米那普仑与度洛西汀治疗抑郁症的疗效和安全性评价

目的：比较米那普仑与度洛西汀治疗抑郁症的疗效和安全性评价，为临床治疗抑郁症提供可选择的药物。方法：采用随机对照、度洛西汀开放式6周对照研究。共收集抑郁症患者120例，米那普仑组60例，男37例，女23例，度洛西汀组60例，男33例，女27例，米那普仑初始剂量是50 mg·d^-1（po，bid），度洛西汀的初始剂量是20 mg·d^-1（po，bid）。主要研究指标为基线到治疗6周后汉密尔顿抑郁量表17项（HAMD-17）总分的变化；次要研究指标汉密尔顿焦虑量表（HAMA）对治疗后患者一般情况进行评价，并应用不良反应量表（TESS）观察试验中不良事件的发生情况。结果：米那普仑组和度洛西汀组治疗6周末，米那普仑组HAMD-17总分下降了（14.56±3.25），度洛西汀组下降了（14.62±3.19）；在各随访点，HAMD-17总分在2组间无明显差异（P>0.05）；米那普仑组和度洛西汀组的有效率分别为78.33%和76.67%，疗效上无明显差异（P>0.05）；2组HAMA评分无显著差异（P>0.05）；米那普仑组的不良事件发生率为13.33%（8/60），度洛西汀组为21.67%（13/60），2组相比有显著差异（P<0.05）。整个研究过程中无严重不良事件发生。结论：米那普仑与度洛西汀治疗抑郁症患者的疗效都有效且耐受性良好；米那普仑出现的相关症状更少。

Clinical effect and safety ofmilnacipran and dutoxetine on patients with depression

OBJECTIVE To compare the efficacy and safety of milnacipran and dutoxetine in the treatment of depression, so as to provide an alternative drug for the treatment of depression. METHODS A randomized controlled, open-label, 6-week study of duloxetine was conducted. A total of 120 patients with depression, including 37 males and 23 females in milnacipran group and 60 males and 27 females in duloxetine group, were recruited.The primary endpoint was the change after 6 weeks of treatment in Hamilton Depression Rating Scale 17(HAMD-17) total score from baseline; the secondary endpoint was Hamilton Anxiety Rating Scale(HAMA) to evaluate the general condition of patients after treatment, and adverse reaction scale(TESS) was used to observe the occurrence of adverse events in the trial. RESULTS At the end of 6 weeks of treatment, the HAMD-17 total score decreased by(14.56±3.25) in the milnacipran group and(14.62±3.19) in the duloxetine group. At each follow-up point, the HAMD-17 total score was not significantly different between the two groups. The effective rates of the two groups were 78.33% and 76.67% respectively, and there was no significant difference in efficacy(P>0.05). There was no significant difference in HAMA scores between two groups(P>0.05). The incidence of adverse events was 13.33%(8/60) in the milnacipran group and 21.67%(13/60) in the duloxetine group and there was a significant difference between the two groups(P<0.05). No serious adverse events occurred during the whole study. CONCLUSION Both milnacipran and duloxetine are effective and well tolerated in the treatment of depression. Milnacipran is associated with fewer symptoms.