Mieno Yuki, Hayashi Masamichi, Souma Tomohide, Horiguchi Tomoya, Niwa Yoshikazu, Fujita Shiho, Fukumoto Jyunichi, Hosoda Nami, Imaizumi Kazuyoshi
Department of Respiratory Medicine, School of Medicine, Fujita Health University, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192 Japan.
Fujita Health University Okazaki Medical Center, Okazaki, Aichi Japan.
Sleep Biol Rhythms. 2024 Sep 12;23(1):29-37. doi: 10.1007/s41105-024-00548-7. eCollection 2025 Jan.
The purpose of this study was to evaluate how the first oral administration of suvorexant affects PSG results in patients with severe obstructive sleep apnea (OSA). Single-center, prospective study conducted in a nonrandomized, uncontrolled, unblinded fashion. Undiagnosed 64 patients with suspected OSA underwent first-night PSG, and 30 patients with severe OSA (Apnea Hypopnea Index [AHI] ≥ 30 events/h) underwent second-night PSG testing after administration of 15 mg suvorexant. The change in AHI between the first and second nights was not significant, although the upper limit of the 95% confidence interval for the mean difference in AHI was high at 5.987.The mean duration of apnea on the second night was significantly prolonged compared to that on the first night, but there were no significant differences n 3% oxygen desaturation index, saturation of percutaneous oxygen<90% time. On the second night, total sleep time was significantly prolonged, mid-night awakenings decreased, REM sleep percentage increased, and REM latency was shorter. Because the environment for PSG testing is very different from the patient's home and many patients have difficulty sleeping, there are clinical cases in which PSG is performed with sleep medication. In this study, PSG after oral administration of 15 mg of suvorexant on the second night showed no significant difference or clear trend in AHI. However, the upper limit of the 95% confidence interval for the mean difference in AHI was greater than 5, suggesting that suvorexant may exacerbate AHI, even with the first administration.
本研究的目的是评估首次口服苏沃雷生对重度阻塞性睡眠呼吸暂停（OSA）患者多导睡眠图（PSG）结果的影响。本研究为单中心前瞻性研究，采用非随机、无对照、非盲法进行。64例疑似OSA但未确诊的患者进行了首夜PSG检查，30例重度OSA患者（呼吸暂停低通气指数[AHI]≥30次/小时）在服用15毫克苏沃雷生后进行了第二夜PSG检查。尽管AHI平均差异的95%置信区间上限较高，为5.987，但首夜和第二夜之间AHI的变化并不显著。与首夜相比，第二夜的平均呼吸暂停持续时间显著延长，但在3%氧饱和度下降指数、经皮血氧饱和度<90%的时间方面无显著差异。在第二夜，总睡眠时间显著延长，午夜觉醒次数减少，快速眼动（REM）睡眠百分比增加，REM潜伏期缩短。由于PSG检查环境与患者家中环境差异很大，许多患者存在睡眠困难，因此存在使用助眠药物进行PSG检查的临床病例。在本研究中，第二夜口服15毫克苏沃雷生后的PSG检查显示，AHI无显著差异或明显趋势。然而，AHI平均差异的95%置信区间上限大于5，这表明即使是首次给药，苏沃雷生也可能会加重AHI。
