肾康宁胶囊对显性糖尿病肾病脾肾气虚证病情进展的延缓作用

陈司汉; 柳尧; 曾炎; 阮凤

doi:10.13422/j.cnki.syfjx.2017100183

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肾康宁胶囊对显性糖尿病肾病脾肾气虚证病情进展的延缓作用

临床 | 更新时间：2024-01-04

- 肾康宁胶囊对显性糖尿病肾病脾肾气虚证病情进展的延缓作用
- Delayed Action of Shenkangning Capsules for Disease Progression of Diabetic Nephropathy with Qi Deficiency of Spleen and Kidney
- 中国实验方剂学杂志 2017年23卷第10期页码：183-188
- 作者机构：
- 作者简介：
- 基金信息：
  
  四川省教育厅科研基金项目（2014SC-04606）;乐山职业技术学院2013年科研基金项目（KY2013002）
- DOI：10.13422/j.cnki.syfjx.2017100183
  中图分类号： R259
- 纸质出版日期：2017
- 稿件说明：
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陈司汉, 柳尧, 曾炎, 等. 肾康宁胶囊对显性糖尿病肾病脾肾气虚证病情进展的延缓作用[J]. 中国实验方剂学杂志, 2017,23(10):183-188.

CHEN Si-han, LIU Yao, ZENG Yan, et al. Delayed Action of Shenkangning Capsules for Disease Progression of Diabetic Nephropathy with Qi Deficiency of Spleen and Kidney[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(10): 183-188.
陈司汉, 柳尧, 曾炎, 等. 肾康宁胶囊对显性糖尿病肾病脾肾气虚证病情进展的延缓作用[J]. 中国实验方剂学杂志, 2017,23(10):183-188. DOI： 10.13422/j.cnki.syfjx.2017100183.

CHEN Si-han, LIU Yao, ZENG Yan, et al. Delayed Action of Shenkangning Capsules for Disease Progression of Diabetic Nephropathy with Qi Deficiency of Spleen and Kidney[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(10): 183-188. DOI： 10.13422/j.cnki.syfjx.2017100183.

摘要

目的：探讨肾康宁胶囊对显性糖尿病肾病（DKD）脾肾气虚证患者的临床疗效及对血清核转录因子-κB（NF-κB），转化生长因子-β1（TGF-β1）和血小板源性生长因子（PDGF）水平的影响。方法：将138例患者采用区组随机，按数字表法分为对照组和观察组各69例。对照组口服替米沙坦片，1片/d，和口服阿托伐他汀钙片，10 mg·d-1。观察组西药使用同对照组，并服用肾康宁胶囊，4粒/次，3次/d。两组疗程均为连续治疗24周或至Ⅴ期，并进行24周随访。记录治疗期和随访期病情进展至Ⅴ期的患者数量，或肌酐（SCr）翻版倍等终点事件发生情况；检测治疗前后空腹血糖（FBG），糖化血红蛋白（HbAlc），尿素氮（BUN），血肌酐（SCr），血红蛋白（Hb），血浆白蛋白（ALB），24 h尿蛋白定量（24 h Upr），胆固醇（TC），甘油三酯（TG），高密度脂蛋白胆固醇（HDL-C）和低密度脂蛋白胆固醇（LDL-C）检测；进行治疗前后脾肾气虚证评分；检测治疗前后TGF-β1，NF-κB和PDGF水平。结果：观察组临床疗效有效率为78.26%

对照组为57.97%，观察组高于对照组（χ2=6.539，P<0.05）；观察组中医证候评分有效率为85.51%

对照组为65.22%，观察组中医证候评分高于对照组（χ2=7.649，P<0.01）；观察组终点事件发生率为15.94%，对照组为33.33%，观察组终点事件发生率低于对照组（χ2=5.619，P<0.05）；治疗后观察组HbAlc，24 h Upr，BUN和SCr水平均低于对照组（P<0.01）；治疗后观察组Hb，ALB和HDL-C水平均高于对照组（P<0.01），LDL-C水平低于对照组（P<0.01），TC和TG组间比较差异无统计学意义；治疗后观察组TGF-β1，NF-κB和PDG水平均低于对照组（P<0.01）。结论：在西医常规治疗的基础上，采用肾康宁胶囊内服治疗DKD Ⅳ期患者，能改善脾肾气虚证症状、减轻蛋白尿，能调节糖、脂代谢，改善患者营养状况，从而降低终点事件的发生率，对DKD病情起到延缓作用，其作用机制可能通过下调血清TGF-β1，PDGF，NF-κB等细胞因子来实现的。

Abstract

Objective: To discuss the clinical efficacy of Shenkangning capsules in treating diabetic nephropathy (Qi deficiency of spleen and kidney) and investigate their effects on levels of transforming growth factor-β1 (TGF-β1)

nuclear transcription factor-κB(NF-κB) and platelet-derived growth factor (PDGF). Method: Altogether one hundred and thirty-eight patients were randomly divided into control group (69 cases) and observation group (69 cases) by random number table. Patients in control group orally took telmisartan tablets

1 tablet/day

atorvastatin calcium tablets

10 mg/day. Based on the treatment in control group

patients in observation group added Shenkangning capsules

4 capsules/time

3 times/day. The treatment course was 24 weeks for both groups

with a follow-up of 24 weeks. The number of patients entering Stage V

or the endpoint events such as serum creatinine (SCr) doubling were recorded during treatment period and follow-up period. The levels of fasting blood-glucose (FBG)

glycosylated hemoglobin (HbAlc)

urea nitrogen (BUN)

serum creatinine (SCr)

hemoglobin (Hb)

plasma-albumin (ALB)

urine protein quantitation at 24 hours (24 h Upr)

cholesterol (TC)

triglyceride (TG)

high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) were detected before and after treatment. The scores of qi deficiency of spleen and kidney were graded.And levels of TGF-β1

NF-κB and PDGF were detected both before and after treatment. Result: The total effective rate of clinical efficacy was 78.26% in observation group

higher than 57.97% in control group (χ2=6.539

P<0.05). The effective rate of traditional Chinese medicine(TCM)symptoms was 85.51% in observation group

higher than 65.22% in control group (χ2=7.649

P<0.01). The incidence of endpoint events was 15.94% in observation group

lower than 33.33% in control group (χ2=5.619

P<0.05). Levels of HbAlc

24 h Upr

BUN

Scr and LDL-C in observation group were lower than those in control group after treatment (P<0.01). Levels of Hb

ALB and HDL-C were higher than those in control group (P<0.01). Levels of TC and TG had no statistically significant difference between two groups. Levels of TGF-β1

NF-κB and PDG in observation group were lower than those in control group after treatment (P<0.01). Conclusion: Based on the conventional western medicine therapy

Shenkangning capsules can ameliorate symptoms of Qi deficiency of spleen and kidney

decrease albuminuria

regulate glucose and lipid metabolism

ameliorate patients' nutritional status

and reduce the incidence of endpoints events to delay the disease development on patients at DKD Ⅳ

and the mechanism of action may be associated with down-regulating the levels of TGF-β1

PDGF and NF-κB.

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