瑞波西汀与氟西汀治疗抑郁症的疗效和安全性对照研究

A control study on the curative effect and reliability of reboxetine with fluoxetine for treatment of depression

目的评价国产瑞波西汀治疗抑郁症的疗效和安全性。方法采用随机、双盲双模拟、氟西汀平行对照研究,汉密尔顿抑郁量表(HAMD)总分减分值作为疗效指标；药物不良反应量表(TESS)、实验室检查、生命体征等观察药物安全性。结果共收集抑郁症病人56例,瑞波西汀组(试验组)28例,氟西汀组(对照组)28例。治疗6周后,瑞波西汀组HAMD总分减分值为(16．8±5．8)分,氟西汀组为(16．0±6．3)分,与治疗前基线相比均差异有显著性(P＜0．01),但2组相比差异无显著性(P＞0．05)；瑞波西汀组有效率(HAMD减分率≥50%)为78．6%,氟西汀组为64．3%,2组相比差异无显著性(P＞0．05)。2组不良反应差异无显著性。结论甲磺酸瑞波西汀胶囊的抗抑郁疗效与氟西汀相似,不良反应轻而少,是一种有效、安全的抗抑郁药物。

Objective To evaluate efficacy and safety of reboxetine in treating depression. Methods In this randomized, double-blind, double-mimicry, fluoxetine parallel controlled, the study group was treated with reboxetine capsule and the control group with fluoxetine. Hamilton Rating Scale for Depression was taken to evaluate efficacy score while. Results At the end of six weekend, compared with the total scores of HAMD before and after treatment, reboxetine （ 16.8 ± 5.8） and fluoxetine （ 16.0 ± 6.3 ） group both showed the significant difference, while the difference compared between two groups ,the efficacy （78.6% and 64.3% ） for depression and side effects were no significance. Conclusion Reboxetine is a efficient and safety antidepressant.