保肾方治疗气阴两虚、肾络瘀阻证糖尿病肾病Ⅳ期的随机对照试验  

Randomized Controlled Study of Baoshen Prescription in Treating StageⅣDiabetic Nephropathy in Patients with Syndromes of Qi-Yin Deficiency and Kidney Collateral Stasis and Obstruction

作　　者：邱依婷 洪双双 刘芷秋 孙欣如 王悦芬[1,2] 刘梦超 赵文景 QIU Yiting;HONG Shuangshuang;LIU Zhiqiu;SUN Xinru;WANG Yuefen;LIU Mengchao;ZHAO Wenjing(Beijing Hospital of Traditional Chinese Medicine(TCM)Affiliated to Capital Medical University,Beijing 100010,China;ZHANG Binghou Studio of National Famous TCM Inheritance,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]张炳厚全国名中医传承工作室,北京100010

出　　处：《中国实验方剂学杂志》2025年第3期124-131,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金面上项目(82374366);北京市中医药科技发展资金项目(JJ-2020-46);北京市属医院科研培育计划项目(PZ2022022)。

摘　　要：目的:评价保肾方治疗气阴两虚、肾络瘀阻证糖尿病肾病Ⅳ期(DNⅣ期)的临床疗效及安全性,探究其延缓肾功能进展的作用机制。方法:采用随机、对照、双盲、多中心临床试验设计,将94例气阴两虚、肾络瘀阻证DNⅣ期患者随机分为保肾方组和对照组,每组各47例,疗程12周。主要疗效指标为肾功能相关指标[尿微量蛋白与肌酐比值(UACR)、24 h尿蛋白(24 h-UTP)、血肌酐(SCr)、估算的肾小球滤过率(eGFR)],次要疗效指标为高糖记忆、足细胞上皮间质转分化相关指标及中医证候评分。结果:与本组治疗前比较,治疗12周后保肾方组患者血清矫正晚期糖基化终末产物(lgAGEs)、结缔组织生长因子(CTGF)、Ⅳ型胶原蛋白(Col-Ⅳ)、AGEs受体(RAGE)、尿成纤维细胞特异蛋白-1(FSP-1)、UACR、24 h-UTP、糖化血红蛋白(HbAlc)水平均明显降低(P<0.05),miR-21 mRNA有上升趋势,但差异无统计学意义;对照组患者SCr、UREA水平明显升高,尿FSP-1、eGFR、HbAlc水平明显降低(P<0.05)。与对照组治疗后比较,观察组患者血清矫正lgAGEs、CTGF、尿FSP-1、SCr、UACR、24 h-UTP水平明显降低,血清Col-Ⅳ、eGFR水平明显升高(P<0.05)。与对照组比较,保肾方组患者治疗前后SCr、eGFR、UACR、24 h-UTP差值差异具有统计学意义(P<0.05)。结论:保肾方可有效改善气阴两虚、肾络瘀阻证DNⅣ期患者肾功能,降低尿蛋白水平,改善临床症状,机制可能与高糖记忆、足细胞上皮间质转分化相关。Objective:To evaluate the clinical efficacy and safety of Baoshen prescription in the treatment of stageⅣdiabetic nephropathy(DN)in the patients with syndromes of Qi-Yin deficiency and kidney collateral stasis and obstruction,and to explore the mechanism of this prescription delaying the disease progression.Methods:A randomized,controlled,double-blind,multicenter clinical trial was conducted,in which 94 stageⅣDN patients with syndromes of Qi-Yin deficiency and kidney collateral stasis and obstruction were randomly assigned into Baoshen prescription and control groups(47 cases).The treatment lasted for 12 weeks.The primary efficacy indicators were mainly renal function indexes,including urine albumin-to-creatinine ratio(UACR),24-hour urine total protein(24 h-UTP),serum creatinine(SCr),and estimated glomerular filtration rate(eGFR).The secondary efficacy indicators were metabolic memory of hyperglycemia,podocyte epithelial-to-mesenchymal transdifferentiationrelated indexes,and TCM syndrome score.Results:After 12 weeks of treatment,the Baoshen prescription group showed lowered levels of advanced glycation end products(lgAGEs),connective tissue growth factor(CTGF),typeⅣcollagen(Col-Ⅳ),receptor of AGEs(RAGE),urinary fibroblast-specific protein-1(FSP-1),UACR,24 h-UTP,and glycated hemoglobin(HbAlc)(P<0.05),and an upward trend of miR-21 mRNA.The control group showed elevated levels of SCr and UREA and lowered levels of urinary FSP-1,eGFR,and HbAlc(P<0.05).After treatment,the Baoshen prescription group had lower levels of lgAGEs,CTGF,urinary FSP-1,SCr,UACR,and 24 h-UTP and higher levels of Col-Ⅳand eGFR than the control group(P<0.05).In addition,the Baoshen prescription group showed statistically significant differences in SCr,eGFR,UACR,and 24 h-UTP before and after treatment(P<0.05).Conclusion:Baoshen prescription can effectively improve the renal function,reduce the urinary protein level,and alleviate clinical symptoms in stageⅣDN patients with syndromes of Qi-Yin deficiency and kidney collateral stasis and

关 键 词：糖尿病肾病 保肾方 高糖记忆 足细胞上皮间质转分化 随机对照试验 晚期糖基化终末产物(AGEs) 晚期糖基化终末产物受体(RAGE) 

分 类 号：R259[医药卫生—中西医结合] R692[医药卫生—中医内科学] R587.2[医药卫生—中医学]