Fluoxetine versus trazodone: efficacy and activating-sedating effects.
Fluoxetine versus trazodone: efficacy and activating-sedating effects.
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氟西汀与曲唑酮：功效和激活镇静作用。
DOI：
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发表时间：
1991
影响因子：
5.3
通讯作者：
M. Sayler
中科院分区：
文献类型：
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作者：
C. Beasley;B. Dornseif;Pultz Ja;J. Bosomworth;M. Sayler
背景
在一项针对严重抑郁发作的门诊患者的试验中，比较了氟西汀（N = 65；中位持续剂量，20 毫克/天）和曲唑酮（N = 61；中位持续剂量，250 毫克/天）的疗效和安全性。还评估了激活和镇静的发生率和时间模式。
方法
选择符合 DSM-III 非精神病性重度抑郁发作标准（但当前发作时间大于或等于 4 周）且 21 项汉密尔顿抑郁量表 (HAM-D21) 得分大于 20 的男性和女性。单盲安慰剂给药 1 周后，符合条件的患者被随机接受双盲氟西汀或曲唑酮治疗，疗程最长为 6 周。每周评估疗效（HAM-D21、临床严重程度和改善总体印象量表、患者改善总体印象量表、公会记忆测试）和不良事件。
结果
两个治疗组的 HAM-D21 评分均有所改善（p 小于 0.001）。各组在终点平均 HAM-D21 改善方面相似。对于治疗期间发生或恶化的个别不良事件，更多的氟西汀治疗患者报告鼻炎和震颤（p小于或等于0.05），而更多的曲唑酮治疗患者报告嗜睡和头晕（p小于或等于0.05）。氟西汀组比曲唑酮组报告了更多提示激活的组合事件（激动、焦虑、紧张、失眠）（15.4% vs. 3.3%，p 小于或等于 0.05），而曲唑酮组报告的提示镇静（嗜睡、乏力）的组合事件比氟西汀组更多（42.6% vs. 21.5%，p 小于或等于 0.05）。 .05）。治疗之间激活和镇静的终止率没有差异。从数字上看，氟西汀的镇静作用（21.5%）多于激活作用（15.4%）。
结论
在疗效和安全性方面，治疗之间几乎没有临床差异。激活和镇静的发生和时间模式在治疗内和治疗之间有所不同。
BACKGROUND
The efficacy and safety of fluoxetine (N = 65; median sustained dose, 20 mg/day) and of trazodone (N = 61; median sustained dose, 250 mg/day) were compared in a trial in outpatients with major depressive episode. The incidence and temporal patterns of activation and sedation were also assessed.
METHOD
Men and women who met DSM-III criteria for nonpsychotic major depressive episode (but with a current episode greater than or equal to 4 weeks) and had a 21-item Hamilton Rating Scale for Depression (HAM-D21) score greater than 20 were selected. After single-blind placebo was administered for 1 week, eligible patients were randomized to double-blind fluoxetine or trazodone treatment for up to 6 weeks. Efficacy (HAM-D21, Clinical Global Impressions Scales for Severity and Improvement, Patient Global Impressions Scale for Improvement, Guild Memory Test) and adverse events were evaluated weekly.
RESULTS
The HAM-D21 score improved within both treatment groups (p less than .001). The groups were similar with respect to endpoint mean HAM-D21 improvement. For individual adverse events that developed or worsened during therapy, more fluoxetine-treated patients reported rhinitis and tremor (p less than or equal to .05), while more trazodone-treated patients reported somnolence and dizziness (p less than or equal to .05). More combined events suggesting activation (agitation, anxiety, nervousness, insomnia) were reported with fluoxetine than with trazodone (15.4% vs. 3.3%, p less than or equal to .05), while more combined events suggesting sedation (somnolence, asthenia) were reported with trazodone than with fluoxetine (42.6% vs. 21.5%, p less than or equal to .05). Discontinuation rates for activation and sedation did not differ between treatments. Numerically, more sedation (21.5%) than activation (15.4%) was reported with fluoxetine.
CONCLUSIONS
There was little clinical difference between treatments with regard to efficacy and safety. The occurrence and temporal patterns of activation and sedation differed within and between treatments.