中国临床药理学杂志

达格列净联合二甲双胍治疗糖尿病肾病患者的临床研究

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刘莉娟 ^1a , 曾红丽 ^1a , 陈宇 ^1b , 黄碟 ^1a , 张倩 ^1a

中国临床药理学杂志 | 临床与基础桥接研究 2025,41(9): 1207-1212

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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (9) : 1207 -1212

达格列净联合二甲双胍治疗糖尿病肾病患者的临床研究

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刘莉娟^1a, 曾红丽^1a, 陈宇^1b, 黄碟^1a, 张倩^1a

作者信息

^1a.萍乡矿业集团有限责任公司总医院，内分泌科，江西萍乡 337000

^1b.萍乡矿业集团有限责任公司总医院，肾病风湿科，江西萍乡 337000

通讯作者:

刘莉娟 MP: 13879957358 E-mail: jyzdqs7358@163.com

作者简介:

刘莉娟（1976-），女，副主任医师，主要从事糖尿病足的诊疗和研究工作

Clinical trial of dapagliflozin combined with metformin in the treatment of patients with diabetic kidney disease

Li-juan LIU^1a, Hong-li ZENG^1a, Yu CHEN^1b, Die HUANG^1a, Qian ZHANG^1a

Affiliations

^1a.Department of Endocrinology, General Hospital of Pingxiang Mining Group Co., Pingxiang 337000, Jiangxi Province, China

^1b.Department of Nephropathy and Rheumatology, General Hospital of Pingxiang Mining Group Co., Pingxiang 337000, Jiangxi Province, China

出版时间: 2025-05-17 doi: 10.13699/j.cnki.1001-6821.2025.09.002

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摘要

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目的

观察达格列净片联合二甲双胍片治疗糖尿病肾病（DKD）患者的临床疗效及安全性。

方法

将DKD患者按队列法分为对照组和试验组。对照组予以二甲双胍片治疗，每次0.5 g，每天2次，口服；试验组在对照组治疗的基础上，予以达格列净片治疗，每次10 mg，每天1次，口服。2组患者均治疗12周。比较2组患者的临床疗效、糖代谢指标[糖化血红蛋白（HbA1c）、空腹血糖（FPG）、餐后2 h血糖（2 h PG）]、肾功能[尿白蛋白/肌酸酐（UACR）、血清肌酸酐（SCr）、估算肾小球滤过率（eGFR）]、肾血管功能[肾内段阻力指数（RI）、搏动指数（PI）、收缩期峰值血流速度（PSV）、舒张末期峰值血流速度（EDV）]、尿液α平滑肌肌动蛋白（SMA）、膜蛋白、转化生长因子（TGF）-β1和炎症因子[白细胞介素（IL）-1β、IL-6、肿瘤坏死因子（TNF）-α]，并评价安全性。

结果

对照组入组40例，试验组入组40例。治疗后，试验组和对照组的总有效率分别为92.50%（37例/40例）和72.50%（29例/40例），在统计学上差异有统计学意义（P<0.05）。治疗后，试验组和对照组的HbA1c水平分别为（6.52±0.76）%和（7.44±0.98）%，FPG水平分别为（7.11±1.05）和（8.05±1.21）mmol·L^-1，2 h PG水平分别为（9.32±1.08）和（10.57±1.35）mmol·L^-1，UACR分别为（104.76±13.85）和（138.41±16.07）mg·g^-1，SCr水平分别为（82.27±10.38）和（101.68±13.54）μmol·L^-1，eGFR分别为（88.06±8.37）和（80.52±7.64）mL·min^-1·1.73 m^-2，RI分别为0.51±0.10和0.65±0.13，PI分别为1.15±0.24和1.49±0.31，PSV分别为（38.30±5.29）和（34.59±4.71）cm·s^-1，EDV分别为（15.73±2.49）和（13.41±2.02）cm·s^-1，尿液SMA水平分别为（26.31±2.39）和（30.47±2.86）kU·L^-1，尿液膜蛋白水平分别为（528.41±50.78）和（581.65±57.22）μg·L^-1，尿液TGF-β1水平分别为（85.01±9.82）和（102.94±13.57）μg·L^-1，血清IL-1β水平分别为（26.93±3.36）和（40.14±4.57）ng·L^-1，血清IL-6水平分别为（14.36±1.59）和（17.94±2.01）ng·L^-1，血清TNF-α分别为（30.22±3.37）和（43.81±4.06）ng·L^-1，试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（均P<0.05）。试验组的药物不良反应主要有食欲缺乏、腹泻、乏力、恶心，对照组的药物不良反应主要有食欲缺乏、头痛、恶心。试验组和对照组的总药物不良反应发生率分别为12.50%（5例/40例）和7.50%（3例/40例），在统计学上差异无统计学意义（P>0.05）。

结论

达格列净联合二甲双胍能改善DKD患者糖代谢，促进肾功能及肾血管功能恢复，调节SMA、膜蛋白和TGF-β1水平，缓解炎症反应，提高临床疗效。

关键词

达格列净片 / 二甲双胍片 / 糖尿病肾病 / 糖代谢 / 肾血管功能 / 临床疗效

Abstract

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Objective

To observe clinical effect and safety of dapagliflozin tablets combined with metformin tablets in the treatment of patients with diabetic kidney disease (DKD).

