瑞波西汀片治疗抑郁症的多中心随机双盲临床研究

目的评价甲磺酸瑞波西汀(抗抑郁药)治疗抑郁症的有效性和安全性以及对伴焦虑症状抑郁症的疗效。方法采取多中心、随机、双盲双模拟、阳性药平行对照、剂量固定的研究方法,对212例抑郁症患者分别进行甲磺酸瑞波西汀(试验组105例)和盐酸氟西汀(对照组107例)治疗,观察疗程均为6周;以汉密尔顿抑郁量表(HAMD)作为主要疗效评价指标,以HAMA评分的变化评价治疗抑郁症伴焦虑症状的疗效;采用不良事件记录、实验室检查、生命体征等评价药物安全性。结果治疗6周末,2组HAMD总分减分值(15.91 vs 15.93)、HAMD总分减分率和治疗有效率差异均无统计学意义(P>0.05);2组HAMA总减分值差异无统计学意义(P>0.05)。2组药物不良反应发生率(20.56%vs 28.57%)差异无统计学意义(P>0.05)。结论甲磺酸瑞波西汀与盐酸氟西汀相似,是一种安全有效的新型抗抑郁药。

Randomized, multicenter, double blind comparative trial of reboxetine in the treatment of depression with or without anxiety

Objective To investigate the efficacy and safety of reboxe- fine compared with fluoxetine in patients with depression.Methods This is a muti-center,randomized,double-blind double-dummy, active-controlled study.A total of 212 patients with depression were en- rolled.Subjects were randomized to reboxetine (trial group,n=105) or fluoxetine(control group,n=107) for six weeks.Primary outcome meas- ures changes in scores on 17-items Hamilton rating scale for depression (HAMD17) from baseline to week 6.Secondary measures were the rate respond and recovery according on the scores of HAMD17,total scores in Hamilton rating scale for anxiety (HAMA) and clinical global impression scale (CGI).Results At the endpoint,the scores of HAMD17 de- creased by mean of 15.91 and 15.93 in trial group and control group, respectively.The intention to treat analysis showed non-inferiority of tri- al group over control group.The incidence of adverse events of the two groups were 20.56 % and 28.57 %,respectively.The commom adverse reaction symptoms were as upset,dry mouth,nausea,loss of appetite, dizziness.Conclusion A novel antidepressant agent reboxetine is as effective as fluoxetine and better tolerated in the treatment of depression mixed with anxiety.