Vogel G, Thurmond A, Gibbons P, Edwards K, Sloan K B, Sexton K
Psychopharmacologia. 1975;41(1):65-9. doi: 10.1007/BF00421308.
The effects of three oral doses of bedtime triazolam (0.25 mg, 0.5 mg, and 1.0 mg) a new benzodiazepine, on the laboratory sleep of insomniacs were studied in a double blind design which used the following 14 consecutive night schedule: 1-4 placebo; 5-11 drug; 12-14 placebo. Effects on sleep were measured objectively by conventional EEG/EOG/EMG sleep recordings and subjectively by questionnaires administered each morning. Side or toxic effects were assessed by screening physicals and questionnaires administered each morning and each evening and by a comparison of the prestudy vs. end-study physical exams and clinical lab tests. At the 0.5 mg dose triazolam significantly reduced several objective and subjective measures of insomnia. It had lesser effects at the 0.25 mg dose and equal or greater effects at 1.0 mg dose. There were no remarkable side or toxic effects at any dose.
采用双盲设计,按照以下连续14晚的时间表,研究了新型苯二氮䓬类药物三唑仑(0.25毫克、0.5毫克和1.0毫克)三种口服剂量在睡前服用对失眠症患者实验室睡眠的影响:第1 - 4晚服用安慰剂;第5 - 11晚服用药物;第12 - 14晚服用安慰剂。通过传统的脑电图/眼电图/肌电图睡眠记录客观测量对睡眠的影响,通过每天早晨发放问卷主观测量。通过每天早晨和晚上进行的体格检查和问卷筛查,以及比较研究前与研究结束时的体格检查和临床实验室检查来评估副作用或毒性作用。在0.5毫克剂量时,三唑仑显著降低了几种失眠的客观和主观指标。在0.25毫克剂量时效果较小,在1.0毫克剂量时效果相同或更大。任何剂量下均未出现明显的副作用或毒性作用。