盐酸度洛西汀肠溶片治疗抑郁症的临床对照研究

Randomized,double-blind controlled study of Duloxetine enteric tables in treatment of depression

目的评价盐酸度洛西汀肠溶片治疗抑郁症的有效性及安全性。方法符合美国精神疾病诊断与统计手册第四版(DSM-Ⅳ)的门诊抑郁症患者50例,随机分为盐酸度洛西汀肠溶片组(实验组)26例和盐酸帕罗西汀片组(对照组)24例,治疗8周。分别于基线期和治疗第1、2、4、6、8周末采用汉密尔顿抑郁量表(HAMD-17)、汉密尔顿焦虑量表(HAMA)评定疗效,以不良反应症状量表(TESS)评定副作用。结果治疗8周后两组HAMD-17、HAMA总分与基线相比均存在非常显著差异(P<0.01),但组间无显著差异(P>0.05);实验组有效率为88.5%,临床缓解率61.5%,对照组有效率为83.3%,临床缓解率62.5%,两组之间差异无统计学意义(P>0.05);实验组总不良反应发生率57.7%,对照组为54.2%,两组相比差异无统计学意义(P>0.05)。结论盐酸度洛西汀肠溶片治疗抑郁症的疗效、安全性及治疗抑郁症伴焦虑的疗效均与盐酸帕罗西汀片相当,是一种安全有效的抗抑郁药。

Objective To evaluate the efficacy and safety of Duloxetine enteric tables in the treatment of depression. Methods 50 outpatients according with the DSM-IV criteria of depression were randomized into study group treated with Duloxetine enteric tables （n = 26 ） and control group treated with Paroxetine （n = 24 ） for 8 weeks. The efficacy was assessed with Hamilton Depression Rating Scale-17 （HAMD-17） and Hamilton Anxiety Rating and the safety was assessed with Treatment Emergent Symptoms Scale （TESS） at baseline and at the Scale （ HAMA ） , end of 1st, 2nd, 4th, 6th, 8th week. Results At the end of the treatment, score of HAMD-17 and HAMA in both groups decreased significantly in comparison with the baseline （P 〈 0.01 ） , but there was no significant difference between the two groups （ P 〉 0.05）. The effective rate and remission rate were 88.5% and 61.5% respectively in study group, and 83.3% and 62.5% respectively in control group （P 〉0.05）. The adverse reactions rate was 57.7% in study group and 54.2% in control group （P 〉 0.05 ）. Conclusion Duloxetine enteric tables is an effective and safe antidepressant as Paroxetine in the treatment of depression.