Department of Digestive and Endoscopy, Madrid Sanchinarro University Hospital, C/Padre Arrupe 89, Chalet, 28050 Madrid, Spain.
Obes Surg. 2011 Jan;21(1):5-9. doi: 10.1007/s11695-010-0093-3. Epub 2010 Mar 20.
The BioEnterics® Intragastric Balloon (BIB®) is a well-established device for temporary treatment in morbidly obese patients. The aim of this study is the evaluation, in a population of 714 consecutive outpatient setting cases, BIB® results in terms of weight loss and comorbidity change.
BIB® was positioned in all cases after diagnostic endoscopy. The device was inflated under direct endoscopic vision with saline solution (600-700 ml) and methylene blue (10 ml). Intubation was carried out in patients with body mass index (BMI) > 40 kg/m(2) affected by sleep apnea or chronic obstructive pulmonary disease. After 6 months, balloon removal was carried out, and patients were discharged with drug therapy and 1,000 kcal diet. More than 100 patients underwent a second consecutive balloon positioning. One month from the removal of the first BIB, patients were given a second BIB. Patients were followed up weekly. Mortality, complications and their treatment, postplacement symptoms, comorbidities, BMI, percentage of excess BMI loss (%EBL), and percentage of excess weight loss (%EWL) were considered. Data are expressed as mean ± standard deviation.
From June 1, 2005, to May 31, 2007, 714 patients underwent BIB® placement (143 males/571 females; mean age, 38.4 ± 16.1; mean BMI, 37.6 ± 5.7 kg/m(2); mean EW, 56.3 ± 27.1 kg). After 6 months, mean BMI was 31.1 ± 7.2, mean %EWL was 41.6 ± 21.8, mean BMI loss was 6.5 ± 12.7, and mean %EBL was 44.5 ± 22.6. Of 714 patients, 112 underwent a second BIB placement. At the time of the second balloon placement, mean BMI was 32.9 ± 6.7 kg/m(2); range was 31-51. After the second balloon removal, mean BMI was 30.3 ± 7.2.
BIB® treatment is a safe and effective procedure for weight reduction, without mortality and with very low morbidity rates even in nonhospitalized patients. A second balloon can also be positioned without difficulties, achieving good results after 12 months of treatment.
BioEnterics® 胃内球囊（BIB®）是一种成熟的设备，可用于治疗病态肥胖患者。本研究的目的是评估 714 例连续门诊病例中 BIB®在体重减轻和合并症变化方面的结果。
在所有病例中，在诊断内镜检查后放置 BIB®。用生理盐水（600-700 毫升）和亚甲蓝（10 毫升）在直视内镜下将球囊充气。对于 BMI>40kg/m2 的患者，在患有睡眠呼吸暂停或慢性阻塞性肺病的情况下进行插管。6 个月后，取出气球，并为患者提供药物治疗和 1000 卡路里的饮食。100 多名患者进行了第二次连续球囊定位。第一次 BIB 取出后一个月，给患者第二次 BIB。每周对患者进行随访。考虑死亡率、并发症及其治疗、放置后症状、合并症、BMI、多余体重减轻百分比（%EWL）和多余体重指数减轻百分比（%EBL）。数据以平均值±标准差表示。
从 2005 年 6 月 1 日至 2007 年 5 月 31 日，714 例患者接受了 BIB®放置（143 例男性/571 例女性；平均年龄 38.4±16.1 岁；平均 BMI 37.6±5.7kg/m2；平均体重 56.3±27.1kg）。6 个月后，平均 BMI 为 31.1±7.2，平均 EWL%为 41.6±21.8，平均 BMI 下降 6.5±12.7，平均 EBL%为 44.5±22.6。714 例患者中有 112 例接受了第二次 BIB 放置。在第二次球囊放置时，平均 BMI 为 32.9±6.7kg/m2；范围为 31-51。第二次球囊取出后，平均 BMI 为 30.3±7.2。
BIB®治疗是一种安全有效的减肥方法，无死亡率，即使是非住院患者，发病率也很低。也可以无困难地定位第二个气球，在 12 个月的治疗后获得良好的效果。
