[Comparative naturalistic study of the efficacy and tolerability of new antidepressants].

F Arias, J J Padín, I Gilaberte, P Varillas, R Sánchez, S Gómez, D García
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Abstract

Objectives: The objective of this study was to compare, in a naturalistic setting, the efficacy and tolerability of currently available Selective Serotonin Re-uptake Inhibitors (SSRIs) and venlafaxine in out-patients from a primary psychiatric-care center.

Material and methods: The sample was composed of 194 patients with mood disorders (major depressive disorder or dysthymic disorder according to the DSM-IV criteria) who initiated treatment either with a SSRI (fluoxetine, fluvoxamine, paroxetine, sertraline, and citalopram) or with venlafaxine. Baseline severity of the mood disorder was assessed using the Hamilton Depression Rating Scale and State-Trait Anxiety Inventory, and therapeutic response was measured with the Clinical Global Impression for Therapeutic Improvement. Tolerability was assessed by recording spontaneously reported adverse experiences. Patients were followed up for six months, with subjects made three o more intermediate visits.

Results: There were no significant differences in the efficacy of the antidepressants under study, but there were differences in the incidence and profiles of adverse events. Fluoxetine was associated with the lowest incidence of adverse effects in a logistical regression model. Particular events seemed to be associated with certain treatments; gastrointestinal discomfort (fluvoxamine), tremor (sertraline) and anticholinergic effects (venlafaxine).

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[新型抗抑郁药疗效和耐受性的比较自然研究]。
目的:本研究的目的是比较,在自然环境下,目前可获得的选择性5 -羟色胺再摄取抑制剂(SSRIs)和文拉法辛在初级精神病护理中心门诊患者中的疗效和耐受性。材料和方法:样本由194例心境障碍(根据DSM-IV标准的重度抑郁症或心境不良)患者组成,他们开始使用SSRI(氟西汀、氟伏沙明、帕罗西汀、舍曲林和西酞普兰)或文拉法辛进行治疗。使用汉密尔顿抑郁评定量表和状态-特质焦虑量表评估情绪障碍的基线严重程度,并使用临床整体治疗改善印象测量治疗反应。通过记录自发报告的不良经历来评估耐受性。患者随访6个月,中间随访3至6次。结果:所研究的抗抑郁药的疗效无显著差异,但不良事件的发生率和概况存在差异。在逻辑回归模型中,氟西汀与最低的不良反应发生率相关。特定事件似乎与某些治疗有关;胃肠道不适(氟伏沙明),震颤(舍曲林)和抗胆碱能作用(文拉法辛)。
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