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葡萄糖激酶激活剂治疗 2 型糖尿病的疗效和安全性的系统评价和荟萃分析方案。

The efficacy and safety of glucokinase activators for the treatment of type-2 diabetes mellitus: A protocol for systematic review and meta-analysis.

机构信息

Affiliated Hospital of Shaoxing University of Edocrine and Metabolism Department, Zhejiang, China.

出版信息

Medicine (Baltimore). 2021 Feb 19;100(7):e24873. doi: 10.1097/MD.0000000000024873.

Abstract

BACKGROUND

Glucokinase activators are a novel family of glucose-lowering agents used for the treatment of type-2 diabetes mellitus (T2DM). Glucokinase activators blind to GK activate the enzyme allosterically. Treatment with different GKAs has been shown to reduce fasting and postprandial glucose in patients with type 2 diabetes. We compared the efficacy/safety of glucokinase activators in T2DM patients through a meta-analysis.

METHODS

We searched PubMed, Excerpt Medica Database, and Cochrane Central Register of Controlled Trials databases for articles published before December 30, 2020. Two independent reviewers extracted the information from article. The quality of articles were assessed by 2 independent reviewers using the 5 items of scale proposed by Jadad. We computed the weighted mean difference and 95% confidence interval (CI) for a change from baseline to the study endpoint for glucokinase activators vs placebo. Egger test and Begg test were used to assess the possible publication bias caused by the tendency of published studies to be positive.

RESULTS

The present meta-analysis will compare the efficacy and safety of glucokinase activators and placebo for the treatment of T2DM.

CONCLUSIONS

This meta-analysis will provide advanced evidence on the efficacy and safety of glucokinase activators for the treatment of T2DM.

ETHICS AND DISSEMINATION

Ethical approval and patient consent are not required because this study is a literature-based study. This systematic review and meta-analysis will be published in a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER

CRD42021220364.

摘要

背景

葡萄糖激酶激活剂是一类新型的降血糖药物,用于治疗 2 型糖尿病(T2DM)。葡萄糖激酶激活剂对 GK 呈盲法,通过变构激活酶。不同 GKAs 的治疗已被证明可降低 2 型糖尿病患者的空腹和餐后血糖。我们通过荟萃分析比较了葡萄糖激酶激活剂在 T2DM 患者中的疗效/安全性。

方法

我们检索了 PubMed、Excerpt Medica Database 和 Cochrane Central Register of Controlled Trials 数据库,以获取截至 2020 年 12 月 30 日之前发表的文章。两名独立的评审员从文章中提取信息。使用 Jadad 提出的 5 项量表,两名独立的评审员评估文章的质量。我们计算了葡萄糖激酶激活剂与安慰剂相比从基线到研究终点的变化的加权均数差和 95%置信区间(CI)。Egger 检验和 Begg 检验用于评估因发表研究的阳性趋势而可能导致的发表偏倚。

结果

本荟萃分析将比较葡萄糖激酶激活剂与安慰剂治疗 T2DM 的疗效和安全性。

结论

本荟萃分析将为葡萄糖激酶激活剂治疗 T2DM 的疗效和安全性提供高级证据。

伦理和传播

由于本研究是基于文献的研究,因此不需要伦理批准和患者同意。本系统评价和荟萃分析将发表在同行评议的期刊上。

PROSPERO 注册号:CRD42021220364。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6769/7899907/484c78bd263b/medi-100-e24873-g001.jpg

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