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关于肥胖症和代谢紊乱外科治疗国际联合会欧洲分会(IFSO-EC)多模式手术治疗肥胖症策略指南制定的随机对照试验的荟萃分析。

Meta-analysis of randomized controlled trials for the development of the International Federation for Surgery of Obesity and Metabolic Disorders-European Chapter (IFSO-EC) guidelines on multimodal strategies for the surgical treatment of obesity.

作者信息

De Luca Maurizio, Belluzzi Amanda, Angrisani Luigi, Bandini Giulia, Becattini Barbara, Bueter Marco, Carrano Francesco Maria, Chiappetta Sonja, Cohen Ricardo V, Copaescu Catalin, Di Lorenzo Nicola, Emous Marloes, Felsenreich Daniel Moritz, Fried Martin, Himpens Jacques, Iannelli Antonio, Navarra Giuseppe, Nienhuijs Simon, Olmi Stefano, Parmar Chetan, Prager Gerhard, Pujol-Rafols Juan, Ragghianti Benedetta, Ribeiro Rui, Ruiz-Úcar Elena, Sakran Nasser, Salminen Paulina, Scoccimarro Daniele, Stenberg Erik, Stier Christine, Taskin Halit Eren, Puy Ramón Vilallonga, Monami Matteo

机构信息

Department of General, Emergency and Metabolic Surgery, Rovigo Hospital, Rovigo, Italy.

Public Health Department, School of Medicine, University Federico II of Naples, Naples, Italy.

出版信息

Diabetes Obes Metab. 2025 Jun;27(6):3347-3356. doi: 10.1111/dom.16352. Epub 2025 Apr 8.

DOI:10.1111/dom.16352
PMID:40197859
Abstract

BACKGROUND

Randomized, controlled trials (RCTs) comparing the effectiveness of metabolic bariatric surgery (MBS) in addition to one or more treatment interventions for obesity (i.e., lifestyle structured interventions-LSI, medical therapy-MT, obesity management medication-OMM or endobariatric procedures-EP) are lacking. This study aims to assess the effectiveness of multiple simultaneous (before or immediately after MBS) interventions for treating obesity.

METHODS

We performed a meta-analysis including all RCTs enrolling patients undergoing different MBS procedures add-on to other anti-obesity strategies (LSI, MT, OMM or ES) versus MBS alone, with a duration of at least 6 months. The primary outcome was BMI at the end-point; secondary end-points included percentage total and excess weight loss (%TWL%, and EBWL%), total weight loss (TWL), fasting plasma glucose (FPG), HbA1c, surgical and non-surgical severe adverse events (SAE), mortality, remission of type 2 diabetes, hypertension, dyslipidemia and health-related quality of life (HR-QoL).

RESULTS

A total of 25 RCTs were retrieved. The addition of either OMM (i.e., liraglutide) or EP (i.e., intragastric balloon-IB, endosleeve-ES) to MBS was associated with a significantly lower BMI at the end-point (p = 0.040). The addition of liraglutide only to MBS was associated with a greater %EWL%, but not %TWL and TBWL (p = 0.008). Three trials evaluated end-point HbA1c, showing a significant reduction in favour of liraglutide as an add-on therapy to MBS (p = 0.007). There was no mortality.

CONCLUSIONS

MBS combined with non-surgical approaches appears more effective than MBS alone in reducing BMI. Further RCTs on combined therapies to MBS for severe obesity are needed to enhance the tailoring of treatment for severe obesity.

摘要

背景

缺乏比较代谢性减肥手术(MBS)联合一种或多种肥胖治疗干预措施(即生活方式结构化干预-LSI、药物治疗-MT、肥胖管理药物-OMM或内镜减肥手术-EP)有效性的随机对照试验(RCT)。本研究旨在评估多种同时进行(MBS之前或之后立即进行)的干预措施治疗肥胖的有效性。

方法

我们进行了一项荟萃分析,纳入了所有RCT,这些试验纳入了接受不同MBS手术并联合其他抗肥胖策略(LSI、MT、OMM或ES)的患者,并与单纯MBS进行比较,试验持续时间至少为6个月。主要结局是终点时的体重指数(BMI);次要终点包括总体重减轻百分比和超重减轻百分比(%TWL%和%EBWL%)、总体重减轻(TWL)、空腹血糖(FPG)、糖化血红蛋白(HbA1c)、手术和非手术严重不良事件(SAE)、死亡率、2型糖尿病缓解情况、高血压、血脂异常以及健康相关生活质量(HR-QoL)。

结果

共检索到25项RCT。在MBS基础上加用OMM(即利拉鲁肽)或EP(即胃内球囊-IB、内镜袖状胃成形术-ES)与终点时显著更低的BMI相关(p = 0.040)。仅在MBS基础上加用利拉鲁肽与更高的%EWL%相关,但与%TWL和TBWL无关(p = 0.008)。三项试验评估了终点时的HbA1c,结果显示利拉鲁肽作为MBS的附加疗法有显著降低(p = 0.007)。无死亡病例。

结论

MBS联合非手术方法在降低BMI方面似乎比单纯MBS更有效。需要进一步开展针对严重肥胖的MBS联合疗法的RCT,以加强对严重肥胖治疗的个性化。

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