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通过可调胃束带减肥和改善日间嗜睡:APEXX 研究的 2 年中期结果。

Weight loss through adjustable gastric banding and improvement in daytime sleepiness: 2 year interim results of APEX study.

机构信息

Health First Medical Group , Melbourne, FL , USA.

出版信息

Curr Med Res Opin. 2014 May;30(5):849-55. doi: 10.1185/03007995.2013.874991. Epub 2014 Jan 17.

Abstract

OBJECTIVE

Obesity is one factor associated with an increased risk of obstructive sleep apnea (OSA). This study reports the investigator-reported resolution or improvement of OSA and improvements in sleep-related quality of life (QOL) 2 years after surgical placement of the LAP-BAND AP * (LBAP) system.

RESEARCH DESIGN AND METHODS

The LBAP Experience (APEX) study is an ongoing 5 year, prospective, observational study assessing change in weight, comorbidities, and QOL after LBAP implantation. This is an interim analysis of patients with evaluable data at 24 months who had OSA at baseline.

CLINICAL TRIAL REGISTRATION

NCT00501085.

RESULTS

At baseline, 117 of 395 patients (29.6%; mean body mass index [BMI], 45.0 kg/m2) reported OSA; of these, 57 had evaluable patient-reported outcome data at 2 years. Investigator-reported resolution or improvement of OSA was 69% and 86% at post-operative years 1 and 2, respectively. Patients reporting resolution, improvement, or no change in OSA experienced mean changes in BMI and percentage of weight loss of -9.7 kg/m(2)/-21.7%, -8.3 kg/m(2)/-18.7%, and -5.7 kg/m(2)/-13.2%, respectively (n = 54). Mean 2 year BMI was not statistically different between the groups (p = not significant). Mean scores for all Epworth Sleepiness Scale responses for the OSA population improved by -0.43 from baseline (p < 0.0001; n = 78) compared with -0.29 for patients without OSA at baseline (n = 177; p = 0.037 between groups). In addition, the overall study population experienced resolution and/or improvement in other obesity-related comorbidities, such as type 2 diabetes (96%) and hypertension (91%).

CONCLUSIONS

These data support that surgically facilitated weight loss can improve sleep-related QOL and may result in resolution or improvement of OSA; the degree of weight loss may be related to these changes.

摘要

目的

肥胖是阻塞性睡眠呼吸暂停(OSA)风险增加的一个因素。本研究报告了 2 年后手术放置 LAP-BAND AP*(LBAP)系统后,OSA 的研究者报告的缓解或改善以及与睡眠相关的生活质量(QOL)的改善。

研究设计和方法

LBAP 经验(APEX)研究是一项正在进行的 5 年前瞻性观察研究,评估 LBAP 植入后体重、合并症和 QOL 的变化。这是基线时患有 OSA 的可评估数据的 24 个月患者的中期分析。

临床试验注册

NCT00501085。

结果

在基线时,395 名患者中有 117 名(29.6%;平均体重指数[BMI],45.0kg/m2)报告有 OSA;其中,57 名患者在 2 年内有可评估的患者报告结局数据。研究者报告 OSA 的缓解或改善分别为术后 1 年和 2 年的 69%和 86%。报告 OSA 缓解、改善或无变化的患者,BMI 平均变化为-9.7kg/m2/-21.7%、-8.3kg/m2/-18.7%和-5.7kg/m2/-13.2%(n=54)。各组之间的 2 年平均 BMI 无统计学差异(p=无显著意义)。OSA 人群的所有 Epworth 嗜睡量表反应的平均评分从基线降低了-0.43(p<0.0001;n=78),而基线无 OSA 的患者降低了-0.29(n=177;p=0.037 组间)。此外,总体研究人群还改善了其他肥胖相关的合并症,如 2 型糖尿病(96%)和高血压(91%)。

结论

这些数据支持手术减肥可以改善与睡眠相关的 QOL,并可能导致 OSA 的缓解或改善;减肥的程度可能与这些变化有关。

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