Moore Metabolics and Tulane University Department of Surgery, New Orleans, Louisiana.
BMI of Texas, San Antonio, Texas.
Surg Obes Relat Dis. 2019 Mar;15(3):417-423. doi: 10.1016/j.soard.2018.12.007. Epub 2018 Dec 6.
Obesity is the most common chronic disease in the United States today. Additional therapies are needed to improve obesity treatment.
A swallowable, gas-filled intragastric balloon system was approved for the treatment of obesity by Food and Drug Administration in September 2016 and commercialization started January 2017. A registry was made available to physicians to capture evidence of safety and effectiveness with use.
United States private clinics, surgery centers, and hospitals.
This study is a retrospective analysis of a prospective registry of patients with body mass index (BMI) ≥25 kg/m that initiated therapy in the first year. Data on demographics, procedural timing, weight loss, adverse events, and device deficiencies were captured.
The final analysis comprised 1343 patients across 108 treating physicians (mean age 45.7 ± 10.8 yr, 78.6% female, baseline BMI of 35.4 ± 5.4 kg/m). Nonserious and serious adverse events were reported in 14.2% and .15% of patients, respectively. There were 7 balloon deflations, none caused obstruction. Weight loss in the indicated use (BMI 30-40 kg/m) was 9.7 ± 6.1 kg and 10.0 ± 6.1% total body weight loss (TBWL). Weight loss in other BMI categories was 8.2 ± 5.6 kg or 10.3 ± 7.0% total body weight loss for BMI 25 to 29.9 kg/m and 11.6 ± 7.8 kg or percent total body weight loss 9.3 ± 6.0 for BMI >40 kg/m.
This swallowable gas-filled intragastric balloon system is safe and effective at inducing weight loss and offers physicians another tool for patients whose obesity has been resistant to noninvasive treatments.
肥胖是当今美国最常见的慢性病。需要额外的治疗方法来改善肥胖症的治疗效果。
一种可吞咽的、充满气体的胃内气球系统于 2016 年 9 月获得美国食品和药物管理局批准用于肥胖症的治疗，并于 2017 年 1 月开始商业化。一个登记处提供给医生，以收集使用该系统的安全性和有效性的证据。
美国私人诊所、手术中心和医院。
本研究是对 2017 年开始的第一年接受治疗的身体质量指数（BMI）≥25kg/m2的患者前瞻性登记的回顾性分析。收集了人口统计学、程序时间、体重减轻、不良事件和设备缺陷的数据。
最终分析包括 1343 名患者，涉及 108 名治疗医生（平均年龄 45.7±10.8 岁，78.6%为女性，基线 BMI 为 35.4±5.4kg/m2）。分别有 14.2%和 0.15%的患者报告了非严重和严重不良事件。有 7 个气球放气，没有造成阻塞。在指示使用（BMI 30-40kg/m2）中体重减轻了 9.7±6.1kg，占总体重减轻（TBWL）的 10.0±6.1%。在其他 BMI 类别中，体重减轻了 8.2±5.6kg，或 BMI 25-29.9kg/m2 时的 10.3±7.0%TBWL，或 BMI>40kg/m2 时的 11.6±7.8kg 或 9.3±6.0%TBWL。
这种可吞咽的充气胃内气球系统在诱导体重减轻方面是安全有效的，为那些对非侵入性治疗有抵抗力的肥胖患者的医生提供了另一种工具。
