Scarpini E, Baron P G, Bet L, Bottini G, Bresolin N, Meola G, Pezzoli G, Vallar G, Monza G C, Scarlato G
Istituto di Clinica Neurologica, Università di Milano, Italia.
Neuropsychobiology. 1988;20(2):74-7. doi: 10.1159/000118476.
A multicenter, double-blind, between-patient trial comparing two doses of ketazolam (15 and 30 mg) with placebo, each given once daily, in the evening, to 92 outpatients affected by generalized anxiety disorders for at least 1 month, was carried out. After 1-week washout period 47 patients were randomized to ketazolam 15 mg, and 45 to placebo for 15 days (first period). At the end of this period, if the patient experienced a decrease on the total Hamilton Anxiety Rating Scale (HAM-A) of at least 25% of basal value, the treatment was kept unchanged for a further 15 days, otherwise 15 mg of ketazolam were added to the previous treatment (second period). Anxiety was rated after 2 and 4 weeks with the Italian HAM-A scale and with a 4-point scale (patient's assessment). Seventy-eight patients completed the first period and 75 the whole study. During the first period the percentage of responders was almost identical in both treatment groups, but during the second period a further slight improvement was observed in the early placebo responders, while the HAM-A score of patients on ketazolam continued to improve significantly (p less than 0.01) throughout the study. Likewise a significant (p less than 0.001) difference between treatments was observed, on the 4-point scale, in the population as a whole (end of first period) as well as in responder patients (end second period). Tolerability was good, except in 1 patient on placebo, who was withdrawn from the study because of severe headache.
一项多中心、双盲、患者间试验开展，将两种剂量的氯氮卓（15毫克和30毫克）与安慰剂进行比较，每种药物均每日一次于晚上给药，对象为92名患有广泛性焦虑症至少1个月的门诊患者。经过1周的洗脱期后，47名患者被随机分配至15毫克氯氮卓组，45名患者被分配至安慰剂组，为期15天（第一阶段）。在该阶段结束时，如果患者汉密尔顿焦虑量表（HAM - A）总分较基础值下降至少25%，则治疗方案维持不变再持续15天，否则在前一治疗方案基础上加用15毫克氯氮卓（第二阶段）。在第2周和第4周时，使用意大利版HAM - A量表以及4分量表（患者评估）对焦虑情况进行评分。78名患者完成了第一阶段，75名患者完成了整个研究。在第一阶段，两个治疗组的有效应答者百分比几乎相同，但在第二阶段，早期安慰剂应答者有进一步轻微改善，而氯氮卓组患者的HAM - A评分在整个研究过程中持续显著改善（p小于0.01）。同样，在整个总体人群（第一阶段结束时）以及有效应答患者（第二阶段结束时）中，在4分量表上观察到治疗组之间存在显著差异（p小于0.001）。耐受性良好，除了1名服用安慰剂的患者因严重头痛退出研究。
