恩格列净与利拉鲁肽联合治疗肥胖/超重2型糖尿病患者的疗效及其对炎症因子的影响:一项前瞻、 随机、开放、平行对照的临床研究

doi:10.3969/j.issn.1004-583X.2024.10.007

摘要/Abstract

摘要：

目的探讨恩格列净与利拉鲁肽联合治疗肥胖/超重2型糖尿病(T2DM)患者的临床疗效及其对炎症因子和胰岛功能的影响。方法选取2021年6月-2023年9月在河北医科大学第二医院住院治疗的肥胖/超重T2DM患者58例。采用随机数表法将受试者随机分为:试验组(Lira+Empa组)和对照组(Lira组),各29例。试验组接受恩格列净+利拉鲁肽联合治疗,对照组仅接受利拉鲁肽治疗,比较两组治疗前、后糖代谢指标、脂代谢指标、炎症因子、胰岛功能指标及不良反应。结果治疗后,两组空腹血糖(FPG)、餐后2 h血糖(2 hPPG)、糖化白蛋白(GA)、总胆固醇、甘油三酯、低密度脂蛋白胆固醇、体重指数(BMI)、白细胞介素(IL)-6、IL-10水平明显低于治疗前,Lira+Empa组 FPG、2 hPPG、GA、BMI、IL-6、IL-10水平均低于Lira组,差异有统计学意义(P<0.05)。治疗后,两组C肽、空腹胰岛素和稳态胰岛素分泌指数(HOMA-β)均较治疗前升高,其中,Lira+Empa组HOMA-β明显高于Lira组,差异有统计学意义(P<0.05)。两组不良反应发生率无明显差异。结论相较于利拉鲁肽单药治疗,恩格列净+利拉鲁肽联合治疗能进一步提高T2DM降糖疗效,明显改善患者血糖水平和胰岛功能,并有效降低体重,对炎症因子水平有改善作用,且安全性良好。

关键词: 糖尿病, 2型, 恩格列净, 利拉鲁肽, 炎症因子, 稳态胰岛素分泌指数

Abstract:

Objective To investigate the clinical efficacy of empagliflozin combined with liraglutide on obese/overweight patients with type 2 diabetes mellitus (T2DM) and its effects on inflammatory factors and islet function. Methods A total of 58 obese/overweight T2DM patients hospitalized and treated at the Second Hospital of Hebei Medical University from June 2021 to September 2023 were selected as the study subjects. They were randomly assigned into the experimental group (Lira+Empa group) and the control group (Lira group), with 29 cases in each group. Patients in the experimental group received a combination therapy of empagliflozin and liraglutide, while those in the control group received liraglutide monotherapy. Pre- and post-treatment glycometabolic indicators, lipid metabolic indicators, inflammatory factors, islet function indicators, and adverse events were compared between groups. Results After treatment, the levels of fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2 hPPG), glycated albumin (GA), total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), body mass index (BMI), interleukin-6 (IL-6), and interleukin-10 (IL-10) in both groups were significantly lower than those before treatment. The levels of FPG, 2 hPPG, GA, BMI, IL-6, and IL-10 in the Lira+Empa group were all significantly lower than those of the Lira group (P<0.05). After treatment, the levels of C-peptide (C-P), fasting insulin (FINS), and homeostasis model assessment of β-cell function (HOMA-β) in both groups were significantly higher than those before treatment, and HOMA-β was significantly higher in the Lira+Empa group than the Lira group (P<0.05). There was no significant difference in the incidence of adverse events between the two groups. Conclusion Compared with liraglutide monotherapy, the combination therapy of empagliflozin and liraglutide can further improve the blood glucose-lowering effect, lower blood sugar levels, promote islet function of patients, reduce body weight, and reduce inflammatory factors in obese/overweight T2DM patients, with a good safety.

Key words: diabetes mellitus, type 2, empagliflozin, liraglutide, inflammatory factors, HOMA-β

中图分类号:

R587.1

王静, 李彩格, 王婷, 刘子渤, 盖斌, 金杨瑜, 张力辉. 恩格列净与利拉鲁肽联合治疗肥胖/超重2型糖尿病患者的疗效及其对炎症因子的影响:一项前瞻、随机、开放、平行对照的临床研究[J]. 临床荟萃, 2024, 39(10): 909-914.

Wang Jing, Li Caige, Wang Ting, Liu Zibo, Gai Bin, Jin Yangyu, Zhang Lihui. Efficacy of empagliflozin combined with liraglutide on obese and overweight T2DM patients and its impact on inflammatory factors: A prospective, randomized, open-label, parallel-controlled clinical study[J]. Clinical Focus, 2024, 39(10): 909-914.

