盐酸西布曲明治疗单纯性肥胖的疗效与安全性

Efficacy and safety of sibutramine in simple over-weighted and obese subjects

目的 :评价盐酸西布曲明治疗单纯性肥胖患者的疗效与安全性。方法 :采用随机、双盲、安慰剂平行对照研究方法 ,选择 80例年龄 18～ 6 0岁 ,体重指数≥ 2 5kg/m2 的单纯性肥胖患者 ,随机分为两组 :口服盐酸西布曲明片 (治疗组 ) 10mg/d ;口服安慰剂片 (对照组 )每天 1片共 12周。结果 :有效病例数为 6 6例 ,其中治疗组 31例 ,对照组 35例 ;经 12周治疗 ,治疗组体重平均降低值为 (2 .7± 2 .5 )kg ,显著大于对照组 (- 0 .1± 1.8)kg(P <0 .0 1) ;治疗组不良反应发生率为 5 8.0 %,高于对照组 2 5 .7%(P <0 .0 5 ) ,但症状轻 ,多在 1～ 2周内消失 ,不影响继续治疗。结论 :盐酸西布曲明 10mg/d能有效降低体重 ,治疗的安全性及耐受性较好 ,适用于单纯性肥胖患者的治疗。

Objective To evaluate the efficacy and safety of sibutramine in simple over weighted and obese subjects. Methods A randomized, double blind, and placebo controlled clinical trial was carried out.Eighty men and women, 18～60 years old, with body mass index surpassing 25 kg/m 2 were randomly divided into 2 groups: receiving sibutramine 10 mg/d and placebo one tablet each day for 12 weeks. Results Of the 66 eligible patients, 31 received sibutramine and 35 received placebo. After 12 weeks, sibutramine treated patients lost more weight[(2.7±2.5)kg] than placebo treated patients[( 0.1±1.8)kg]( P <0.01).The side effects of sibutramine treated patients and placebo treated patients were 58.0% and 25.7%, respectively ( P <0.05), which were mostly mild and transient, disappeared within 1～2 weeks, and did not interrupt the therapy.Conclusion Sibutramine results in more weight loss than placebo does during the 12 week treatment. Sibutramine 10 mg each day is well tolerated to patients and effective and safe therapy for weight reduction in simple over weighted and obese subjects.