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内镜袖状胃成形术和腹腔镜袖状胃切除术在接受12个月以上辅助多学科支持下的疗效与安全性。

Efficacy and safety of endoscopic sleeve gastroplasty and laparoscopic sleeve gastrectomy with 12+ months of adjuvant multidisciplinary support.

作者信息

Carr Prudence, Keighley Tim, Petocz Peter, Blumfield Michelle, Rich Graeme G, Cohen Felicity, Soni Asha, Maimone Isabella R, Fayet-Moore Flavia, Isenring Elizabeth, Marshall Skye

机构信息

Department of Science, Nutrition Research Australia, Level 10, 20 Martin Place, Sydney, New South, Wales.

Bariatric Gastroenterologist & Director, Bariatrics Australia, Sydney Adventist Hospital, Wahroonga, Australia.

出版信息

BMC Prim Care. 2022 Feb 5;23(1):26. doi: 10.1186/s12875-022-01629-7.

DOI:10.1186/s12875-022-01629-7
PMID:35123409
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8817771/
Abstract

BACKGROUND

The laparoscopic sleeve gastrectomy (LSG) and the incisionless endoscopic sleeve gastroplasty (ESG) weight loss procedures require further investigation of their efficacy, safety and patient-centered outcomes in the Australian setting.

METHODS

The aim was to examine the 6- and 12-month weight loss efficacy, safety, and weight-related quality of life (QoL) of adults with obesity who received the ESG or LSG bariatric procedure with 12+ months of adjuvant multidisciplinary pre- and postprocedural support. Data were from a two-arm prospective cohort study that followed patients from baseline to 12-months postprocedure from a medical center in Queensland. Percent excess weight loss (%EWL) was the primary outcome. Secondary outcomes were body composition (fat mass, fat-free mass, android:gynoid ratio, bone mineral content) via dual energy X-ray absorptiometry, weight-related QoL, lipid, glycemic, and hepatic biochemistry, and adverse events.

RESULTS

16 ESG (19% attrition; 81.2% female; aged:41.4 (SD: 10.4) years; BMI: 35.5 (SD: 5.2) kg/m) and 45 LSG (9% attrition; 84.4% female; aged:40.4 (SD: 9.0) years; BMI: 40.7 (SD: 5.6) kg/m) participants were recruited. At 12-months postprocedure, ESG %EWL was 57% (SD: 32%; p < 0.01) and LSG %EWL was 79% (SD: 24%; p < 0.001). ESG and LSG cohorts improved QoL (19.8% in ESG [p > 0.05]; 48.1% in LSG [p < 0.05]), liver function (AST: - 4.4 U/L in ESG [p < 0.05]; - 2.7 U/L in LSG [p < 0.05]), HbA1c (- 0.5% in ESG [p < 0.05]; - 0.1% in LSG [p < 0.05]) and triglycerides (- 0.6 mmol/L in ESG [p > 0.05]; - 0.4 mmol/L in LSG [P < 0.05]) at 12-months. Both cohorts reduced fat mass (p < 0.05). The ESG maintained but LSG decreased fat-free mass at 6-months (p < 0.05); and both cohorts lost fat-free mass at 12-months (p < 0.05). There were no adverse events directly related to the procedure. The ESG reported 25% mild-moderate adverse events possibly related to the procedure, and the LSG reported 27% mild-severe adverse events possibly related to the procedure.

CONCLUSIONS

In this setting, the ESG and LSG were safe and effective weight loss treatments for obese adults alongside multidisciplinary support. Patients who elected the ESG maintained fat-free mass at 6-months but both cohorts lost fat-free mass at 12-months postprocedure. Patients who elected the LSG had large and significant improvements to weight-related quality of life. Further well-powered studies are required to confirm these findings.

TRIAL REGISTRATION

This study was registered prospectively at the Australia New Zealand Clinical Trials Registry on 06/03/2018, Registration Number ACTRN12618000337279 .

摘要

背景

在澳大利亚的环境下,腹腔镜袖状胃切除术(LSG)和无创内镜袖状胃成形术(ESG)减肥手术的疗效、安全性和以患者为中心的结果需要进一步研究。

方法

目的是研究接受ESG或LSG减肥手术并在术前和术后接受12个月以上辅助多学科支持的肥胖成年人在6个月和12个月时的减肥效果、安全性和与体重相关的生活质量(QoL)。数据来自一项双臂前瞻性队列研究,该研究跟踪了昆士兰州一家医疗中心的患者从基线到术后12个月的情况。超重百分比减轻(%EWL)是主要结果。次要结果包括通过双能X线吸收法测量的身体成分(脂肪量、去脂体重、腰臀比、骨矿物质含量)、与体重相关的QoL、血脂、血糖和肝脏生化指标以及不良事件。

结果

招募了16名接受ESG手术的患者(失访率19%;女性占81.2%;年龄:41.4(标准差:10.4)岁;BMI:35.5(标准差:5.2)kg/m²)和45名接受LSG手术的患者(失访率9%;女性占84.4%;年龄:40.4(标准差:9.0)岁;BMI:40.7(标准差:5.6)kg/m²)。术后12个月时,ESG组的%EWL为57%(标准差:32%;p<0.01),LSG组的%EWL为79%(标准差:24%;p<0.001)。ESG组和LSG组的生活质量均有所改善(ESG组为19.8%[p>0.05];LSG组为48.1%[p<0.05]),肝功能(ESG组AST降低4.4 U/L[p<0.05];LSG组降低2.7 U/L[p<0.05]),糖化血红蛋白(ESG组降低0.5%[p<0.05];LSG组降低0.1%[p<0.05])和甘油三酯(ESG组降低0.6 mmol/L[p>0.05];LSG组降低0.4 mmol/L[P<0.05])在术后12个月时也有所改善。两组的脂肪量均减少(p<0.05)。ESG组在6个月时维持但LSG组在6个月时降低了去脂体重(p<0.05);两组在12个月时均减少了去脂体重(p<0.05)。没有与手术直接相关的不良事件。ESG组报告了25%可能与手术相关的轻度至中度不良事件,LSG组报告了27%可能与手术相关的轻度至重度不良事件。

结论

在这种情况下,ESG和LSG是肥胖成年人在多学科支持下安全有效的减肥治疗方法。选择ESG的患者在6个月时维持了去脂体重,但两组在术后12个月时均减少了去脂体重。选择LSG的患者在与体重相关的生活质量方面有显著改善。需要进一步进行有足够样本量的研究来证实这些发现。

试验注册

本研究于2018年3月6日在澳大利亚新西兰临床试验注册中心进行前瞻性注册,注册号为ACTRN12618000337279。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2d5/8818155/8baae98c4bae/12875_2022_1629_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2d5/8818155/7ccee24bb33f/12875_2022_1629_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2d5/8818155/8baae98c4bae/12875_2022_1629_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2d5/8818155/7ccee24bb33f/12875_2022_1629_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2d5/8818155/8baae98c4bae/12875_2022_1629_Fig2_HTML.jpg

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