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关于非手术干预措施预防成人糖尿病前期患者糖尿病进展的有效性和成本效益的系统评价方案。

Systematic review protocol for effectiveness and cost-effectiveness of non-surgical interventions to prevent diabetes progression in adults with prediabetes.

作者信息

Sui Chee Fai, Ming Long Chiau, Soh Yee Chang, Ng Chin Hui, Al-Worafi Yaser Mohammed, Hussain Zahid

机构信息

Sir Jeffrey Cheah Sunway Medical School, Faculty of Medical and Life Sciences, Sunway University, Sunway City, Selangor, Malaysia.

Sir Jeffrey Cheah Sunway Medical School, Faculty of Medical and Life Sciences, Sunway University, Sunway City, Selangor, Malaysia

出版信息

BMJ Open. 2025 Jul 22;15(7):e093768. doi: 10.1136/bmjopen-2024-093768.

DOI:10.1136/bmjopen-2024-093768
PMID:40701593
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12306239/
Abstract

UNLABELLED

IntroductionPrediabetes (PD), defined by impaired glucose tolerance or impaired fasting glucose, represents a growing global health challenge, with a prevalence projected to increase substantially. PD is a critical intervention target because of its high annual progression rate (5-10%) to type 2 diabetes mellitus (T2DM) and elevated cardiovascular disease (CVD) risk. Non-surgical interventions (NSIs), particularly lifestyle modifications (LMs) and pharmacological therapies, are the cornerstone of PD management, demonstrating efficacy and cost efficiency over surgical options. However, despite LM's ability to reduce T2DM incidence by 40-70% in trials such as the Diabetes Prevention Program, real-world implementation faces barriers, including resource intensity and complex delivery requirements, which increase upfront costs. We aim to review scientific literature reporting on the effectiveness and cost-effectiveness of NSIs for preventing the progression of PD to T2DM among adults.

METHODS AND ANALYSIS

A comprehensive systematic search will be conducted across major biomedical databases (PubMed, Scopus, Cochrane Library, Web of Science) for records published up to July 2024. We will include studies involving adults diagnosed with PD according to the American Diabetes Association (ADA) or WHO criteria, focusing on LM and pharmacological treatments. Observational and interventional study designs, including economic evaluations, will be considered.

PRIMARY OUTCOME

diabetes incidence (ADA or WHO glycaemic criteria).

SECONDARY OUTCOMES

(1) CVD risk factors, (2) health utilities and (3) healthcare cost analyses. The protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 guidelines and is registered with PROSPERO (CRD42024561294). Data extraction and quality assessment will be performed by two reviewers, with discrepancies resolved by the consensus of a third reviewer. Data will be narratively synthesised; if the data allow, a meta-analysis will be conducted.

ETHICS AND DISSEMINATION

This systematic review was exempt from ethical approval as it involved no collection of individual patient data and posed no confidentiality risks. The findings will be shared via publication in a peer-reviewed journal or presentation at relevant conferences.

PROSPERO REGISTRATION NUMBER

CRD42024561294.

摘要

未标注

引言

糖尿病前期(PD),由糖耐量受损或空腹血糖受损定义,是一个日益严峻的全球健康挑战,预计患病率将大幅上升。由于其每年向2型糖尿病(T2DM)的高进展率(5 - 10%)以及心血管疾病(CVD)风险升高,PD是一个关键的干预靶点。非手术干预(NSIs),特别是生活方式改变(LMs)和药物治疗,是PD管理的基石,在疗效和成本效益方面优于手术选择。然而,尽管在诸如糖尿病预防计划等试验中,LMs能够将T2DM发病率降低40 - 70%,但在实际应用中面临障碍,包括资源密集和复杂的实施要求,这增加了前期成本。我们旨在综述关于非手术干预措施预防成人PD进展为T2DM的有效性和成本效益的科学文献。

方法与分析

将对主要生物医学数据库(PubMed、Scopus、Cochrane图书馆、科学网)进行全面系统检索,以获取截至2024年7月发表的记录。我们将纳入根据美国糖尿病协会(ADA)或世界卫生组织(WHO)标准诊断为PD的成人研究,重点关注LMs和药物治疗。将考虑观察性和干预性研究设计,包括经济评估。

主要结局

糖尿病发病率(ADA或WHO血糖标准)。

次要结局

(1)心血管疾病风险因素,(2)健康效用,(3)医疗保健成本分析。该方案遵循《系统评价和Meta分析方案的首选报告项目2015指南》,并在PROSPERO注册(CRD42024561294)。数据提取和质量评估将由两名审阅者进行,分歧由第三名审阅者协商解决。数据将进行叙述性综合;如果数据允许,将进行Meta分析。

伦理与传播

本系统评价无需伦理批准,因为它不涉及收集个体患者数据,也不存在保密风险。研究结果将通过在同行评审期刊上发表或在相关会议上展示的方式分享。

PROSPERO注册号:CRD42024561294。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/276d/12306239/aa846f3d7a19/bmjopen-15-7-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/276d/12306239/aa846f3d7a19/bmjopen-15-7-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/276d/12306239/aa846f3d7a19/bmjopen-15-7-g001.jpg

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本文引用的文献

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Front Endocrinol (Lausanne). 2024 Mar 1;15:1294819. doi: 10.3389/fendo.2024.1294819. eCollection 2024.
2
Association between cardiovascular disease risk and incident type 2 diabetes mellitus in individuals with prediabetes: A retrospective cohort study.心血管疾病风险与糖尿病前期个体中 2 型糖尿病发病的相关性:一项回顾性队列研究。
Diabetes Res Clin Pract. 2024 Feb;208:111125. doi: 10.1016/j.diabres.2024.111125. Epub 2024 Feb 1.
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2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024.
2. 糖尿病的诊断与分类:《2024年糖尿病医疗护理标准》
Diabetes Care. 2024 Jan 1;47(Suppl 1):S20-S42. doi: 10.2337/dc24-S002.
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Global Prevalence of Prediabetes.全球糖尿病前期患病率。
Diabetes Care. 2023 Jul 1;46(7):1388-1394. doi: 10.2337/dc22-2376.
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