盐酸西布曲明治疗单纯性肥胖的对照研究

目的评价盐酸西布曲明治疗单纯性肥胖患者的有效性和安全性.方法采用多中心、随机、双盲、安慰剂平行对照的研究方法.选择年龄18～65岁,体质指数(BMI)27～40的单纯性肥胖患者.口服盐酸西布曲明10mg/d或安慰剂1粒/d,24周.观察体重变化及临床和常规实验室检查结果以评价药物的疗效和安全性.结果有效病例233例,其中对照组113例,治疗组120例.从第4周起盐酸西布曲明组体重降低值即大于安慰剂组,至24周盐酸西布曲明组平均体重降低值为(6.8±3.1)kg,安慰剂组为(0.48±2.6)kg.治疗组不良反应的发生率高于安慰剂组,但症状轻微,易于耐受.结论盐酸西布曲明10mg/d,治疗单纯性肥胖是有效和安全的.

A randomized, double-blind, placebo-controlled,multicenter study on sibutramine in over-weighted and obese subjects

OBJECTIVES: To assess weight loss efficacy, safety and tolerability of sibutramine in simple obese subjects. METHODS: Randomized, double-blind, placebo-controlled clinical trial. Four hospital outpatient clinics in Shanghai, Chongqing, Shandong and Tianjin, respectively. Participants: 233 men and women, 18-65 years old, with body mass index (BMI) ranging from 27 to 40 kg/m2 were randomly divided into an intervened group and a placebo control group. Sibutramine 10 mg or placebo once a day. Main outcome measures: Body weight, routine laboratory and clinical safety monitoring. RESULTS: Of 233 eligible patients, 120 received sibutramine and 113 placebo. Weight reduction was significantly greater in the intervented group (6.8 +/- 3.1) kg than the placebo control group (0.48 +/- 2.6) kg from week 4 onwards to week 24 (P < 0.001). Some minor side effects were noticed in the subjects who took sibutramine. But the symptoms were light and short term. Sibutramine was well tolerated. CONCLUSIONS: Sibutramine 10 mg once a day is an effective and safe therapy for weight reduction in simple over-weighted and obese subjects.