Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
Lancet. 2021 Nov 27;398(10315):1965-1973. doi: 10.1016/S0140-6736(21)02394-1. Epub 2021 Nov 15.
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.
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.
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% (4·5-5·8) 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.
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.
Spatz Medical.
胃内球囊是一种保持解剖结构完整、微创的肥胖症治疗方法。提高耐受性和耐用性有助于拓宽临床应用。我们研究了一种可调节胃内球囊（aIGB）在肥胖成年人中的安全性和疗效。
这是一项在美国 7 个地点进行的前瞻性、多中心、开放标签、随机临床试验，年龄在 22-65 岁的肥胖成年人被随机分配（2:1）接受 aIGB 联合生活方式干预或仅生活方式干预（对照组），治疗 32 周。可以增加球囊体积以促进体重减轻，或者减少球囊体积以提高耐受性。主要终点包括 32 周时平均总体重减轻百分比和应答率（体重减轻≥5%）。我们采用了多重插补意向治疗人群分析。本研究在 ClinicalTrials.gov 注册，NCT02812160。
2016 年 8 月 9 日至 2018 年 12 月 7 日期间，我们将 288 名患者随机分配至 aIGB 组（n=187[65%]）或对照组（n=101[35%]）。32 周时，aIGB 组的总体重减轻率为 15.0%（95%CI 13.9-16.1），对照组为 3.3%（2.0-4.6）（p<0.0001）。aIGB 组 171 名（92%）患者出现临床应答。145 名（80%）患者因体重减轻平台期或不耐受而调整了 aIGB。向上调整球囊体积使总体重减轻额外增加 5.2%（4.5-5.8）。向下调整球囊体积使 aIGB 组 21 名（75%）患者完成了整个疗程。不耐受导致 31 名（17%）患者早期取出装置。在 aIGB 组未观察到微量营养素缺乏。7 名（4%）患者发生与装置相关的严重不良事件，无死亡。
当 aIGB 与生活方式改变联合使用时，可显著减轻体重，并在去除后 6 个月内保持减轻。球囊体积可调节性允许个体化治疗，最大限度地提高减重效果和耐受性。
Spatz Medical。
