在完全盲人中治疗非24小时睡眠和清醒障碍的Tasimelteon:两个多中心,随机,双面膜,安慰剂控制的第三阶段试验
Steven W Lockley1, Marlene A Dressman2, Louis Licamele2
1Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Department of Medicine, Harvard Medical School, Boston, MA, USA.
Lancet (London, England)
|October 16, 2015
概括
塔斯梅龙有效地治疗非24小时睡眠和清醒障碍的完全盲人. 在非24小时患者中,持续治疗对于维持昼夜节律的改善至关重要.
科学领域:
- 循环时间生物学
- 睡眠医学
- 药理学
背景情况:
- 非24小时睡眠和清醒障碍 (non-24) 影响大多数完全失明的人.
- 这种情况是由于光线无法重置生理节奏器.
- 作为双黑激素受体激动剂的Tasmelteon在非24治疗中进行了研究.
研究的目的:
- 在完全失明的非24岁患者中评估每日Tasimelteon的安全性和有效性.
- 为了评估tasimelteon的吸引和维持昼夜节律的能力.
- 在临床试验中比较tasimelteon与安慰剂的影响.
主要方法:
- 进行了两项随机双面试验 (SET和RESET).
- 参与者是18- 75岁的完全失明的成年人,其昼夜周期 (τ) 为≥24. 25小时.
- 训练时间定义为t ≤24. 1小时,其CI为95%,包括24. 0小时.
主要成果:
- 在SET中,20%的接受tasimelteon治疗的患者获得了引入,而接受安慰剂的患者只有3% (p=0. 0171).
- 24% 的受试者获得了临床反应,而安慰剂患者的比例为 0% (p=0. 0028).
- 在 RESET 试验中,90% 的继续接受治疗的患者继续接受治疗,而转换为安慰剂的患者则为 20% (p=0. 0026).
结论:
- 每天一次的测量可以成功地控制24小时以外的完全失明个体的昼夜节律.
- 持续治疗是维持这些生理节律的改善所必需的.
- 塔斯梅隆的安全性表现良好,治疗中断率与安慰剂相当.
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