美国梅奥诊所Barham K Abu Dayyeh团队研究了可调式胃内球囊治疗肥胖的效果。2021年11月15日出版的《柳叶刀》杂志发表了这项成果。

胃内球囊是一种保留解剖结构的微创肥胖疗法。增强耐受性和持久性有助于扩大临床应用范围。该研究探讨了可调节胃内球囊（aIGB）治疗肥胖成人的安全性和有效性。

研究组在美国七个机构进行了一项前瞻性、多中心、开放标签、随机临床试验，招募22-65岁的肥胖成年人，将其按2:1随机分配，分别接受aIGB+生活方式干预，或单纯生活方式干预（对照）治疗32周。球囊容积可以增加以促进体重减轻，也可以减少以使患者耐受。主要终点包括≥32周时平均总体重减轻百分比和缓解率（体重下降5%）。使用多重插补意向来处理总体分析。

2016年8月9日至2018年12月7日，研究组将288名患者随机分组，其中aIGB组187例（65%），对照组101例（35%）。aIGB组参与者32周时的平均总体重减轻15.0%，显著大于对照组的3.3%。aIGB组有171例（92%）患者观察到临床缓解。145例（80%）患者因体重下降平稳或不耐受而调整aIGB。

容量增加调整促进了额外的平均5.2%的总体重减轻。容量减少调整使aIGB组的21名（75%）患者能够完成整个疗程。不耐受导致31例（17%）患者在早期移除该装置。在aIGB队列中未观察到微量营养素缺乏。在7名（4%）患者中观察到与设备相关的严重不良事件，无1例死亡。

研究结果表明，aIGB与生活方式改变相结合治疗肥胖人群，体重显著减轻，并在移除后可维持6个月。可调式球囊容积实现了患者的个性化治疗，能最大限度地减轻体重和保持耐受性。

附：英文原文

Title: Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial

Author: Barham K Abu Dayyeh, Daniel B Maselli, Babusai Rapaka, Thomas Lavin, Mark Noar, Hisham Hussan, Christopher G Chapman, Violeta Popov, Pichamol Jirapinyo, Andres Acosta, Eric J Vargas, Andrew C Storm, Fateh Bazerbachi, Marvin Ryou, Matthew French, Sabrena Noria, Daniel Molina, Christopher C Thompson

Issue&Volume: 2021-11-15

Abstract:

Background

Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity.

Methods

In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22–65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160.

Findings

Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9–16·1) in the aIGB group versus 3·3% (2·0–4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths.

Interpretation

When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance.

DOI: 10.1016/S0140-6736(21)02394-1

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02394-1/fulltext