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利拉鲁肽治疗非酒精性脂肪性肝病患者:一项随机对照试验的系统评价和荟萃分析

Liraglutide in patients with non-alcoholic fatty liver disease: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Kalogirou Maria-Styliani, Patoulias Dimitrios, Haidich Anna-Bettina, Akriviadis Evangelos, Sinakos Emmanouil

机构信息

Fourth Department of Internal Medicine, Aristotle University of Thessaloniki, General Hospital "Hippokration", Greece.

Second Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, General Hospital "Hippokration", Greece.

出版信息

Clin Res Hepatol Gastroenterol. 2021 May;45(3):101568. doi: 10.1016/j.clinre.2020.10.012. Epub 2020 Dec 11.

Abstract

BACKGROUND

A few randomized controlled trials (RCTs) have assessed the use of liraglutide as a treatment option in patients with non-alcoholic fatty liver disease (NAFLD). We aimed at critically appraising and summarizing these RCTs, providing precise effect estimates regarding the safety and efficacy of liraglutide in NAFLD.

METHODS

We searched major databases and grey literature from their inception to May 2019, for RCTs comparing liraglutide with placebo or active comparator in patients with NAFLD. We defined as primary efficacy outcomes the observed changes in hepatic fat content (HFC) and alanine aminotransferase levels (ALT). Metabolic outcomes of interest and major safety endpoints were also assessed.

RESULTS

We included five trials with 371 randomised participants in total. Liraglutide produced a non-significant decrease in HFC and ALT levels, compared to control. It induced a significant reduction in body mass index, primarily driven by reduction in patients with type 2 diabetes, while it did not affect significantly glycated hemoglobin levels and Homeostatic Model Assessment of Insulin Resistance. We also showed that liraglutide significantly decreased serum triglyceride levels, also driven by the observed reduction in patients with type 2 diabetes, however it did not significantly affect the rest lipid parameters. Liraglutide was associated with increased incidence of gastrointestinal adverse events, while, no other safety issues were identified.

CONCLUSION

Our results do not substantiate the use of liraglutide in patients with NAFLD yet, despite its promising role.

摘要

背景

少数随机对照试验(RCT)评估了利拉鲁肽作为非酒精性脂肪性肝病(NAFLD)患者治疗选择的应用情况。我们旨在严格评估和总结这些RCT,提供关于利拉鲁肽在NAFLD中安全性和有效性的精确效应估计。

方法

我们检索了主要数据库和灰色文献,时间跨度从其创建至2019年5月,以查找在NAFLD患者中比较利拉鲁肽与安慰剂或活性对照的RCT。我们将观察到的肝脂肪含量(HFC)和丙氨酸转氨酶水平(ALT)的变化定义为主要疗效结局。还评估了感兴趣的代谢结局和主要安全终点。

结果

我们总共纳入了五项试验,共有371名随机参与者。与对照组相比,利拉鲁肽使HFC和ALT水平出现非显著性下降。它使体重指数显著降低,主要是由2型糖尿病患者体重减轻所致,而它对糖化血红蛋白水平和胰岛素抵抗稳态模型评估没有显著影响。我们还表明,利拉鲁肽显著降低血清甘油三酯水平,同样是由观察到的2型糖尿病患者甘油三酯水平降低所致,然而它对其他血脂参数没有显著影响。利拉鲁肽与胃肠道不良事件发生率增加相关,同时,未发现其他安全问题。

结论

尽管利拉鲁肽有潜在作用,但我们的结果尚未证实其可用于NAFLD患者。

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