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吗氯贝胺与氟西汀治疗双重抑郁的随机双盲研究

Moclobemide versus fluoxetine for double depression: a randomized double-blind study.

作者信息

Duarte A, Mikkelsen H, Delini-Stula A

机构信息

Mental Health Department, British Hospital, School of Medicine, University of Buenos Aires, Argentina.

出版信息

J Psychiatr Res. 1996 Nov-Dec;30(6):453-8. doi: 10.1016/s0022-3956(96)00030-1.

Abstract

The efficacy and tolerability of the selective reversible monoamine oxidase A inhibitor, moclobemide (300 mg/day) and the selective serotonin uptake inhibitor, fluoxetine (200 mg/day), were compared in a six-week single-centre double-blind fixed-dose study in patients (n = 42) with double depression (DSM-III-R: dysthymia with superimposed major depressive episode) using weekly assessment on the Hamilton depression rating scale (HDRS-17 items) and clinical global impression (CGI) scale. The primary efficacy outcome measure was a decrease > or = 50% in end of treatment HDRS score, secondary measures were the mean total endpoint HDRS scores and percentages of CGI very good and good responses. Tolerability was measured by the frequency and severity of volunteered adverse events. There were no significant differences in secondary efficacy outcome measures, but more patients achieved a > or = 50% decrease in HDRS score on moclobemide (71% vs 38%, p < 0.05). The only adverse event was mild transient anxiety (n = 1) with moclobemide. The results suggest that moclobemide and fluoxetine are equally well tolerated and at least similar in efficacy in double depression. Evidence that moclobemide may be more effective requires confirmation in a larger comparative study incorporating a placebo control group.

摘要

在一项为期六周的单中心双盲固定剂量研究中,对42例双相抑郁症(DSM-III-R:恶劣心境伴叠加的重度抑郁发作)患者,使用汉密尔顿抑郁量表(HDRS-17项)和临床总体印象(CGI)量表进行每周评估,比较了选择性可逆单胺氧化酶A抑制剂吗氯贝胺(300毫克/天)和选择性5-羟色胺再摄取抑制剂氟西汀(200毫克/天)的疗效和耐受性。主要疗效指标是治疗结束时HDRS评分降低≥50%,次要指标是总终点HDRS平均得分以及CGI非常好和良好反应的百分比。通过自发不良事件的频率和严重程度来衡量耐受性。次要疗效指标没有显著差异,但吗氯贝胺组有更多患者HDRS评分降低≥50%(71%对38%,p<0.05)。唯一的不良事件是使用吗氯贝胺时出现的轻度短暂焦虑(1例)。结果表明,吗氯贝胺和氟西汀耐受性相当,在双相抑郁症中的疗效至少相似。吗氯贝胺可能更有效的证据需要在纳入安慰剂对照组的更大规模比较研究中得到证实。

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