Bourin M, André-David F
Therapie. 1989 Mar-Apr;44(2):107-14.
In a double-blind cross over randomized study for the first two nights efficacy and safety of triazolam 0.25 mg and loprazolam 1 mg have been compared in 67 out-patients complaining of common insomnia and treated by general practitioners. After the second night patients had to choose one of the two treatments and were continuing a 3-week treatment period with the preferred one. In case of no preference they received one of the 2 drugs according to a new randomization. Cross over administration of the two drugs for the first two nights shows that with triazolam global help to get in sleep is greater (p = 0.016) and sleep latency is shorter (p = 0.07) than with loprazolam, and number of night awakenings is decreased (p = 0.02) compared to loprazolam. Patients felt more rested under triazolam (p = 0.015) than loprazolam. Triazolam (N = 31) is more frequently preferred than loprazolam (N = 19) p = 0.09. Preferred treatment continued to be effective during the following three weeks and quality of sleep improved drastically for all items compared to baseline data (p = 0.01). Both treatments are well tolerated (4 drop-outs for side-effects: 2 under each treatment). The one-week tapering period allows progressive withdrawal with rare reappearance of minimum sleep disorders (5 cases: 2 under triazolam, 3 under loprazolam).
在一项双盲交叉随机研究中,对67名主诉普通失眠且由全科医生治疗的门诊患者,比较了0.25毫克三唑仑和1毫克氯普唑仑在前两晚的疗效和安全性。第二晚后,患者必须从两种治疗方法中选择一种,并继续使用首选药物进行为期3周的治疗期。如果没有偏好,他们将根据新的随机分组接受两种药物中的一种。两种药物在前两晚的交叉给药显示,与氯普唑仑相比,三唑仑在促进入睡方面的总体帮助更大(p = 0.016),睡眠潜伏期更短(p = 0.07),夜间觉醒次数减少(p = 0.02)。与氯普唑仑相比,患者在服用三唑仑后感觉休息得更好(p = 0.015)。三唑仑(N = 31)比氯普唑仑(N = 19)更常被首选,p = 0.09。在接下来的三周内,首选治疗持续有效,与基线数据相比,所有项目的睡眠质量都有显著改善(p = 0.01)。两种治疗耐受性良好(4例因副作用退出:每种治疗各2例)。为期一周的逐渐减量期允许逐渐停药,很少出现最小程度的睡眠障碍复发(5例:三唑仑组2例,氯普唑仑组3例)。