论文部分内容阅读
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、依从性高的减肥药
OBJECTIVE: To evaluate the efficacy and safety of sibutramine in reducing weight loss in individuals with simple obesity or body mass index (BMI) ≥ 25. Methods: placebo as a control for 8wk randomized double-blind, multicenter clinical study; test group, control group were enrolled in the subjects of 104 cases, 1 day before meals or after meals 1h oral sibutramine tablets 10mg Or the same number of placebo. After 8wk blindness, the experimental group continued to observe medication until 24wk. Results: Sibutramine significantly reduced waist circumference, hip circumference, BMI and body weight (P <0.01), with a total effective rate of 73.8% and a control group of 15.5%, P <0 .0 1. The impact on blood lipids and blood glucose was no significant difference between the two groups. The incidence of adverse reactions of sibutramine at the end of 8 weeks of treatment was 56.6% and that of the control group was 41.4%. The incidence of adverse effects of sibutramine at the end of 4wk was 35.7%. No serious adverse reactions were found. Conclusion: Sibutramine tablets are effective, less adverse reactions, convenient administration, high compliance diet pills