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1.北京中医药大学 东直门医院,北京 100700
2.北京航天总医院,北京 100076
3.北京中医药大学,北京 100029
Received:14 August 2025,
Revised:2025-10-13,
Accepted:20 October 2025,
Online First:23 October 2025,
Published:20 May 2026
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王颖超,王佳琪,赵宗江等.真实世界芪归抵挡汤治疗Ⅲ~Ⅳ期糖尿病肾脏疾病肾络瘀阻证的临床有效性和作用机制[J].中国实验方剂学杂志,2026,32(10):162-169.
WANG Yingchao,WANG Jiaqi,ZHAO Zongjiang,et al.Clinical Efficacy and Mechanisms of Qigui Didang Decoction in Treatment of Stage Ⅲ-Ⅳ Diabetic Kidney Disease with Kidney Collateral Stasis Syndrome in Real World[J].Chinese Journal of Experimental Traditional Medical Formulae,2026,32(10):162-169.
王颖超,王佳琪,赵宗江等.真实世界芪归抵挡汤治疗Ⅲ~Ⅳ期糖尿病肾脏疾病肾络瘀阻证的临床有效性和作用机制[J].中国实验方剂学杂志,2026,32(10):162-169. DOI: 10.13422/j.cnki.syfjx.20252123.
WANG Yingchao,WANG Jiaqi,ZHAO Zongjiang,et al.Clinical Efficacy and Mechanisms of Qigui Didang Decoction in Treatment of Stage Ⅲ-Ⅳ Diabetic Kidney Disease with Kidney Collateral Stasis Syndrome in Real World[J].Chinese Journal of Experimental Traditional Medical Formulae,2026,32(10):162-169. DOI: 10.13422/j.cnki.syfjx.20252123.
目的
2
探讨真实世界中芪归抵挡汤治疗Ⅲ~Ⅳ期糖尿病肾脏疾病(DKD)肾络瘀阻证的临床有效性和作用机制。
方法
2
选取2022年1月至2024年12月北京航天总医院收治的Ⅲ~Ⅳ期DKD肾络瘀阻证患者进行临床研究,根据治疗方法分为芪归抵挡汤组(芪归抵挡汤+常规治疗)与对照组(常规治疗)。按1∶1倾向评分匹配(PSM)法进行匹配,减少混杂因素带来的偏倚。对比两组临床疗效、中医症状评分、肾功能指标、通路机制相关mRNA表达、糖脂代谢指标及不良反应情况。
结果
2
共纳入120例Ⅲ~Ⅳ期DKD肾络瘀阻证患者,其中芪归抵挡汤组62例,对照组58例。匹配前,两组DKD分期、基线尿微量蛋白与肌酐比值(UACR)、24 h尿蛋白(24 h-UTP)、估算的肾小球滤过率(eGFR)比较,差异有统计学意义(
P
<
0.05)。匹配后,纳入芪归抵挡汤组和对照组,各47例,两组基线资料比较,差异无统计学意义。匹配后,芪归抵挡汤组临床总有效率明显高于对照组(
χ
2
=4.681,
P
<
0.05)。与本组治疗前比较,芪归抵挡汤组中医主证评分和中医次证评分均明显降低(
P
<
0.05)。与本组治疗前比较,芪归抵挡汤组血肌酐(SCr)、24 h-UTP水平、UACR均明显降低(
P
<
0.05),eGFR明显升高(
P
<
0.05)。与本组治疗前比较,芪归抵挡汤组沉默信息调节因子1(Sirt1)mRNA表达明显上调,核转录因子-
κ
B(NF-
κ
B)mRNA、肿瘤抑制基因p53(p53) mRNA表达明显下调(
P
<
0.05)。与本组治疗前比较,芪归抵挡汤组空腹血糖(FPG)、餐后2 h血糖(2 hPG)、糖化血红蛋白(HbA1c)、总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)水平均降低,高密度脂蛋白胆固醇(HD
L-C)水平明显升高(
P
<
0.05)。两组不良反应比较,差异无统计学意义。
结论
2
芪归抵挡汤联合常规治疗可显著改善Ⅲ~Ⅳ期DKD肾络瘀阻证患者肾功能,改善糖脂代谢及中医证候,且安全性良好,其机制可能与调控Sirt1/NF-
κ
B/p53信号通路相关。
Objective
2
To investigate the clinical efficacy and mechanisms of Qigui Didang decoction in the treatment of kidney collateral stasis syndrome in patients with stage Ⅲ-Ⅳ diabetic kidney disease (DKD) in a real-world setting.
Methods
2
Patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome admitted to Beijing Aerospace General Hospital from January 2022 to December 2024 were selected for clinical study. According to treatment methods, patients were divided into the Qigui Didang decoction group (Qigui Didang decoction + conventional treatment) and the control group (conventional treatment alone). A 1∶1 propensity score matching (PSM) method was used to reduce bias caused by confounding factors. Clinical efficacy, traditional Chinese medicine (TCM) symptom scores, renal function indicators, mRNA expression related to pathway mechanisms, glycolipid metabolism indices, and adverse reactions were compared between the two groups.
Results
2
A total of 120 patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome were included, including 62 cases in the Qigui Didang Decoction group and 58 cases in the control group. Before matching, there were statistically significant differences between the two groups in DKD stage, baseline urinary albumin-to-creatinine ratio (UACR), 24-hour urine total protein (24 h-UTP), and estimated glomerular filtration rate (eGFR) (
P
<
0.05). After matching, 47 cases were included in each group, and there was no statistically significant difference in baseline data between the two groups. After matching, the total clinical effective rate of the Qigui Didang decoction group was significantly higher than that of the co
ntrol group (
χ
2
=4.681,
P
<
0.05). Compared with data before treatment, the scores of primary and secondary TCM symptoms in the Qigui Didang decoction group were significantly decreased (
P
<
0.05). Compared with data before treatment, serum creatinine (SCr), 24 h-UTP, and UACR levels were significantly decreased, while eGFR was significantly increased in the Qigui Didang decoction group (
P
<
0.05). Compared with data before treatment, the mRNA expression of silent information regulator 1 (Sirt1) was significantly upregulated, while the mRNA expression of nuclear factor-kappa B (NF-
κ
B) and tumor suppressor protein p53 (p53) was significantly downregulated in the Qigui Didang decoction group (
P
<
0.05). Compared with data before treatment, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2 hPG), glycated hemoglobin A1c (HbA1c), total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C) levels were decreased, while high-density lipoprotein cholesterol (HDL-C) levels were increased (
P
<
0.05). There was no statistically significant difference in adverse reactions between the two groups.
Conclusion
2
Qigui Didang decoction combined with conventional treatment can significantly improve renal function, glycolipid metabolism, and TCM syndromes in patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome, with good safety. The mechanism may be related to the regulation of the Sirt1/NF-
κ
B/p53 signaling pathway.
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