Department of Internal Medicine, Gastroenterology and Hepatology Division, University Hospital Sestre Milosrdnice, Zagreb, Croatia.
Obes Surg. 2011 Aug;21(8):1305-10. doi: 10.1007/s11695-010-0101-7.
This study aims to assess the effectiveness, tolerance, safety, and patient satisfaction of obesity treatments using the Bioenterics intragastric balloon (BIB).
Prospective controlled trial of 33 obese patients who were treated with the BIB from March 2008 to March 2009 and who completed the 6 months treatment. Patients were selected on the basis of workup by a multidisciplinary team. The 33 obese patients (26 females, seven males) had a median age of 35 years (range 20-58). Their median baseline body weight (BW) was 114 kg (range 89-197) and their median body mass index (BMI) was 41.4 kg/m(2) (range 31.2-60.8).
Average weight reduction was 14 kg (range 2-37), loss total weight 10.1% (range 1.4-23.1), control BMI 35.6 kg/m(2) (range 29.4-50.3), delta BMI 4.5 (range 0.6-13.1), percentage excess weight loss 29.2 (range 2.8-53.6), and percent of excess BMI loss 29.3 (range 2.7-67.4). In one female patient the BIB was removed early due to intolerance. During the first week, minor side effects were noticed: nausea/vomiting occurred in 21 patients (63.6%), and abdominal cramps in 15 (45.5%). There was one balloon deflation and one impaction in the stomach. Those incidents were both successfully treated endoscopically. Patients had no major complications from mucosal lesions and no need for surgical interventions. All intragastric balloons were successfully removed endoscopically. Patients' treatment satisfaction correlated with the degree of BW loss (p = 0.0138).
BIB treatment in our setting showed the best results for individuals with BMI from 35 to 40 kg/m(2). Our preliminary results showed that BIB is safe, well tolerated with minor side effects, and alters quality of life for the better. The complication rate was negligible, due to the detailed pretreatment examinations and follow-up.
本研究旨在评估 Bioenterics 胃内球囊（BIB）治疗肥胖的有效性、耐受性、安全性和患者满意度。
对 2008 年 3 月至 2009 年 3 月接受 BIB 治疗且完成 6 个月治疗的 33 例肥胖患者进行前瞻性对照试验。根据多学科团队的检查结果选择患者。33 例肥胖患者（26 名女性，7 名男性）的中位年龄为 35 岁（范围 20-58）。他们的中位基线体重（BW）为 114kg（范围 89-197），中位体重指数（BMI）为 41.4kg/m²（范围 31.2-60.8）。
平均体重减轻 14kg（范围 2-37），总减重 10.1%（范围 1.4-23.1），BMI 控制在 35.6kg/m²（范围 29.4-50.3），BMI 差值为 4.5（范围 0.6-13.1），超重体重减轻百分比为 29.2%（范围 2.8-53.6），超重 BMI 减轻百分比为 29.3%（范围 2.7-67.4）。有 1 名女性患者因不耐受而提前取出 BIB。在第一周，观察到轻微的副作用：21 名患者（63.6%）出现恶心/呕吐，15 名患者（45.5%）出现腹痛。有 1 例球囊充气，1 例球囊嵌顿。这两起事件均在内镜下成功治疗。患者无明显黏膜损伤并发症，无需手术干预。所有胃内球囊均在内镜下成功取出。患者的治疗满意度与 BW 减轻程度相关（p=0.0138）。
在我们的研究中，BIB 治疗 BMI 在 35 至 40kg/m²的个体效果最佳。我们的初步结果表明，BIB 是安全的，耐受性良好，副作用轻微，并能改善生活质量。由于详细的预处理检查和随访，并发症发生率可忽略不计。
