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
10.13288/j.11-2166/r.2025.06.008
- VernacularTitle: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
- Author:
Yun MA
1
;
Kaishuang WANG
2
;
Shuang CAO
1
;
Bingwu ZHAO
1
;
Lu BAI
3
;
Su WU
3
;
Yuwei GAO
4
;
Xinghua WANG
4
;
Dong BIAN
1
;
Zhiqiang CHEN
1
Author Information
1. Hebei Provincial Hospital of Traditional Chinese Medicine，Shijiazhuang，050011
2. Baoding Hospital of Guang'anmen Hospital，China Academy of Chinese Medical Sciences
3. The Third Hospital of Hebei Medical University
4. The First Hospital of Hebei Medical University
- Publication Type:Journal Article
- Keywords:
diabetes kidney disease;
blood stasis syndrome;
Huayu Tongluo Formula （化瘀通络方）;
proteinuria;
endothelial function;
randomized controlled trial
- From:
Journal of Traditional Chinese Medicine
2025;66(6):588-595
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo 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. MethodsA 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. ResultsIn 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. ConclusionOn 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.
