根据 FDA 标准，内镜胃成形术治疗肥胖症的疗效：基于随机对照试验的系统评价和荟萃分析。
The Effectiveness of Endoscopic Gastroplasty for Obesity Treatment According to FDA Thresholds: Systematic Review and Meta-Analysis Based on Randomized Controlled Trials.
机构信息
Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of São Paulo Medical School, Dr. Arnaldo Av, 455, São Paulo, 01246-903, Brazil.
Bariatric and Metabolic Surgery Unit, Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil.
出版信息
Obes Surg. 2018 Sep;28(9):2932-2940. doi: 10.1007/s11695-018-3335-4.
Endoscopic bariatric therapies (EBTs) are promising alternatives to conventional surgery for obesity. The aim of this study is to compare efficacy and safety through a systematic review and meta-analysis of the endoscopic gastroplasty techniques versus conservative treatment. We searched MEDLINE, EMBASE, Cochrane CENTRAL, Lilacs/Bireme. Randomized controlled trials (RCTs) enrolling obese patients comparing endoscopic gastroplasty to sham or diet/exercise were considered eligible. Among 6014 records, three RCTs were selected for meta-analysis. The total sample was 459 patients (312 EBTs vs 147 control). Mean total body weight loss in the intervention group (IG) was 4.8% higher than the control group (CG) at 12 months (p = 0.01). The IG responder rate was 44.31% at 12 months. Therefore, the endoscopic gastroplasty is more effective than conservative therapies but do not achieve FDA thresholds.
内镜减重治疗（EBTs）是肥胖症传统手术的一种有前途的替代方法。本研究旨在通过对内镜胃成形术与保守治疗的系统评价和荟萃分析比较其疗效和安全性。我们检索了 MEDLINE、EMBASE、Cochrane 中央、Lilacs/Bireme。纳入比较内镜胃成形术与假手术或饮食/运动的肥胖患者的随机对照试验（RCT）被认为符合条件。在 6014 条记录中，选择了三项 RCT 进行荟萃分析。总样本为 459 名患者（312 例 EBT 与 147 例对照组）。干预组（IG）在 12 个月时的总体体重减轻比对照组（CG）高 4.8%（p=0.01）。IG 在 12 个月时的应答率为 44.31%。因此，内镜胃成形术比保守疗法更有效，但未达到 FDA 阈值。
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