Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with <italic style="font-style: italic">Huayu Tongluo Formula </italic>（化瘀通络方） as an Adjunct Therapy： A Multi-Center， Randomized， Double-Blind， Placebo-Controlled Trial

MA Yun; WANG Kaishuang; CAO Shuang; ZHAO Bingwu; BAI Lu; WU Su; GAO Yuwei; WANG Xinghua; BIAN Dong; CHEN Zhiqiang

doi:10.13288/j.11-2166/r.2025.06.008

您当前的位置：

首页 >

文章列表页 >

Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with Huayu Tongluo Formula （化瘀通络方） as an Adjunct Therapy： A Multi-Center， Randomized， Double-Blind， Placebo-Controlled Trial

更新时间：2025-03-12

- Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with Huayu Tongluo Formula （化瘀通络方） as an Adjunct Therapy： A Multi-Center， Randomized， Double-Blind， Placebo-Controlled Trial
- Journal of Traditional Chinese Medicine Vol. 66, Issue 6, Pages: 588-595(2025)
- 作者机构：
  
  1.河北省中医院，石家庄市长安区中山东路389号，050011
  2.中国中医科学院广安门医院保定医院
  3.河北医科大学第三医院
  4.河北医科大学第一医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.06.008
  CLC：
- Received：30 August 2024，
  
  Revised：2024-12-30，
  
  Published：17 March 2025
- 稿件说明：
移动端阅览
马赟,王开爽,曹爽等.化瘀通络方辅助治疗糖尿病肾脏疾病中期血瘀证患者40例——一项多中心、随机双盲、安慰剂平行对照研究[J].中医杂志,2025,66(06):588-595.

MA Yun,WANG Kaishuang,CAO Shuang,et al.Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with Huayu Tongluo Formula （化瘀通络方） as an Adjunct Therapy： A Multi-Center， Randomized， Double-Blind， Placebo-Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(06):588-595.
马赟,王开爽,曹爽等.化瘀通络方辅助治疗糖尿病肾脏疾病中期血瘀证患者40例——一项多中心、随机双盲、安慰剂平行对照研究[J].中医杂志,2025,66(06):588-595. DOI： 10.13288/j.11-2166/r.2025.06.008.

MA Yun,WANG Kaishuang,CAO Shuang,et al.Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with Huayu Tongluo Formula （化瘀通络方） as an Adjunct Therapy： A Multi-Center， Randomized， Double-Blind， Placebo-Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(06):588-595. DOI： 10.13288/j.11-2166/r.2025.06.008.

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（

＜0.05），Alb、NO水平升高（

＜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（

＜0.05）。对照组治疗前后各指标比较差异均无统计学意义（

＞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（

＜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（

＜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（

＜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。

Abstract

Objective

To evaluate the clinical efficacy of

Huayu Tongluo Formula

（化瘀通络方， HTF） in patients with mid-stage diabetic k

idney 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 24 weeks. 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 （

＜0.05）， Alb and NO levels significantly increased （

＜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 （

＜0.05）. In the control group， no significant changes were observed in any of the indicators after treatment （

＞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 （

＜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 （

＜0.05）. The total effective rat

e 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 （

＜0.05）. A total of 7 adverse events occurred across both groups， with no significant difference （

＞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.

关键词

Keywords

references

RUIZ-ORYEGA M ， RODRIGUES-DIEZ RR ， LAVOZ C ， et al . Special issue "diabetic nephropathy： diagnosis， prevention and treatment "［J］. J Clin Med ， 2020 ， 9 （ 3 ）： 813 .

NEUEN BL ， BELLO AK ， LEVIN A ， et al . National health policies and strategies for addressing chronic kidney disease： data from the International Society of Nephrology Global Kidney Health Atlas ［J］. PLOS Glob Public Health ， 2023 ， 3 （ 2 ）： e0001467 .

LALIĆ K ， POPOVIĆ L ， SINGH LUKAČ S ， et al . Practicalities and importance of assessing urine albumin excretion in type 2 diabetes： a cutting-edge update ［J］. Diabetes Res Clin Pract ， 2024 ， 215 ： 111819 . doi： 10.1016/j.diabres. 2024.111819 http://dx.doi.org/10.1016/j.diabres.2024.111819 .

ZHAO M ， CAO Y ， MA L . New insights in the treatment of DKD： recent advances and future prospects ［J］. BMC Nephrol ， 2025 ， 26 （ 1 ）： 72 .

国家中医药管理局医政司 . 22个专业95个病种中医诊疗方案［M］. 北京：国家中医药管理局医政司， 2010 ： 209 - 213 .

李雅纯，方敬，杨帆，等 . 化瘀通络中药对糖尿病肾病大鼠肾脏和AMPK/Nox4信号通路的作用研究［J］. 中草药， 2021 ， 52 （ 11 ）： 3278 - 3285 .

马赟，潘永梅，郭倩，等 . 化瘀通络方对糖尿病大鼠肾组织血管内皮生长因子表达的影响［J］. 中国中西医结合杂志， 2022 ， 42 （ 4 ）： 464 - 469 .

北京大学医学系糖尿病肾脏病专家共识协作组 . 糖尿病肾脏病诊治专家共识［J］. 中华医学杂志， 2020 ， 100 （ 4 ）： 247 - 260 .

王凤丽，陈志强，王月华，等 . 益气养阴消癥通络方治疗早期糖尿病肾病临床观察［J］. 中国中西医结合杂志， 2012 ， 32 （ 1 ）： 35 - 38 .

李康，贺佳 . 医学统计学［M］. 北京：人民卫生出版社， 2018 ： 168 - 169 .

