Lopez-Nava G, Bautista-Castaño I, Jimenez-Baños A, Fernandez-Corbelle J P
Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, C/Oña n° 10, 28050, Madrid, Spain.
Obes Surg. 2015 Dec;25(12):2263-7. doi: 10.1007/s11695-015-1715-6.
Many obese patients fail conventional medical management and decline bariatric surgery. Less invasive weight loss options such as intragastric balloons may provide an opportunity to reach this large number of untreated patients. The aim of this study was to investigate the safety and effectiveness of the Dual Intragastric Balloon (DIGB) in the treatment of obese patients, as well as the impact of degree of obesity, age, and gender.
The study was conducted at the Bariatric Endoscopy Unit of the Madrid Sanchinarro University Hospital. Sixty patients (11 men, 49 women) underwent endoscopic placement of a DIGB filled with a total of 900 cc of saline (450 cc in each balloon) for at least 6 months, along with regular counseling from a multidisciplinary team. Study outcomes included: change in body weight (TBWL), % of loss of initial body weight (%TBWL), % of excess body weight loss (%EWL), and adverse events.
Initial BMI 38.8 kg/m(2) decreased 6.1 units, with mean TBWL, %TBWL, and %EWL of 16.6 kg, 15.4 %, and 47.1 %, respectively. We found no difference in %TBWL between grade of obesity, age or sex, but morbidly obese patients demonstrated greater TBWL, and women and less obese subjects obtained higher %EWL. The DIGB was generally well tolerated, with one early removal for patient intolerance, one early deflation without migration, and one gastric perforation. Fourteen patients had small, clinically insignificant ulcers or erosions noted at the time of removal.
The present study shows that the DIGB was easy to use, resulted in significant weight loss, safe, and well tolerated.
许多肥胖患者常规药物治疗效果不佳且拒绝接受减肥手术。诸如胃内球囊等侵入性较小的减肥方法可能为大量未得到治疗的患者提供机会。本研究的目的是调查双腔胃内球囊（DIGB）治疗肥胖患者的安全性和有效性，以及肥胖程度、年龄和性别的影响。
该研究在马德里圣奇纳罗大学医院的减肥内镜科进行。60例患者（11例男性，49例女性）接受了内镜下放置充满总计900 cc生理盐水（每个球囊450 cc）的DIGB，放置时间至少6个月，并接受多学科团队的定期咨询。研究结果包括：体重变化（TBWL）、初始体重减轻百分比（%TBWL）、多余体重减轻百分比（%EWL）和不良事件。
初始体重指数（BMI）38.8 kg/m²下降了6.1个单位，平均TBWL、%TBWL和%EWL分别为16.6 kg、15.4%和47.1%。我们发现肥胖程度、年龄或性别之间的%TBWL没有差异，但病态肥胖患者的TBWL更大，女性和肥胖程度较低的受试者的%EWL更高。DIGB总体耐受性良好，1例因患者不耐受而早期取出，1例早期放气且未移位，1例胃穿孔。14例患者在取出时发现有小的、临床意义不大的溃疡或糜烂。
本研究表明，DIGB使用简便，能显著减轻体重，安全且耐受性良好。
