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两种不同滴定方式的盐酸帕罗西汀溶液的疗效与耐受性:一项观察性研究

Efficacy and Tolerability of Two Different Kinds of Titration of Paroxetine Hydrocloride Solution: an Observational Study.

作者信息

Ielmini Marta, Poloni Nicola, Caselli Ivano, Bianchi Lucia, Diurni Marcello, Vender Simone, Callegari Camilla

机构信息

Ielmini, Caselli and Bianchi, Medical Doctor at the Department of Medicine and Surgery, Psychiatry, University of Insubria, Via Guicciardini 2, 21100 Varese, Italy. Poloni, Universitary Researcher at the Department of Medicine and Surgery, Psychiatry, University of Insubria, Via Guicciardini 2, 21100 Varese, Italy. Diurni, PhD and Medical Doctor at the Department of Medicine and Surgery, Psychiatry, University of Insubria, Via Guicciardini 2, 21100 Varese, Italy. Vender, Honorary Professor at the University of Insubria, Via Guicciardini 2, 21100 Varese, Italy. Callegari, Associate Professor at the Department of Medicine and Surgery, Psychiatry, University of Insubria, Via Guicciardini 2, 21100 Varese, Italy.

出版信息

Psychopharmacol Bull. 2018 Mar 13;48(3):33-41.

Abstract

BACKGROUND

Depressive disorders are expected to be the second highest cause of morbidity in the world until few years. Moreover, patients with depression frequently show many side effects and low compliance to therapy. To find a more tolerated and more efficacy therapy is a growing need.

OBJECTIVE

This observational study investigates the efficacy, safety and tolerability of paroxetine hydrochloride comparing slow versus standard titration in a population affected by Depressive Disoders (according to DSM 5).

METHODS

186 outpatients were assessed throught the following scales: Hamilton Depression Rating Scale (HDRS) for depression and World Health Organization Quality of Life Scale Bref for the perceived quality of life (WHOQOL BREF). Treatment-emerged Adverse Events (TEAEs) were recorded throught self-reports. Statystical analysys was performed by GraphPad Prism Version 5.1.

RESULTS

The efficacy of paroxetine was confirmed in both titrations by the number of clinical remitters (HDRS ≤ 7 at 12 weeks for 53% of the standard titration group and 58% of the slow titration group), without differences. About safety and tolerability there were more frequent TEAEs among the standard titration group (p < 0.01). Comparing WHOQOL BREF between the two groups at the recruitment and at the twelth week emerged a statistically significant difference (p = 0.003), with highest scores reached in slow titration group.

CONCLUSIONS

Although the short observation period is an evident limit, this study is consistent to the literature about the efficacy of both titrations of paroxetine to improve depression and shows promising results about the increased tolerability of paroxetine slow titration.

摘要

背景

在未来几年内,抑郁症预计将成为全球第二大致病原因。此外,抑郁症患者经常出现许多副作用,且对治疗的依从性较低。因此,寻找一种耐受性更好、疗效更佳的治疗方法的需求日益增长。

目的

本观察性研究旨在调查盐酸帕罗西汀在抑郁症患者(根据《精神疾病诊断与统计手册》第5版)中,缓慢滴定与标准滴定相比的疗效、安全性和耐受性。

方法

通过以下量表对186名门诊患者进行评估:用于评估抑郁程度的汉密尔顿抑郁量表(HDRS)和用于评估生活质量感知的世界卫生组织生活质量简表(WHOQOL BREF)。通过自我报告记录治疗中出现的不良事件(TEAE)。使用GraphPad Prism 5.1版本进行统计分析。

结果

两种滴定方式下,临床缓解者的数量均证实了帕罗西汀的疗效(标准滴定组12周时HDRS≤7的患者占53%,缓慢滴定组占58%),无差异。在安全性和耐受性方面,标准滴定组的TEAE更为频繁(p<0.01)。比较两组在入组时和第12周时的WHOQOL BREF,发现存在统计学显著差异(p = 0.003),缓慢滴定组得分更高。

结论

尽管观察期较短是一个明显的局限,但本研究与关于帕罗西汀两种滴定方式改善抑郁症疗效的文献一致,并显示出帕罗西汀缓慢滴定耐受性增加的有前景的结果。

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