瑞波西汀与氟西汀治疗抑郁症随机双盲多中心临床研究

目的:评价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、剂量固定的多中心研究。受试者分别口服瑞波西汀胶囊8mg·d-1或氟西汀片20mg·d-1。采用汉密尔顿抑郁量表(HAMD)总分减分值作为主要疗效指标,以临床总体印象量表(CGI)和汉密尔顿焦虑量表(HAMA)评分作为次要疗效指标;采用药物不良反应量表(TESS)、实验室检查、生命体征等观察药物安全性。结果:共收集符合意向治疗抑郁症病人(ITT)222例,瑞波西汀组(试验组)109例,氟西汀组(对照组)113例。符合研究方案病人(PP)213例,瑞波西汀组104例,氟西汀组109例。治疗6wk后,瑞波西汀组HAMD总分减分值为(16±s7)分,氟西汀组为(16±7)分,与治疗基线相比差异均有非常显著意义(P<0.01),但2组相比差异无显著意义(P>0.05);瑞波西汀组有效率(HAMD减分率≥50%)为81.7%,氟西汀组为77.9%,2组相比差异无显著意义(P>0.05);瑞波西汀组临床治愈率(HAMD总分≤8)为62.4%,氟西汀组为58.4%,2组差异无显著意义(P>0.05);在CGI,HAMA评分上,2组差异亦无显著意义。安全性分析显示,2组不良反应的症状和发生率相比差异均无显著意义。结论:瑞波西汀治疗抑郁症安全有效。

Comparison of reboxetine with fluoxetine in treatment of depression: a randomized, double-blind, multicenter study

AIM: To evaluate efficacy and safety of reboxetine in treating depression. METHODS: In this randomized, double-blind, double-mimicry, fluoxetine parallel controlled, fixed dosage, multicenter study, the study group was treated with reboxetine capsule 8 (mg·d~(-1)) and the control group with fluoxetine tablet 20 mg·d~(-1). Hamilton Rating Scale for Depression (17-(item) HAMD) total reduction value was taken as the primary efficacy score while Clinical Global Impression (CGI) and Hamilton Rating Scale for Anxiety (HAMA) were used as secondary score, items including the TESS, lab examination and vital signs for assessment of safety. RESULTS: Among 222 patients with depression (ITT), 109 subjects treated with reboxetine (study group) and other 113 patients with fluoxetine (control group). Per Protocol (PP) 213 patients included reboxetine group (104) and fluoxetine group (109). After 6 wk treatment, a statistically significant greater reduction in HAMD total score was found for both reboxetine group (16±7) and fluoxetine group (16±7) showing statistical significsnce with their baseline (P<(0.01)), however, there was no significant difference between two active treatment groups (P>(0.05)). There were great proportion of patients treated with either reboxetine or fluoxetine showing positive response rates (≥50 % reduction in HAMD, (81.7 %) versus 77.9 %) and remission rates ((HAMD≤)8 points, 62.4 % versus 58.4 %), nevertheless still no significant difference between two groups was shown (both P>(0.05)). Similar findings were recorded in CGI and HAMA. Safety assessment showed there was no statistically significant deference between the symptoms and incidence of adverse reaction. CONCLUSION: Reboxetine is an effective and safe antidepressant.