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一项新诊断为 1 型糖尿病患者中干预措施以保护胰岛素分泌β细胞功能的系统评价和荟萃分析:旨在改善血糖控制的干预研究结果。

A systematic review and meta-analysis of interventions to preserve insulin-secreting β-cell function in people newly diagnosed with type 1 diabetes: Results from intervention studies aimed at improving glucose control.

机构信息

Institute of Immunology and Immunotherapy, University of Birmingham, and University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

出版信息

Diabet Med. 2022 Jan;39(1):e14730. doi: 10.1111/dme.14730. Epub 2021 Nov 2.

Abstract

AIMS

Type 1 diabetes is characterised by the destruction of pancreatic β-cells. Significant levels of β-cells remain at diagnosis. Preserving these cells improves glucose control and protects from long-term complications. We undertook a systematic review and meta-analyses of all randomised controlled trials (RCTs) of interventions to preserve β-cell function in people newly diagnosed with type 1 diabetes. This paper reports the results of interventions for improving glucose control to assess whether they preserve β-cell function.

METHODS

Searches for RCTs in MEDLINE, Embase, Cochrane CENTRAL, ClinicalTrials.gov and WHO International Clinical Trials Registry. Eligible studies included newly diagnosed patients with type 1 diabetes, any intervention to improve glucose control and at least 1 month of follow-up. Data were extracted using a pre-defined data-extraction sheet with 10% of extractions checked by a second reviewer.

RESULTS

Twenty-eight studies with 1662 participants were grouped by intervention into six subgroups (alternative insulins, subcutaneous and intravenous insulin delivery, intensive therapy, glucose sensing, adjuncts). Only three studies demonstrated an improvement in glucose control as well as β-cell function. These interventions included intensive insulin therapy and use of an alternative insulin.

CONCLUSIONS

This is the largest comprehensive review of RCTs in this area. It demonstrates a lack of robust evidence that interventions to improve glucose control preserve β-cell function in new onset type 1 diabetes, although analysis was hampered by low-quality evidence and inconsistent reporting of studies. Development of guidelines to support the design of trials in this field is a priority.

摘要

目的

1 型糖尿病的特征是胰岛β细胞的破坏。在诊断时仍存在大量的β细胞。保留这些细胞可以改善血糖控制并预防长期并发症。我们对所有新诊断为 1 型糖尿病的患者β细胞功能保护的干预措施进行了系统评价和荟萃分析。本文报告了改善血糖控制的干预措施的结果,以评估它们是否能保护β细胞功能。

方法

在 MEDLINE、Embase、Cochrane 中心、ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台上进行 RCT 检索。合格的研究包括新诊断的 1 型糖尿病患者、任何改善血糖控制的干预措施以及至少 1 个月的随访。使用预先定义的数据提取表提取数据,由第二名审核员对 10%的数据进行核对。

结果

28 项研究共纳入 1662 名参与者,根据干预措施分为六组(替代胰岛素、皮下和静脉胰岛素输注、强化治疗、血糖监测、辅助治疗)。只有三项研究显示出改善血糖控制和β细胞功能的效果。这些干预措施包括强化胰岛素治疗和使用替代胰岛素。

结论

这是该领域最大规模的 RCT 综合评价。它表明,改善血糖控制的干预措施并不能保护新诊断的 1 型糖尿病患者的β细胞功能,尽管分析受到低质量证据和研究报告不一致的限制。制定指南以支持该领域试验的设计是当务之急。

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