Washington University School of Medicine, St. Louis, Missouri; University of Colorado School of Medicine, Aurora, Colorado.
HonorHealth Research Institute, Scottsdale, Arizona.
Surg Obes Relat Dis. 2018 Dec;14(12):1876-1889. doi: 10.1016/j.soard.2018.09.486. Epub 2018 Sep 29.
Obesity is a significant health problem and additional therapies are needed to improve obesity treatment.
Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss.
Fifteen academic and private practice centers in the United States.
This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group.
Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks.
Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.
肥胖是一个严重的健康问题，需要额外的治疗方法来改善肥胖症的治疗效果。
评估一种可吞咽的充气式胃内球囊系统在减肥方面的疗效和安全性，该系统的使用时长为 6 个月。
美国 15 个学术和私人实践中心。
这是一项双盲、随机假对照试验，试验组接受可吞咽的充气式胃内球囊系统联合生活方式疗法，对照组仅接受生活方式疗法，两组均治疗 6 个月，以评估 22 至 60 岁、体重指数为 30 至 40kg/m²的参与者的减肥效果。试验的主要终点为：治疗组与对照组的总体重减轻百分比差值>2.1%，治疗组的应答率>35%。
387 名患者至少吞咽了 1 粒胶囊。93.3%的参与者完成了所有 24 周的双盲研究测试。91.1%的患者发生了非严重不良事件，但仅有 0.4%的患者为严重不良事件。1 例发生了出血性溃疡，1 例发生了球囊破裂。在完成治疗的患者分析中，治疗组和对照组分别实现了 7.1±5.0%和 3.6±5.1%的总体重减轻，平均差值为 3.5%（P=0.0085）。治疗组和对照组的总体重减轻分别为 7.1±5.3kg 和 3.6±5.1kg（P<0.0001），体重指数变化分别为 2.5±1.8kg/m 和 1.3±1.8kg/m（P<0.0001）。治疗组的应答率为 66.7%（P<0.0001）。治疗组在 48 周时的体重维持率为 88.5%。
生活方式疗法联合 6 个月可吞咽的充气式胃内球囊系统治疗安全有效，与假对照相比，体重减轻效果增加了一倍，且在 48 周时体重维持率较高。
