1型糖尿病儿童和青少年中常规人胰岛素与速效胰岛素类似物的比较：一项系统评价、荟萃分析和试验序贯分析方案
Regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis.
作者信息
Petersen Johanne Juul, Juul Sophie, Kamp Caroline Barkholt, Faltermeier Pascal, Sillassen Christina Dam Bjerregaard, Dos Santos Tiago Jeronimo, Jakobsen Janus Christian
机构信息
Centre for Clinical Intervention Research, Copenhagen Trial Unit, Capital Region of Denmark, Copenhagen, Denmark.
Faculty of Health and Medical Sciences, Copenhagen University, Copenhagen, Denmark.
出版信息
Syst Rev. 2025 Jan 6;14(1):5. doi: 10.1186/s13643-024-02729-4.
BACKGROUND
Type 1 diabetes is a serious, chronic disorder with an increasing incidence among children and adolescents. Glycemic control in individuals with type 1 diabetes is better managed through a basal-bolus regimen with either regular human or rapid-acting insulin analogues administered as a bolus at mealtimes. Rapid-acting insulin analogues have been hypothesized to cause optimal glycemic control and less risk of hypoglycemic episodes compared to regular human insulins. However, this has never been systematically assessed in children and adolescents with type 1 diabetes. Therefore, this systematic review aims to assess the beneficial and harmful effects of regular human insulins versus rapid-acting insulin analogues in children and adolescents.
METHODS
This is a protocol for a systematic review. A search in major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries will be performed by a search specialist. We will include published and unpublished randomized clinical trials comparing regular human insulins versus rapid-acting insulin analogues (lispro, aspart, or glulisine). Two review authors will independently extract data and conduct risk of bias assessments. Primary outcomes will be severe hypoglycemia, ketoacidosis, and serious adverse events. Secondary outcomes will be quality of life, HbA1c, and non-serious adverse events. Data will be analyzed using fixed-effect meta-analyses, random-effects meta-analyses, and Trial Sequential Analysis. Several subgroup analyses are planned. Risk of bias will be assessed with the Cochrane Risk of Bias tool-version 2, an eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE).
DISCUSSION
The beneficial and adverse effects of regular human insulins versus rapid-acting insulin analogues have not been systematically assessed in children and adolescents. There is a need for a comprehensive systematic review of the current evidence.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO: CRD42024508625.
背景
1型糖尿病是一种严重的慢性疾病，在儿童和青少年中的发病率呈上升趋势。1型糖尿病患者的血糖控制可通过基础-餐时胰岛素治疗方案更好地管理，即餐时给予常规人胰岛素或速效胰岛素类似物作为大剂量注射。与常规人胰岛素相比，速效胰岛素类似物被认为能实现最佳血糖控制，且低血糖发作风险更低。然而，这从未在1型糖尿病儿童和青少年中得到系统评估。因此，本系统评价旨在评估常规人胰岛素与速效胰岛素类似物对儿童和青少年的有益和有害影响。
方法
这是一项系统评价方案。由一名检索专家在主要医学数据库（如MEDLINE、EMBASE、CENTRAL）和临床试验注册库中进行检索。我们将纳入比较常规人胰岛素与速效胰岛素类似物（赖脯胰岛素、门冬胰岛素或谷赖胰岛素）的已发表和未发表的随机临床试验。两名综述作者将独立提取数据并进行偏倚风险评估。主要结局将是严重低血糖、酮症酸中毒和严重不良事件。次要结局将是生活质量、糖化血红蛋白和非严重不良事件。数据将使用固定效应荟萃分析、随机效应荟萃分析和试验序贯分析进行分析。计划进行多项亚组分析。将使用Cochrane偏倚风险工具第2版评估偏倚风险，将采用八步程序评估是否超过临床意义阈值，并将通过推荐分级、评估、制定与评价（GRADE）来评估证据的确定性。
讨论
常规人胰岛素与速效胰岛素类似物对儿童和青少年的有益和不良影响尚未得到系统评估。有必要对现有证据进行全面的系统评价。
系统评价注册
PROSPERO：CRD42024508625
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