芪黄益肾颗粒治疗糖尿病肾脏病气阴两虚证的随机对照临床试验  

Qihuang Yishen Granules in treating diabetic kidney disease with qi and yin deficiency:A clinical randomized controlled trial

作　　者：闫璞 张宁[1] 李同侠[1] 布天杰 YAN Pu;ZHANG Ning;LI Tong-xia;BU Tian-jie(Department of Nephrology and Endocrinology,Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China)

机构地区：[1]中国中医科学院望京医院肾病内分泌科,北京100102

出　　处：《中华中医药杂志》2021年第6期3318-3323,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：首都卫生发展科研专项(No.首发2018-1-4161)。

摘　　要：目的:探讨芪黄益肾颗粒对糖尿病肾脏病的影响。方法:采用随机、盲法、安慰剂对照的加载试验设计,将2019年10月至2020年7月就诊于中国中医科学院望京医院的50例糖尿病肾脏病患者随机分为试验组(23例)和对照组(27例),两组患者均接受西医常规的基础治疗,在此基础上试验组加用芪黄益肾颗粒,对照组加用芪黄益肾颗粒模拟剂,疗程为12周。观察两组患者治疗前后24h尿蛋白定量、尿微量白蛋白和尿肌酐比值(ACR)、肾功能、空腹血糖、糖化血红蛋白、甘油三酯、胆固醇、肾小管损伤标志物及中医症状积分的变化,并探索24h尿蛋白定量与尿ACR、肾小管损伤标志物之间的相关性。结果:试验组在降低24h尿蛋白定量、尿ACR、糖化血红蛋白、甘油三酯、肾小管损伤标志物,改善肾功能方面显著优于对照组(P<0.05),并且24h尿蛋白定量分别与尿ACR、NAG/Cr呈线性相关(P<0.01);尿α1-微球蛋白分别与视黄醇结合蛋白(P<0.01)和N-乙酰-β-D-氨基葡萄糖苷酶/肌酐(P<0.05)呈线性相关。结论:芪黄益肾颗粒能降低糖尿病肾脏病患者的尿蛋白、肾小管损伤标志物,改善糖脂代谢,延缓肾功能进展,改善临床症状,是治疗糖尿病肾脏病的有效药物。Objective:To explore the effects of Qihuang Yishen Granules in the treatment of diabetic kidney disease Methods:Using a randomized,blinded,and placebo-controlled loading trial design,patients with diabetic kidney disease from Wangjing Hospital,China Academy of Chinese Medical Sciencis from October 2019 to July 2020 were randomly divided into the experimental group(23 cases)and the control group(27 cases).Both groups of patients received basic treatment of western medicine.On this basis,the experimental group was treated with Qihuang Yishen Granules,and the control group was treated with Qihuang Yishen Granules simulation agent.The course of treatment was 12 weeks.Observe the changes of 24h urine protein quantification,urinary ACR,renal function,fasting blood glucose,glycosylated hemoglobin,triglycerides,cholesterol,renal tubule injury markers,and TCM symptom score in the two groups before and after treatment,and explore the correlation of 24h urine protein quantification and ACR,renal tubules injury markers.Results:The treatment group was significantly better than the control group in reducing 24h urine protein quantification,ACR,glycosylated hemoglobin,triglycerides,renal tubular injury markers,and improving renal function(P<0.05).24h urine protein quantification was linearly correlated with urine ACR and NAG/Cr(P<0.01);α1-MA was linearly correlated with RBP(P<0.01)and NAG/Cr(P<0.05).Conclusion:Qihuang Yishen Granules can reduce urine protein and renal tubule damage markers in patients with diabetic nephropathy,improve glucose and lipid metabolism,delay the progression of renal function,and improve clinical symptoms.It is an effective drug for the treatment of diabetic kidney diseases.

关 键 词：芪黄益肾颗粒 糖尿病肾脏病 临床研究 随机对照试验 气阴两虚 

分 类 号：R259[医药卫生—中西医结合] R277.5[医药卫生—中医内科学]