Kasper S, Zivkov M, Roes K C, Pols A G
Department of General Psychiatry, University of Vienna, Austria.
Eur Neuropsychopharmacol. 1997 May;7(2):115-24. doi: 10.1016/s0924-977x(96)00394-x.
Efficacy data were available from 405 severely depressed patients (baseline 17-item Hamilton Rating Scale for Depression-HAMD scores > or = 25) participating in randomized, double-blind, amitriptyline-controlled studies of mirtazapine. Main efficacy variable were changes from baseline in the group mean 17-item HAMD scores and responder rates. Secondary efficacy variables were changes in depressed mood item on the HAMD and in factors derived from the 17-item HAMD scale. Treatment with either mirtazapine or amitriptyline resulted in robust reductions of baseline HAMD scores and in similar and high percentages of responders. Both drugs produced favourable effects on depressed mood and on symptoms commonly associated with depression, such as anxiety, sleep and vegetative disturbances. There were neither statistically significant nor clinically relevant differences between mirtazapine and amitriptyline at any assessment point nor at endpoint. The results demonstrate that the new antidepressant mirtazapine and the tricyclic antidepressant amitriptyline are equally effective in the treatment of severely depressed patients.
疗效数据来自405名重度抑郁症患者(基线17项汉密尔顿抑郁量表 - HAMD评分≥25),这些患者参与了米氮平的随机、双盲、阿米替林对照研究。主要疗效变量是组平均17项HAMD评分相对于基线的变化以及有效率。次要疗效变量是HAMD中抑郁情绪项目的变化以及从17项HAMD量表得出的因子变化。米氮平或阿米替林治疗均使基线HAMD评分显著降低,且有效率相近且较高。两种药物对抑郁情绪以及通常与抑郁症相关的症状(如焦虑、睡眠和植物神经功能紊乱)均产生了有益影响。在任何评估点及终点,米氮平与阿米替林之间均无统计学显著差异或临床相关差异。结果表明,新型抗抑郁药米氮平与三环类抗抑郁药阿米替林在治疗重度抑郁症患者方面同样有效。