Jovanović U J
J Int Med Res. 1977;5(2):77-84. doi: 10.1177/030006057700500201.
By means of polygraphic sleep recordings (EEG, EOG, EMG, ECG, EDG, Respirogram, Positogram), neurologic-psychologic investigation and questionnaires on subjective feeling, ten patients aged from 22 to 40 years (mean: 29 years), who suffered from irregular disturbances in falling asleep and in sleeping continuously, were examined over a period of ten consecutives nights. The first investigation night was reserved for adaptation of the patients and could therefore not be evaluated. On the following three evenings placebo (Placebo I) was given, then 2 mg of flunitrazepam for the ensuing three nights and placebo again (Placebo II) for the last three nights. Thus, 90 investigation nights could be evaluated. 1. Latency times until the patients fell asleep and up to the first deep sleep were reduced significantly by the active preparation. Latency times up to the first REM-phase were prolonged. 2. The frequency of nocturnal awakenings was lessened significantly. Thus, disturbances in sleeping continuously disappeared for the duration of the treatment. Duration of wakefulness after having woken during the night decreased considerably. 3. Duration of wakefulness during the total night was reduced considerably, deeper sleep stages, such as D (stage III) and E(stage IV) were prolonged. 4. Duration of the REM-phases was reduced slightly. This reduction was not significant according to the t-test. 5. According to these results, the preparation showed a clear effect. A placebo-effect can be excluded, since the improvements mentioned were not found when placebo was given before administration of the medication and afterwards (Placebo I and II). 6. When comparing our results to those of other authors, who described the effects of various preparations, we found that the substance flunitrazepam showed different effects.
通过多导睡眠记录(脑电图、眼电图、肌电图、心电图、皮肤电图、呼吸图、体位图)、神经心理学调查以及关于主观感受的问卷,对10名年龄在22至40岁(平均29岁)、入睡和持续睡眠存在不规则障碍的患者进行了连续10个晚上的检查。第一个调查夜用于患者适应,因此无法进行评估。在接下来的三个晚上给予安慰剂(安慰剂I),然后在随后的三个晚上给予2毫克氟硝西泮,最后三个晚上再次给予安慰剂(安慰剂II)。这样,90个调查夜可用于评估。1. 活性制剂显著缩短了患者入睡直至首次进入深度睡眠的潜伏期。直至首次快速眼动期的潜伏期延长。2. 夜间觉醒频率显著降低。因此,在治疗期间持续睡眠障碍消失。夜间醒来后的清醒时间大幅减少。3. 全夜清醒时间大幅减少,更深的睡眠阶段,如D(III期)和E(IV期)延长。4. 快速眼动期的持续时间略有减少。根据t检验,这种减少不显著。5. 根据这些结果,该制剂显示出明显效果。可以排除安慰剂效应,因为在给药前和给药后给予安慰剂(安慰剂I和II)时未发现上述改善。6. 将我们的结果与其他描述各种制剂效果的作者的结果进行比较时,我们发现氟硝西泮这种物质显示出不同的效果。