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帕罗西汀与阿米替林治疗复发性重度抑郁症的比较:一项双盲试验。

Paroxetine versus amitriptyline in patients with recurrent major depression: A double-blind trial.

出版信息

Int J Psychiatry Clin Pract. 2002;6(1):23-9. doi: 10.1080/136515002753489380.

Abstract

INTRODUCTION

Long-term exposure to antidepressants is required to prevent relapses and recurrences in patients with recurrent major depression. Furthermore, a good pharmacological compliance is the key to successful long-term treatment. Since the early phases of a treatment influence long-term compliance and compliance is adversely affected by poorly tolerated treatments, efficacy and tolerability of paroxetine and amitryptiline over 12 weeks were compared as an introduction to the issue of long-term compliance to these two agents.

METHOD

A 12-week, randomized, double-blind, doubledummy, parallel-group trial which involved 129 patients with recurrent major depression.

RESULTS

Both paroxetine and amitriptyline were effective in controlling the symptoms of depression, as shown by the reduction in HAMD total score and CGI severity-of-illness score at endpoint compared to baseline. There was no statistically or clinically significant difference between the two treatments in terms of efficacy. However, marked numerical differences were noted in tolerability: the percentage of patients who reported treatment-emergent adverse experiences was greater in the amitriptyline group (40.0% vs 28.1%). This difference was mainly due to anticholinergic adverse events, which were six times more frequent with amitriptyline than with paroxetine.

CONCLUSION

When compared with amitriptyline, paroxetine should allow patients with recurrent major depression to receive an equally effective treatment with a relatively lower incidence of adverse experiences.

摘要

介绍

为了防止复发性重度抑郁症患者病情复发,需要长期服用抗抑郁药。此外,良好的药物依从性是长期治疗成功的关键。由于治疗的早期阶段会影响长期依从性,而较差的耐受性会影响依从性,因此比较了帕罗西汀和阿米替林在 12 周内的疗效和耐受性,以探讨这两种药物长期依从性的问题。

方法

这是一项为期 12 周、随机、双盲、双模拟、平行组试验,共纳入 129 例复发性重度抑郁症患者。

结果

帕罗西汀和阿米替林均能有效控制抑郁症状,与基线相比,在终点时 HAMD 总分和 CGI 严重程度评分均有显著降低。两种治疗方法在疗效方面无统计学或临床意义上的差异。然而,在耐受性方面存在明显的数值差异:报告治疗中出现不良事件的患者比例,阿米替林组(40.0%)明显高于帕罗西汀组(28.1%)。这种差异主要是由于抗胆碱能不良事件引起的,与帕罗西汀相比,阿米替林发生抗胆碱能不良事件的频率高 6 倍。

结论

与阿米替林相比,帕罗西汀可使复发性重度抑郁症患者接受同样有效的治疗,且不良反应发生率相对较低。

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