Lapierre Y D, Joffe R, McKenna K, Bland R, Kennedy S, Ingram P, Reesal R, Rickhi B G, Beauclair L, Chouinard G, Annable L
Royal Ottawa Hospital, Ontario, Canada.
J Psychiatry Neurosci. 1997 Mar;22(2):118-26.
The objective of the present study was to compare the safety and efficacy of moclobemide versus fluoxetine in adult patients with major depressive disorder. The design of the study was a multicenter, double-blind, comparative, and randomized trial. A 1- to 2-week single-blind placebo washout phase was followed by 6 weeks of double-blind treatment with moclobemide or fluoxetine. A total of 150 patients were enrolled in the study. There were 128 patients eligible to be randomized, with 66 patients receiving moclobemide and 62 patients receiving fluoxetine. At the termination of the study, patients in the moclobemide group were receiving a mean dose of 440 mg +/- 123 mg, while the mean dose in the fluoxetine group was 35 mg +/- 8 mg. No significant treatment differences were found for any of the efficacy parameters. Headache and nausea were the most frequently reported adverse events in both treatment groups. Headache and blurred vision were reported significantly more often (P < 0.05) in the fluoxetine group, whereas significantly more dry mouth was reported (P < 0.05) in the moclobemide group. These results provide supporting evidence of the comparable efficacy of moclobemide and fluoxetine and the better tolerability of moclobemide when used in the treatment of major depressive disorder.
本研究的目的是比较吗氯贝胺与氟西汀在成年重度抑郁症患者中的安全性和疗效。该研究的设计为多中心、双盲、对照和随机试验。在1至2周的单盲安慰剂洗脱期之后，进行为期6周的吗氯贝胺或氟西汀双盲治疗。共有150名患者参与了该研究。其中128名患者符合随机分组条件，66名患者接受吗氯贝胺治疗，62名患者接受氟西汀治疗。在研究结束时，吗氯贝胺组患者的平均剂量为440 mg±123 mg，而氟西汀组的平均剂量为35 mg±8 mg。在任何疗效参数方面均未发现显著的治疗差异。头痛和恶心是两个治疗组中最常报告的不良事件。氟西汀组中头痛和视力模糊的报告显著更频繁（P<0.05），而吗氯贝胺组中口干的报告显著更多（P<0.05）。这些结果为吗氯贝胺和氟西汀疗效相当以及吗氯贝胺用于治疗重度抑郁症时耐受性更好提供了支持性证据。
