Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.
Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.
复制标题
ReCharge 试验中迷走神经阻滞 (vBloc) 治疗肥胖的两年结果。
DOI：
10.1007/s11695-016-2325-7
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发表时间：
2017-01
期刊：
影响因子：
2.9
通讯作者：
Shikora, Scott A.
中科院分区：
文献类型：
--
作者：
Apovian, Caroline M.;Shah, Sajani N.;Wolfe, Bruce M.;Ikramuddin, Sayeed;Miller, Christopher J.;Tweden, Katherine S.;Billington, Charles J.;Shikora, Scott A.
ReCharge 试验表明，迷走神经阻断装置 (vBloc) 是治疗中度至重度肥胖的安全有效的方法。本报告总结了 24 个月的结果。体重指数 (BMI) 为 40 至 45 kg/m2 或 35 至 40 kg/m2 且至少患有一种合并症的参与者被随机分配接受 vBloc 治疗或假干预，为期 12 个月。 12 个月后，随机接受 vBloc 的参与者继续开放标签 vBloc 治疗，这也是本报告的重点。体重减轻、不良事件、共病风险因素和生活质量 (QOL) 将持续 5 年进行评估。 24 个月时，仍有 123 名 (76%) vBloc 参与者参与试验。 24 个月时出现的参与者 (n = 103) 平均超重减轻 (EWL) 为 21%（总体重减轻 8% [TWL]）； 58% 的参与者的 TWL ≥5%，34% 的 TWL ≥10%。在术前数值异常的参与者子集中，平均 LDL (-16 mg/dL) 和 HDL 胆固醇 (+4 mg/dL)、甘油三酯 (-46 mg/dL)、HbA1c (-0.3%) 以及收缩压 (-11 mmHg) 和舒张压 (-10 mmHg) 均显着改善。生活质量指标显着改善。胃灼热/消化不良和植入部位疼痛是最常报告的不良事件。主要相关严重不良事件发生率为 4.3%。 vBloc 疗法在 2 年内持续带来具有医学意义的体重减轻，且安全性良好。 https://clinicaltrials.gov/ct2/show/NCT01327976
The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. Participants with body mass index (BMI) 40 to 45 kg/m2, or 35 to 40 kg/m2 with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (−16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), HbA1c (−0.3 %), and systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. https://clinicaltrials.gov/ct2/show/NCT01327976
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影响因子：
2.9
作者：
Sarr, Michael G.;Billington, Charles J.;Rosenthal, Raul
通讯作者：
Rosenthal, Raul
DOI：
10.1038/oby.2001.13
发表时间：
2001-02-01
期刊：
OBESITY RESEARCH
影响因子：
--
作者：
Kolotkin, RL;Crosby, RD;Williams, GR
通讯作者：
Williams, GR
DOI：
10.1056/nejmoa1401329
发表时间：
2014-05-22
期刊：
The New England journal of medicine
影响因子：
--
作者：
Schauer PR;Bhatt DL;Kirwan JP;Wolski K;Brethauer SA;Navaneethan SD;Aminian A;Pothier CE;Kim ES;Nissen SE;Kashyap SR;STAMPEDE Investigators
通讯作者：
STAMPEDE Investigators
影响因子：
3.3
作者：
Shikora SA;Wolfe BM;Apovian CM;Anvari M;Sarwer DB;Gibbons RD;Ikramuddin S;Miller CJ;Knudson MB;Tweden KS;Sarr MG;Billington CJ
通讯作者：
Billington CJ
影响因子：
3.8
作者：
Camilleri, M.;Toouli, J.;Anvari, M.
通讯作者：
Anvari, M.