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度洛西汀肠溶片与帕罗西汀片治疗抑郁症患者的随机、双盲对照研究

王继才 刘芳 王艳娇 李文昱 许秀峰

四川精神卫生Issue(2):132-136,5.
四川精神卫生Issue(2):132-136,5.DOI:10.3969/j.issn.1007-3256.2014.02.012

度洛西汀肠溶片与帕罗西汀片治疗抑郁症患者的随机、双盲对照研究

The second phase clinical trial of duloxetine enteric-coated tablets for the treatment of the maj or depressive disorder

王继才 1刘芳 1王艳娇 1李文昱 1许秀峰1

作者信息

  • 1. 650032 昆明医科大学第一附属医院精神科
  • 折叠

摘要

Abstract

Objective The aim of this study was to evaluate the efficacy and safety of duloxetine to the patients with depres-sive disorders.Methods a randomized,double-blind,double-dummy,parallel controlled study was carried out between 5 1 patients who met the DSM-Ⅳcriteria of depression and depressed episode.The 25 of total patients were treated with duloxetine(40~60 mg·d-1)and the others were treated with paroxetine(20mg·d-1 )for 8 weeks.The efficacy were assessed by Hamilton De-pression Rating Scale(HAMD),Hamilton Anxiety Scale(HAMA),Montgomery Depression Rating Scale(MADRS),Sheehan Disability Scale(SDS)visual analogue scale(VAS-PI)、Clinical Global Impression (CGI)and the safety was assessed by Ad-verse Event .Results After 8 weeks treatment,the total effective rates of duloxetine group and paroxetine group were 72.0%and 73.1% respectively,with no significant difference(P>0.05).The clinical curing rate of duloxetine group and paroxetine group were 20.0% and 23.1% respectively,with no significant difference(P>0.05).The scores of HAMD17,HAMA, MADRS,SDS,VAS-PI and CGI in both groups decreased significantly,with statistically difference between the baseline and other observation time points(P<0.001).The adverse event rates of the duloxetine group and paroxetine group were 36.0%and 34.6% respectively,with no significant difference(P>0.05).The main adverse events of two groups were dry mouth, nausea,dizziness,Stomach discomfort,et al.Conclusion Duloxetine Enteric-coated Tablet as well as paroxetine is an effective antidepressants,with less side effects,better safety.

关键词

抑郁症/度洛西汀肠溶片/随机对照试验/双盲法/疗效/安全性

Key words

Depressive disorder/Duloxetine Enteric-coated Tablet/Randomized controlled trials/Double-blinded meth-od/Efficacy/Safety

分类

医药卫生

引用本文复制引用

王继才,刘芳,王艳娇,李文昱,许秀峰..度洛西汀肠溶片与帕罗西汀片治疗抑郁症患者的随机、双盲对照研究[J].四川精神卫生,2014,(2):132-136,5.

四川精神卫生

1007-3256

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