Robinson R G, Schultz S K, Castillo C, Kopel T, Kosier J T, Newman R M, Curdue K, Petracca G, Starkstein S E
Department of Psychiatry, University of Iowa, Iowa City 52242, USA.
Am J Psychiatry. 2000 Mar;157(3):351-9. doi: 10.1176/appi.ajp.157.3.351.
This study compared nortriptyline and fluoxetine with placebo in the treatment of depression and in recovery from physical and cognitive impairments after stroke.
A total of 104 patients with acute stroke enrolled between 1991 and 1997 entered a double-blind randomized study comparing nortriptyline, fluoxetine, and placebo over 12 weeks of treatment. The majority of patients were recruited from a rehabilitation hospital in Des Moines, Iowa, but other enrollment sites were also used. Both depressed and nondepressed patients were enrolled to determine whether improved recovery could be mediated by mechanisms unrelated to depression. Nortriptyline in doses of 25 mg/day gradually increased to 100 mg/day or fluoxetine in doses of 10 mg/day gradually increased to 40 mg/day or identical placebo were given over 12 weeks. Response to treatment of depression for individual patients was defined as a greater-than-50% reduction in scores on the Hamilton Rating Scale for Depression and no longer fulfilling diagnostic criteria for major or minor depression. Improved recovery for a treatment group was defined as a significantly higher mean score from baseline to end of the treatment trial, compared with patients treated with placebo, on measures of impairment in activities of daily living and levels of cognitive and social functioning.
Nortriptyline produced a significantly higher response rate than fluoxetine or placebo in treating poststroke depression, in improving anxiety symptoms, and in improving recovery of activities of daily living as measured by the Functional Independence Measure. There was no effect of nortriptyline or fluoxetine on recovery of cognitive or social functioning among depressed or nondepressed patients. Fluoxetine in increasing doses of 10-40 mg/day led to an average weight loss of 15. 1 pounds (8% of initial body weight) over 12 weeks of treatment that was not seen with nortriptyline or placebo.
Given the doses of medication used in this study, nortriptyline was superior to fluoxetine in the treatment of poststroke depression. Demonstrating a benefit of antidepressant treatment in recovery from stroke may require the identification of specific subgroups of patients, alternative measurement scales, or the optimal time of treatment.
本研究比较了去甲替林、氟西汀与安慰剂在治疗抑郁症以及中风后身体和认知功能障碍恢复方面的效果。
1991年至1997年间共纳入104例急性中风患者，进行一项为期12周的双盲随机研究，比较去甲替林、氟西汀和安慰剂的疗效。大多数患者来自爱荷华州得梅因的一家康复医院，但也使用了其他招募地点。纳入了抑郁和非抑郁患者，以确定改善的恢复情况是否可由与抑郁无关的机制介导。去甲替林剂量从25毫克/天逐渐增加至100毫克/天，或氟西汀剂量从10毫克/天逐渐增加至40毫克/天，或给予相同的安慰剂，持续12周。个体患者对抑郁症治疗的反应定义为汉密尔顿抑郁量表评分降低超过50%，且不再符合重度或轻度抑郁症的诊断标准。治疗组恢复情况改善定义为与接受安慰剂治疗的患者相比，在日常生活活动能力损害以及认知和社会功能水平的测量中，从基线到治疗试验结束时平均得分显著更高。
在治疗中风后抑郁症、改善焦虑症状以及通过功能独立性测量评估的日常生活活动恢复方面，去甲替林产生的反应率显著高于氟西汀或安慰剂。去甲替林或氟西汀对抑郁或非抑郁患者的认知或社会功能恢复均无影响。在12周的治疗中，氟西汀剂量从10毫克/天增加至40毫克/天导致平均体重减轻15.1磅（占初始体重的8%），而去甲替林或安慰剂组未出现这种情况。
就本研究中使用的药物剂量而言，去甲替林在治疗中风后抑郁症方面优于氟西汀。证明抗抑郁治疗对中风恢复有益可能需要识别特定的患者亚组、采用替代测量量表或确定最佳治疗时间。
