单用或联用瑞波西汀治疗抑郁障碍的疗效与安全性研究

Efficacy and Safety of Reboxetine Alone or in Combination with Other Antidepressants for Depressive Disorder

目的:探讨瑞波西汀单独应用或联合其他抗抑郁药治疗重症抑郁症障碍的疗效与安全性。方法:对194例重症抑郁发作患者,分为单用组和联用组,分别单独给予瑞波西汀或者瑞波西汀联用其他抗抑郁药(主要是选择性5-羟色胺再摄取抑制剂)治疗,为期8周。应用汉密尔顿抑郁量表(HDRS)、汉密尔顿焦虑量表(HARS)评估抗抑郁疗效,并观察不良反应的发生情况。结果:194例患者的HDRS评分、HARS评分均明显下降。单用组的HDRS减分率[(73.39±17.73)%]显著高于联用组[(62.71±29.33)%](P<0.01),有效率(90.8%)也显著高于联用组(78.8%)(P<0.05)。常见不良反应为头晕、口干和出汗,多为轻微和轻度,总体不良反应发生率为39.2%;未发生严重不良事件。结论:瑞波西汀单独及联合应用治疗抑郁症均疗效明显,且瑞波西汀单独应用疗效优于联合应用。瑞波西汀具有良好的耐受性。

OBJECTIVE：To explore the efficacy and safety of reboxetine alone or in combination with other antidepressants for major depressive disorder. METHODS：A total of 194 patients with major depressive order were assigned to receive reboxetine alone or in combination with other antidepressants （mainly selective serotonin reuptake inhibitors,SSRIs） for 8 weeks. Hamilton depression rating scale （17 items）（HDRS）,Hamilton anxiety rating scale （HARS） were used to evaluate the efficacy of antide-pressant treatment,and the adverse drug reactions were also recorded. RESULTS：Both HDRS scores and the HARS scores in the 194 patients decreased significantly;however,the reduction rate of HDRS scores [（73.39 ± 17.73）% vs. （62.71 ± 29.33）%]（P〈0.01） as well as the response rate（90.8% vs. 78.8%）（P〈0.05）in those patients treated with reboxetine alone were significantly higher than those treated with reboxetine plus other antidepressants. The most common adverse drug reactions included dizziness, dry month and sweating,mostly in mild or moderate degree. The rate of total adverse drug reactions was 39.2%. No serious ad-verse drug reaction case was found. CONCLUSIONS：Reboxetine used alone or in combination with other antidepressants show re-markable efficacy in the treatment of major depression;however,reboxetine used alone shows significantly better efficacy than its combination therapy. Moreover,reboxetine is well-tolerant.