文拉法辛缓释剂和帕罗西汀治疗抑郁症随机对照研究

A randomized controlled trial of velanfaxine and paroxetine in patients with depression

目的:比较文拉法辛缓释剂和帕罗西汀治疗抑郁症的疗效及安全性。方法:80例住院抑郁症病人随机分为文拉法辛组和帕罗西汀组,疗程8 wk,用汉密尔顿抑郁量表(HAMD),临床疗效总体评定量表(CGI)和不良反应症状量表(TESS)在基线及治疗后wk 1、2、4、8末进行评定。结果:治疗1 wk文拉法辛组HAMD评分与帕罗西汀组比较有显著差异(P<0.05),治疗8 wk末2组减分值分别为14±s 4和14±4,2组治疗前后比较差异均有非常显著意义(P<0.01),但2组间比较差异无显著意义(P>0.05)。文拉法辛组不良反应发生率为20%,帕罗西汀组为20%,2组间比较差异无显著意义(P>0.05)。结论:文拉法辛与帕罗西汀对抑郁症病人的疗效相当,而文拉法辛缓释剂起效快于帕罗西汀,2药不良反应有所不同,但均较轻,安全性好。

AIM： To compare the efficacy and safety of velanfaxine extended release and paroxetine in the treatment of depression. METHODS： Eighty inpatients with a diagnosis of depression were randomly assigned to velanfaxine or paroxetine groups for 8 weeks treatment. Efficacy and safety were assessed by HAMD （Hamilton Rating Scale for depression）, CGI （Clinical Impression rating scale） and TESS. Assessments were performed at baseline and at the end of wk 1, 2, 4 and 8 of the trial. RESULTS： There was significant difference between velanfaxine and paroxetine groups at the end of wk 1 （P 〈 0.05）. Decrease in HAMD scores were 14 ± s 4 and 14 ± 4 from baseline in velanfaxine and paroxetine groups, respectively. Both groups showed a significant improvement after 8 weeks treatment （P 〈 0.01 ）. There was no significant difference between the mean HAMD scores of two groups （P 〉 0.05） The rates of adverse reactions were 20 % and 20 % in velanfaxine and paroxetine groups, respectively. The adverse reactions of both were less （P 〉 0.05） . CONCLUSION ： Velanfaxine is as effective and safe as paroxetine in the treatment of depression. Velanfaxine has rapid efficacy. Both two drugs have good safety and compliance in patients with depression.