Hernández Lara R, Del Rosal P L, Ponce M C
J Int Med Res. 1983;11(3):162-6. doi: 10.1177/030006058301100306.
The hypnotic efficacy and safety of quazepam 15 mg was compared with placebo in thirty-six out-patients with insomnia. The study was double-blind, with two comparable groups of patients established by random allocation. Following a placebo baseline period, patients took placebo or quazepam for 5 consecutive nights and completed sleep questionnaires the next day. Quazepam was rated better than placebo in terms of sleep quality, sleep induction time, total sleep time, and early morning awakenings. Quazepam treatment was rated as good or excellent by the physician and the patients who received it almost three times more often was placebo. Quazepam was proved to be safe, with no reports of unexpected or serious adverse experiences.
对36名失眠门诊患者比较了15毫克夸西泮与安慰剂的催眠疗效和安全性。该研究为双盲研究,通过随机分配建立了两组具有可比性的患者。在安慰剂基线期之后,患者连续5晚服用安慰剂或夸西泮,并于次日完成睡眠问卷。在睡眠质量、入睡时间、总睡眠时间和清晨觉醒方面,夸西泮的评分优于安慰剂。医生对夸西泮治疗的评价为良好或优秀,接受夸西泮治疗的患者评价良好或优秀的次数几乎是接受安慰剂患者的三倍。已证明夸西泮是安全的,未报告意外或严重不良事件。