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吗氯贝胺:一种可逆性单胺氧化酶A抑制剂,在一项对照多中心研究中显示出比氯米帕明弱的抗抑郁效果。丹麦大学抗抑郁药研究组。

Moclobemide: a reversible MAO-A-inhibitor showing weaker antidepressant effect than clomipramine in a controlled multicenter study. Danish University Antidepressant Group.

出版信息

J Affect Disord. 1993 Jun;28(2):105-16. doi: 10.1016/0165-0327(93)90039-m.

Abstract

Antidepressant and unwanted effects of moclobemide (400 mg/day) and clomipramine (150 mg/day) were compared in a double-blind, randomised, in-patient, fixed-dose study with weekly ratings and drug level measurements. After 1 week of single-blind placebo treatment, 115 patients with major depression fulfilled the criterion of a Hamilton Depression Scale (17-item, HDS) score of > or = 18 and were started on active treatment for 6 weeks. Drop-outs on moclobemide (n = 20) were in particular due to worsening and suicidality (n = 9) whereas drop-outs on clomipramine (n = 12) in particular were due to side effects/adverse events (n = 6) and no drop-outs due to worsening. End-point analysis on the basis of different depression ratings showed consistently a significantly weaker effect of moclobemide (final median HDS: 15) compared with clomipramine (final median HDS: 11). The difference involved both sleep and depression symptoms. These results are generally at variance with the main body of literature on moclobemide, although a higher frequency of drop-out due to worsening in moclobemide-treated patients compared to tricyclic antidepressant-treated patients has been reported in several studies.

摘要

在一项双盲、随机、住院、固定剂量的研究中,对吗氯贝胺(400毫克/天)和氯米帕明(150毫克/天)的抗抑郁作用及不良反应进行了比较,研究中每周进行评分并测量药物水平。在1周的单盲安慰剂治疗后,115名重度抑郁症患者达到汉密尔顿抑郁量表(17项,HDS)评分≥18的标准,并开始接受6周的积极治疗。吗氯贝胺组的退出者(n = 20)尤其因病情恶化和自杀倾向(n = 9),而氯米帕明组的退出者(n = 12)尤其因副作用/不良事件(n = 6),且没有因病情恶化而退出的情况。基于不同抑郁评分的终点分析显示,与氯米帕明(最终中位数HDS:11)相比,吗氯贝胺(最终中位数HDS:15)的疗效始终显著较弱。这种差异涉及睡眠和抑郁症状。尽管在几项研究中报道,与三环类抗抑郁药治疗的患者相比,吗氯贝胺治疗的患者因病情恶化而退出的频率更高,但这些结果总体上与关于吗氯贝胺的文献主体不一致。

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