益气养阴消癥通络方联合西药治疗Ⅲ、Ⅳ期糖尿病肾病气阴两虚、络脉癥积瘀结证163例多中心随机对照试验

郭帅; 王月华; 郭登州; 王元松; 周潮; 陈志强

doi:10.13288/j.11-2166/r.2021.18.009

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益气养阴消癥通络方联合西药治疗Ⅲ、Ⅳ期糖尿病肾病气阴两虚、络脉癥积瘀结证163例多中心随机对照试验

临床研究 | 更新时间：2021-09-14

- 益气养阴消癥通络方联合西药治疗Ⅲ、Ⅳ期糖尿病肾病气阴两虚、络脉癥积瘀结证163例多中心随机对照试验
- Yiqi Yangyin Xiaozheng Tongluo Formula （益气养阴消癥通络方） in Combination with Western Routine Treatment for Stages Ⅲ to Ⅳ Diabetic Nephropathy with the Syndrome of Qi and Yin Deficiency， Concretions Accumulation and Stasis Constraint in the Collaterals：A Multicenter， Randomize-Controlled Trial of 163 Patients
- 中医杂志 2021年62卷第18期页码：1606-1611
- 作者机构：
  
  1.河北中医学院，河北省石家庄市桥西区新石南路326号，050091
  2.河北省中医院
  3.河北省沧州中西医结合医院
  4.河北省秦皇岛市中医院
- 作者简介：
  
  chenzhqiang2021@163.com；13930486188
- 基金信息：
  
  河北省科技支撑计划(09276101D-27)
- DOI：10.13288/j.11-2166/r.2021.18.009
  中图分类号：
- 收稿：2021-01-16，
  
  修回：2021-07-10，
  
  纸质出版：2021-09-17
- 稿件说明：
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郭帅,王月华,郭登州等.益气养阴消癥通络方联合西药治疗Ⅲ、Ⅳ期糖尿病肾病气阴两虚、络脉癥积瘀结证163例多中心随机对照试验[J].中医杂志,2021,62(18):1606-1611.

GUO Shuai,WANG Yuehua,GUO Dengzhou,et al.Yiqi Yangyin Xiaozheng Tongluo Formula （益气养阴消癥通络方） in Combination with Western Routine Treatment for Stages Ⅲ to Ⅳ Diabetic Nephropathy with the Syndrome of Qi and Yin Deficiency， Concretions Accumulation and Stasis Constraint in the Collaterals：A Multicenter， Randomize-Controlled Trial of 163 Patients[J].Journal of Traditional Chinese Medicine,2021,62(18):1606-1611.
郭帅,王月华,郭登州等.益气养阴消癥通络方联合西药治疗Ⅲ、Ⅳ期糖尿病肾病气阴两虚、络脉癥积瘀结证163例多中心随机对照试验[J].中医杂志,2021,62(18):1606-1611. DOI： 10.13288/j.11-2166/r.2021.18.009.

GUO Shuai,WANG Yuehua,GUO Dengzhou,et al.Yiqi Yangyin Xiaozheng Tongluo Formula （益气养阴消癥通络方） in Combination with Western Routine Treatment for Stages Ⅲ to Ⅳ Diabetic Nephropathy with the Syndrome of Qi and Yin Deficiency， Concretions Accumulation and Stasis Constraint in the Collaterals：A Multicenter， Randomize-Controlled Trial of 163 Patients[J].Journal of Traditional Chinese Medicine,2021,62(18):1606-1611. DOI： 10.13288/j.11-2166/r.2021.18.009.

摘要

目的

观察益气养阴消癥通络方联合西医基础疗法治疗Ⅲ、Ⅳ期糖尿病肾病气阴两虚、络脉癥积瘀结证的临床疗效和安全性。

方法

采用随机、安慰剂对照、多中心研究方法。将323例Ⅲ、Ⅳ期糖尿病肾病气阴两虚、络脉癥积瘀结证患者随机分为中药组163例和对照组160例。两组患者均给予西医基础治疗，中药组给予益气养阴消癥通络方口服，每日1剂，同时予厄贝沙坦安慰剂150 mg，每日1次；对照组给予厄贝沙坦片和中药安慰剂口服，服法同中药组。两组患者均治疗24个月。治疗前后进行实验室主要指标检测［包括尿微量白蛋白排泄率（UAER）、24小时尿蛋白定量（24 h UTP）、肾小球滤过率（GFR）、内生肌酐清除率（Ccr）和血肌酐（Scr）］、次要指标检测［包括糖化血红蛋白（HbA1c）和总胆固醇（TC）］，治疗后判定实验室主要检测指标疗效，治疗前后进行中医证候评分并判定中医证候疗效，记录终点事件发生率，采用健康调查简表（SF-36）评价患者生活质量，观察不良反应。

