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斋月期间禁食的2型糖尿病患者使用胰高血糖素样肽-1受体激动剂的安全性和有效性:一项系统评价和荟萃分析

Safety and efficacy of glucagon-like peptide-1 receptor agonists in individuals with type 2 diabetes mellitus fasting during Ramadan: a systematic review and meta-analysis.

作者信息

Kamrul-Hasan Abul Bashar Mohammad, Pappachan Joseph M, Ashraf Hamid, Nagendra Lakshmi, Dutta Deep, Kuchay Mohammad Shafi, Shaikh Shehla

机构信息

Department of Endocrinology, Mymensingh Medical College, Mymensingh 2200, Bangladesh.

Faculty of Science, Manchester Metropolitan University, Manchester M156BH, United Kingdom.

出版信息

World J Methodol. 2025 Dec 20;15(4):105478. doi: 10.5662/wjm.v15.i4.105478.

Abstract

BACKGROUND

Data on the use of glucagon-like peptide-1 receptor agonists (GLP-1RAs) in individuals with type 2 diabetes mellitus (T2DM) during Ramadan fasting is limited. No meta-analysis has summarized the safety and effectiveness of GLP-1RAs in these situations.

AIM

To evaluate the safety and efficacy of GLP-1RA in patients with T2DM fasting during Ramadan.

METHODS

Electronic databases were systematically searched for relevant studies that featured GLP-1RA in the intervention arm and other glucose-lowering medications in the control arm. The primary outcome was adverse events (AEs) during Ramadan for both groups; other outcomes included changes in glycemic and anthropometric measures during the peri-Ramadan period.

RESULTS

Four studies [three randomized-controlled trials with low risk of bias (RoB) and one prospective observational study with serious RoB] involving 754 subjects were analyzed. GLP-1RA group achieved greater glycated hemoglobin reduction than the non-GLP-1RA group [mean difference (MD): -0.31%, 95%CI: -0.61 to -0.01, = 0.04, = 77%] with a lower risk of documented symptomatic hypoglycemia (risk ratio = 0.38, 95%CI: 0.16 to 0.88, = 0.02). Any AEs, serious AEs, or AEs that led to treatment discontinuation were comparable between the two groups. The GLP-1RA group experienced greater weight loss compared to the non-GLP-1RA group (MD: -2.0 kg, 95%CI: -3.37 to -0.63, = 0.004, = 95%). There were comparable changes in blood pressure and lipid profile between the two groups. GLP-1RA users experienced higher risks of gastrointestinal AEs, nausea, and vomiting; however, the risks of heartburn, abdominal pain, and diarrhea were similar in both groups.

CONCLUSION

Limited evidence suggests that GLP-1RAs are safe for T2DM management during Ramadan, offering modest benefits in blood sugar control and weight loss. Large multicenter trials are needed to confirm their safety and efficacy in at-risk populations, improving clinical practice decision-making.

摘要

背景

关于2型糖尿病(T2DM)患者在斋月禁食期间使用胰高血糖素样肽-1受体激动剂(GLP-1RAs)的数据有限。尚无荟萃分析总结GLP-1RAs在这些情况下的安全性和有效性。

目的

评估GLP-1RA对斋月期间禁食的T2DM患者的安全性和疗效。

方法

系统检索电子数据库,查找干预组使用GLP-1RA且对照组使用其他降糖药物的相关研究。主要结局是两组在斋月期间的不良事件(AE);其他结局包括斋月前后期间血糖和人体测量指标的变化。

结果

分析了四项研究[三项偏倚风险(RoB)低的随机对照试验和一项RoB严重的前瞻性观察性研究],涉及754名受试者。GLP-1RA组糖化血红蛋白降低幅度大于非GLP-1RA组[平均差(MD):-0.31%,95%置信区间(CI):-0.61至-0.01,P = 0.04,I² = 77%],有记录的症状性低血糖风险较低(风险比 = 0.38,95%CI:0.16至0.88,P = 0.02)。两组之间的任何AE、严重AE或导致治疗中断的AE相当。与非GLP-1RA组相比,GLP-1RA组体重减轻更多(MD:-2.0 kg,95%CI:-3.37至-0.63,P = 0.004,I² = 95%)。两组之间血压和血脂谱变化相当。使用GLP-1RA的患者胃肠道AE、恶心和呕吐风险较高;然而,两组烧心、腹痛和腹泻风险相似。

结论

有限的证据表明,GLP-1RAs在斋月期间用于T2DM管理是安全的,在血糖控制和体重减轻方面有一定益处。需要大型多中心试验来证实其在高危人群中的安全性和疗效,以改善临床实践决策。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4c8/12400322/a03b7616d273/wjm-15-4-105478-g001.jpg

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