【罂粟摘要】口服右美托咪定促进人类非快速动眼睡眠第二阶段
口服右美托咪定促进人类非快速动眼睡眠第二阶段
背景:右美托咪定的给药仅限于高度监测的护理环境,因为它只能在人体内作为静脉药物使用。右旋美托咪定口服制剂可将其应用范围扩大到所有护理场所。作者研究了右美托咪定胶囊固体口服制剂对睡眠多导睡眠图的影响。
方法:作者对右美托咪定的固体口服制剂(700 mcg;n=15)进行了单点、安慰剂对照、随机、交叉、双盲的II期研究。主要观察指标是多导睡眠图监测的睡眠质量。次要观察指标包括分别在夜间和早上对每个受试者进行运动顺序任务和精神运动警戒任务的表现,以评估运动记忆巩固和精神运动功能。此外,还进行了睡眠问卷调查。
结果:口服右美托咪定可使非快速动眼睡眠第二阶段(非快速动眼)睡眠时间延长63(95%CI,19-107)分钟(P=0.010),快速动眼(REM)睡眠时间缩短42(5-78)分钟(P=0.031)。口服安慰剂睡眠后(7.9%;P=0.003)夜间运动顺序任务表现有所改善,但口服右美托咪定后则(-0.8%;P=0.900)没有改善。在探索性分析中,我们发现非快速动眼第二阶段睡眠中的纺锤体密度与安慰剂组的夜间测试成绩的改善呈正相关(Spearman Rho=0.57;P=0.028;n=15),而口服右美托咪定的患者(Spearman Rho=0.04;P=0.899;n=15)则不是(Spearman Rho=0.04;P=0.899;n=15)。两组在夜间运动序列任务的表现、精神运动警觉性任务指标和睡眠问卷上的差异均未达到统计学意义上的阈值。
结论:这些结果表明,夜间口服右旋美托咪定固体制剂与增加非REM2睡眠和减少REM睡眠有关。右美托咪定睡眠期间的纺锤体密度与夜间运动顺序的改善无关。
原始文献来源:Shubham Chamadia, Lauren Hobbs, Sophia Marota, Reine Ibala,et al.Oral Dexmedetomidine Promotes Non-rapid Eye Movement Stage 2 Sleep in Humans.Anesthesiology 2020; 133:1234–43.
Oral Dexmedetomidine Promotes Non-rapid Eye Movement Stage 2 Sleep in Humans
ABSTRACT
Background: The administration of dexmedetomidine is limited to highly monitored care settings because it is only available for use in humans as intra venous medication. An oral formulation of dexmedetomidine may broaden its use to all care settings. The authors investigated the effect of a capsule-based solid oral dosage formulation of dexmedetomidine on sleep polysomnography.
Methods: The authors performed a single-site, placebo-controlled, randomized, crossover, double-blind phase II study of a solid oral dosage for
mulation of dexmedetomidine (700 mcg; n = 15). The primary outcome was polysomnography sleep quality. Secondary outcomes included performance on the motor sequence task and psychomotor vigilance task administered to each subject at night and in the morning to assess motor memory consolida
tion and psychomotor function, respectively. Sleep questionnaires were also administered.
Results: Oral dexmedetomidine increased the duration of non-rapid eye movement (non-REM) stage 2 sleep by 63 (95% CI, 19 to 107) min (P = 0.010) and decreased the duration of rapid eye movement (REM) sleep by 42 (5 to 78) min (P = 0.031). Overnight motor sequence task performance improved after placebo sleep (7.9%; P = 0.003) but not after oral dexmedetomidine–induced sleep (–0.8%; P = 0.900). In exploratory analyses, we found a positive correlation between spindle density during non-REM stage 2 sleep and improvement in the overnight test performance (Spearman rho = 0.57; P = 0.028; n = 15) for placebo but not oral dexmedetomidine (Spearman
rho = 0.04; P = 0.899; n = 15). Group differences in overnight motor sequence task performance, psychomotor vigilance task metrics, and sleep
questionnaires did not meet the threshold for statistical significance.
Conclusions: These results demonstrate that the nighttime administration of a solid oral dosage formulation of dexmedetomidine is associated with
increased non-REM 2 sleep and decreased REM sleep. Spindle density during dexmedetomidine sleep was not associated with overnight improvement in the
motor sequence task.
翻译:任文鑫 编辑:佟睿 审校:曹莹