Comparison of efficacy and safety of milnacipran and fluoxetine in Korean patients with major depression
Comparison of efficacy and safety of milnacipran and fluoxetine in Korean patients with major depression
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米那普仑和氟西汀治疗韩国重度抑郁症患者的疗效和安全性比较
DOI：
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发表时间：
2005
影响因子：
2.3
通讯作者：
I. Paik
中科院分区：
文献类型：
--
作者：
Min;B. Ham;B. Kee;Jung;B. Yeon;K. Oh;B. Oh;Chul Lee;Han;I. Chee;B. Choe;I. Paik
摘要 目的：比较米那普仑和氟西汀在韩国重度抑郁症患者中的疗效和安全性。研究设计和方法：该设计是一项多中心、随机、比较临床研究。招募患有重性抑郁症（DSM-IV 诊断标准）的患者，这些患者在 17 项汉密尔顿抑郁量表（HAM-D）上得分超过 17 分，在蒙哥马利-阿斯伯格抑郁量表（MADRS）上得分超过 21 分，并随机接受米那普仑（50mg/天，1 周后增加至 100mg/天）或氟西汀（20mg/天）治疗，持续 6 组。几周。在进入研究前至少 7 天停止之前的所有药物治疗。在基线以及治疗 1、2、4 和 6 周后对患者进行评估（HAM-D、MADRS 和临床总体印象量表，CGI）。记录研究期间发生的所有不良事件。结果：该研究纳入了 70 名患者（米那普仑 39 名；氟西汀 31 名）。 1 周后，两组的 HAM-D、MADRS 和 CGI 总分均显着下降，并且在整个研究过程中持续下降。两组在任何时间点的任何测量都没有显着差异。两种抗抑郁药的耐受性均良好。米那普仑组有 13 名患者报告了 28 项不良反应，氟西汀组有 11 名患者报告了 18 项不良反应。米那普仑组有两名患者因不良事件而停药，氟西汀组有三名患者因不良事件而停药。在整个研究过程中，生命体征、常规血液实验室检查、生物化学或心电图没有出现临床上显着的变化。恶心和头痛是米那普仑最常见的不良事件，而氟西汀则更常见消化紊乱、腹泻和失眠。结论：米那普仑与氟西汀一样，被发现对于治疗韩国抑郁症患者的重度抑郁症有效且耐受性良好。该研究的主要局限性是其开放式设计、样本量小以及持续时间相对较短。
ABSTRACT Object: To compare efficacy and safety of milnacipran and fluoxetine in a population of Korean patients with major depression. Research design and methods: The design was a multi-centre, randomised, comparative clinical study. Patients with major depression (DSM‐IV diagnostic criteria) scoring over 17 points on the 17-item Hamilton Depression Scale (HAM‐D) and over 21 points on the Montgomery-Asberg Depression Rating Scale (MADRS) were recruited and randomised to receive milnacipran (50 mg/day increasing after 1 week to 100 mg/day) or fluoxetine (20 mg/day) for 6 weeks. All previous medication was stopped at least 7 days before entry into the study. Patients were evaluated (HAM‐D, MADRS and clinical global impression scale, CGI) at baseline and after 1, 2, 4 and 6 weeks of treatment. All adverse events which developed during the study period were recorded. Results: 70 patients (milnacipran 39; fluoxetine 31) were included in the study. Total score on both HAM‐D, MADRS and CGI decreased significantly in both groups after 1 week and continued to decrease throughout the study. There was no significant difference between the two groups for any measurement at any time point. Both antidepressants were well tolerated. In the milnacipran group, 13 patients reported 28 adverse reactions, and in the fluoxetine group 11 patients reported 18 adverse reactions. Two patients discontinued due to adverse events in the milnacipran group and three in the fluoxetine group. There were no clinically significant modifications in vital signs, routine blood laboratory tests, biochemistry or ECG throughout the study. Nausea and headache were the most frequently reported adverse events with milnacipran while digestive disturbances, diarrhoea and insomnia were more common with fluoxetine. Conclusion: Milnacipran, like fluoxetine, was found to be effective and well tolerated for the treatment of major depression in this population of depressed Korean patients. Principal limitations of the study were its open design, its small sample size and its relatively short duration.
DOI：
10.1001/jama.1989.03420150079041
发表时间：
1989-04
期刊：
JAMA
影响因子：
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作者：
G. Klerman;Myrna M. Weissman
通讯作者：
G. Klerman;Myrna M. Weissman