Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study.
Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study.
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DOI：
10.1007/s11695-016-2143-y
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发表时间：
2016-05
期刊：
影响因子：
2.9
通讯作者：
Shikora SA
中科院分区：
文献类型：
--
作者：
Morton JM;Shah SN;Wolfe BM;Apovian CM;Miller CJ;Tweden KS;Billington CJ;Shikora SA
迷走神经阻断(VBLOC)治疗中重度肥胖是一种安全有效的治疗方法。这份报告总结了VBLOC疗法在预先指定的中度肥胖患者亚组中的安全性和有效性。充电试验是一项双盲随机对照临床试验，参与者的体重指数(BMI)为40-45或35-40千克/平方米，至少有一种与肥胖相关的共病情况。参与者被随机分成2：1组，植入VBLOC或带有体重管理咨询的假装置。84名受试者在随机分组时有中度肥胖(BMI 35-40 mg/m2)。53名参与者被随机分为VBLOC组和31名Sham组。符合条件的肥胖相关合并症包括血脂异常(73%)、高血压(58%)、睡眠呼吸暂停(33%)和2型糖尿病(8%)。VBLOC组在12个月时超额减重百分比(%EWL)为33%(总减重百分比(%TWL))，而假治疗组为19%EWL(6%TWL)(治疗差异14个百分点，95%CI，7-22；p <； 0.0001)。VBLOC在12个月内常见的不良事件是烧心/消化不良和植入部位疼痛；据报道，大多数事件为轻度或中度。在中度肥胖和耐受性良好的并发症的参与者中，VBLOC治疗导致的体重减轻显著高于假控制。
Vagal nerve blockade (vBloc) therapy was shown to be a safe and effective treatment for moderate to severe obesity. This report summarizes the safety and efficacy of vBloc therapy in the prespecified subgroup of patients with moderate obesity. The ReCharge Trial is a double-blind, randomized controlled clinical trial of participants with body mass index (BMI) of 40–45 or 35–40 kg/m2 with at least one obesity-related comorbid condition. Participants were randomized 2:1 to implantation with either a vBloc or sham device with weight management counseling. Eighty-four subjects had moderate obesity (BMI 35–40 kg/m2) at randomization. Fifty-three participants were randomized to vBloc and 31 to sham. Qualifying obesity-related comorbidities included dyslipidemia (73 %), hypertension (58 %), sleep apnea (33 %), and type 2 diabetes (8 %). The vBloc group achieved a percentage excess weight loss (%EWL) of 33 % (11 % total weight loss (%TWL)) compared to 19 % EWL (6 % TWL) with sham at 12 months (treatment difference 14 percentage points, 95 % CI, 7–22; p < 0.0001). Common adverse events of vBloc through 12 months were heartburn/dyspepsia and implant site pain; the majority of events were reported as mild or moderate. vBloc therapy resulted in significantly greater weight loss than the sham control among participants with moderate obesity and comorbidities with a well-tolerated safety profile.