在睡前服用沃诺雷克桑特后的早晨驾驶表现:使用驾驶模拟器的随机临床试验
Yusuke Miyazaki1, Kunihiro Iwamoto2, Daiji Kambe1
1Development Headquarters, Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.
作为一种新型的素受体抗剂,Vornorexant没有影响驾驶性能. 在健康参与者中,该研究没有发现诺药对第二天早上的驾驶能力有临床意义的残留作用.
科学领域:
- 药理学
- 神经科学
- 睡眠医学
背景情况:
- 镇静性催眠药可以降低驾驶能力,类似于0.05%- 0.08%的血液酒精度.
- 素受体抗剂是一种用于治疗失眠的新型药物.
- 评估残留驾驶障碍对于患者的安全至关重要.
研究的目的:
- 评估单次和重复剂量使用后第二天早上的残留驾驶性能.
- 为了与安慰剂和已知镇静催眠药佐皮克隆进行比较.
- 确定沃诺雷克桑的作用是否超过预先定义的临床意义上的损伤值.
主要方法:
- 在健康的日本参与者中进行四方交叉双盲研究.
- 在8个连续的晚上服用伏诺雷克桑 (10和20毫克),安慰剂和佐皮克隆.
- 在第2天和第9天,使用经过验证的驾驶模拟器测量横向位置的标准偏差 (SDLP) 进行驾驶性能评估.
主要成果:
- 与安慰剂相比,沃诺雷克桑 (10和20毫克) 并没有显著增加SDLP.
- 沃诺雷克桑对SDLP影响的90%置信区间的上限低于临床显著的值.
- 佐皮克隆导致驾驶性能显著下降,作为积极对照.
结论:
- 单次和重复服用沃诺雷克桑特 (10和20毫克) 并没有导致临床上有意义的驾驶能力下降.
- 弗诺雷克桑似乎是治疗失眠的安全选择,而不会导致第二天早上残留的驾驶障碍.
- 这些发现支持沃诺雷克桑在临床实践中用于睡眠障碍.
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