Suplicy H, Boguszewski C L, dos Santos C M C, do Desterro de Figueiredo M, Cunha D R, Radominski R
Endocrine Division (SEMPR), Department of Internal Medicine, Parana Federal University, Curitiba, Brazil.
Int J Obes (Lond). 2014 Aug;38(8):1097-103. doi: 10.1038/ijo.2013.225. Epub 2013 Nov 29.
No long-term studies have compared centrally acting drugs for treating obesity.
To compare the efficacy and safety of diethylpropion (DEP), fenproporex (FEN), mazindol (MZD), fluoxetine (FXT) and sibutramine (SIB) in promoting weight loss.
A prospective, randomized, placebo (PCB)-controlled study conducted at a single academic institution.
A total of 174 obese premenopausal women.
Participants randomly received DEP 75 mg (n=28), FEN 25 mg (n=29), MZD 2 mg (n=29), SIB 15 mg (n=30), FXT 20 mg (n=29) or PCB (n=29) daily over 52 weeks. Diet and physical activity were encouraged.
The primary endpoints were changes in body weight and the proportion of women who achieved at least 5% weight loss by week 52 in the intent-to-treat population. Other measurements included anthropometry, safety, metabolic and cardiovascular parameters.
Weight loss was greater than PCB (-3.1±4.3 kg) with DEP (-10.0±6.4 kg; P<0.001), SIB (-9.5±5.9 kg; P<0.001), FEN (-7.8±6.9 kg; P<0.01) and MZD (-7.4±4.9 kg; P<0.01) but not with FXT (-2.5±4.1 kg). Ten (33.3%) women lost⩾5% of their initial weight with PCB, compared with 20 (71.4%; P<0.001) with DEP, 20 (69%; P<0.02) with FEN, 21 (72.4%; P<0.01) with MZD, 22 (73.3%; P<0.001) with SIB and 10 (35.5%) with FXT. Each medically treated group experienced more adverse events compared with PCB (P<0.001). Compared with PCB, constipation was more prevalent with DEP, SIB and MZD (P<0.01); anxiety was more prevalent with DEP (P=0.01); and irritability occurred more frequently with DEP and FEN (P=0.02). Significant improvements in the depression and anxiety scores, binge-eating episodes and quality of life correlated with weight loss.
The centrally acting drugs DEP, FEN, MZD and SIB were more effective than PCB in promoting weight loss in obese premenopausal women, with a satisfactory benefit-risk profile.
尚无长期研究对用于治疗肥胖症的中枢作用药物进行比较。
比较二乙丙胺苯丙酮（DEP）、芬普雷司（FEN）、马吲哚（MZD）、氟西汀（FXT）和西布曲明（SIB）在促进体重减轻方面的疗效和安全性。
在一家学术机构进行的一项前瞻性、随机、安慰剂（PCB）对照研究。
总共174名肥胖的绝经前女性。
参与者在52周内随机每日接受75毫克DEP（n = 28）、25毫克FEN（n = 29）、2毫克MZD（n = 29）、15毫克SIB（n = 30）、20毫克FXT（n = 29）或PCB（n = 29）。鼓励进行饮食和体育活动。
主要终点是意向性治疗人群中体重的变化以及到第52周时体重减轻至少5%的女性比例。其他测量指标包括人体测量学、安全性、代谢和心血管参数。
与PCB组（-3.1±4.3千克）相比，DEP组（-10.0±6.4千克；P<0.001）、SIB组（-9.5±5.9千克；P<0.001）、FEN组（-7.8±6.9千克；P<0.01）和MZD组（-7.4±4.9千克；P<0.01）的体重减轻更明显，但FXT组（-2.5±4.1千克）无明显差异。PCB组有10名（33.3%）女性体重减轻了≥初始体重的5%，而DEP组为20名（71.4%；P<0.001），FEN组为20名（69%；P<0.02），MZD组为21名（72.4%；P<0.01），SIB组为22名（73.3%；P<0.001），FXT组为10名（35.5%）。与PCB组相比，每个药物治疗组的不良事件更多（P<0.001）。与PCB组相比，DEP、SIB和MZD组便秘更常见（P<0.01）；DEP组焦虑更常见（P = 0.01）；DEP和FEN组易怒更频繁（P = 0.02）。抑郁和焦虑评分、暴饮暴食发作次数和生活质量的显著改善与体重减轻相关。
在促进肥胖绝经前女性体重减轻方面，中枢作用药物DEP、FEN、MZD和SIB比PCB更有效，且效益风险比令人满意。
