Moja E A, Scamonatti L, Maxia D, Camera A, Gherardi S
Clin Ther. 1983;5(6):580-4.
The efficacy and safety of lormetazepam (LMZ) and placebo were compared in 30 patients with sleep difficulties who were treated by general practitioners. During the three weeks of the study, each patient received placebo during either the first or last week and 1 mg/night of LMZ during the other two weeks. Neither patients nor physicians knew which week's medication was active drug and which was placebo. Twenty-three of the 30 patients completed the three-week trial. Both the quantity and the quality of sleep were significantly better during the weeks patients were given LMZ than during the week they used placebo. Physicians also rated the hypnotic performance as significantly better than that of placebo. Adverse reactions were evenly distributed among the LMZ and placebo treatment periods and were usually minor. Vital signs and laboratory values were unchanged during either treatment period. It is thus concluded that LMZ is a safe and effective hypnotic for use in general practice.
在30名有睡眠困难且由全科医生治疗的患者中，比较了氯美扎酮（LMZ）和安慰剂的疗效与安全性。在研究的三周期间，每位患者在第一周或最后一周接受安慰剂治疗，在另外两周接受每晚1毫克的LMZ治疗。患者和医生都不知道哪一周的药物是活性药物，哪一周的是安慰剂。30名患者中有23名完成了为期三周的试验。在给予患者LMZ的几周内，睡眠的数量和质量均显著优于使用安慰剂的那一周。医生也将催眠效果评定为显著优于安慰剂。不良反应在LMZ和安慰剂治疗期间分布均匀，且通常较轻微。在任何一个治疗期间，生命体征和实验室值均未改变。因此得出结论，LMZ在全科医疗中是一种安全有效的催眠药。
