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一项关于达格列净在 1 型糖尿病患者中的疗效的系统评价和剂量反应荟萃分析。

A systematic review and dose-response meta-analysis on the efficacy of dapagliflozin in patients with type 1 diabetes mellitus.

机构信息

Department of Pharmacology, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States; College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.

Department of Medicine, Alhada Armed Forces Hospital, Taif, Saudi Arabia.

出版信息

Pharmacol Res. 2021 Mar;165:105456. doi: 10.1016/j.phrs.2021.105456. Epub 2021 Jan 27.

DOI:10.1016/j.phrs.2021.105456
PMID:33515709
Abstract

Formulation of insulin analogs and its delivery are developed in over recent years but glycemic control in most patients with type-1 diabetes mellitus (DM) is not adequate yet. The aim of this meta-analysis is to evaluate the efficacy of dapagliflozin in patients with type-1 DM. The MEDLINE/PubMed, Scopus, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases were searched up to Aug 2020 to identify the potential literature. Random-effects model (DerSimonian and Laird method) was used to estimate the pooled effect size as weighted mean difference (WMD) with 95 % confidence interval (CI). Five randomized placebo-controlled trials with 11 arms were included in the quantitative analysis. The pooled results suggested a significant reduction in glycated hemoglobin A1C (HbA1C; WMD: -0.36 %, 95 % CI: -0.55, -0.18), body weight (WMD: -4.02 kg, 95 % CI: -4.78, -3.25), and total daily insulin dose (TDID; WMD: -10.36 %, 95 % CI: -13.42, -7.29), as well as an increase in 24-h urinary glucose excretion (24-h UGE; WMD: 90.02 g/24-h, 95 % CI: 72.96, 107.09) in dapagliflozin group compared to control group. Dose of dapagliflozin had a significant effect on body weight reduction (Coef = -3.7, p = 0.01) and 24-h UGE (coef = 0.85, p = 0.005). Pooled results of this meta-analysis identified a significant reduction in HbA1c levels, body weight, and TDID, and a substantial increase in 24-h UGE in patients who received dapagliflozin versus placebo.

摘要

近年来,胰岛素类似物的配方及其输送得到了发展,但大多数 1 型糖尿病 (DM) 患者的血糖控制仍不理想。本荟萃分析的目的是评估达格列净在 1 型 DM 患者中的疗效。检索了 MEDLINE/PubMed、Scopus、Embase、Cochrane 对照试验中心注册库 (CENTRAL) 和 Web of Science 数据库,以确定潜在的文献。使用随机效应模型 (DerSimonian 和 Laird 方法) 估计合并效应大小作为加权均数差 (WMD),置信区间 (CI) 为 95%。纳入了 5 项随机安慰剂对照试验的 11 个臂进行定量分析。汇总结果表明,糖化血红蛋白 A1C (HbA1C; WMD: -0.36%,95%CI:-0.55,-0.18)、体重 (WMD: -4.02kg,95%CI:-4.78,-3.25) 和总日胰岛素剂量 (TDID; WMD: -10.36%,95%CI:-13.42,-7.29) 显著降低,达格列净组 24 小时尿葡萄糖排泄量 (24-h UGE; WMD: 90.02g/24-h,95%CI:72.96,107.09) 也较对照组增加。达格列净的剂量与体重减轻 (Coef = -3.7,p = 0.01) 和 24-h UGE (coef = 0.85,p = 0.005) 呈显著相关。本荟萃分析的汇总结果表明,与安慰剂相比,接受达格列净治疗的患者 HbA1c 水平、体重和 TDID 显著降低,24-h UGE 显著增加。

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