Objective To evaluate the efficacy and safety of Duloxetine enteric tables in the treatment of depression. Methods 50 outpatients according with the DSM-FV 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 Scale (HAMA), and the safety was assessed with Treatment Emergent Symptoms Scale (TESS) at baseline and at the 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.%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.
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