【摘要】 目的 评价化瘀通络方对糖尿病肾脏疾病中期血瘀证患者的临床疗效并探讨其可能机制。方法 采用多中心、随机、双盲、安慰剂平行对照临床试验设计，将90例糖尿病肾脏疾病中期血瘀证患者分为对照组46例、治疗组44例。两组均采用常规西医基础治疗，治疗组加服化瘀通络方，对照组加服化瘀通络方安慰剂，每日1剂，两组疗程均为24周。主要指标为治疗前后24小时尿蛋白定量（24 h-UTP）、血白蛋白（Alb）、糖化血红蛋白（HbA1c）、血肌酐（Scr）；次要指标为治疗前后血内皮素1 (ET-1)、一氧化氮（NO）、血管内皮生长因子（VEGF）水平及中医证候评分，治疗后评价中医证候疗效及疾病临床疗效，记录治疗前后不良反应和终点事件发生情况。结果 治疗组治疗后24 h-UTP、ET-1、VEGF水平均较治疗前降低（P<0.05）,Alb、NO水平升高（P<0.05），水肿、腰痛、肌肤甲错或肢体麻木、口唇紫暗、舌色紫暗或有瘀点和脉细涩中医证候积分均较治疗前降低（P<0.05）。对照组治疗前后各指标比较差异均无统计学意义（P>0.05）。与对照组比较，治疗组治疗后24 h-UTP、ET-1、VEGF水平降低，Alb、NO水平升高（P<0.05），水肿、腰痛、舌色紫暗或有瘀点和脉象细涩积分均低于对照组（P<0.05）。治疗组中医证候总有效率59.09%(26/44)，疾病临床总有效率45.45%(20/44)；对照组分别为15.22%(7/46)及8.70%(4/46)，治疗组均优于对照组（P<0.05）。两组患者共发生不良事件7例次，差异无统计学意义，研究期间两组无终点事件发生。结论 在西医常规治疗基础上，化瘀通络方可以进一步降低糖尿病肾脏疾病中期血瘀证患者尿蛋白量，改善临床症状，作用机制可能与影响血管内皮功能相关。更多还原

【Abstract】 Objective To evaluate the clinical efficacy of Huayu Tongluo Formula （化瘀通络方, HTF） in patients with mid-stage diabetic kidney disease of blood stasis syndrome and explore its potential mechanisms. Methods A multi-center, randomized, double-blind, placebo-controlled clinical trial was conducted. Ninety patients of mid-stage diabetic kidney disease of blood stasis syndrome were divided into a control group of 46 cases and a treatment group of 44 cases. Both groups received conventional western medicine treatment, the treatment group additionally taking HTF, while the control group taking a placebo of the formula. The treatment was administered once daily for 24weeks. The primary outcomes included 24-hour urine total protein(24 h-UTP), serum albumin(Alb), glycated hemoglobin(HbA1c), and serum creatinine(Scr). The secondary outcomes included changes in levels of endothelin-1(ET-1), nitric oxide(NO), vascular endothelial growth factor(VEGF), and traditional Chinese medicine(TCM) syndrome scores before and after treatment. Clinical efficacy was evaluated based on TCM syndrome scores and overall disease outcomes. Adverse reactions and endpoint events were recorded. Results In the treatment group after treatment, 24 h-UTP, ET-1, and VEGF levels significantly decreased(P<0. 05), Alb and NO levels significantly increased(P<0. 05); while the TCM syndrome scores for edema, lumbar pain, numbness of limbs, dark purple lips, dark purple tongue or purpura, and thin, rough pulse all significantly decreased(P<0. 05). In the control group, no significant changes were observed in any of the indicators after treatment(P>0. 05). Compared with the control group, the treatment group showed significant reductions in 24 h-UTP, ET-1, and VEGF levels, and increases in Alb and NO levels(P<0. 05). The TCM syndrome scores for edema, lumbar pain, dark purple tongue or purpura, and thin, rough pulse were all lower in the treatment group than in the control group(P<0. 05). The total effective rate of TCM syndrome in the treatment group was 59. 09%(26/44), and the overall clinical effective rate was 45. 45%(20/44). In the control group, these rates were 15. 22%(7/46) and 8. 7%(4/46), respectively, with the treatment group showing significantly better outcomes(P<0. 05). A total of 7 adverse events occurred across both groups, with no significant difference(P>0. 05). No endpoint events occurred during the study. Conclusion On the basis of conventional treatment of Western medicine, HTF can further reduce urinary protein levels and improve clinical symptoms in patients with mid-stage diabetic kidney disease of blood stasis syndrome. The mechanism may be related to its effects on endothelial function.更多还原