Shenshuai Guanchang Prescription Treats Non-dialysis Patients with Chronic Kidney Disease Stage 4-5 of Spleen and Kidney Deficiency，Blood Stasis and Dampness Turbidity： A Randomized Controlled Trial
10.13422/j.cnki.syfjx.20260797
- VernacularTitle:肾衰灌肠方治疗脾肾亏虚、血瘀湿浊型慢性肾脏病4~5期非透析患者随机对照试验
- Author:
Xiangyu LI
1
;
Ning ZHANG
1
;
Tongxia LI
1
;
Pu YAN
1
;
Qian ZHANG
1
;
Fanyu HOU
1
;
Zhiquan ZHAO
1
;
Xinrong FAN
2
;
Kaifeng SHI
1
Author Information
1. Wangjing Hospital，China Academy of Chinese Medical Sciences，Beijing 100102，China
2. Experimental Research Center，China Academy of Chinese Medical Sciences，Beijing 100700，China
- Publication Type:Journal Article
- Keywords:
chronic kidney disease;
Shenshuai Guanchang prescription;
randomized controlled trial;
external treatment of traditional Chinese medicine
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(22):198-208
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical efficacy and safety of Shenshuai Guanchang prescription in improving the intestinal barrier function，reducing non-indole uremic toxins，ameliorating micro-inflammatory state，and delaying renal function progression in non-dialysis patients with chronic kidney disease （CKD） stage 4-5. MethodsA total of 80 patients with CKD stage 4-5 who did not receive dialysis replacement therapy and were diagnosed with the syndrome of spleen and kidney deficiency，blood stasis and dampness turbidity were randomly assigned into a control group and a treatment group，with 40 patients in each group. The control group received conventional basic treatment and Western medicine symptomatic treatment，while the treatment group received combined intervention with Shenshuai Guanchang prescription through retention enema in addition to the treatment of the control group. Both groups had a treatment course of 4 weeks. The two groups were compared regarding the changes in urine toxin indicators ［p-cresyl sulfate （PCS） and trimethylamine oxide （TMAO）］，intestinal barrier indicators ［D-lactic acid （D-LA），lipopolysaccharide （LPS），and intestinal fatty acid-binding protein （I-FABP）］，renal function indicators ［serum creatinine （SCr），blood urea nitrogen （BUN），and estimated glomerular filtration rate （eGFR）］，and micro-inflammatory state indicators ［interleukin-6 （IL-6），tumor necrosis factor-α （TNF-α），and neutrophil-to-lymphocyte ratio （NLR）］ before and after treatment. The therapeutic effects were evaluated from three aspects：The efficacy regarding traditional Chinese medicine （TCM） symptom scores，the efficacy regarding laboratory indicators，and comprehensive efficacy. The safety of the clinical research drugs used by both groups of patients was also observed. ResultsA total of 37 cases in the treatment group and 38 cases in the control group completed the observation. After treatment，the treatment group showed declined levels of PCS，TMAO，D-LA，SCr，TNF-α，and NLR，spleen and kidney deficiency symptom score，blood stasis and dampness symptom score，and total symptom score （P<0.05），and increased eGFR （P<0.05）. Moreover，the treatment group had lower levels of PCS，TMAO，D-LA，I-FABP，IL-6，and TNF-α，spleen and kidney deficiency symptom score，blood stasis and dampness symptom score，and total symptom score （P<0.05），higher response rate regarding TCM symptoms （χ2=6.68，P<0.05），and higher comprehensive efficacy （χ2=4.08，P<0.05） than the control group. No significant abnormalities were observed in the safety indicators of the two groups of patients. During the treatment period，adverse reactions were reduced after symptomatic treatment，and no serious adverse reactions occurred. ConclusionShenshuai Guanchang prescription can alleviate the clinical symptoms，improve the intestinal barrier function，reduce non-indole-type uremic toxins，alleviate the micro-inflammatory state，and has good clinical application safety of non-dialysis patients with CKD stage 4-5.
