗前升高（P<0.05）；两组患者治疗后空腹血糖、血红蛋白、白蛋白、血尿酸比较，差异无统计学意义（P>0.05）；观察组患者治疗后24 h尿蛋白定量、Scr、BUN、HbA1c低于对照组，eGFR高于对照组（P<0.05）。治疗后，两组患者各中医症状积分，血清白介素6（IL-6）、肿瘤坏死因子α（TNF-α）水平，尿液白介素1β（IL-1β）、白介素18（IL-18）水平均较治疗前降低，且观察组低于对照组（P<0.05）。治疗期间，观察组2例患者出现轻微腹泻。结论　通络地龟汤可以改善2型糖尿病肾病Ⅳ期患者的临床症状和肾功能，减少蛋白尿，减轻炎性状态，且安全性较高。

关键词: 糖尿病肾病；糖尿病, 2型；通络地龟汤；中医药；治疗结果