1.上海市宝山区中西医结合医院,上海 201999
2.上海中医药大学 附属宝山医院,上海 201999
3.上海中医药大学 附属曙光医院,上海 201203
4.上海中医药大学 中医肾病研究所,上海 201203
5.上海中医药大学 肝肾疾病病证教育部重点实验室,上海市中医临床重点实验室,上海 201203
杨超茅,博士,副主任医师,从事老年病、肾病研究,E-mail:yang_chaomao@126.com
高建东,博士,主任医师,从事肾病研究,E-mail:gaojiandong@Hotmail.com
收稿:2025-01-05,
修回:2025-03-12,
录用:2025-03-14,
网络首发:2025-03-21,
纸质出版:2026-03-20
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杨超茅,张顺宵,杨志新等.糖肾地黄汤治疗肝肾阴虚兼血瘀型糖尿病肾病的临床疗效观察及对肠道菌群的影响[J].中国实验方剂学杂志,2026,32(06):171-178.
YANG Chaomao,ZHANG Shunxiao,YANG Zhixin,et al.Clinical Efficacy of Tangshen Dihuang Decoction in Treating Diabetic Kidney Disease with Liver-kidney Yin Deficiency and Blood Stasis Syndrome and Its Impact on Gut Microbiota[J].Chinese Journal of Experimental Traditional Medical Formulae,2026,32(06):171-178.
杨超茅,张顺宵,杨志新等.糖肾地黄汤治疗肝肾阴虚兼血瘀型糖尿病肾病的临床疗效观察及对肠道菌群的影响[J].中国实验方剂学杂志,2026,32(06):171-178. DOI: 10.13422/j.cnki.syfjx.20251124.
YANG Chaomao,ZHANG Shunxiao,YANG Zhixin,et al.Clinical Efficacy of Tangshen Dihuang Decoction in Treating Diabetic Kidney Disease with Liver-kidney Yin Deficiency and Blood Stasis Syndrome and Its Impact on Gut Microbiota[J].Chinese Journal of Experimental Traditional Medical Formulae,2026,32(06):171-178. DOI: 10.13422/j.cnki.syfjx.20251124.
目的
2
观察糖肾地黄汤治疗肝肾阴虚兼血瘀型糖尿病肾病(DKD)的临床疗效及对肠道菌群的影响。
方法
2
采用随机、对照的临床试验设计,将102例肝肾阴虚兼血瘀型DKD患者随机分为中药组(糖肾地黄汤)和对照组,每组各51例,疗程3个月。主要疗效指标为尿蛋白肌酐比值(UACR)、空腹血糖(FBG)、餐后2 h血糖(2 hPBG)、糖化血红蛋白(HbA1c)、血肌酐(SCr)、尿素氮(BUN)、血管紧张素Ⅱ(AngⅡ)、血清胱抑素C(Cys-C)、尿
N
-乙酰-
β
氨基葡萄糖苷酶(NAG)、尿
β
2
微球蛋白(U
β
2
-MB)、中医证候积分和肠道菌群。
结果
2
治疗后中药组总有效率87.23%(41/47),对照组总有效率69.57%(32/46),中药组疗效优于对照组(
Z
=4.30,
P
<
0.05)。与本组治疗前比较,两组患者的中医证候积分均显著降低(
P
<
0.01),治疗后与对照组比较,中药组患者中医证候积分显著降低(
P
<
0.01)。治疗后,与本组治疗前比较,对照组的UACR、U
β
2
-MB、AngⅡ、FBG明显降低(
P
<
0.05),2 hPBG、HbA1c显著降低(
P
<
0.01),BUN、Cys-C、eGFR、SCr、NAG差异无统计学意义;中药组的eGFR明显升高(
P
<
0.05),UACR、BUN、Cys-C、U
β
2
-MB、AngⅡ、FBG、2 hPBG、NAG、HbA1c均显著降低(
P
<
0.01),SCr差异无统计学意义。治疗后与对照组比较,中药组患者BUN、Cys-C、AngⅡ、2 hPBG均明显降低(
P
<
0.05);U
β
2
-MB、NAG均明显降低(
P
<
0.01),eGFR明显升高(
P
<
0.05)。与本组治疗前比较,对照组的香农-威纳(Shannon)指数、观测物种数(Observed_species)指数、蔡1估计量(Chao1)指数均明显降低(
P
<
0.05)。治疗后,两组患者各样本在主坐标分析图(PCoA)上经Anosim分析比较差异有统计学意义(
P
<
0.05)。治疗后,与本组治疗前比较,中药组的放线菌门明显降低(
P
<
0.05)。治疗后与对照组比较,中药组的放线菌门明显降低(
P
<
0.05)。治疗后,与本组治疗前比较,对照组的双歧杆菌属显著降低(
P
<
0.05),中药组的双歧杆菌属、布劳特氏菌A属显著升高(
P
<
0.05)。治疗后与对照组比较,双歧杆菌属显著升高(
P
<
0.01)。
结论
2
糖肾地黄汤治疗肝肾阴虚兼血瘀型DKD患者效果显著,能明显改善患者的临床症状,减少蛋白尿,降低餐后血糖,机制可能与拮抗局部肾素-血管紧张素系统(RAS),改善肠道菌群紊乱有关。
Objective
2
To observe the clinical efficacy of Tangshen Dihuang decoction in treating diabetic kidney disease (DKD) with liver-kidney Yin deficiency and blood stasis syndrome and its impact on gut microbiota.
