Nair N P, Bakish D, Saxena B, Amin M, Schwartz G, West T E
Douglas Hospital Research Centre, Verdun, Quebec, Canada.
Anxiety. 1996;2(4):192-8. doi: 10.1002/(SICI)1522-7154(1996)2:4<192::AID-ANXI6>3.0.CO;2-Q.
Fluvoxamine and imipramine were compared to placebo in an 8-week doubleblind randomized multicentre trial comprising of 148 outpatients between 19 and 57 years of age (mean: 35) with a DSM-III-R diagnosis of Panic Disorder. mean daily dose at endpoint was: fluvoxamine, 171.4 mg; imipramine 164.7 mg. The mean number of panic attacks per week at baseline were 10.9, 14.4 and 6.5 for fluvoxamine, imipramine and placebo, respectively. The intent-to-treat analysis of the change from baseline (difference score) of the number of panic attacks at endpoint revealed: a difference of 3.3 attacks (95% CI: -0.3, 6.8) between fluvoxamine and placebo and a difference of 6.0 attacks (95% CI: 1.5, 10.5) between imipramine and placebo. Treatment was stopped prematurely in 31 (62%) on fluvoxamine, 16 (33%) on imipramine and 29 (58%) on placebo. The number of patients withdrawing due to intolerance was 13 (26%) for fluvoxamine, 10 (21%) for imipramine and 4 (8%) for placebo. The number of patients withdrawing due to lack of efficacy was 10 (20%) for fluvoxamine, 4 (8%) for imipramine and 12 (24%) for placebo. Overall, this study demonstrated that fluvoxamine was not effective in the treatment of panic disorder but did show a strong effect for imipramine. A chance occurrence of significantly fewer number of panic attacks in the placebo group at baseline may limit the conclusions of this study.
在一项为期8周的双盲随机多中心试验中，将氟伏沙明和丙咪嗪与安慰剂进行了比较。该试验纳入了148名年龄在19至57岁（平均35岁）之间、根据《精神疾病诊断与统计手册》第三版修订版（DSM-III-R）诊断为惊恐障碍的门诊患者。终点时的平均每日剂量为：氟伏沙明171.4毫克；丙咪嗪164.7毫克。基线时，氟伏沙明组、丙咪嗪组和安慰剂组每周惊恐发作的平均次数分别为10.9次、14.4次和6.5次。对终点时惊恐发作次数相对于基线的变化（差值分数）进行的意向性分析显示：氟伏沙明与安慰剂之间的差值为3.3次发作（95%置信区间：-0.3，6.8），丙咪嗪与安慰剂之间的差值为6.0次发作（95%置信区间：1.5，10.5）。氟伏沙明组有31名患者（62%）、丙咪嗪组有16名患者（33%）、安慰剂组有29名患者（58%）提前终止治疗。因不耐受而退出的患者人数，氟伏沙明组为13名（26%），丙咪嗪组为10名（21%），安慰剂组为4名（8%）。因缺乏疗效而退出的患者人数，氟伏沙明组为10名（20%），丙咪嗪组为4名（8%），安慰剂组为12名（24%）。总体而言，这项研究表明氟伏沙明对惊恐障碍治疗无效，但丙咪嗪显示出显著疗效。安慰剂组在基线时偶然出现的惊恐发作次数明显较少，这可能会限制本研究的结论。
