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目的 对中国肥胖症患者应用西布曲明 (Sibutramine ,商品名 :诺美亭 ,德国基诺药厂 )的疗效及安全性进行评价。方法 2 5 1例年龄在 18～ 6 5岁、体重指数 (BMI)在 2 7～ 45kg/m2 的受试者 ,在进持续低热卡饮食的同时按 1:1的比例随机双盲给予西布曲明 (10 8例 ) 10mg/d或安慰剂(10 7例 )治疗 2 4周。结果 经 2 4周的治疗 ,西布曲明治疗组的体重降低了 (6 .5 2± 3.95 )kg ,显著大于安慰剂组 (3.18± 3.5 9)kg(P <0 .0 0 1) ;两组受试者体重的下降率分别是 (7.0± 5 .0 ) %和 (4 .0±4.0 ) %(P <0 .0 0 1) ;治疗组和对照组血糖水平的下降值 :空腹血糖下降 (0 .96± 1.48比 0 .35± 1.45 )mmol/L(P <0 .0 5 ) ;餐后 1小时血糖下降 (2 .17± 3.32比 0 .73± 2 .85 )mmol/L(P <0 .0 5 ) ;餐后 2小时血糖曲线下面积下降值分别为 (339.38± 35 9.90 )比 (2 0 3.33± 332 .6 3)mmol·min-1·L-1(P =0 .0 5 )。治疗组与对照组不良事件发生率分别为 5 9.2 %和 48.4%(P =0 .0 3) ,治疗组不良事件主要为头痛、头晕 (18.4%) ,便秘 (14.4%)和口干、发苦 (13.6 %)。不良事件大多轻微 ,在 4～ 8周内消失 ,不影响继续治疗。结论 西布曲明结合轻度低热卡饮食治疗可显著促进体重降低 ,并能改善部分肥胖症相关疾病的
Objective To evaluate the efficacy and safety of Sibutramine in Chinese obesity patients. Methods Twenty-five subjects, aged 18 to 65 years with a body mass index (BMI) of 27 to 45 kg / m2, were randomized to double blind for sibu Qu Ming (108 cases) 10mg / d or placebo (107 cases) for 24 weeks. Results After 24 weeks’ treatment, the body weight of sibutramine group was significantly lower than that of placebo group (6. 52 ± 3.95) kg (3.18 ± 3.5 9) kg (P 0 01). The body weight loss rates of the two groups were (7.0 ± 5.0)% and (4.0 ± 4.0)%, respectively (P <0.01); the decrease of blood glucose in the treatment group and the control group was: fasting Blood glucose decreased (0.96 ± 1.48 vs. 0.35 ± 1.45 mmol / L, P <0.05), and decreased 1 hour postprandial glucose (2.17 ± 3.32 vs. 0.73 ± 2.85 mmol / L (P <0.05). The area under the curve of blood glucose at 2 hours after meal was (339.38 ± 35 9.90) vs (20.33 ± 332.63) mmol · min-1 · L-1 = 0 .0 5). The incidence of adverse events in the treatment group and the control group were 52.2% and 48.4%, respectively (P = .0 3). The main adverse events in the treatment group were headache, dizziness (18.4%), constipation (14.4%) and dry mouth Bitter (13.6%). Adverse events are mostly mild, disappear in 4 to 8 weeks, does not affect the continued treatment. Conclusion Sibutramine combined with mild low-calorie diet can significantly reduce weight loss and improve some obesity-related diseases