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吗氯贝胺与反苯环丙胺治疗抑郁症的双盲对照研究

Double-blind comparison of moclobemide and tranylcypromine in depression.

作者信息

Heinze G, Rossel L, Gabelic I, Galeano-Munoz J, Stabl M, Allen S R

机构信息

Instituto Mexicano de Psiquiatria, Mexico, D.F.

出版信息

Pharmacopsychiatry. 1993 Nov;26(6):240-5. doi: 10.1055/s-2007-1014361.

Abstract

Moclobemide is the first of a new generation of reversible inhibitors of monoamine oxidase-A (RIMA) with no clinically relevant potentiation of the hypertensive actions of dietary tyramine. The present study was conducted to compare the efficacy and safety of moclobemide with an established irreversible monoamine oxidase inhibitor, tranylcypromine, in depressed patients. Patients were randomized to receive moclobemide (81 patients) or tranylcypromine (79 patients) at individually titrated doses (100-300 mg/day of moclobemide and 10-30 mg/day of tranylcypromine) under double-blind conditions for at least four weeks, in a multicenter trial. Antidepressant efficacy was assessed using items 1-17 of the Hamilton depression rating scale (HAMD-17), the von Zerssen 'Befindlichkeits' scales, a visual analog scale and the clinicians' global impression. Both treatments resulted in significant amelioration of depression as determined by all rating instruments. HAMD-17 scores were reduced by 63% and 58% with moclobemide and tranylcypromine respectively, although the difference between the groups was not significant. The other rating instruments yielded similar results, apart from the clinician's assessment of efficacy at day 28. In this assessment, efficacy was rated as very good/good in 78% of moclobemide treated patients and in 88% of the tranylcypromine treated patients; however, only patients who had not dropped out of the trial were included in this assessment. The tolerability of both drugs was good, although moclobemide appeared to possess a small advantage in this regard since only one patient in this group was prematurely withdrawn from the trial due to inadequate tolerability/adverse events, compared with nine withdrawals in the tranylcypromine group.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

吗氯贝胺是新一代可逆性单胺氧化酶 -A 抑制剂(RIMA)中的首个药物,对饮食中酪胺的高血压作用无临床相关增强作用。本研究旨在比较吗氯贝胺与一种已确立的不可逆性单胺氧化酶抑制剂反苯环丙胺在抑郁症患者中的疗效和安全性。在一项多中心试验中,患者被随机分配,在双盲条件下接受个体化滴定剂量(吗氯贝胺 100 - 300 毫克/天,反苯环丙胺 10 - 30 毫克/天)的吗氯贝胺(81 例患者)或反苯环丙胺(79 例患者)治疗至少四周。使用汉密尔顿抑郁评定量表(HAMD - 17)的第 1 - 17 项、冯·泽尔森“情绪状态”量表、视觉模拟量表和临床医生整体印象来评估抗抑郁疗效。所有评定工具均显示,两种治疗均使抑郁症得到显著改善。吗氯贝胺和反苯环丙胺治疗后 HAMD - 17 评分分别降低了 63%和 58%,尽管两组之间差异不显著。除临床医生在第 28 天对疗效的评估外,其他评定工具得出了相似结果。在此评估中,78%接受吗氯贝胺治疗的患者和 88%接受反苯环丙胺治疗的患者疗效被评为非常好/好;然而,此评估仅纳入了未退出试验的患者。两种药物的耐受性均良好,不过吗氯贝胺在这方面似乎有微小优势,因为该组中仅有 1 例患者因耐受性不足/不良事件而提前退出试验,相比之下,反苯环丙胺组有 9 例退出。(摘要截断于 250 字)

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