Division of Nephrology and Immunology, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada
Division of Nephrology and Immunology, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada.
BMJ Open. 2024 May 16;14(5):e078393. doi: 10.1136/bmjopen-2023-078393.
Metformin is a first-line antihyperglycaemic agent for type 2 diabetes (T2DM). In addition to glycaemic control, it offers benefits related to cardiovascular health, weight neutrality and metabolic syndrome. However, its benefits in kidney transplant recipients remain unclear as metformin use is controversial in this population due to a lack of evidence and there are recommendations against its use in patients with poor kidney function. Hence, we seek to describe a protocol for a systematic review, which will assess the impact of metformin use on graft survival and mortality in kidney transplant recipients.
This protocol was guided by the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols 2015. We will search empirical databases such as MEDLINE, Embase, Cochrane Library, CINAHL and Web of Science Core Collection for relevant studies conducted in kidney transplant recipients using metformin, which report outcomes related to graft and patient survival. All studies meeting these criteria in adults and published in English from inception to 2023 will be included in our review. We will employ the Cochrane Risk of Bias Tool 2 for randomised controlled trials and the Risk of Bias in Non-randomised Studies of Intervention for non-randomised studies. We will present our data and study characteristics in a table format and determine if a meta-analysis can be performed by clinical and methodological heterogeneity, using the I statistics. If a meta-analysis cannot be performed, we will provide a narrative synthesis of included studies using the Synthesis Without Meta-Analysis Reporting Guideline.
Ethical approval will not be required for this review as the data used will be extracted from already published studies with publicly accessible data. As this study will assess the impact of metformin use on graft and patient survival in kidney transplant recipients, evidence gathered through it will be disseminated using traditional approaches that include open-access peer-reviewed publication, scientific presentations and a report. We will also disseminate our findings to appropriate academic bodies in charge of publishing guidelines related to T2DM and transplantation, as well as patient and research centred groups.
CRD42023421799.
二甲双胍是治疗 2 型糖尿病（T2DM）的一线抗高血糖药物。除了控制血糖外，它还具有心血管健康、体重中性和代谢综合征相关的益处。然而，其在肾移植受者中的益处尚不清楚，因为由于缺乏证据，二甲双胍的使用在这一人群中存在争议，并且有建议反对在肾功能不佳的患者中使用。因此，我们旨在描述一项系统评价的方案，该评价将评估二甲双胍在肾移植受者中的使用对移植物存活率和死亡率的影响。
本方案遵循 2015 年系统评价和荟萃分析首选报告项目的标准。我们将在 MEDLINE、Embase、Cochrane 图书馆、CINAHL 和 Web of Science 核心合集等实证数据库中搜索使用二甲双胍的肾移植受者相关研究，这些研究报告与移植物和患者存活率相关的结果。所有符合这些标准的、在成人中进行的、并以英文发表的从开始到 2023 年的研究都将纳入我们的综述。我们将使用 Cochrane 随机对照试验风险偏倚工具 2 和非随机干预研究的偏倚风险评估非随机研究。我们将以表格形式呈现我们的数据和研究特征，并根据临床和方法学异质性，使用 I 统计量确定是否可以进行荟萃分析。如果不能进行荟萃分析，我们将使用无荟萃分析报告指南提供纳入研究的叙述性综合。
由于本综述将使用已发表的具有公开可获得数据的研究的数据进行评估，因此不需要进行伦理审查。由于本研究将评估二甲双胍在肾移植受者中的使用对移植物和患者存活率的影响，因此通过它收集的证据将通过传统方法传播，包括开放获取的同行评审出版物、科学演讲和报告。我们还将向负责发布与 T2DM 和移植相关指南的适当学术机构以及以患者和研究为中心的团体传播我们的发现。
PROSPERO 注册号：CRD42023421799。
