Usher R W, Beasley C M, Bosomworth J C
Division of Clinical Neurosciences, Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, IN 46285.
J Clin Psychiatry. 1991 Mar;52(3):134-6.
A total of 120 patients who met DSM-III criteria for unipolar major depressive episode were equally randomized to fluoxetine a.m. or fluoxetine p.m. treatment groups, such that 30 patients were in each group at each of two sites. Patients received 20 to 80 mg of fluoxetine every day for 5 weeks; the dose was based on clinical response. Highly significant within-treatment improvement was reflected by changes in mean scores on the Hamilton Rating Scale for Depression (total score and factors), the Raskin Depression Scale, the Covi Anxiety Scale, the Clinical Global Impressions Scale for Severity, and the Clinical Global Impressions Scale for Improvement. No significant differences occurred between the a.m. and p.m. groups for any efficacy variable. Evaluation of adverse events and vital signs indicated no clinically significant differences between the two treatment groups. The data indicate that fluoxetine is equally efficacious and well tolerated regardless of the time of day it is administered and suggest that fluoxetine may be administered at either time of day without affecting clinical course.
共有120名符合《精神疾病诊断与统计手册》第三版单相重度抑郁发作标准的患者被随机分为氟西汀上午治疗组或氟西汀下午治疗组，每个治疗组各有30名患者，共两个地点。患者每天服用20至80毫克氟西汀，持续5周；剂量根据临床反应调整。汉密尔顿抑郁评定量表（总分及各因子）、拉斯金抑郁量表、科维焦虑量表、临床总体印象严重程度量表和临床总体印象改善量表的平均得分变化反映了治疗期间的高度显著改善。上午组和下午组在任何疗效变量上均无显著差异。不良事件和生命体征评估表明，两个治疗组之间无临床显著差异。数据表明，无论在一天中的什么时间服用，氟西汀的疗效相同且耐受性良好，这表明氟西汀可在一天中的任何时间服用，而不影响临床病程。
