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新型葡萄糖激酶激活剂多格列艾汀治疗 2 型糖尿病的疗效和安全性的 Meta 分析:随机对照试验研究。

Efficacy and safety of dorzagliatin, a novel glucokinase activators, in the treatment of T2DM: A meta-analysis of randomized controlled trials.

机构信息

Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.

Hangzhou Children's Hospital, Zhejiang, China.

出版信息

Medicine (Baltimore). 2024 Feb 23;103(8):e36916. doi: 10.1097/MD.0000000000036916.

Abstract

OBJECT

To evaluate the efficacy and safety of dorzagliatin for the treatment of type 2 diabetes (T2DM).

METHODS

Seven databases were systematically searched, spanning the interval from 2016 to August 2023. Randomized controlled trials (RCTS) comparing dorzagliatin with placebo for the treatment of T2DM were applicable for containing this study. The relevant data were extracted, and a meta-analysis was implemented using RevMan 5.4 software.

RESULTS

A total of 3 studies involving 1332 patients were included. We use glycated hemoglobin (HbA1c) levels as the major indicator of efficacy, FBG, 2h postprandial blood glucose, Homa-β and Homa-IR to be Secondary outcome measures. Compared with placebo group, dorzagliatin significantly reduced blood glucose levels as well as enhanced insulin resistance. In terms of safety, no serious adverse events occurred. However, lipid-related indicators, especially triglycerides levels, and the incidence of hypoglycemia were higher in patients in the dorzagliatin group compared with those in the control group, but the increase from baseline was mild.

CONCLUSIONS

Dorzagliatin exerted favorable effects in hypoglycemic control, effectively reduced the HbA1c, FBG, and 2h postprandial blood glucose levels in T2DM patients, stimulated the secretion of insulin during the initial phase, and exerted a consistent hypoglycemic effect. However, the incidence of adverse events such as elevated blood lipids and cardiovascular risk warrants further investigations through long-term clinical trials.

摘要

目的

评估度拉糖肽治疗 2 型糖尿病(T2DM)的疗效和安全性。

方法

系统检索了 2016 年 8 月至 2023 年 8 月期间的 7 个数据库。本研究纳入了比较度拉糖肽与安慰剂治疗 T2DM 的随机对照试验(RCT)。提取相关数据,使用 RevMan 5.4 软件进行荟萃分析。

结果

共纳入 3 项研究,涉及 1332 例患者。我们将糖化血红蛋白(HbA1c)水平作为主要疗效指标,空腹血糖(FBG)、餐后 2 小时血糖、Homa-β和 Homa-IR 作为次要疗效指标。与安慰剂组相比,度拉糖肽能显著降低血糖水平,改善胰岛素抵抗。在安全性方面,未发生严重不良事件。然而,度拉糖肽组的血脂相关指标,特别是甘油三酯水平,以及低血糖的发生率高于对照组,但从基线开始的增加幅度较小。

结论

度拉糖肽在控制血糖方面具有良好的效果,有效降低了 T2DM 患者的 HbA1c、FBG 和餐后 2 小时血糖水平,在初始阶段刺激胰岛素分泌,并产生持续的降糖作用。然而,血脂升高和心血管风险等不良事件的发生率需要通过长期临床试验进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc6e/11309680/db7324a756a1/medi-103-e36916-g001.jpg

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