结果

中药组实验室主要检测指标总有效率和中医证候疗效分别为67.84%、70.55%，对照组分别为46.88%、52.50%，两组差异均有统计学意义（

＜0.01）。两组治疗后HbA1c、TC水平均显著低于治疗前（

＜0.05或

＜0.01）。SF-36量表各维度评分均显著高于治疗前，且治疗后中药组SF-36量表躯体疼痛、情感功能和精神健康维度评分显著高于对照组（

＜0.05或

＜0.01）。中药组终点事件发生率为8.51%，对照组为10.53%，两组差异无统计学意义（

＞0.05）；治疗前后未发现与试验药物有关的不良反应。

结论

益气养阴消癥通络方结合西医基础疗法治疗Ⅲ、Ⅳ期糖尿病肾病气阴两虚、络脉癥积瘀结证可有效改善患者临床症状，降低尿蛋白，保护肾功能，提高患者生活质量，与对照药物厄贝沙坦比较，疗效更佳。

Abstract

Objective

To explore the clinical effect and safety of

Yiqi Yangyin Xiaozheng Tongluo Formula

(益气养阴消癥通络方

YYXTF) combined with Western medicine for stage Ⅲ and Ⅳ diabetic nephropathy (DN Ⅲ-Ⅳ) with the syndrome of

and

yin

deficiency

corrections accumulation and stasis constraint in the collaterals.

Methods

A multicenter， randomized-controlled trial was conducted

in which 323 patients of stage DN Ⅲ-Ⅳ were randomly divided into Chinese herbal medicine (CHM) group (163 patients) and the control group (160 patients). Based on routine westen medicine

patients in the CHM group were given oral administration of YYXTF

one dose per day

and placebo of irbesartan

150 mg

once daily

while those in the control group were treated with irbesartan and placebo of YYXTF

with the same administration way as CHM group. The treatment duration was 24 months. Before and after treatment

The primary laboratory indicators including urinary microalbumin excretion rate (UMER)

24-hour urinary total protein (24h UTP)

glomerular filtration rate (GFR)

endogenous creatinine clearance rate (Ccr) and serum creatinine (SCr) and secondary laboratory indicators including hemoglobin A1c (HbA1c) and total cholesterol (TC) were assessed

and the effects on the primary laboratory indicators were evaluated; the score of traditional Chinese medicine (TCM) syndromes were assessed before and after treatment

and the effect on TCM syndromes was evaluated; the incidence of the endpoints events was recorded; 36-item short form health survey (SF-36) was used to assess the quality of life; the adverse events were observed.

Results

The total effective rate regarding primary laboratory indicators and TCM syndromes of the CHM group was 67.84% and 70.55%

respectively

while those of control group were 46.88% and 52.50% correspondingly

with significant differences between groups (

＜0.01). The levels of HbA1c and TC significantly decreased after treatment in both groups (

＜0.05

＜0.01). All the domain scores of SF-36 significantly increased after treatment

and more increases were found in the CHM group than in the control group in the domains of physical pain

emotional function and mental health (

＜0.05

＜0.01). The incidence of the endpoints events was 8.51% in the CHM group and 10.5% in the control group

with no statistically significant differences between groups (

＞0.05); no adverse events has been found to be related to the drugs of the trials.

Conclusion

YYXTF combined with Western medicine is superior to irbesartan in improving the clinical symptoms

reducing urinary protein

protecting renal function

and improveing the quality of life in DN patients of stage Ⅲ-Ⅳ with syndrome of

and

yin

deficiency

corrections accumulation and stasis constraint in the collaterals.

关键词

Keywords

references

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