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 major depressive disorder

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 depressive 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 Depression 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 Adverse 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.