Caldwell J R
Pharmatherapeutica. 1982;3(4):278-82.
The efficacy and safety of 15 mg quazepam was compared with placebo in 57 geriatric outpatients with insomnia. The study was double-blind, with treatments randomly assigned to patients. Placebo was taken by all patients for the first 3 nights followed by either placebo or quazepam for 5 nights. Post-sleep questionnaires were completed each day and the physician and patients rated the treatment at the end of the study. Quazepam was significantly better than placebo on all measures of efficacy. Indices of sleep quantity and quality showed that 15 mg quazepam produced significantly greater improvement in sleep than placebo on the first night of treatment and for the treatment period as a whole. There were no reports of unexpected or serious adverse experiences, and quazepam did not cause ataxia or impairment of motor co-ordination in any patient.
在57名老年失眠门诊患者中,对15毫克夸西泮与安慰剂的疗效和安全性进行了比较。该研究为双盲试验,治疗方案随机分配给患者。所有患者在头3晚服用安慰剂,随后5晚服用安慰剂或夸西泮。每天完成睡眠后问卷调查,医生和患者在研究结束时对治疗进行评分。在所有疗效指标上,夸西泮均显著优于安慰剂。睡眠数量和质量指标显示,在治疗的第一晚以及整个治疗期间,15毫克夸西泮比安慰剂在改善睡眠方面有显著更大的效果。没有关于意外或严重不良事件的报告,且夸西泮在任何患者中均未引起共济失调或运动协调障碍。