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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 ,安全性较好
Objective: To observe the efficacy and safety of sibutramine capsule in the treatment of simple obesity. Methods: One hundred thirty-three simple obesity patients were randomly divided into two groups. In the sibutramine group, 69 cases were given orally sibutramine capsules 10 ~ 20mg, qd × 2 4wk. Placebo group 70 cases, oral analog capsules, usage and sibutramine group. In the sibutramine group and the placebo group, 61 and 59 were completed, respectively. RESULTS: After 24 weeks of treatment, the body weight and the body mass index (BMI) of sibutramine group were significantly decreased (4 ± s 4 and kg · m -2, 1.8 ± 1.8, (0 .6 ± 3) kg and (0 .2 ± 1. 2) kg · m-2 respectively. There was significant difference between the two groups (P <0.01). Adverse reactions in sibutramine group were mainly dry mouth, anorexia, etc. The incidence rate was 34%, higher than placebo group (10%), P <0.01, but no serious adverse reactions occurred. Conclusion: Sibutramine capsule can effectively reduce the weight of simple obesity patients, and is safe