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佐匹克隆与硝西泮:老年慢性失眠患者疗效与耐受性的双盲对照研究。

Zopiclone versus nitrazepam: a double-blind comparative study of efficacy and tolerance in elderly patients with chronic insomnia.

作者信息

Klimm H D, Dreyfus J F, Delmotte M

机构信息

Lehrbeauffragter für Allgemeinmedizin an der Universität Heidelberg, Kuppenheim, F.R.G.

出版信息

Sleep. 1987;10 Suppl 1:73-8. doi: 10.1093/sleep/10.suppl_1.73.

Abstract

A randomized, double-blind, comparative trial of zopiclone versus nitrazepam was conducted in 74 geriatric chronic insomniac patients. Following a 7-day wash-out period, two parallel groups, successively received a placebo for 7 days, then either 7.5 mg zopiclone or 5 mg nitrazepam for another 7-day period. Efficacy on sleep was assessed by a sleep analogue scale and the Spiegel Sleep Questionnaire, residual effects by psychometric tests and tolerance by a standardized question, as well as by clinical and laboratory tests. Zopiclone and nitrazepam were more active than placebo on all tests of efficacy. In contrast with nitrazepam, zopiclone was devoid of effect on neurological function. In addition, the condition on awakening was better with zopiclone.

摘要

对74名老年慢性失眠患者进行了佐匹克隆与硝西泮的随机、双盲、对照试验。经过7天的洗脱期后,两个平行组先后接受7天的安慰剂治疗,然后再接受7天的7.5毫克佐匹克隆或5毫克硝西泮治疗。通过睡眠模拟量表和施皮格尔睡眠问卷评估睡眠疗效,通过心理测试评估残留效应,通过标准化问题以及临床和实验室测试评估耐受性。在所有疗效测试中,佐匹克隆和硝西泮都比安慰剂更有效。与硝西泮不同,佐匹克隆对神经功能没有影响。此外,服用佐匹克隆后醒来时的状况更好。

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