Randomized Controlled Study of Baoshen Prescription in Treating Stage Ⅳ Diabetic Nephropathy in Patients with Syndromes of Qi-Yin Deficiency and Kidney Collateral Stasis and Obstruction
10.13422/j.cnki.syfjx.20250597
- VernacularTitle: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
- Author:
Yiting QIU
1
;
Shuangshuang HONG
1
;
Zhiqiu LIU
1
;
Xinru SUN
1
;
Yuefen WANG
1
;
Mengchao LIU
1
;
Wenjing ZHAO
1
Author Information
1. Beijing Hospital of Traditional Chinese Medicine（TCM） Affiliated to Capital Medical University，Beijing 100010，China
- Publication Type:Journal Article
- Keywords:
diabetic nephropathy;
Baoshen prescription;
metabolic memory of hyperglycemia;
podocyte epithelial-to-mesenchymal transdifferentiation;
randomized controlled trial;
advanced glycation end products （AGEs）;
receptor of advanced glycation end products （RAGE）
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(3):124-131
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical efficacy and safety of Baoshen prescription in the treatment of stage Ⅳ diabetic 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. MethodsA randomized， controlled， double-blind， multicenter clinical trial was conducted， in which 94 stage Ⅳ DN 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 transdifferentiation-related indexes， and TCM syndrome score. ResultsAfter 12 weeks of treatment， the Baoshen prescription group showed lowered levels of advanced glycation end products （lgAGEs）， connective tissue growth factor （CTGF）， type Ⅳ collagen （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-Ⅳ and 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）. ConclusionBaoshen prescription can effectively improve the renal function， reduce the urinary protein level， and alleviate clinical symptoms in stage Ⅳ DN patients with syndromes of Qi-Yin deficiency and kidney collateral stasis and obstruction. The mechanism may be related to the metabolic memory of hyperglycemia and epithelial-to-mesenchymal transdifferentiation of podocytes.