郑筱萸 . 中药新药临床研究指导原则（试行）［M］. 北京：中国医药科技出版社， 2002 ： 156 - 168 .

高东宸 . 药物不良反应监察指南［M］. 北京：中国医药科技出版社， 1996 ： 10 - 12 .

国家中医药管理局 . 中医病证诊断疗效标准［M］. 南京：南京大学出版社， 1994 ： 40 - 45 .

HEYMAN SN ， RAZ I ， DWYER JP ， et al . Diabetic proteinuria revisited： updated physiologic perspectives ［J］. Cells ， 2022 ， 11 （ 18 ）： 2917 .

何旭，胡顺金 . 活血化瘀方治疗糖尿病肾病的Meta分析［J］. 中国中西医结合肾病杂志， 2020 ， 21 （ 3 ）： 236 - 240 .

DHAUN N ， WEBB DJ . Endothelins in cardiovascular biology and therapeutics ［J］. Nat Rev Cardiol ， 2019 ， 16 （ 8 ）： 491 - 502 .

BISWAS S ， FENG B ， THOMAS A ， et al . Endothelin-1 regulation is entangled in a complex web of epigenetic mechanisms in diabetes ［J］. Physiol Res ， 2018 ， 67 （ Suppl 1 ）： S115 - S125 .

KOHAN DE ， INSCHO EW ， WESSON D ， et al . Physio-logy of endothelin and the kidney ［J］. Compr Physiol ， 2011 ， 1 （ 2 ）： 883 - 919 .

HEERSPINK HJL ， PARVING HH ， ANDRESS DL ， et al . Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease （SONAR）： a double-blind， randomised， placebo-controlled trial ［J］. Lancet ， 2019 ， 393 （ 10184 ）： 1937 - 1947 .

GARCIA X ， STEINN F . Nitric oxide ［J］. Semin Pediatr Infect Dis ， 2006 ， 17 （ 2 ）： 55 - 57 .

RAJAPAKSE NW ， MATTSON DL . Role of L-arginine in nitric oxide production in health and hypertension ［J］. Clin Exp Pharmacol Physiol ， 2009 ， 36 （ 3 ）： 249 - 255 .

TESSARI P ， CECCHET D ， COSMA A ， et al . Nitric oxide synthesis is reduced in subjects with type 2 diabetes and nephropathy ［J］. Diabetes ， 2010 ， 59 （ 9 ）： 2152 - 2159 .

NOORI N ， TABIBI H ， HOSSEINPANAH F ， et al . Effects of combined lipoic acid and pyridoxine on albuminuria， advanced glycation end-products， and blood pressure in diabetic nephropathy ［J］. Int J Vitam Nutr Res ， 2013 ， 83 （ 2 ）： 77 - 85 .

AHMAD A ， NAWAZ MI . Molecular mechanism of VEGF and its role in pathological angiogenesis ［J］. J Cell Biochem ， 2022 ， 123 （ 12 ）： 1938 - 1965 .

HANEFELD M ， APPELT D ， ENGELMANN K ， et al . Serum and plasma levels of vascular endothelial growth factors in relation to quality of glucose control， biomarkers of inflammation， and diabetic nephropathy ［J］. Horm Metab Res ， 2016 ， 48 （ 8 ）： 529 - 534 .

DOI K ， NOIRI E ， FUJITA T . Role of vascular endothelial growth factor in kidney disease ［J］. Curr Vasc Pharmacol ， 2010 ， 8 （ 1 ）： 122 - 128 .

MIRONIDOU-TZOUVELEKI M ， TSARTSALIS S ， TOMOS C . Vascular endothelial growth factor （VEGF） in the pathogenesis of diabetic nephropathy of type 1 diabetes mellitus ［J］. Curr Drug Targets ， 2011 ， 12 （ 1 ）： 107 - 114 .

查看原文

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Methodological Issues in the Design，Evaluation，and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"

Effect of Electroacupuncture on Metabolism-Inflammation Network in Patients with Simple Obesity：A Randomized Controlled Trial

Acupuncture Treatment for Severe Bell's Palsy and Its Impact on Serum GDNF and NGF：A Randomized Controlled Trial

Effect of Heat-sensitive Moxibustion on Quality of Life and Immune Function in Non-Small Cell Lung Cancer Patients with Qi Deficiency and Phlegm Stasis Syndrome Undergoing Chemotherapy：A Randomized Controlled Trial

Current Status and Strategic Recommendations for Randomized Controlled Trials on Functional Dyspepsia-Irritable Bowel Syndrome Comorbidity：from a Real-World Research Perspective

Related Author

WANG Lu

WANG Jiajia

ZHANG Yingying

LUO Xufei

CHEN Yaolong

LI Jiansheng

SHU Qi

PENG Qiumei

Related Institution

Lung Disease Diagnosis and Treatment，The First Affiliated Hospital of Henan University of Chinese Medicine

Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province Education Ministry of P.R.China/Henan Key Laboratory of Chinese Medicine for Respiratory Diseases，Henan University of Chinese Medicine

School of Chinese Medicine，Hong Kong Baptist University

Research Unit of Evidence-Based Evaluation and Guidelines，Chinese Academy of Medical Sciences，School of Basic Medical Sciences，Lanzhou University

Key Laboratory of Evidence Based Medicine of Gansu Province

Address：No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing Postal code：100700
Tel：010-64035632 Email：jtcmcn@188.com
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备09064830号-19 京公网安备11010102007558号
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰

Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with Huayu Tongluo Formula （化瘀通络方） as an Adjunct Therapy： A Multi-Center， Randomized， Double-Blind， Placebo-Controlled Trial

DOI：10.13288/j.11-2166/r.2025.06.008

摘要

Abstract

关键词

Keywords

references