High-dose fluoxetine: efficacy and activating-sedating effects in agitated and retarded depression.
High-dose fluoxetine: efficacy and activating-sedating effects in agitated and retarded depression.
复制标题
高剂量氟西汀：对激越和迟发性抑郁症的功效和激活镇静作用。
DOI：
10.1097/00004714-199106000-00004
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发表时间：
1991
影响因子：
2.9
通讯作者：
Wernicke Jf
中科院分区：
文献类型：
--
作者：
Charles M. Beasley;M. Sayler;J. Bosomworth;Wernicke Jf
对706例符合DSM-III诊断标准的门诊抑郁症患者进行了大剂量氟西汀(中位数80 mg/天)、标准剂量丙咪嗪(中位数200 mg/天)和安慰剂的疗效研究。每个患者的基线精神运动活动被前瞻性地归类为激动、迟缓或两者都不是。在总体基础上和在基线精神运动活动的类别内，比较不同治疗之间引发不良事件(失眠、烦躁、焦虑、紧张)和镇静事件(嗜睡、虚弱)的总的和显著的(导致停止)不良事件的发生率。此外，还比较了每种治疗的基线精神运动活动的这些比率。疗效是在总体基础上进行的，并参照基线精神运动活动进行评估。氟西汀的总激活比安慰剂多(p=0.008)，但氟西汀的总激活(28%)仅显示出一种趋势(p=0.092)，高于丙咪嗪(21%)。停用氟西汀(5%)和丙咪嗪(5%)没有不同。氟西汀和丙咪嗪的镇静和停药显著高于安慰剂。停药的唯一药物差异是在镇静方面，丙咪嗪(11%)超过氟西汀(5%；p=0.008)。只有丙咪嗪镇静的发生率(在基线迟缓的患者中占47%)才与基线精神运动活动显著相关(p=0.021)。在降低汉密尔顿抑郁量表(Ham-D)、睡眠障碍Ham-D因子、焦虑/躯体化Ham-D因子分方面，氟西汀和丙咪嗪均优于安慰剂，疗效相当。这些改善与基线精神运动活动无关。
The effects of high-dose fluoxetine (median 80 mg/day), standard-dose imipramine (median 200 mg/day), and placebo were studied in 706 outpatients meeting DSM-III criteria for major depressive disorder. Baseline psychomotor activity of each patient was prospectively categorized as agitated, retarded, or neither. Rates of occurrence of total and significant (leading to discontinuation) activating adverse events (insomnia, agitation, anxiety, nervousness) and sedating events (somnolence, asthenia) were compared between treatments on an overall basis and within categories of baseline psychomotor activity. Additionally, these rates were compared across baseline psychomotor activity for each treatment. Efficacy was evaluated on an overall basis and with respect to baseline psychomotor activity. There was more total activation with fluoxetine than placebo (p = 0.008), but total activation with fluoxetine (28%) showed only a trend (p = 0.092) for being greater than with imipramine (21%). Discontinuations for activation with fluoxetine (5%) did not differ from imipramine (5%). Sedation and discontinuations for sedation with both fluoxetine and imipramine significantly exceeded placebo. The only drug-drug difference in discontinuations was for sedation where imipramine (11%) exceeded fluoxetine (5%; p = 0.008). Only for the occurrence of sedation with imipramine (47% among patients retarded at baseline) was there a significant association with baseline psychomotor activity (p = 0.021). Both fluoxetine and imipramine were superior to placebo and equal in efficacy in decreasing total Hamilton Rating Scale for Depression (HAM-D), the sleep disturbance HAM-D factor, and the anxiety/somatization HAM-D factor scores. These improvements were independent of baseline psychomotor activity.