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链接本文: https://huicui.hebmu.edu.cn/CN/10.3969/j.issn.1004-583X.2024.10.007

https://huicui.hebmu.edu.cn/CN/Y2024/V39/I10/909

图/表 6

参考文献 25

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组别	例数	性别[例(%)]		年龄 (岁)	BMI (kg/m²)	病程 (年)	FPG (mmol/L)	HbA₁c (%)	TC (mmol/L)	TG (mmol/L)	LDL-C (mmol/L)
组别	例数	男	女	年龄 (岁)	BMI (kg/m²)	病程 (年)	FPG (mmol/L)	HbA₁c (%)	TC (mmol/L)	TG (mmol/L)	LDL-C (mmol/L)
对照组	29	22(75.9%)	7(24.1%)	49.17±10.72	27.39±9.17	1.00(0.10, 7.50)	9.53±2.11	9.10(8.20, 9.45)	4.74±0.94	2.59±1.59	3.05±0.90
试验组	29	21(72.4%)	8(27.6%)	44.97±10.03	27.55±7.56	1.00(0.37, 5.00)	9.56±1.57	9.20(8.15, 9.50)	4.84±1.23	2.23±1.06	3.35±0.65
t/Z/χ²值		0.09		1.543	-0.474	-0.039	-0.384	-0.241	-0.331	-1.392	-1.459
P值		0.764		0.128	0.635	0.969	0.701	0.809	0.742	0.164	0.151

组别	例数	性别[例(%)]		年龄 (岁)	BMI (kg/m²)	病程 (年)	FPG (mmol/L)	HbA₁c (%)	TC (mmol/L)	TG (mmol/L)	LDL-C (mmol/L)
组别	例数	男	女	年龄 (岁)	BMI (kg/m²)	病程 (年)	FPG (mmol/L)	HbA₁c (%)	TC (mmol/L)	TG (mmol/L)	LDL-C (mmol/L)
对照组	29	22(75.9%)	7(24.1%)	49.17±10.72	27.39±9.17	1.00(0.10, 7.50)	9.53±2.11	9.10(8.20, 9.45)	4.74±0.94	2.59±1.59	3.05±0.90
试验组	29	21(72.4%)	8(27.6%)	44.97±10.03	27.55±7.56	1.00(0.37, 5.00)	9.56±1.57	9.20(8.15, 9.50)	4.84±1.23	2.23±1.06	3.35±0.65
t/Z/χ²值		0.09		1.543	-0.474	-0.039	-0.384	-0.241	-0.331	-1.392	-1.459
P值		0.764		0.128	0.635	0.969	0.701	0.809	0.742	0.164	0.151

组别	例数	FPG(mmol/L)		2 hPPG(mmol/L)		GA(%)
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
试验组	29	9.53±2.11	5.86±0.90^*	14.85±1.84	6.97±1.00^*	27.07±7.17	19.69±3.61^*
对照组	29	9.56±1.57	6.82±0.97^*	14.84±1.95	7.87±0.94^*	26.99±3.93	22.05±3.42^*
t值		-0.384	-3.523	-0.152	-3.658	0.046	-2.496
P值		0.701	<0.001	0.879	0.001	0.964	0.015

组别	例数	FPG(mmol/L)		2 hPPG(mmol/L)		GA(%)
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
试验组	29	9.53±2.11	5.86±0.90^*	14.85±1.84	6.97±1.00^*	27.07±7.17	19.69±3.61^*
对照组	29	9.56±1.57	6.82±0.97^*	14.84±1.95	7.87±0.94^*	26.99±3.93	22.05±3.42^*
t值		-0.384	-3.523	-0.152	-3.658	0.046	-2.496
P值		0.701	<0.001	0.879	0.001	0.964	0.015

组别	例数	BMI(kg/m²)		TC(mmol/L)		TG(mmol/L)		LDL-C(mmol/L)
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
对照组	29	27.39±9.17	26.38±4.99^*	4.74±0.94	3.60±0.57^*	2.59±1.59	1.27±0.48^*	3.05±0.90	2.20±0.33^*
试验组	29	27.55±7.56	24.69±1.89^*	4.84±1.23	3.39±0.69^*	2.23±1.06	1.09±0.30^*	3.35±0.65	2.06±0.33^*
t值		-0.474	3.112	-0.331	1.284	-1.392	0.879	-1.459	1.397
P值		0.635	0.002	0.742	0.199	0.164	0.379	0.151	0.163