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

摘要

目的：评价度洛西汀肠溶片治疗抑郁症的有效性和安全性。方法对符合美国《精神疾病诊断与统计手册(第4版)》(DSM- IV)抑郁症诊断标准的51例抑郁症患者进行度洛西汀肠溶片和帕罗西汀片的随机、双盲、双模拟、平行对照研究,其中度洛西汀肠溶片治疗组(A 组)25例(40~60mg/d),帕罗西汀片治疗组(B 组)26例(20mg/d),共治疗8周。采用汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)、蒙哥马利抑郁评定量表(MADRS)、Sheehan残疾量表(SDS)、视觉模拟疼痛程度(VAS-PI)、临床总体印象评定量表(CGI)评定临床疗效,不良事件量表(AE)评定安全性。结果经8周治疗后,两组总有效率分别为72.0%,73.1%,缓解率分别为20.0%,23.1%,差异均无统计学意义(P>0.05)。治疗前后两组 HAMD、HAMA、MADRS、CGI-S、VAS-PI、SDS评分差异有统计学意义(P<0.001)。两组药物不良反应发生率分别为36.0%和34.6%,差异无统计学意义(P>0.05),常见的不良反应有口干、恶心、头昏,胃部不适。结论度洛西汀肠溶片和帕罗西汀片治疗抑郁症可能均有效且相当；两组不良反应少而轻且相当。%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.