瑞波西汀治疗重性抑郁障碍对照研究

A control study of reboxetine in the treament of major depressive disorder

目的探讨瑞波西汀治疗重性抑郁障碍的临床疗效与安全性。方法将66例重性抑郁障碍患者随机分为研究组35例口服瑞波西汀治疗，对照组31例口服氟西汀治疗，观察6w。于治疗前及治疗2w、4w、6w末采用汉密顿抑郁量表、汉密顿焦虑量表评定临床疗效，临床疗效总评量表评定病情严重程度，副反应量表评定不良反应。结果治疗6w末，研究组有效率85．7％，对照组为64．5％，研究组有效率显著高于对照组（χ2=4．02，P〈0．05）。两组治疗后汉密顿抑郁量表、汉密顿焦虑量表、临床疗效总评量表总分均较治疗前有显著性下降，并随着治疗时间的延续均呈持续性下降；研究组治疗4W、6w末均较对照组下降显著（P〈0．05或0．01）。两组不良反应均轻微，研究组发生率22．9％，对照组发生率为25．8％，两组差异无显著性（χ2=0．08，P〉O．05）。结论瑞波西汀与氟西汀治疗重性抑郁障碍均有效，但瑞波西汀疗效、安全性高、依从性优于氟西汀。

Objective To explore the efficacy and safety of reboxetine in the treatment of major depressive disorder. Methods Sixty-six patients with major depressive disorder were randomly divided into research group （n=35） took orally rehoxetine and control group （n=31） did fluoxetine for 6 weeks. Clinical efficacies were assessed with the Hamilton Depression Scale（HAMD） and Hamilton Anxiety Scale（HAMA）, severity of patient＇s condition with the Clinical Global Impression（CGI） and adverse reactions with the Treatment Emergent Symptom Scale（TESS） before treatment and at the end of the 2nd,4th and 6th week treatment. Results At the end of the 6th week,effective rates were respectively 85.7% in the research and 64.5%in the control group, the former was significantly hgiher than the latter（χ2 =4.02,P〈0.05）. The total scores of the HAMD, HAMA and CGI of both groups after treatment lowered more significantly com- pared with pretreatment and did continously along with the time of therapy lasting; those at the ends of the 4th and6th week lowered more significantly in the research than in the control group（P〈0.05 or 0.01）. Adverse reactions of both groups were mild, incidences were respectively 9,2. 9% in the research and 25.8% in the control, and the difference was not significant（χ2 =0. 08,P）0. 05）. Conclusion Both rehoxetine and fluoxetine are effective against major depressive disorder,but reboxetine has an advantage over fluoxetine in efficacy,higher safety and better compliance.