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EndoBarrier胃肠道内衬对肥胖症和2型糖尿病的影响:一项系统评价和荟萃分析。

Effect of the EndoBarrier Gastrointestinal Liner on obesity and type 2 diabetes: a systematic review and meta-analysis.

作者信息

Rohde U, Hedbäck N, Gluud L L, Vilsbøll T, Knop F K

机构信息

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.

GastroUnit, Medical Section, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.

出版信息

Diabetes Obes Metab. 2016 Mar;18(3):300-5. doi: 10.1111/dom.12603. Epub 2016 Jan 15.

Abstract

Compared with bariatric surgery, less invasive and reversible techniques to counteract obesity and type 2 diabetes (T2D) have been developed, including the EndoBarrier Gastrointestinal Liner [duodenal-jejunal bypass sleeve (DJBS)]. We conducted a systematic review and meta-analyses of eligible trials to evaluate the efficacy and safety of the DJBS. Five randomized controlled trials (RCTs; 235 subjects) and 10 observational studies (211 subjects) were included. The risk of bias was evaluated as high in all studies. The mean body mass index ranged from 30 to 49.2 kg/m(2) and 10-100% of the subjects had T2D. Meta-analysis showed that the DJBS was associated with significant mean differences in body weight and excess weight loss of -5.1 kg [95% confidence interval (CI) -7.3, -3.0; four trials; n = 151; I(2)  = 37%] and 12.6% (95% CI 9.0, 16.2; four trials; n = 166; I(2)  = 24%), respectively, compared with diet modification. The mean differences in glycated haemoglobin (-0.9%; 95% CI -1.8, 0.0) and fasting plasma glucose (-3.7 mM; 95% CI -8.2, 0.8) among subjects with T2D did not reach statistical significance. Adverse events consisted mainly of abdominal pain, nausea and vomiting. No deaths occurred. Future high-quality long-term RCTs are needed to further assess efficacy and safety.

摘要

与减肥手术相比,已开发出侵入性较小且可逆的技术来对抗肥胖症和2型糖尿病(T2D),包括EndoBarrier胃肠道内衬[十二指肠-空肠旁路套管(DJBS)]。我们对符合条件的试验进行了系统评价和荟萃分析,以评估DJBS的疗效和安全性。纳入了五项随机对照试验(RCT;235名受试者)和十项观察性研究(211名受试者)。所有研究的偏倚风险均被评估为高。平均体重指数范围为30至49.2kg/m²,10%-100%的受试者患有T2D。荟萃分析表明,与饮食调整相比,DJBS在体重和超重减轻方面具有显著的平均差异,分别为-5.1kg[95%置信区间(CI)-7.3,-3.0;四项试验;n = 151;I² = 37%]和12.6%(95%CI 9.0,16.2;四项试验;n = 166;I² = 24%)。T2D受试者的糖化血红蛋白(-0.9%;95%CI -1.8,0.0)和空腹血糖(-3.7mM;95%CI -8.2,0.8)的平均差异未达到统计学意义。不良事件主要包括腹痛、恶心和呕吐。无死亡病例发生。未来需要高质量的长期RCT来进一步评估疗效和安全性。

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