瑞波西汀治疗抑郁症的Ⅱ期临床观察

The second phase clinical trials of reboxitine for the treatment of the major depressive disorder

目的评价瑞波西汀片治疗抑郁症的临床疗效和安全性。方法对符合《CCMD-3》抑郁症诊断标准的46例抑郁症患者进行瑞波西汀片和氟西汀的随机双盲对照研究,其中瑞波西汀片组22例(8mg/d),氟西汀组24例(20mg/d),共治疗6周。采用汉密尔顿抑郁量表(HAMD),汉密尔顿焦虑量表(HAMA),临床总体评定量表(CGI)评定临床疗效,不良事件量表评定安全性。结果经6周治疗后,瑞波西汀片组治疗总有效率为69.57%,氟西汀组为76.00%,两组相比较,差异无显著性(P>0.05)。两组的HAMD,HAMA评分治疗前后相比较差异有高度显著性(P<0.01)。不良反应分析,两组药物不良反应的发生率无显著性差异(P>0.05),常见的不良反应有口干、出汗、恶心、便秘等。结论瑞波西汀片治疗抑郁症疗效好,安全性较高,适合临床应用。

Objective The aim of this study was to determine the efficacy and safety of reboxitine for the depressive patients. Methods A controlled study was carried out in 46 patients who met the CCMD-3 criteria of major depression and depressed episode. 22 of total patients were treated with reboxitine （8mg / d） and the others were treated with fluoxetine （20mg/d） for 6 weeks. The efficacy was assessed by Hamilton Depression Rating scale （HAMD） , Hamilton Anxiety scale （HAMA） , Clinical Global Impression （CGI） and the safety was assessed by adverse event. Results After six weeks treatment, the improvement rate of reboxitine group and fluoxetine group were 69.57% and 76.00%, respectively （P〉 0.05） The scores of HAMD and HAMA in two groups were statistically different before and after treatment （P 〈 0.01） The main adverse events of two groups were dry mouth, hidrosis, nausea, constipation, There was no significant difference in incidence of adverse events between reboxitine and fluoxetine groups. Conclusions Reboxitine is an effective antidepressants, with better safety, suiting for clinical use.