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唑吡坦持续给药与间歇给药在慢性失眠症患者中的比较:一项双盲、随机试点研究。

Comparison of continuous versus intermittent administration of zolpidem in chronic insomniacs: a double-blind, randomized pilot study.

作者信息

Cluydts R, Peeters K, de Bouyalsky I, Lavoisy J

机构信息

Department of Psychology, Free University of Brussels, Belgium.

出版信息

J Int Med Res. 1998 Jan-Feb;26(1):13-24. doi: 10.1177/030006059802600102.

DOI:10.1177/030006059802600102
PMID:9513073
Abstract

The subjective efficacy and safety of intermittent administration of a hypnotic for insomnia was assessed, since such a regime may provide a potential means of reducing the risk of habituation and dependence. A total of 160 adult patients (mean 45 years) with chronic insomnia were treated for 2 weeks with zolpidem, 10 mg, either continuously or intermittently (five nights zolpidem, two consecutive nights placebo per week) in this multicentre, out-patient, pilot study. At the end of the 2-week treatment, patients subjectively estimated their nightly total sleep time as 6.96 +/- 1.19 h (from 6.07 +/- 1.25 h at baseline) and 6.94 +/- 1.30 h (from 5.72 +/- 1.46 h) after the continuous and intermittent treatments, respectively. Patients' reports did not indicate any differences between the two groups in global evaluation of impairment, sleep quality, or the incidence of adverse events. These results suggest that the efficacy and safety of zolpidem, 10 mg, are comparable whether the drug is administered every night or intermittently. Further studies with a broader well-defined patient base, are needed to confirm these data.

摘要

对用于失眠症的催眠药物间歇性给药的主观疗效和安全性进行了评估,因为这种给药方案可能提供一种降低成瘾和依赖风险的潜在方法。在这项多中心门诊试点研究中,共有160名成年慢性失眠患者(平均45岁)接受了为期2周的治疗,治疗药物为10毫克唑吡坦,给药方式为持续给药或间歇性给药(每周服用5晚唑吡坦,连续2晚服用安慰剂)。在为期2周的治疗结束时,连续治疗组和间歇治疗组的患者主观估计其夜间总睡眠时间分别从基线时的6.07±1.25小时增加到6.96±1.19小时,以及从5.72±1.46小时增加到6.94±1.30小时。患者报告显示,两组在整体损害评估、睡眠质量或不良事件发生率方面均无差异。这些结果表明,10毫克唑吡坦无论是每晚给药还是间歇性给药,其疗效和安全性相当。需要在更广泛的明确患者群体中进行进一步研究以证实这些数据。

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