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恩格列净与利格列汀对肾功能和血糖控制影响的比较:一项双盲、随机临床试验。

Comparison of effects of Empagliflozin and Linagliptin on renal function and glycaemic control: a double-blind, randomized clinical trial.

作者信息

Mohammad Zadeh Gharabaghi Mohammad Amin, Rezvanfar Mohammad Reza, Saeedi Nasser, Aghajani Faezeh, Alirezaei Mohammad, Yarahmadi Pourya, Nakhostin-Ansari Amin

机构信息

Internal Medicine Department, Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Iran.

Research Development Center, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Clin Diabetes Endocrinol. 2022 May 25;8(1):5. doi: 10.1186/s40842-022-00142-1.

DOI:10.1186/s40842-022-00142-1
PMID:35610696
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9131518/
Abstract

BACKGROUND

This study aimed to compare the effects of Linagliptin and Empagliflozin on renal function and glycaemic control in patients with type 2 diabetes mellitus (DM).

METHOD

We conducted a randomized, double-blind, parallel trial on patients aged 30 to 80 years with type 2 DM and HbA1c ≤ 9%, regardless of background medical therapy, to compare the effects of Empagliflozin and Linagliptin on albuminuria, FBS, HbA1c, and eGFR. Participants were given the mentioned drugs for 12 weeks. Statistical analysis was performed using appropriate tests in IBM™SPSS® statistics software for windows version 24.

RESULTS

In total, 60 patients participated in the study, thirty patients in each group. The mean age of participants was 56.8 (SD = 8.15) in the Empagliflozin group and 60.9 (SD = 7.22) in the Linagliptin group. Before the intervention, FBS, HbA1C, and albuminuria values were significantly higher in the Empagliflozin group than those in the Linagliptin group (P < 0.05), but there was no significant difference between groups regarding eGFR (P = 0.271). Changes in the FBS, HbA1C, and eGFR were not significantly different between groups (P > 0.05), but there was more decrease in albuminuria in the Empagliflozin group compared to the Linagliptin group (P = 0.001, Cohen's d = 0.98).

CONCLUSIONS

Regardless of baseline albuminuria, eGFR, or HbA1c, Empagliflozin 10 mg daily significantly reduced albuminuria at 12 weeks compared to Linagliptin 5 mg daily in patients with type 2 diabetes.

TRIAL REGISTRATION

Iranian Registry of Clinical Trials, IRCT20200722048176N1 . Registered 3 August 2020.

摘要

背景

本研究旨在比较利格列汀和恩格列净对2型糖尿病(DM)患者肾功能和血糖控制的影响。

方法

我们对年龄在30至80岁、糖化血红蛋白(HbA1c)≤9%的2型糖尿病患者进行了一项随机、双盲、平行试验,无论其背景治疗方案如何,以比较恩格列净和利格列汀对蛋白尿、空腹血糖(FBS)、HbA1c和估算肾小球滤过率(eGFR)的影响。参与者服用上述药物12周。使用适用于Windows版IBM™SPSS®统计软件24的测试进行统计分析。

结果

共有60名患者参与研究,每组30名。恩格列净组参与者的平均年龄为56.8岁(标准差=8.15),利格列汀组为60.9岁(标准差=7.22)。干预前,恩格列净组的FBS、HbA1C和蛋白尿值显著高于利格列汀组(P<0.05),但两组间eGFR无显著差异(P=0.271)。两组间FBS、HbA1C和eGFR的变化无显著差异(P>0.05),但与利格列汀组相比,恩格列净组的蛋白尿减少更多(P=0.001,科恩d值=0.98)。

结论

在2型糖尿病患者中,无论基线蛋白尿、eGFR或HbA1c如何,与每日5mg利格列汀相比,每日10mg恩格列净在12周时能显著降低蛋白尿。

试验注册

伊朗临床试验注册中心,IRCT20200722048176N1。于2020年8月3日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c83a/9131518/6d9d2c127878/40842_2022_142_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c83a/9131518/6d9d2c127878/40842_2022_142_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c83a/9131518/6d9d2c127878/40842_2022_142_Fig1_HTML.jpg

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