尼沙胺用于肥胖成人减肥:一项随机对照试验
Kishore M Gadde1, Deborah M Franciscy, H Ryan Wagner
1Obesity Clinical Trials Program, Department of Psychiatry, Duke University Medical Center, Durham, NC 27710, USA. gadde001@mc.duke.edu
JAMA
|April 10, 2003
概括
西胺,一种抗药物,在与低热量饮食相结合时,在肥胖的成年人中显著帮助减肥. 这项初步试验显示,在32周内,与安慰剂相比,尼萨米德的体重减少更大.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
- 肥胖问题研究研究
背景情况:
- 佐尼萨米德是一种抗药物,具有已知的血清和多巴胺活性.
- 在之前的zonisamide试验中,体重减轻被观察为不良影响.
- 这项研究探讨了尼萨米德作为减肥治疗的潜力.
研究的目的:
- 评估佐尼萨米德在促进肥胖成年人减肥方面的疗效.
- 在一项受控试验中,将zonizamide的减肥效应与安慰剂进行比较.
主要方法:
- 一项为期16周的随机,双盲,安慰剂对照试验,可选延长16周.
- 患有肥胖症的参与者 (n=60) 除了低热量饮食外,还接受了佐尼萨米德或安慰剂.
- 根据体重减轻的进展,佐尼萨米德的剂量被定位至600毫克/天.
主要成果:
- 在16周后 (P<.001) 佐尼萨米德治疗导致体重减轻 (5.9公斤) 与安慰剂 (0.9公斤) 相比显著增加 (P<.001).
- 到了第16周,57%的佐尼萨米德患者体重至少减少了5%,而安慰剂组的体重减少了10% (P<.001).
- 延长至32周的治疗表明,在zonizamide组 (9.2公斤) 与安慰剂 (1.5公斤) 相比,该组的体重持续下降 (P<.001).
结论:
- 佐尼萨米德与低热量饮食相结合,与安慰剂和饮食单独相比,显示出更高的减肥效果.
- 在这项初步肥胖治疗试验中,该药物耐受性良好,副作用最小.
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