A 2-week, polysomnographic, safety study of sodium oxybate in obstructive sleep apnea syndrome
A 2-week, polysomnographic, safety study of sodium oxybate in obstructive sleep apnea syndrome
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DOI：
10.1007/s11325-009-0320-0
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发表时间：
2011-01-01
影响因子：
2.5
通讯作者：
Inhaber, Neil
中科院分区：
文献类型：
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作者：
George, Charles F. P.;Feldman, Neil;Inhaber, Neil
羟丁酸钠(SXB)被批准用于发作性睡病的猝倒和白天过度嗜睡。阻塞性睡眠呼吸暂停综合征(OSAS)对9%-50%的发作性睡病患者的影响类似。采用多导睡眠图对48例OSAS患者进行为期2周的多导睡眠监测，观察SXB对OSAS患者呼吸暂停低通气指数(AHI)、血氧饱和度(SaO(2))和睡眠结构的影响。次要结果包括SaO(2)和睡眠结构的改变。与PBO相比，SXB显著增加了平均AHI和阻塞性呼吸暂停指数的降低(分别为-0.8+/-13.3vs.-8.2+/-10.0；p=0.0327和3.54+/-11.1vs.-4.72+/-7.7；p=0.0054)，并显著增加了慢波睡眠时间的改变(5.2+/-25.0min vs.29.4+/-37.0min；P=0.0038)。两种治疗方法在血氧饱和度、中枢性呼吸暂停事件或其他指标上没有差异。接受SXB和PBO的27名患者中有9名(33%)和23名患者中的6名(26%)出现了不良事件，最常见的是头痛。短期使用4.5g/晚的SXB在OSAS患者中没有产生呼吸抑制效应，根据AHI、阻塞性呼吸暂停事件、中枢性呼吸暂停和SaO2的测量。SXB在治疗剂量较大的阻塞性睡眠呼吸暂停综合征中的推广应用尚未被研究，值得注意。
Sodium oxybate (SXB) is approved for cataplexy and excessive daytime sleepiness in narcolepsy. Obstructive sleep apnea syndrome (OSAS) affects similar to 9-50% of narcoleptics. Effects of 2-week SXB administration on apnea-hypopnea index (AHI), oxygen saturation (SaO(2)), and sleep architecture were investigated in OSAS patients.OSAS patients (n = 48) received 2-week SXB or placebo (PBO) treatment with polysomnography at baseline and day 14. The primary outcome measure was change from baseline in mean AHI. Secondary outcomes included changes from baseline in SaO(2), and sleep architecture.Compared with PBO, SXB significantly increased reduction in mean AHI and obstructive apnea index with SXB (-0.8 +/- 13.3 vs. -8.2 +/- 10.0; p = 0.0327 and 3.54 +/- 11.1 vs. -4.72 +/- 7.7; p = 0.0054, respectively) and significantly increased change in slow wave sleep duration (5.2 +/- 25.0 min vs. 29.4 +/- 37.0 min; p = 0.0038). There were no differences between treatments in SaO2, central apneic events, or other measures. Adverse events, most commonly headache, were noted in nine of 27 (33%) and six of 23 (26%) patients receiving SXB and PBO, respectively.Short-term use of 4.5 g/night SXB did not generate respiratory depressant effects in OSAS patients as measured by AHI, obstructive apnea events, central apneas, and SaO2. Extended use of SXB in higher therapeutic doses in OSAS has not been studied, and merits caution.