Zopiclone and nitrazepam: a multicenter placebo controlled comparative study of efficacy and tolerance in insomniac patients in general practice.
Zopiclone and nitrazepam: a multicenter placebo controlled comparative study of efficacy and tolerance in insomniac patients in general practice.
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佐匹克隆和硝西泮：一项多中心安慰剂对照比较研究，研究一般实践中失眠患者的疗效和耐受性。
DOI：
10.1093/sleep/10.suppl_1.54
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发表时间：
1987
期刊：
影响因子：
5.6
通讯作者：
A. Anderson
中科院分区：
文献类型：
--
作者：
A. Anderson
在一项多中心双盲平行组研究中，比较了佐匹克隆与硝西泮和安慰剂在失眠患者中的疗效和耐受性。在7天安慰剂洗脱期后，99例患者（年龄范围20 - 69岁）接受口服胶囊7.5 mg佐匹克隆或5 mg硝西泮或安慰剂治疗2周。在第四周，所有患者均接受安慰剂治疗。患者的睡眠评估显示，与安慰剂相比，佐匹克隆和硝西泮从第一晚起改善了所有睡眠有效性指标，并且在整个治疗期间保持有效性。医生对疗效的总体评估也支持佐匹克隆和硝西泮优于安慰剂治疗。治疗期间佐匹克隆的主观晨起嗜睡显著少于硝西泮或安慰剂，这对非卧床患者具有明显优势。在佐匹克隆或硝西泮治疗后7天停药期内，无明显的反弹性失眠。所有处理的耐受性良好。
The efficacy and tolerance of zopiclone were compared with nitrazepam and placebo in a multicenter double-blind parallel-group study in insomniac patients. Following a 7-day placebo washout period, 99 patients (age range 20 to 69 years) received oral capsules of 7.5 mg zopiclone or 5 mg nitrazepam or placebo for 2 weeks. During the fourth week all patients received placebo treatment. Sleep assessments by the patients showed that, compared with placebo, zopiclone and nitrazepam improved all sleep measures of efficacy from the first night and that effectiveness was maintained throughout treatment. The physicians global assessment of efficacy also favored zopiclone and nitrazepam over placebo treatment. Subjective morning drowsiness during treatment was significantly less for zopiclone than for either nitrazepam or placebo and represents a clear advantage for ambulatory patients. No rebound insomnia was evident during a 7 day post-treatment withdrawal period for either zopiclone or nitrazepam. Tolerance was good for all treatments.