盐酸西布曲明治疗单纯性肥胖的疗效与安全性观察

目的 评价盐酸西布曲明治疗单纯性肥胖的疗效与安全性。方法用多中心、随机、双盲、平行、安慰剂对照的研究方法,共观察240例,中途退出29例,全部完成例数为211例,其中治疗组103例,对照组108例,随机分为2组,清洗期7～10天,口服盐酸西布曲明片每天1 0 mg或安慰剂每天1片共1 2周,观察体重变化,并进行临床和实验室检查。结果从第2周起,治疗组体重降低大干安慰剂组,至1 2周,治疗组体重平均降低3.28 kg,安慰剂组0.25 kg,治疗组药物不良反应主要有口干、心率增快、便秘等,但症状轻,大部分能耐受。结论 盐酸西布曲明治疗单纯性肥胖有效且较安全。

Observation of efficacy and tolerability of sibutramine hydrochloride in the treatment of simple obesity

Objective Evaluation of efficacy and tolerability of sibutramine in the treatment of obese patients. Methods A randomized ,double blind, placebo controlled multicenter clinical trial was conducted. Two hundreds forty obese patients, aged 18~60years, were evaluated. In the first phase of the study (7~10days),the patients were given low-calorie diet, physical exercise. In the next stage, the double blind phase(12weeks), we compared placebo and sibutramine (10mg, ones a day).The criteria for evaluating efficacy were weight loss, reduction in body mass(BMI),and abdominal and hip circumferences. Tolerability was assessed based on reported profile(fasting glucose, total cholesterol and triglycerides), laboratory tests(renal and hepatic functions). Results We observed a greater weight loss(3.28kg, 4.42% vs 0.25kg, 0.32%) and a reduction in hip circumferences (2.24cm vs 0.58cm )in the sibutramine group than in the placebo group. Total effective rate was 65.0% in the sibutramine group , 13.0% in the placebo group(P<0.001), 35.8% of sibutramine-treated patients reported side effects,most commonly including dry mouth, constipation and a small increase in heart rate compared with 12.5% of patients receiving placebo. Side effects did not result in discontinuation of treatment.Conclusion Sibutramine is safe and effective in the treatment of obesity.