Courcoulas A, Abu Dayyeh B K, Eaton L, Robinson J, Woodman G, Fusco M, Shayani V, Billy H, Pambianco D, Gostout C
Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Mayo Clinic, Rochester, MN, USA.
Int J Obes (Lond). 2017 Mar;41(3):427-433. doi: 10.1038/ijo.2016.229. Epub 2016 Dec 23.
BACKGROUND/OBJECTIVES: This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.
SUBJECTS/METHODS: In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg m were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss.
At 6 months, weight loss was -3.3% of total body weight (-3.2 kg) in the lifestyle arm vs -10.2% (-9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was -3.4% (-3.2 kg) vs -9.1% (-8.8 kg, P⩽0.001); and at 12 months, -3.1% (-2.9 kg) vs -7.6% (-7.4 kg, P⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found.
Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.
背景/目的：本试验评估了奥贝拉胃内球囊作为生活方式干预辅助手段的安全性和有效性。
受试者/方法：在这项多中心、随机、开放标签的临床试验中，对255名体重指数为30 - 40 kg/m²的成年人进行了治疗，并对长达12个月的结果进行了评估。参与者被随机分为内镜下放置胃内球囊加生活方式干预组或单纯生活方式干预组。球囊在6个月时取出，两组的生活方式干预均持续至12个月。在9个月时，共同主要终点是两项体重减轻指标。
在6个月时，单纯生活方式干预组的体重减轻为总体重的-3.3%（-3.2 kg），而胃内球囊加生活方式干预组为-10.2%（-9.9 kg）（P<0.001）；在9个月时（球囊取出后3个月），体重减轻分别为-3.4%（-3.2 kg）和-9.1%（-8.8 kg，P⩽0.001）；在12个月时，分别为-3.1%（-2.9 kg）和-7.6%（-7.4 kg，P⩽0.001）。对于主要终点，在9个月时，胃内球囊组和对照组体重超过理想体重的平均减轻百分比（标准差）分别为26.5%（20.7）（P = 0.32）和9.7%（15.1）。此外，随机分配到胃内球囊组的受试者中，45.6%（36.7，54.8）实现了体重超过理想体重至少减轻15%，高于对照组（P<0.001）。大多数胃内球囊组受试者经历了不良事件；86.9%出现恶心，75.6%出现呕吐，57.5%出现腹痛，18.8%因不良事件或受试者要求在6个月前取出了装置。胃内球囊组有5名受试者（3.1%）在取出装置时出现胃部异常，未发现溃疡。
胃内球囊在球囊取出后3个月和6个月时实现的短期体重减轻比单纯生活方式干预更大。胃肠道不良事件很常见。
