西布曲明胶囊治疗单纯性肥胖  

Sibutramine capsules for treatment of simple obesity

作　　者：李启富[1] 李蓉[1] 罗蓉[1] 汪志红[1] 刘智平[1] 何军[1] 粟绍初[1] 李萍[1] 张素华[1] 舒昌达[1] 

机构地区：[1]重庆医科大学附属第一医院内分泌科,重庆400016

出　　处：《中国新药与临床杂志》2002年第7期401-404,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :观察西布曲明胶囊治疗单纯性肥胖症的疗效及安全性。方法 :1 3 9例单纯性肥胖病人随机分为 2组。西布曲明组 69例 ,口服西布曲明胶囊 1 0～ 2 0mg ,qd× 2 4wk。安慰剂组 70例 ,口服模拟胶囊 ,用法同西布曲明组。西布曲明组和安慰剂组完成试验者分别为 61例、5 9例。结果 :治疗 2 4wk后 ,西布曲明组体重减轻 (4±s 4)kg ,体重指数(BMI)下降 (1 .8± 1 .8)kg·m-2 ,安慰剂组体重、BMI分别增加 (0 .6± 3 )kg和 (0 .2± 1 .2 )kg·m-2 ,2组比较差异有非常显著意义 (P <0 .0 1 )。西布曲明组不良反应主要为口干、厌食等 ,发生率为 3 4% ,高于安慰剂组 (1 0 % ) ,P <0 .0 1 ,但无严重不良反应发生。结论 :西布曲明胶囊能有效降低单纯性肥胖病人的体重 。AIM: To evaluate the efficacy and safety of sibutramine capsules on simple obesity. METHODS: One hundred and thirty nine obese patients were randomly divided into sibutramine group and control group. Sixty nine patients in the sibutramine group received sibutramine capsules 10 20 mg, qd, for 24 wk. Seventy patients in the control group took placebo. Sixty one patients in the sibutramine group and fifty nine patients in the control group completed the trial. RESULTS: After 24 wk treatment, the average weight and BMI in the sibutramine group decreased (4±4) kg and (1.8±1.8) kg·m -2 respectively and those in the control group increased (1±3) kg and (0.2±1.2) kg·m -2 respectively, and there was a significant difference between two groups ( P <0.01). Adverse reaction rate in the sibutramine group was 34 %, significantly higher than that in the control group (10 %, P < 0.01 ). The common adverse reactions were dry mouth, insomnia, and so on. No serious adverse reaction was observed. CONCLUSION: Sibutramine can effectively decrease the body weight of obese patients and it is safe.

关 键 词：西布曲明 肥胖症 体重 双盲法 随机对照试验 治疗 

分 类 号：R589.205[医药卫生—内分泌]