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西布曲明治疗单纯性肥胖的临床研究
作者:钟历勇 孙子林 杨兵全 李玲 董莉 葛祖恺 
单位:东南大学附属中大医院内分泌科,
关键词:单纯性肥胖 西布曲明 临床研究 
分类号:R589.2
出版年·卷·期(页码):2001·20·第二期(93-97)
摘要:

目的:评价西布曲明治疗单纯性肥胖病的临床疗效和安全性,并比较西布曲明和安慰剂对静息代谢率的影响。方法:采用随机、双盲、安慰剂平行对照、多中心的临床研究方法,对58例单纯性肥胖作为期24周的临床观察。结果:1.西布曲明能明显降低肥胖的各项指标,包括体重、体重指数、腰围、臀围,与治疗前相比,P<0.0001,而安慰剂组前后相比无显著差异。2.两组治疗前后血常规及生化指标均无显著差异(P>0.05)。3.西布曲明在治疗4、8、12周心率及舒张压有明显升高,但仍在正常范围内,安慰剂组无明显变化。西布曲明及安慰剂组静息代谢率的变化无明显差异。结论:西布曲明有明显的减肥作用,对静息代谢率无明显影响,但西布曲明能明显增加心率,升高舒张压。

Objective  To evaluate the clinical therapeutic efficacy and safety  of sibutramine to simple obesity and compare the effects of sibutramine and placebo on resting metabolic rate.Method  By means of random,double  blind,placebo  parallel control and multicentral trial,58 simple obesity volunteers were observed for 24 weeks.Results  1.Compared with placebo,sibutramine can reduce parameters of simple obesity,including body weight,body weight index,waist and hip size,significantly(  P  &lt;0.000?1).Whereas,there were no significant differences to be observed in the placebo group.2.In each group there were no significant differences to be observed in blood routine and biochemistry parameters before and  after the clinical trial.3.Sibutramine increased diastolic pressure significantly in the trial of 4,8 and 12 weeks,but the variation of the diastolic pressure still in the normal range,whereas there was no significant variation of diastolic pressure to be observed in placebo group.4.There were no significant differences of the variation of resting metabolic rate between sibutramine and placebo group during the clinical trial.Conclusion  Sibutramine,compared with placebo,can significantly reduce bodyweight and increase diastolic pressure,whereas no significant variations of resting metabolic rate to be observed.

参考文献:

[1] Rossner S. Long-term intervention strategies in obesity treatment, 1995(Suppl)
[2] JACHSON H C, BEARHAN M C, MAZURKIEWICZ S E. Investigation of the mechanisms underlying the hypophagic effects of the 5-HT and NA uptake inhibitor sibutramine in the rat, 1996
[3] 邹大进. 实用临床肥胖学, 1999
[4] PISUNYER. Guidelines for the approval and use of drugs to treat obesity-a position paper of the North American Association for the Study of Obesity, 1995(3)
[5] ROLLS B J, SHIDE D J, THORWART M L. Sibutramine reduces food intake in non-dieting women with obesity, 1998(1)
[6] LEAN M E. Sibutramine-a review of clinical efficacy, 1997  

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