Methods

According to cohort method, DKD patients were divided into control group and treatment group. The control group was given oral metformin tablets (0.5 g per time, twice a day), while treatment group was given oral dapagliflozin tablets (10 mg per time, once a day) on basis of control group. All patients were treated for 12 weeks. The clinical curative effect, glucose metabolism indexes [glycated hemoglobin (HbA1c), fasting blood glucose (FPG), 2 h postprandial blood glucose (2 h PG)], renal function [urine albumin/creatinine (UACR), serum creatinine (SCr), estimated glomerular filtration rate (eGFR)], renal vascular function [resistance index (RI), pulsatility index (PI), peak systolic velocity (PSV), end-diastolic velocity (EDV)], urine α-smooth muscle actin (SMA), membrane protein, transforming growth factor (TGF)-β1 and inflammatory factors [interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α] in the two groups were compared, and the safety was evaluated.

Results

There were 40 cases in control group and 40 cases in treatment group. After treatment, difference in total response rate between treatment group and control group was statistically significant [92.50% (37 cases/40 cases) vs 72.50% (29 cases/40 cases), P<0.05]. After treatment, HbA1c levels in treatment group and control group were (6.52±0.76)% and (7.44±0.98)%; FPG levels were (7.11±1.05) and (8.05±1.21)mmol·L^-1; 2 h PG levels were (9.32±1.08) and (10.57±1.35) mmol·L^-1; UACR levels were (104.76±13.85) and (138.41±16.07)mg·g^-1; SCr levels were (82.27±10.38) and (101.68±13.54) μmol·L^-1; eGFR levels were (88.06±8.37) and (80.52±7.64) mL·min^-1·1.73 m^-2; RI levels were 0.51±0.10 and 0.65±0.13; PI were 1.15±0.24 and 1.49±0.31; PSV were (38.30±5.29) and (34.59±4.71) cm·s^-1; EDV were (15.73±2.49) and (13.41±2.02) cm·s^-1; levels of urine SMA were (26.31±2.39) and (30.47±2.86)kU·L^-1; levels of urine membrane protein were (528.41±50.78) and (581.65±57.22) μg·L^-1; levels of urine TGF-β1 were (85.01±9.82) and (102.94±13.57) μg·L^-1; levels of serum IL-1β were (26.93±3.36) and (40.14±4.57)ng·L^-1; levels of serum IL-6 were (14.36±1.59) and (17.94±2.01) ng·L^-1; levels of serum TNF-α were (30.22±3.37) and (43.81±4.06) ng·L^-1, and differences of all the above indexes between the two groups were statistically significant (all P<0.05). The adverse drug reactions were mainly on loss of appetite, diarrhea, fatigue and nausea in treatment group, while which were mainly on loss of appetite, headache and nausea in control group. There was no significant difference in total incidence of adverse drug reactions between treatment group and control group [12.50% (5 cases/40 cases) vs 7.50% (3 cases/40 cases), P>0.05].

Conclusion

Dapagliflozin combined with metformin can improve glucose metabolism, promote recovery of renal function and renal vascular function, regulate levels of SMA, membrane protein and TGF-β1, relieve inflammatory response and improve clinical curative effect in DKD patients.

Key words

dapagliflozin tablet / metformin tablet / diabetic kidney disease / glucose metabolism / renal vascular function / clinical efficacy

引用本文

刘莉娟, 曾红丽, 陈宇, 黄碟, 张倩. 达格列净联合二甲双胍治疗糖尿病肾病患者的临床研究. 中国临床药理学杂志, 2025 , 41 (9) : 1207 -1212 . DOI: 10.13699/j.cnki.1001-6821.2025.09.002

Li-juan LIU, Hong-li ZENG, Yu CHEN, Die HUANG, Qian ZHANG. Clinical trial of dapagliflozin combined with metformin in the treatment of patients with diabetic kidney disease[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (9) : 1207 -1212 . DOI: 10.13699/j.cnki.1001-6821.2025.09.002

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2025年第41卷第9期

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doi: 10.13699/j.cnki.1001-6821.2025.09.002

接收时间：2024-12-07
首发时间：2026-08-04
出版时间：2025-05-17

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收稿日期：2024-12-07

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^1a.萍乡矿业集团有限责任公司总医院，内分泌科，江西萍乡 337000

^1b.萍乡矿业集团有限责任公司总医院，肾病风湿科，江西萍乡 337000

通讯作者:

刘莉娟 MP: 13879957358 E-mail: jyzdqs7358@163.com

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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