睡眠时间转换后的过渡性失眠的黑色素激素agonisttasimelteon (VEC-162):两个随机对照的多中心试验
Shantha Mw Rajaratnam1, Mihael H Polymeropoulos, Dennis M Fisher
1Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.
Lancet (London, England)
|December 5, 2008
概括
塔西梅尔顿通过改善睡眠启动和维持来有效治疗暂时的失眠. 这种黑激素激动剂也会改变昼夜节律,为睡眠障碍管理提供了潜力.
科学领域:
- 睡眠医学 睡眠医学
- 时间生物学 时间生物学
- 药理学 药理学是指药理学的学科.
背景情况:
- 循环节律睡眠障碍是失眠的重要原因之一.
- 过渡性失眠通常是由于睡眠和觉醒时间的变化造成的.
- 对于治疗这种睡眠障碍的方法,正在研究美拉宁激动剂.
研究的目的:
- 在II期研究中确定tasimelteon的疗效和生理机制.
- 在第三阶段研究中,证实Tasimelteon对暂时失眠的疗效.
主要方法:
- 进行了两项随机,双盲,安慰剂控制的研究 (II期和III期).
- 参与者接受了不同剂量的tasimelteon或安慰剂.
- 睡眠效率,睡眠延迟和昼夜阶段是主要的疗效指标.
主要成果:
- 在这两项研究中,Tasimelteon减少了睡眠延迟和提高了睡眠效率.
- 观察到血黑色素节律的剂量依赖的变化.
- 在tasimelteon和安慰剂组之间,不良事件的频率是可比的.
结论:
- 在睡眠时间突然提前后,Tasimelteon改善了睡眠的启动和维护.
- 药物同时改变了内源的昼夜节律.
- 在昼夜节律睡眠障碍中,Tasimelteon证明了对过渡性失眠的治疗潜力.
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