西布曲明片治疗单纯性肥胖的临床研究  

Clinical trial of sibutramine in treatment of simple obesity

作　　者：周燕文[1] 于志清[1] 罗左杰[1] 欧阳玲莉[1] 雷闽湘[2] 段文若[3] 刘红[1] 邓宏明[1] 杨正鸿[1] 张英健[2] 徐国士[3] 

机构地区：[1]广西医科大学第一附属医院,广西南宁530027 [2]湖南医科大学湘雅医院,湖南长沙410008 [3]青岛市立医院,山东青岛266011

出　　处：《中国新药与临床杂志》2003年第7期395-399,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :评价西布曲明 (sibutramine)对单纯性肥胖或体重指数 (BMI)≥ 2 5的超重者的减肥疗效及安全性。方法 :以安慰剂作为对照进行 8wk的随机双盲、多中心临床研究 ;试验组、对照组各纳入受试者 10 4例 ,每日 1次饭前或饭后 1h口服西布曲明片 10mg或相同片数的安慰剂。 8wk启盲后 ,试验组继续用药观察至 2 4wk。结果 :西布曲明可明显减少受试者的腰围、臀围、BMI、体重 (P <0 .0 1) ,总有效率为 73.8% ,对照组为 15 .5 % ,P <0 .0 1。对血脂及血糖的影响 2组间差异无显著意义。治疗至 8wk末西布曲明不良反应发生率为5 8.6% ,对照组为 4 1.4 %。 2 4wk末西布曲明不良反应发生率为 35 .7%。未发现严重的不良反应。结论 :西布曲明片是疗效肯定、不良反应较轻、给药方便。AIM:To evaluate the efficacy and safety of sibutramine for simple obesity or overweight with body mass index (BMI) no less than 25. METHODS: Double-blind randomized controlled multicenter clinical trial for 8 wk was conducted compared with placebo. One hundred and four volunteers in each group received sibutramine 10 mg or the same does of placebo po, qd, before meal or 1 h after meal. After 8 wk blind trial, the application of the drug was observed up to wk 24 in sibutramine treatment group. RESULTS: Sibutramine could obviously reduce the waist circumference, hip circumference, BMI, body mass (P<0.01). The total effective rate was 73.8 % in treatment group while that was 15.5 % in placebo controlled group (P<0.01). There were no statistical differences in plasma adipose levels and blood sugar levels between two groups. The adverse reaction rate was 58.6 % and that of the placebo group was 41.4 % in the first 8 wk treatment and that in all 24 wk was 35.7 % in sibutramine treatment group. No serious adverse drug reaction could be found. CONCLUSION:The sibutramine is an effective weight loss drug with mild adverse reactions, simple administration and higher compliance.

关 键 词：西布曲明片 单纯性肥胖 给药方案 减肥疗效 不良反应 

分 类 号：R971[医药卫生—药品] R589.2[医药卫生—药学]