与氟西汀相比，噻奈普汀治疗抑郁症的疗效和安全性。

Efficacy and safety of tianeptine in the treatment of depressive disorders in comparison with fluoxetine.

作者信息

Lôo H, Saiz-Ruiz J, Ansseau M, Herrington R, Vaz-Serra A, Dilling H, de Risio S

机构信息

Service Hospitalo Universitaire de Santé Mentale et de Therapeutique, Sainte-Anne Hospital, Paris, France.

出版信息

J Affect Disord. 1999 Dec;56(2-3):109-18. doi: 10.1016/s0165-0327(99)00009-9.

DOI:10.1016/s0165-0327(99)00009-9

PMID:10701468

Abstract

BACKGROUND

Depression is treated by a great variety of antidepressant treatments. SSRIs (such as fluoxetine) are well known: it is, however, sure that further progress is needed and the search for antidepressants with other mechanisms of action (such as tianeptine) or different efficacy is still of interest.

METHODS

A multinational study compared tianeptine with fluoxetine in 387 patients with Depressive Episode, or Recurrent Depressive Disorder, or Bipolar Affective Disorder (ICD-10), in a double-blind parallel group design. They were treated for six weeks.

RESULTS

At inclusion, no significant difference between groups was shown. Final MADRS scores were 15.7 and 15.8 with tianeptine and fluoxetine, respectively (ITT population) (p = 0.944). MADRS responders were 58% and 56% with tianeptine and fluoxetine, respectively (p = 0.710). No statistical difference was observed for the other efficacy parameters. Thirty-six withdrawals occurred in each group, without any difference for the reasons of discontinuation. There was no major difference between groups for the other safety parameters.

CONCLUSIONS

In this study, both tianeptine and fluoxetine exhibited a good efficacy and safety.

摘要

背景

抑郁症可通过多种抗抑郁治疗方法进行治疗。选择性5-羟色胺再摄取抑制剂（如氟西汀）广为人知：然而，可以肯定的是，仍需取得进一步进展，寻找具有其他作用机制（如噻奈普汀）或不同疗效的抗抑郁药仍然具有重要意义。

方法

一项跨国研究采用双盲平行组设计，对387例患有抑郁发作、复发性抑郁障碍或双相情感障碍（国际疾病分类第10版）的患者比较了噻奈普汀和氟西汀的疗效。他们接受了为期六周的治疗。

结果

入组时，两组之间未显示出显著差异。在ITT人群中，接受噻奈普汀和氟西汀治疗的患者最终蒙哥马利-艾森伯格抑郁量表（MADRS）得分分别为15.7和15.8（p = 0.944）。接受噻奈普汀和氟西汀治疗的患者中，MADRS反应者分别为58%和56%（p = 0.710）。其他疗效参数未观察到统计学差异。每组均有36例患者退出研究，停药原因无差异。两组在其他安全性参数方面无显著差异。