【目的】 观察丹芪益肾方对糖尿病肾病（DN）的治疗效果，并分析其肾保护作用机制。【方法】 将 2021 年 10 月至 2023 年 4 月广州中医药大学附属三亚中医院收治的 150例 DN气阴两虚夹瘀证患者按随机数字表法随机分成对照组和观察组，每组 各75例。2组患者均给予饮食治疗、控制血糖、控制血压、降脂治疗以及并发症治疗等常规治疗，在此基础上，对照组给予 注射用还原型谷胱甘肽静脉滴注治疗，观察组给予丹芪益肾方煎剂内服及肾区中药离子导入治疗。30 d为1个疗程，共治疗 3个疗程。观察2组患者治疗前后中医证候积分、肾功能指标、肾脏血流动力学指标、凝血纤溶指标、血管内皮功能指标的 变化情况。【结果】（1）中医证候积分方面，治疗后，2组患者的疲倦乏力、心悸气短、头晕耳鸣、自汗盗汗、心烦失眠、口 渴喜饮等中医证候积分均较治疗前降低（P < 0.01），且观察组的降低幅度均明显优于对照组（P < 0.01）。（2）肾功能指标方面， 治疗后，2组患者的血尿素氮（BUN）、血肌酐（SCr）、Ⅳ型胶原（CⅣ）、血浆层黏蛋白（LN）等肾功能指标均较治疗前改善（P < 0.01）， 观察组的改善幅度均明显优于对照组（P < 0.01）。（3）肾脏血流动力学指标方面，治疗后，2组患者肾主动脉（MRA）、叶间动 脉（IRA）处的收缩期最大血流速度（Vsmax）、舒张期最低血流速度（Vdmin）均较治疗前升高（P < 0.05或P < 0.01），MRA处的 阻力指数（RI）、搏动指数（PI），IRA处的RI以及观察组IRA处的PI均较治疗前降低（P < 0.05或P < 0.01），且观察组对MRA和 IRA处Vsmax、Vdmin的升高幅度及对MRA和IRA处RI、PI的降低幅度均明显优于对照组（P < 0.05或P < 0.01）。（4）凝血纤溶 指标方面，治疗后，2组患者的血浆凝血酶原时间（PT）、活化部分凝血酶时间（APTT）、D-二聚体（D-D）和纤维蛋白原（FIB） 等凝血纤溶指标均较治疗前改善（P < 0.01），且观察组的改善幅度均明显优于对照组（P < 0.01）。（5）血管内皮功能指标方面， 治疗后，2组患者的血清血管生成抑制蛋白1（VASH-1）水平均较治疗前升高（P < 0.01），血清血管内皮生长因子（VEGF）、内 皮素 1（ET-1）水平均较治疗前降低（P < 0.01），且观察组对血清 VASH-1水平的升高幅度及对血清 VEGF、ET-1水平的降低 幅度均明显优于对照组（P < 0.01）。【结论】 丹芪益肾方在 DN气阴两虚夹瘀证患者中具有良好的临床应用效果，其可能通过 改善患者凝血纤溶系统及血管内皮功能达到保护肾功能的作用。

Objective To observe the clinical efficacy of Dan Qi Yishen Prescription in treating diabetic nephropathy（DN）and explore its renal protective mechanism. Methods A total of 150 patients with DN of qi-yin deficiency complicated with blood stasis syndrome who admitted to Sanya Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine from October 2021 to April 2023 were divided into a control group and an observation group according to the random number table method， with 75 patients in each group. Both groups were given conventional therapies such as dietary treatment，blood glucose control，blood pressure control， lipid-lowering treatment and treatment of complications. Additionally， the control group was given intravenous injection of reduced glutathione，while the observation group was given oral use of the decoction of Dan Qi Yishen Prescription and ionic introduction of Dan Qi Yishen Prescription in renal region. Thirty days constituted one course of treatment，and both groups were treated for three courses. Before and after treatment，the scores of traditional Chinese medicine（TCM）syndrome，and the levels of renal function indicators，renal hemodynamic indicators， coagulation and fibrinolysis indicators， and vascular endothelial function indicators in the two groups were observed. Results（1）After treatment，the scores of TCM symptoms such as fatigue and weakness，palpitations and shortness of breath， dizziness and tinnitus， spontaneous sweating and night sweating， restlessness and insomnia， and thirst with preference for drinks in the two groups were decreased compared with those before treatment（P < 0.01），and the decrease in the observation group was significantly superior to that in the control group（P < 0.01）.（2）After treatment，the levels of renal function indicators such as blood urea nitrogen（BUN）， serum creatinine（SCr）， collagen Ⅳ（C Ⅳ）， and plasma laminin（LN）of patients in the two groups were improved compared with those before treatment（P < 0.01），and the improvement in the observation group was significantly superior to that in the control group（P < 0.01）.（3）After treatment，the levels of renal hemodynamic indicators such as systolic maximum blood flow velocity （Vsmax）and diastolic minimum blood flow velocity （Vdmin）of the main renal artery（MRA）and interlobar artery（IRA）in the two groups were increased compared with those before treatment（P < 0.05 or P < 0.01），while the resistance index（RI）and pulsatility index（PI）of MRA and RI of IRA in the two group as well as PI of IRA in the observation group were decreased compared with those before treatment（P < 0.05 or P < 0.01）. The increase of Vsmax and Vdmin of MRA and IRA as well as the decrease of RI and PI of MRA and IRA in the observation group was significantly superior to that in the control group（P < 0.05 or P < 0.01）.（4）After treatment，the levels of coagulation and fibrinolysis indicators such as prothrombin time（PT），activated partial thromboplastin time（APTT），D-dimer（D-D），and fibrinogen（FIB） in the two groups were improved compared with those before treatment（P < 0.01），and the improvement in the observation group was significantly superior to that in the control group（P < 0.01）.（5）The analysis of vascular endothelial function indicators showed that after treatment， the serum vasohibin 1（VASH-1）level in the two groups was increased compared with that before treatment（P < 0.01），and the serum vascular endothelial growth factor（VEGF）and endothelin 1（ET-1）levels were decreased compared with those before treatment（P < 0.01）， and the increase of serum VASH-1 level as well as the decrease of serum VEGF and ET-1 levels in the observation group was significantly superior to that in the control group（P < 0.01）. Conclusion Dan Qi Yishen Prescription exerts good clinical efficacy in treating patients with DN of qi-yin deficiency complicated with blood stasis syndrome， and it has protective effect on renal function probably by improving the coagulation and fibrinolysis system and vascular endothelial function of the patients.

R259.872

海南省自然科学基金高层次人才项目（编号：821RC1146）；海南省卫健委科研立项课题（编号：19A200186）