Translational Research Institute for Metabolism and Diabetes, Florida Hospital/Burnham Institute, Winter Park, FL 32789, USA.
Diabetes Obes Metab. 2013 Sep;15(9):863-6. doi: 10.1111/dom.12095. Epub 2013 Apr 5.
The effects of combination naltrexone/bupropion therapy on body composition and visceral adipose tissue (VAT) mass were examined in a subset (n = 107) of obese subjects from a Phase 2 trial that compared the efficacy and safety of placebo, naltrexone monotherapy, bupropion monotherapy or one of three naltrexone/bupropion dose combinations for 24 weeks. Body composition data were obtained using dual-energy X-ray absorptiometry and computed tomography. Eighty subjects completed the substudy. Naltrexone/bupropion resulted in weight loss and a greater reduction in body fat (-14.0 ± 1.3%) than placebo (-4.0 ± 2.0%), naltrexone monotherapy (-3.2 ± 2.5%) and bupropion monotherapy (-4.1 ± 2.9%; all p < 0.01). Reduction in VAT mass was also greater with naltrexone/bupropion (-15.0 ± 1.8%) than placebo (-4.6 ± 2.7%), naltrexone monotherapy (-0.1 ± 3.5%) and bupropion monotherapy (-2.3 ± 4.2%; all p < 0.01). Reductions in body fat and VAT mass with naltrexone/bupropion were proportional with weight loss. Weight loss with naltrexone/bupropion was not associated with a greater relative reduction in lean mass than placebo or the monotherapies.
在一项为期 24 周的 2 期试验中，比较了安慰剂、纳曲酮单药治疗、安非他酮单药治疗和三种纳曲酮/安非他酮剂量组合之一的疗效和安全性，在肥胖受试者亚组（n=107）中检查了联合纳曲酮/安非他酮治疗对身体成分和内脏脂肪组织（VAT）质量的影响。使用双能 X 射线吸收法和计算机断层扫描获得身体成分数据。80 名受试者完成了子研究。与安慰剂（-4.0±2.0%）、纳曲酮单药治疗（-3.2±2.5%）和安非他酮单药治疗（-4.1±2.9%）相比，纳曲酮/安非他酮导致体重减轻和体脂减少更多（-14.0±1.3%，所有 p<0.01）。与安慰剂（-4.6±2.7%）、纳曲酮单药治疗（-0.1±3.5%）和安非他酮单药治疗（-2.3±4.2%）相比，纳曲酮/安非他酮治疗也导致 VAT 质量减少更多（所有 p<0.01）。纳曲酮/安非他酮的体脂和 VAT 质量减少与体重减轻成正比。纳曲酮/安非他酮治疗的体重减轻与安慰剂或单药治疗相比，并不伴有瘦体重的相对减少更大。
