Fabre L F, Harris R T
J Int Med Res. 1976;4(1):50-4. doi: 10.1177/030006057600400107.
The safety and efficacy of ketazolam (15 mg capsules) was compared to placebo in seventy-nine out-patients suffering from psychoneurotic anxiety, moderate or worse in severity. A flexible dosage range of 15-75 mg was used in this double-blind study lasting twenty-eight days. The average optimum therapeutic dose of ketazolam was 46-9 mg administered as a once-day dose at bedtime. Ketazolam was found to be significantly better than placebo in alleviating anxiety and its concomitant symptomatology as measured by the Hamilton Anxiety Rating Scale, three Physician's Global Impressions, two Patient's Global Impressions, and three Target Symptoms. Fifteen patients dropped from the placebo group before completion of the study, and two withdrew from the ketazolam group. The patients receiving ketazolam experienced a greater reduction in symptomatology throughout the study when compared to the placebo group. Side-effects experienced by the ketazolam patients were less than, or equal to, the placebo patients. No deleterious side-effects occurred. No differences between the two groups were found for vital signs, EKG's, laboratory tests, or physical examinations.
在79名患有精神神经症性焦虑且病情为中度或更严重的门诊患者中，比较了氯氮卓（15毫克胶囊）与安慰剂的安全性和有效性。在这项为期28天的双盲研究中，使用了15 - 75毫克的灵活剂量范围。氯氮卓的平均最佳治疗剂量为46.9毫克，作为睡前单次剂量给药。通过汉密尔顿焦虑评定量表、三位医生的整体印象、两位患者的整体印象和三种目标症状来衡量，发现氯氮卓在缓解焦虑及其伴随症状方面明显优于安慰剂。15名患者在研究完成前退出了安慰剂组，2名患者退出了氯氮卓组。与安慰剂组相比，接受氯氮卓治疗的患者在整个研究过程中症状减轻得更多。氯氮卓组患者出现的副作用少于或等于安慰剂组患者。未发生有害副作用。两组在生命体征、心电图、实验室检查或体格检查方面未发现差异。
