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评估胃内球囊的安全性:代谢和减重外科认证和质量改进计划的分析。

Evaluating the safety of intragastric balloon: An analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.

机构信息

Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.

Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.

出版信息

Surg Obes Relat Dis. 2018 Sep;14(9):1340-1347. doi: 10.1016/j.soard.2018.05.003. Epub 2018 May 17.

DOI:10.1016/j.soard.2018.05.003
PMID:29934235
Abstract

BACKGROUND

Laparoscopic bariatric surgery (LBS) is effective for severe obesity but is invasive and costly. Intragastric balloons (IGBs) are increasingly popular as an alternative to LBS with modest short-term weight loss. However, IGBs are associated with complications and a comparison of the safety of IGB to LBS is warranted.

OBJECTIVES

The objective of this study was to compare the safety profile of IGB with LBS through analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database.

SETTING

The MBSAQIP collects data from 791 bariatric surgery centers in the United States and Canada.

METHODS

A propensity-matched analysis was performed between IGB and LBS. Multivariable logistic regression analysis was performed to determine if IGBs were independently associated with adverse outcomes.

RESULTS

A total of 145,408 patients were included, of which 144,627 (99.5%) underwent LBS and 781 (0.5%) underwent IGB therapy. With one-to-one propensity score matching, 684 pairs of IGB and LBS patients were selected. Multivariable logistic regression found that IGB (odds ratio 1.97, confidence interval 1.10-3.52, P = .023) was independently predictive of 30-day adverse outcomes. This was due to a significantly higher nonoperative reintervention rate in the IGB cohort (4.2% versus 1.0%, P < .001) from early balloon removal (2.8%).

CONCLUSIONS

In this propensity-matched analysis, IGBs were associated with a higher adverse event rate than LBS, due to a 4-times higher nonoperative reintervention rate. The utility of IGB as a primary weight loss intervention should be reconsidered due to its poor safety profile compared with LBS.

摘要

背景

腹腔镜减重手术(LBS)对重度肥胖症有效,但具有侵入性且费用高昂。胃内球囊(IGB)作为 LBS 的替代方案越来越受欢迎,其短期减重效果适度。然而,IGB 与并发症相关,因此需要对 IGB 与 LBS 的安全性进行比较。

目的

本研究通过分析代谢和减重手术认证和质量改进计划(MBSAQIP)数据库,比较 IGB 和 LBS 的安全性。

设置

MBSAQIP 从美国和加拿大的 791 个减重手术中心收集数据。

方法

对 IGB 和 LBS 进行倾向评分匹配分析。采用多变量逻辑回归分析确定 IGB 是否与不良结局独立相关。

结果

共纳入 145408 例患者,其中 144627 例(99.5%)接受 LBS,781 例(0.5%)接受 IGB 治疗。通过一对一倾向评分匹配,选择了 684 对 IGB 和 LBS 患者。多变量逻辑回归发现,IGB(比值比 1.97,95%置信区间 1.10-3.52,P=0.023)与 30 天不良结局独立相关。这归因于 IGB 组的非手术再干预率显著更高(4.2%比 1.0%,P<0.001),主要原因是早期(2.8%)因气球取出导致的非手术再干预。

结论

在这项倾向评分匹配分析中,与 LBS 相比,IGB 与更高的不良事件发生率相关,原因是其非手术再干预率高 4 倍。与 LBS 相比,IGB 的安全性较差,应重新考虑将其作为主要减重干预措施的应用。

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