瑞波西汀治疗老年抑郁症的临床观察

Clinical Research on Reboxetine for Senile Depressive Disorder

目的:评价瑞波西汀治疗首发老年抑郁症的疗效和安全性。方法:采用随机、单盲、平行对照方法。受试者分别口服瑞波西汀胶囊8 mg.d-1或帕罗西汀片20 mg.d-1。采用HAMD、HAMA(汉密尔顿抑郁、焦虑量表)总分减分率以及CG1分作为主要疗效指标;实验室检查、生命体征等观察药物安全性。结果:共收集符合入组标准的患者80例,瑞波西汀组(试验组)与帕罗西汀组(对照组)各40例。治疗42 d后,瑞波西汀组HAMD、HAMA总分明显下降,与治疗基线相比均有显著性差异(P<0.01),但两组间相比差异无统计学意义(P>0.05);瑞波西汀组有效率(HAMD减分率≥50%)为82.5%,帕罗西汀组为77.5%,两组间相比差异无统计学意义(P>0.05);瑞波西汀组临床治愈率(HAMD、HAMA总分≤8)为62.5%,帕罗西汀组为55.0%,两组间差异无统计学意义(P>0.05);在CGI评分上,两组间差异亦无统计学意义。安全性分析显示:两组不良反应的症状和发生率相比差异均无统计学意义。结论:瑞波西汀治疗首发老年抑郁症安全有效,不良反应较少。

OBJECTIVE： To evaluate the efficacy and safety of Reboxetine in treatment of first - onset of senile depressive disorder. METHODS： A randomized, single blind parallel clinical trial was performed in which 80 patients with first- onset of senile depressive disorder were assigned to receive Reboxetine capsule 8 mg· d^-1 or Paroxetine tablet 20 mg·d^-1. The efficacy of both treatment groups was evaluated based on the Hamilton Depression Scale （HAMD）, Hamilton Anxiety Scale （HAMA） and Clinical General Impression Scale （CGI） and the drug safety was evaluated based on laborator data and vital signs etc. RESULTS： Of the total 80 patients who met the inclusion criteria were assgined to receive Reboxetine （trial group, n = 40） or paroxetine （control group, n = 40）. After treatment for 42 days, the scores of HAMD, HAMA and CGI in the two groups at the end of therapy were significantly reduced compared with the baseline in both groups （P 〈 0.01）, however, there was no significant difference between the two groups （P 〉 0.05）. The effective rate in the trial group was 82.5% （HAMD score reducation rate 〉150%） versus 77.5% in the control group, the P value showed no statistical difference between the two groups （ P 〉 0.05 ）. There were no statistical differences between the two groups in cure rate （HAMD and HAMA total scores ≤8） （62.5% vs. 55.0%）, CGI score and safety （symptoms and incidence of adverse drug reactions）. CONCLUSION： Reboxetine has proved efficacy and safety and less side effects in the treatment of first - onset of senile depressive disorder.