Kasper S
Department of General Psychiatry, University of Vienna, Austria.
Int Clin Psychopharmacol. 1995 Dec;10 Suppl 4:25-35. doi: 10.1097/00004850-199512004-00005.
Mirtazapine is a novel antidepressant with a unique mode of action, which can be best summarized as a noradrenaline and specific serotonin antidepressant. Its unique mode of action, involving both the noradrenergic and serotonergic neurotransmitter systems, results in strong clinical efficacy. A comprehensive clinical trial programme in Europe and the United States has demonstrated that mirtazapine has clear clinical benefits in a broad range of patients treated across different therapeutic settings. The individual placebo-controlled trials and a meta-analysis on pooled efficacy data from all available placebo-controlled studies have shown that mirtazapine has sustained antidepressant efficacy, as assessed by changes from baseline in group mean scores on the Hamilton Rating Scale for Depression (HAMD) and in the depressed mood item, from week 1 throughout the whole study period. Corroborative evidence on the clinical efficacy of mirtazapine has been obtained in comparative studies with antidepressant drugs of well established efficacy, such as amitriptyline, clomipramine, doxepin and trazodone. As with the placebo-controlled studies, a meta-analysis was performed on data from all the randomized, double-blind, comparative studies of mirtazapine and amitriptyline. Data from 732 patients were available (364 patients taking mirtazapine and 368 taking amitriptyline) for efficacy analysis. Equivalent improvements in total 17-item HAMD scores from baseline were observed in both treatment groups at all scheduled assessments and at the end of the study period, and similarly high percentages of patients responded to treatment with either mirtazapine (70%) or amitriptyline (73%). The efficacy of mirtazapine was also assessed in the treatment of moderately (baseline 17-item HAMD score 18-24) or severely depressed patients (baseline 17-item HAMD score > or = 25). A meta-analysis was performed on the pooled data from the moderately or severely depressed patients in the comparative studies of mirtazapine and placebo or mirtazapine and amitriptyline. Statistically and clinically significant improvements from baseline were seen in both moderately and severely depressed patients treated with mirtazapine compared with placebo, while an equivalent extent of improvement was present with mirtazapine and amitriptyline. A similar pattern was observed in the improvement of depressed mood (HAMD item 1) and other clinically important symptoms of depression: mirtazapine was significantly more efficacious than placebo, and of equivalent efficacy to amitriptyline. Therefore, it can be concluded that the new antidepressant mirtazapine offers distinct therapeutic benefits for a variety of depressed patients in either in- or outpatient settings.
米氮平是一种具有独特作用方式的新型抗抑郁药，其作用方式可概括为去甲肾上腺素能和特异性5-羟色胺能抗抑郁药。其独特的作用方式涉及去甲肾上腺素能和5-羟色胺能神经递质系统，从而产生强大的临床疗效。在欧洲和美国开展的一项全面临床试验项目表明，米氮平在不同治疗环境下接受治疗的广泛患者群体中具有明确的临床益处。各项安慰剂对照试验以及对所有现有安慰剂对照研究的汇总疗效数据进行的荟萃分析均显示，根据汉密尔顿抑郁量表（HAMD）的组平均得分以及抑郁情绪项目从基线的变化评估，米氮平在整个研究期间（从第1周开始）具有持续的抗抑郁疗效。在与疗效已得到充分证实的抗抑郁药物（如阿米替林、氯米帕明、多塞平和曲唑酮）的比较研究中，已获得关于米氮平临床疗效的确证性证据。与安慰剂对照研究一样，对米氮平与阿米替林的所有随机、双盲、比较研究的数据进行了荟萃分析。有732例患者的数据可用于疗效分析（364例患者服用米氮平，368例患者服用阿米替林）。在所有预定评估以及研究期末，两个治疗组从基线开始的17项HAMD总分均有同等程度的改善，服用米氮平（70%）或阿米替林（73%）的患者对治疗有反应的百分比同样很高。还对米氮平治疗中度（基线17项HAMD评分为18 - 24）或重度抑郁患者（基线17项HAMD评分≥25）的疗效进行了评估。对米氮平与安慰剂或米氮平与阿米替林比较研究中中度或重度抑郁患者的汇总数据进行了荟萃分析。与安慰剂相比，接受米氮平治疗的中度和重度抑郁患者从基线开始在统计学和临床上均有显著改善，而米氮平与阿米替林的改善程度相当。在抑郁情绪（HAMD项目1）以及其他临床上重要的抑郁症状的改善方面观察到类似模式：米氮平比安慰剂显著更有效，且与阿米替林疗效相当。因此，可以得出结论，新型抗抑郁药米氮平为各种抑郁患者（无论是门诊患者还是住院患者）提供了明显的治疗益处。
