西布曲明在中国肥胖症患者中的疗效及安全性分析

Efficacy and safety of sibutramine in Chinese obese patients

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 。

Objective To evaluate the clinical efficacy and safety of sibutramine (Reductile )in Chinese obese patients. Methods Obese adults (BMI 27～45 kg/m 2) in six research centers received sibutamine 10 mg or placebo one tablet each day with a controlled-energy diet for 24 weeks by randomized, double-blinded, placebo-controlled study. Results For intent-to-treat analysis, 125 sibutramine-treated subjects and 126 placebo-treated subjects were evaluated. After 24 weeks, sibutramine-treated patients lost more weight (6.52±3.95)kg than placebo-treated patients (3.18±3.59)kg(P<0.001). Sibutramine-treated patients showed significant decreases of fasting blood glucose (P<0.05), 1h postprandial blood glucose (P<0.05) and area under of glucose curve (P=0.05) in comparison with placebo-treated patients. Both groups had similar adverse-event profiles, the main adverse events of sibutramine-treatedpatientswereheadache,dizziness(18.4%),constipation (14.4%) and thirsty (13.6%), which were mostly mild and transient, and dissapeared within 4-8 weeks. There were no serious adverse events in both groups. Conclusion Sibutramine in conjunction with a low-energy diet results in more weight loss than placebo does during 24 weeks treatment. There is also an improvement in most blood glucose parameters. Sibutramine is well tolerated and offers a new approach to the management of obesity.