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一种用于催眠药物比较的新试验设计:一项具有患者偏好评估和首选治疗延续性的双盲交叉试验。

A new design of trial for hypnotics comparison: a double-blind cross-over trial with patient's preference assessment and continuation of the preferred treatment.

作者信息

Bourin M, Malinge M

机构信息

GIS Médicament, Faculté de Médecine, Nantes, France.

出版信息

Prog Neuropsychopharmacol Biol Psychiatry. 1996 Apr;20(3):373-85. doi: 10.1016/0278-5846(96)00003-6.

Abstract
  1. This study compared two hypnotics administrated at comparable therapeutic dosages: triazolam (0.25 mg) and loprazolam (1 mg), were administered using an original scheme (cross-over on the first 2 nights, and continuation of the preferred treatment or new randomization). 2. Sixty-seven outpatients complaining of common insomnia participated in this study conducted by general practitioners. 3. Both drugs provided improvement in sleep quality (decreased sleep latency, increased total duration of sleep, decreased number of night awakenings), and are equally well tolerated. 4. For the first 2 nights, triazolam was evaluated to be more efficient than loprazolam (p < 0.001), and patients felt more rested the following day (p < 0.01) with the former drug. Moreover, triazolam is more frequently preferred than loprazolam by 47.7% and 29.2%, respectively, (p = 0.09). 5. No interaction was found between treatment and order of administration or specific effects and order of administration.
摘要
  1. 本研究比较了两种给予相当治疗剂量的催眠药:三唑仑(0.25毫克)和氯普唑仑(1毫克),采用了一种原始方案给药(在前两晚交叉给药,并继续使用首选治疗药物或重新随机分组)。2. 67名主诉普通失眠的门诊患者参与了由全科医生进行的这项研究。3. 两种药物均改善了睡眠质量(缩短了入睡潜伏期、增加了总睡眠时间、减少了夜间觉醒次数),且耐受性相当。4. 在前两晚,三唑仑被评估为比氯普唑仑更有效(p < 0.001),且使用前一种药物的患者次日感觉休息得更好(p < 0.01)。此外,三唑仑比氯普唑仑更常被首选,比例分别为47.7%和29.2%,(p = 0.09)。5. 在治疗与给药顺序之间或特定效应与给药顺序之间未发现相互作用。

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