Sallet José A, Marchesini João B, Paiva Dyker S, Komoto Keila, Pizani Carlos E, Ribeiro Maurélio L B, Miguel Pablo, Ferraz Alvaro M, Sallet Paulo C
Coordinator of the Brazilian Intragastric Balloon Protocol, Interdisciplinary Obesity Treatment Group, Sallet Clinic, São Paulo.
Obes Surg. 2004 Aug;14(7):991-8. doi: 10.1381/0960892041719671.
Intragastric balloons have been used in obese patients to provide early satiety and thereby induce weight loss. Several studies have reported promising results with a new balloon (BIB((R))) designed to overcome some of the technical pitfalls of earlier devices. We assessed both safety and effectiveness of the BIB((R)).
From November 2000 to February 2004, 483 overweight and obese patients were treated with the BIB((R)). 323 patients completed a 6-month follow-up, and 85 of them completed a 1-year follow-up. All patients took part in a multidisciplinary program involving clinical, psychiatric, physical training, and dietary approaches.
Compared to baseline values, after a 6-month follow-up subjects showed significant reductions in weight (15.2 +/- 10.5 kg), percent excess weight loss (48.3 +/- 28.1), and BMI (-5.3 +/- 3.4 kg/m(2)) (P < 0.000). At 1-year follow-up, 85 patients have maintained more than 90% of their BMI reduction. The main side-effects were nausea/vomiting (40%), and epigastric pain (20%), requiring removal of the BIB (R) in 11 patients (3.4%). Minor complications were reflux esophagitis (12%) and symptomatic gastric stasis (9%). Balloon impaction occurred in 2 cases (0.6%), and in 1 patient (0.3%) there was spontaneous deflation of the balloon leading to a small-bowel obstruction solved by a surgical approach.
The BIB((R)) has been effective to temporarily control obesity, inducing an excess weight loss of approximately 48%. It was not associated with mortality and showed minimal risk of major complications.
胃内球囊已用于肥胖患者，以提供早期饱腹感从而诱导体重减轻。多项研究报告了一种新型球囊（BIB((R))）取得了令人鼓舞的结果，该球囊旨在克服早期装置的一些技术缺陷。我们评估了BIB((R))的安全性和有效性。
从2000年11月至2004年2月，483例超重和肥胖患者接受了BIB((R))治疗。323例患者完成了6个月的随访，其中85例完成了1年的随访。所有患者都参与了一个多学科项目，包括临床、心理、体育锻炼和饮食方法。
与基线值相比，6个月随访后，受试者体重显著减轻（15.2±10.5kg），超重减轻百分比（48.3±28.1），BMI降低（-5.3±3.4kg/m(2)）（P<0.000）。在1年随访时，85例患者维持了超过90%的BMI降低幅度。主要副作用为恶心/呕吐（40%）和上腹部疼痛（20%），11例患者（3.4%）需要取出BIB((R))。轻微并发症为反流性食管炎（12%）和症状性胃潴留（9%）。发生2例球囊嵌顿（0.6%），1例患者（0.3%）球囊自发瘪陷导致小肠梗阻，通过手术方法解决。
BIB((R))在暂时控制肥胖方面有效，可使超重减轻约48%。它与死亡率无关，且主要并发症风险极小。
