A comparison of the efficacy, tolerance and residual effects of zopiclone, flurazepam and placebo in insomniac outpatients.
A comparison of the efficacy, tolerance and residual effects of zopiclone, flurazepam and placebo in insomniac outpatients.
复制标题
佐匹克隆、氟西泮和安慰剂在门诊失眠患者中的疗效、耐受性和残留效应比较。
DOI：
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发表时间：
1990
影响因子：
2.6
通讯作者：
Ian Hindmarch
中科院分区：
文献类型：
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作者：
E. Ponciano;F. Freitas;J. Camara;M. Faria;M. Barreto;Ian Hindmarch
采用双盲、随机、平行组设计，在一组24名主诉睡眠障碍的门诊患者中比较佐匹克隆7.5 mg、泮30 mg和安慰剂每晚服用3周的耐受性和疗效。使用焦虑评定量表评估治疗的有效性，同时每周使用一组性能测试（临界闪烁融合阈值、选择反应时间、字母取消和数字跨度）测量耐受性和残留效应。在实验期前后进行体格和临床检查，包括ECG和EEG，并记录自发报告的副作用。对24例完成病例（每个治疗组8例患者）的方差分析显示，两种活性药物治疗在缩短睡眠起始潜伏期方面均显著优于安慰剂。氟安定增加了睡眠时间，并产生了精神功能受损的“后遗症”。佐匹克隆对清晨表现无明显影响，且无残留镇静活性。佐匹克隆7.5 mg在临床有效剂量下无残留效应，表明其用于日间镇静可能干扰日常活动的门诊或门诊患者人群。
A double-blind randomized parallel group design was used to compare the tolerance and efficacy of zopiclone 7.5 mg, flurazepam 30 mg and placebo taken each night for 3 weeks in a group of 24 out-patients complaining of sleep disturbance. Analogue rating scales were used to assess the efficacy of the treatments while tolerance and residual effects were measured weekly using a battery of performance tests (Critical Flicker Fusion Threshold, Choice Reaction Time, Letter Cancellation and Digit Span). Physical and clinical examinations, including ECG and EEG, were conducted before and after the experimental period and spontaneously reported side-effects were recorded. Analysis of variance on 24 completed cases (8 patients in each treatment group) showed both active treatments to be significantly better than placebo in shortening sleep onset latency. Flurazepam increased the duration of sleep and produced a "hangover" of impaired psychomotor function. Zopiclone had no observable effect on early morning performance and was free from residual sedative activity. The lack of residual effects with zopiclone 7.5 mg, at a dose shown to be clinically effective, suggests its use in ambulant or out-patient populations where daytime sedation could interfere with every day activities.