Department of Medicine, University of Minnesota, Minnesota, USA.
Division of Gastroenterology and Hepatology, Mayo Clinic Rochester, Minnesota, USA.
Obes Surg. 2020 Sep;30(9):3341-3346. doi: 10.1007/s11695-020-04522-3.
Intragastric balloons have been used to bridge the obesity treatment gap with the benefits of being minimally invasive but still required endoscopy. The Elipse intragastric balloon (EIGB) is a swallowable balloon that is spontaneously excreted through a natural orifice at approximately 16 weeks. Several concerns exist, including the treatment efficacy and risk of bowel obstruction. Our meta-analysis aimed to evaluate the efficacy and safety of EIGB.
A literature search was performed from several databases from database inception to November 2019. Eligible studies must report percent total weight loss (%TWL) after completion of treatment and adverse events. The pooled means and proportions of our data were analyzed using random effects model, generic inverse variance method.
Six studies involving 2013 unique patients met our eligibility criteria and were included. The mean baseline BMI ranged from 30.6 to 36.2. The pooled early removal rate was 2.3% (95% CI, 1.1-3.5%; I 31%). The pooled %TWL after completion of treatment (4-6 months) was 12.8% (95% CI, 11.6-13.9%; I 83%) and at 12 months was 10.9% (95% CI, 5.0-16.9%, I 98%). For serious adverse events, three patients had small bowel obstruction, and one patient had gastric perforation requiring surgery. Early expulsion by emesis and early deflation were seen in 3 and 9 patients, respectively.
This meta-analysis demonstrates that EIGB is a safe device offering an effective weight loss that warrants further studies for its long-term weight loss outcomes. Severe adverse events are rare, and the rate of early removal is low.
胃内球囊已被用于弥补肥胖治疗的差距，其优点是微创，但仍需要内窥镜检查。Elipse 胃内球囊（EIGB）是一种可吞咽的球囊，大约在 16 周时通过自然孔道自然排出。存在一些担忧，包括治疗效果和肠梗阻的风险。我们的荟萃分析旨在评估 EIGB 的疗效和安全性。
从几个数据库进行了文献检索，检索时间从数据库建立到 2019 年 11 月。符合条件的研究必须报告治疗完成后的总体重减轻百分比（%TWL）和不良事件。使用随机效应模型、通用倒数方差法对我们的数据的平均值和比例进行分析。
六项研究共纳入 2013 名患者符合入选标准。平均基线 BMI 范围为 30.6 至 36.2。早期取出率为 2.3%（95%CI，1.1-3.5%；I 31%）。治疗完成后（4-6 个月）的平均 %TWL 为 12.8%（95%CI，11.6-13.9%；I 83%），12 个月时为 10.9%（95%CI，5.0-16.9%，I 98%）。对于严重不良事件，有 3 例患者发生小肠梗阻，1 例患者发生胃穿孔需要手术。分别有 3 名和 9 名患者出现早期呕吐排出和早期放气。
这项荟萃分析表明，EIGB 是一种安全的装置，可有效减轻体重，需要进一步研究其长期减肥效果。严重不良事件罕见，早期取出率低。
