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溴隐亭 QR 作为辅助治疗在血糖控制不佳的 2 型糖尿病患者中的疗效和安全性:系统评价和荟萃分析。

Efficacy and Safety of Bromocriptine-QR as an Adjunctive Therapy on Glycemic Control in Subjects with Uncontrolled Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis.

机构信息

Department of Internal Medicine, Faculty of Medicine, Universitas Pelita Harapan, Karawaci, Tangerang, Banten, Indonesia.

出版信息

J ASEAN Fed Endocr Soc. 2024;39(1):95-105. doi: 10.15605/jafes.039.01.19. Epub 2024 Feb 21.

Abstract

INTRODUCTION

There has been an increasing awareness of the effects of combining bromocriptine-QR with other medications for diabetes mellitus type 2. This study aimed to assess the efficacy and safety of bromocriptine-QR as an adjunctive therapy for patients with uncontrolled type 2 diabetes mellitus.

METHODOLOGY

This systematic review is registered at the International Prospective Register of Systematic Reviews (CRD42022360326). Literature search was done via MEDLINE, NCBI, Google Scholar, Science Direct, Europe PMC and Cochrane Library databases. We included randomized controlled trials with participants 18 years old and above with uncontrolled type 2 diabetes mellitus. The primary outcome of interest is the efficacy and safety of bromocriptine-QR as an adjunctive therapy for glycemic control. Case reports, case series, reviews and animal studies were excluded. The risk of bias was reviewed using the Cochrane Risk of Bias tool. Meta-analysis was performed using Review Manager 5.4 and presented as a weighted mean difference and 95% confidence interval for changes from the baseline level.

RESULTS

Nine studies were included in the systematic review with a total of 2709 participants. The baseline HbA1c in the bromocriptine-QR group was 7.42% and 7.51% in the control group. The bromocriptine-QR group was favoured, outperforming the control group in terms of reducing hemoglobin A1c(HbA1c), with a statistically significant difference (weighted mean difference -0.6%; 95% CI [-0.83,-0.36]; p<0.00001). The most common side effects were nausea (33.75% vs 6.92%), fatigue (13.11% vs 5.94%), and headache (11.17% vs 6.87%).

CONCLUSION

Administration of bromocriptine-QR at a dose range of 1.6 to 4.8 mg/day as an adjunctive therapy reduced HbA1c and FBG in patients with uncontrolled type 2 diabetes mellitus (T2DM). However, there were also statistically greater odds of the occurrence of adverse events such as nausea, vomiting, and headache compared to controls.

摘要

简介

人们越来越意识到将溴隐亭-QR 与其他治疗 2 型糖尿病的药物联合使用的效果。本研究旨在评估溴隐亭-QR 作为辅助治疗方法对未控制的 2 型糖尿病患者的疗效和安全性。

方法

本系统评价已在国际前瞻性系统评价注册库(CRD42022360326)中注册。通过 MEDLINE、NCBI、谷歌学术、Science Direct、欧洲 PMC 和 Cochrane 图书馆数据库进行文献检索。我们纳入了年龄在 18 岁及以上且患有未控制的 2 型糖尿病的参与者的随机对照试验。主要观察指标是溴隐亭-QR 作为辅助治疗方法对血糖控制的疗效和安全性。排除病例报告、病例系列、综述和动物研究。使用 Cochrane 偏倚风险工具对偏倚风险进行评估。使用 Review Manager 5.4 进行荟萃分析,结果表示为从基线水平变化的加权均数差和 95%置信区间。

结果

本系统评价共纳入 9 项研究,共 2709 名参与者。溴隐亭-QR 组的基线糖化血红蛋白(HbA1c)为 7.42%,对照组为 7.51%。溴隐亭-QR 组更优,与对照组相比,降低血红蛋白 A1c(HbA1c)的效果更显著,差异具有统计学意义(加权均数差-0.6%;95%置信区间[-0.83,-0.36];p<0.00001)。最常见的不良反应是恶心(33.75%比 6.92%)、疲劳(13.11%比 5.94%)和头痛(11.17%比 6.87%)。

结论

溴隐亭-QR 剂量范围为 1.6 至 4.8 mg/天作为辅助治疗可降低未控制的 2 型糖尿病患者的 HbA1c 和空腹血糖(FBG)。然而,与对照组相比,发生恶心、呕吐和头痛等不良反应的可能性也更大。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f5a/11163318/9e8d61fbc5ae/JAFES-39-1-95-g001.jpg

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