Dipartimento di Chirurgia. UOC Chirurgia Generale d'Urgenza e metabolica, Centro per il Trattamento dell'Obesità, Ospedale Pineta Grande, Castelvolturno, Caserta, Italy.
Obes Surg. 2012 Dec;22(12):1916-9. doi: 10.1007/s11695-012-0786-x.
The positioning of an intragastric saline-filled balloon has been developed as temporary and reversible therapeutic option for treatment of morbid obesity. Recently, an air-filled balloon was also developed. The aim of this study is to prospectively compare these two devices in terms of weight loss parameters, safety, and tolerance.
Sixty patients were randomized into two groups: group A (Bioenterics Intragastric Balloon-BIB; n = 30; 20 F/10 M, mean age 36.7 ± 10.9; mean BMI 46.5 ± 5.9) and group B (Endobag-Heliosphere; n = 30; 20 F/10 M, mean age 37.8 ± 10.6; mean BMI 46.1 ± 5.6). All patients of both groups were sedated with midazolam (5 mg) + Propofol (2 mg/kg i.v.). The Heliosphere Bag was air-filled with 950 ml while BIB® was inflated with 500 ml of saline and 10 ml of methylene blue. Percentage of excess weight loss (%EWL) and body mass index (BMI) were evaluated. Student t test, Fisher exact test, and χ(2) test were used for statistical analysis.
Similar weight loss parameters were observed in patients treated with liquid or air-filled balloon at time of removal: mean BMI was 40.8 ± 6.2 and 41.9 ± 6.5(p = ns), and mean %EWL was 20 ± 12 and 18 ± 14 (p = ns) in groups A and B, respectively. Significant longer extraction time, with high patient discomfort, was observed in group B due to difficult passage through the cardia and the lower pharynx.
Air-filled balloon can be another valid therapeutic option in the temporary treatment of obesity, but at this time, the quality of the device must be improved to ameliorate the patient compliance at removal and avoid the spontaneous deflations.
胃内盐水填充球囊已被开发为治疗病态肥胖的临时和可逆治疗选择。最近，还开发了一种充气球囊。本研究的目的是前瞻性比较这两种设备在体重减轻参数、安全性和耐受性方面的差异。
60 名患者被随机分为两组：A 组（Bioenterics 胃内球囊-BIB；n=30；20 女/10 男，平均年龄 36.7±10.9；平均 BMI 46.5±5.9）和 B 组（Endobag-Heliosphere；n=30；20 女/10 男，平均年龄 37.8±10.6；平均 BMI 46.1±5.6）。两组所有患者均用咪达唑仑（5 mg）+丙泊酚（2 mg/kg 静脉注射）镇静。Heliosphere 袋用 950 ml 空气充气，而 BIB®用 500 ml 生理盐水和 10 ml 亚甲蓝充气。评估体重减轻的百分比（%EWL）和体重指数（BMI）。使用学生 t 检验、Fisher 确切检验和 χ(2)检验进行统计学分析。
在取出时，用液体或充气球囊治疗的患者观察到相似的体重减轻参数：平均 BMI 分别为 40.8±6.2 和 41.9±6.5（p=ns），平均%EWL 分别为 20±12 和 18±14（p=ns）在 A 组和 B 组中。由于通过贲门和下咽部困难，B 组观察到明显更长的提取时间，患者不适感增加。
充气球囊可以是肥胖症临时治疗的另一种有效治疗选择，但此时，必须提高设备质量，以改善患者取出时的依从性，并避免自发放气。