Methods
2
A randomized controlled clinical trial was conducted, in which 102 DKD patients with liver-kidney Yin deficiency and blood stasis syndrome were randomly assigned to the Tangshen Dihuang decoction group and the control group. Each group consisted of 51 cases, and the treatment period was 3 months. The primary efficacy indicators included urinary albumin-to-creatinine ratio (UACR), fasting blood glucose (FBG), 2-hour postprandial blood glucose (2 hPBG), glycated hemoglobin (HbA
1
C), serum creatinine (SCr), blood urea nitrogen (BUN), angiotensinⅡ (AngⅡ), serum cystatin C (Cys-C), urinary N-acetyl-
β
-
D
-glucosaminidase (NAG), urinary
β
2
-microglobulin (U
β
2
-MB), traditional Chinese medicine (TCM) symptom scores, and gut microbiota.
Results
2
After treatment, the total response rate in the Tangshen Dihuang decoction was 87.23% (41/47), which was higher than that (69.57%, 32/46) in the control group (
Z
=4.30,
P
<
0.05). After treatment, the TCM symptom scores decreased in both groups (
P
<
0.01) and were lower in the Tangshen Dihuang decoction group than in the control group (
P
<
0.01). After treatment, the control group showed decreases in UACR, U
β
2
-MG, AngⅡ, and FBG (
P
<
0.05) as well as 2 hPBG and HbA
1
C (
P
<
0.01), and no significant differences in BUN, Cys-C, eGFR, SCr, and NAG. The Tangshen Dihuang decoction group showed increased eGFR (
P
<
0.05), declined levels of UACR, BUN, Cys-C, U
β
2
-
MB, AngⅡ, FBG, 2 hPBG, NAG, and HbA
1
C (
P
<
0.01), and no significant difference in SCr. The Tangshen Dihuang decoction group had lower BUN (
P
<
0.05), Cys-C (
P
<
0.05), AngⅡ (
P
<
0.05), 2 hPBG (
P
<
0.05), U
β
2
-MG (
P
<
0.01), and NAG (
P
<
0.01) and higher eGFR level (
P
<
0.05) than the control group. After treatment, the control group showed declines in Shannon, Observed_species, and Chao1 indices (
P
<
0.05). The samples from both groups showed statistically significant differences in the principal coordinates analysis (PCoA) plot based on Anosim analysis (
P
<
0.05). After treatment, the Tangshen Dihuang decoction group showed decreased relative abundance of Actinobacteria (
P
<
0.05). Moreover, the relative abundance of Actinobacteria was significantly lower in the Tangshen Dihuang decoction group than in the control group (
P
<
0.05). At the genus level, the control group showed decreased relative abundance of
Bifidobacterium
(
P
<
0.05), and the Tangshen Dihuang decoction group presented increased relative abundance of
Bifidobacterium
and
Blautia_
A (
P
<
0.05). After treatment, the Tangshen Dihuang decoction group had higher relative abundance of
Bifidobacterium
than the control group (
P
<
0.01).
Conclusion
2
Tangshen Dihuang decoction has a significant therapeutic effect on DKD patients with liver-kidney Yin deficiency and blood stasis syndrome. It can markedly relieve clinical symptoms and reduce proteinuria and postprandial blood glucose by antagonizing the local renin-angiotensin system (RAS) and alleviating gut microbiota dysbiosis.
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