Ponce Jaime, Woodman George, Swain James, Wilson Erik, English Wayne, Ikramuddin Sayeed, Bour Eric, Edmundowicz Steven, Snyder Brad, Soto Flavia, Sullivan Shelby, Holcomb Richard, Lehmann John
Chattanooga Bariatrics, Chattanooga, TN, and Hamilton Weight Management Center, Hamilton Medical Center, Dalton, GA.
MidSouth Bariatrics, Memphis, TN, and Baptist Memorial Hospital, Memphis, TN.
Surg Obes Relat Dis. 2015 Jul-Aug;11(4):874-81. doi: 10.1016/j.soard.2014.12.006. Epub 2014 Dec 16.
Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake.
To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone.
Academic and community practice, United States.
Participants (n = 326) with body mass index (BMI) 30-40 kg/m(2) were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment.
Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P = .004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%).
The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.
充生理盐水的胃内气球装置是一种可逆的内镜装置，旨在占据胃容积并减少食物摄入量。
评估双气球系统联合饮食和运动治疗肥胖症相较于单纯饮食和运动的安全性和有效性。
美国的学术和社区医疗机构。
将体重指数（BMI）为30 - 40 kg/m²的参与者（n = 326）随机分为内镜双气球系统治疗联合饮食和运动组（DUO组，n = 187）或假内镜检查联合单纯饮食和运动组（DIET组，n = 139）。共同主要终点是在24周时两组间超重减轻百分比（%EWL）的组间比较以及DUO组受试者的反应率。此后，DUO组患者取出双气球系统，随后再进行24周的咨询；DIET组患者可接受双气球系统治疗。
平均BMI为35.4。两个主要终点均达到。DUO组的体重减轻是DIET组的两倍多。DUO组患者在24周时的%EWL显著更高（意向性治疗（ITT）为25.1%，完成病例（CC，n = 167）为27.9%），而DIET组患者分别为11.3%（ITT，P = 0.004）和12.3%（CC，n = 126）。DUO组患者体重减轻二分法为25%EWL时显著超过35%的反应率（ITT为49.1%，P < 0.001，CC为54.5%）。适应性症状在支持和药物治疗下迅速缓解。6%的患者气球未移位而自行瘪缩。9%的患者因非溃疡不耐受而早期取出。观察到胃溃疡；对装置进行微小改变后，溃疡大小和发生率显著降低（10%）。
双气球系统在导致体重减轻方面显著优于饮食和运动，且不良事件发生率低。
