腹腔镜可调节胃束带术治疗重度肥胖青少年：一项随机试验。

Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial.

机构信息

Centre for Obesity Research and Education, Monash University Medical School, Alfred Hospital, Melbourne, 3004, Australia.

出版信息

JAMA. 2010 Feb 10;303(6):519-26. doi: 10.1001/jama.2010.81.

DOI:10.1001/jama.2010.81

PMID:20145228

Abstract

CONTEXT

Adolescent obesity is a common and serious health problem affecting more than 5 million young people in the United States alone. Bariatric surgery is being evaluated as a possible treatment option. Laparoscopic adjustable gastric banding (gastric banding) has the potential to provide a safe and effective treatment.

OBJECTIVE

To compare the outcomes of gastric banding with an optimal lifestyle program on adolescent obesity.

DESIGN, SETTING, AND PATIENTS: A prospective, randomized controlled trial of 50 adolescents between 14 and 18 years with a body mass index (BMI) higher than 35, recruited from the Melbourne, Australia, community, assigned either to a supervised lifestyle intervention or to undergo gastric banding, and followed up for 2 years. The study was performed between May 2005 and September 2008.

MAIN OUTCOME MEASURES

Weight loss. Secondary outcomes included change in metabolic syndrome, insulin resistance, quality of life, and adverse outcomes.

RESULTS

Twenty-four of 25 patients in the gastric banding group and 18 of 25 in lifestyle group completed the study. Twenty-one (84%) in the gastric banding and 3 (12%) in the lifestyle groups lost more than 50% of excess weight, corrected for age. Overall, the mean changes in the gastric banding group were a weight loss of 34.6 kg (95% CI, 30.2-39.0), representing an excess weight loss of 78.8% (95% CI, 66.6%-91.0%), 12.7 BMI units (95% CI, 11.3-14.2), and a BMI z score change from 2.39 (95% CI, 2.05-2.73) to 1.32 (95% CI, 0.98-1.66). The mean losses in the lifestyle group were 3.0 kg (95% CI, 2.1-8.1), representing excess weight loss of 13.2% (95% CI, 2.6%-21.0%), 1.3 BMI units (95% CI, 0.4-2.9), and a BMI z score change from 2.41 (95% CI, 2.21-2.66) to 2.26 (95% CI, 1.91-2.43). At entry, 9 participants (36%) in the gastric banding group and 10 (40%) in the lifestyle group had the metabolic syndrome. At 24 months, none of the gastric banding group had the metabolic syndrome (P = .008; McNemar chi(2)) compared with 4 of the 18 completers (22%) in the lifestyle group (P = .13). The gastric banding group experienced improved quality of life with no perioperative adverse events. However, 8 operations (33%) were required in 7 patients for revisional procedures either for proximal pouch dilatation or tubing injury during follow-up.

CONCLUSIONS

Among obese adolescent participants, use of gastric banding compared with lifestyle intervention resulted in a greater percentage achieving a loss of 50% of excess weight, corrected for age. There were associated benefits to health and quality of life.

TRIAL REGISTRATION

ANZCTR Identifier: 12605000160639.

摘要

背景

青少年肥胖是一个普遍且严重的健康问题，仅在美国就有超过 500 万名年轻人受到影响。减重手术正被评估为一种可能的治疗选择。腹腔镜可调节胃束带术（胃束带）有可能提供安全有效的治疗。

目的

比较胃束带术与最佳生活方式方案对青少年肥胖的治疗效果。

设计、地点和患者：这是一项前瞻性、随机对照试验，纳入了 50 名年龄在 14 至 18 岁之间、BMI 高于 35 的澳大利亚墨尔本社区青少年，他们被分配到接受监督生活方式干预或接受胃束带术治疗，并随访 2 年。该研究于 2005 年 5 月至 2008 年 9 月进行。

主要观察指标

体重减轻。次要结局包括代谢综合征、胰岛素抵抗、生活质量和不良结局的变化。

结果

胃束带组 25 例患者中有 24 例和生活方式组 25 例患者中有 18 例完成了研究。胃束带组 21 例（84%）和生活方式组 3 例（12%）患者的体重减轻超过了 50%的多余体重，经年龄校正。总体而言，胃束带组的平均变化为体重减轻 34.6kg（95%CI，30.2-39.0），多余体重减轻 78.8%（95%CI，66.6%-91.0%），体重指数（BMI）降低 12.7 个单位（95%CI，11.3-14.2），BMI z 分数从 2.39（95%CI，2.05-2.73）变为 1.32（95%CI，0.98-1.66）。生活方式组的平均体重减轻量为 3.0kg（95%CI，2.1-8.1），多余体重减轻 13.2%（95%CI，2.6%-21.0%），BMI 降低 1.3 个单位（95%CI，0.4-2.9），BMI z 分数从 2.41（95%CI，2.21-2.66）变为 2.26（95%CI，1.91-2.43）。在入组时，胃束带组有 9 名（36%）参与者和生活方式组有 10 名（40%）参与者患有代谢综合征。24 个月时，胃束带组没有一人患有代谢综合征（P=0.008；McNemar χ2），而生活方式组 18 名完成者中有 4 人（22%）（P=0.13）。胃束带组的生活质量得到了改善，且无围手术期不良事件。然而，在随访期间，7 名患者中有 8 次（33%）需要进行修订手术，以治疗近端囊袋扩张或管道损伤。