Allard Per, Gram Lars, Timdahl Kristina, Behnke Kirsten, Hanson Martin, Søgaard Jesper
Department of Clinical Sciences, Division of Psychiatry, Umeå University, Umeå, Sweden.
Int J Geriatr Psychiatry. 2004 Dec;19(12):1123-30. doi: 10.1002/gps.1190.
The objectives of the study were to compare efficacy and tolerability of venlafaxine ER 75-150 mg/day with that of citalopram 10-20 mg/day in elderly patients with major depression according to DSM-IV criteria.
A randomised, double-blind, parallel group 6-month study. Efficacy was assessed by MADRS, CGI Global Improvement, CGI Severity of Illness and GDS-20 scores and safety by physical examinations, vital signs, adverse events and UKU side effect rating. Plasma levels of venlafaxine, its major metabolite O-desmethylvenlafaxine and citalopram were followed.
One hundred and fifty-one male and female patients (64-89 years) were enrolled and 118 patients completed the study. Comparable improvements in MADRS, CGI Severity of Illness, CGI Global Improvement and GDS-20 were observed during venlafaxine and citalopram treatment. The MADRS remission rate was 19% for venlafaxine and 23% for citalopram. Side effects were common during both treatments but differed in tremor being more common during citalopram and nausea/vomiting during venlafaxine treatment. There were no clinically significant changes in blood pressure or body weight.
The observed benefits of venlafaxine treatment in elderly patients with major depression were similar to those observed in younger adults as were reported adverse events and side effects. Treatment with venlafaxine ER was well tolerated and induced beneficial effects of similar magnitude as those of citalopram.
本研究的目的是根据《精神疾病诊断与统计手册》第四版标准，比较文拉法辛缓释片75 - 150毫克/天与西酞普兰10 - 20毫克/天在老年重度抑郁症患者中的疗效和耐受性。
一项随机、双盲、平行组6个月的研究。通过蒙哥马利-艾森伯格抑郁量表（MADRS）、临床总体印象量表（CGI）的总体改善情况、CGI疾病严重程度以及老年抑郁量表（GDS - 20）评分评估疗效，通过体格检查、生命体征、不良事件和UKU副作用评级评估安全性。跟踪文拉法辛及其主要代谢产物O - 去甲基文拉法辛以及西酞普兰的血浆水平。
共纳入151名男性和女性患者（64 - 89岁），118名患者完成了研究。在文拉法辛和西酞普兰治疗期间，观察到MADRS、CGI疾病严重程度、CGI总体改善情况和GDS - 20有类似的改善。文拉法辛的MADRS缓解率为19%，西酞普兰为23%。两种治疗期间副作用都很常见，但有所不同，西酞普兰治疗期间震颤更常见，文拉法辛治疗期间恶心/呕吐更常见。血压和体重没有临床显著变化。
观察到文拉法辛治疗老年重度抑郁症患者的益处与年轻成年人相似，不良事件和副作用也相似。文拉法辛缓释片治疗耐受性良好，产生的有益效果与西酞普兰相似。
