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