正常人服用扎来普隆在噪声干扰下的催眠效果观察

Effects of zaleplon on polysomnographic features during sleep in noisy environment

目的利用强噪声干扰造成情景性失眠，比较不同剂量扎来普隆的催眠效果。方法在模拟歼-6飞机噪声干扰环境中（约95dB），观察8名健康青年男性志愿者于14：00交叉服用扎来普隆10mg、15mg以及安慰剂后4h多导睡眠图的变化，指标包括睡眠潜时（SL）、睡眠效率（SE）、睡眠结构（各期慢波和快速眼动睡眠百分比）。觉醒后进行睡眠质量和嗜睡感的主观评价。采用单因素方差分析进行数据的统计处理。结果与安慰剂组相比，扎来普隆10mg组的SL明显缩短（F=9．48，P〈0．05），主观睡眠质量分值和睡眠深度分值显著提高（F=14．89，P〈0．01；F=10．67，P〈0．05）；而扎来普隆15mg组SL明显缩短（F=16．35，P〈0．01），SE明显提高（F=17．43，P〈0．01），快速眼动睡眠百分比显著增加（F=18．15，P〈0．01），主观睡眠质量分值和睡眠深度分值亦显著增加（F=20．58，P〈0．01；F=18．27，P〈0．01）。服用各组药物觉醒后均无明显的主观嗜睡感和其它不良反应。结论扎来普隆的催眠效果具有一定的剂量相关特性，为提高催眠效果可将服药剂量由常用量10mg增加至15mg。

Objective To evaluate the effectiveness of zaleplon at two doses in healthy volunteers with noise-induced sleep maintenance insomnia. Methods Exposed to the simulated noise interference of Fighter-6 （about 95 dB ）, 8 healthy young male volunteers took 10 mg or 15 mg of zaleplon and placebo alternately at 14：00. The changes of polysomnography （PSG） indices after 4 hours of taking pills were observed, including sleep latency（SL）, sleep efficiency（SE） and sleep structure（percent of stage 1, 2 , 3, 4 and rapid eye movement sleep）. After awakening, their subjective judgment of sleep quality and sleepiness was recorded. These data were submitted to oneway variance analysis. Results Compared with the placebo group, the SL was significantly shortened （F= 9. 48, P〈 0. 05） and the scores of subjective sleep quality and sleep depth were obviously increased （F= 14.89, P〈0.01 ; F = 10. 67, P〈 0.05） in zaleplon 10 mg group. Compared with the placebo group, the SL was shortened significantly（F=16. 35,P〈0. 01）, and the SE （F= 17.43,P〈0.01）, rapid eye movement sleep（REM）% （F= 18. 15,P〈0.01） and subjective scores of sleep quality and sleep depth （F=20.58,P〈0.01;F=18.27,P〈0.01） were increased remarkably in zaleplon 15 mg group. There were no evident subjective sleepiness and other adverse reaction after awakening. Conclusion The hypnotic effects of zaleplon are dose related. In order to enhance the hypnotic effects of zaleplon, the commonly used dose of 10 mg can be increased to 15 mg.