Fluoxetine: activating and sedating effects at multiple fixed doses.
Fluoxetine: activating and sedating effects at multiple fixed doses.
复制标题
氟西汀：多次固定剂量具有激活和镇静作用。
DOI：
10.1097/00004714-199210000-00006
复制
发表时间：
1992
影响因子：
2.9
通讯作者：
J. Potvin
中科院分区：
文献类型：
--
作者：
C. Beasley;M. Sayler;A. Weiss;J. Potvin
5-羟色胺摄取抑制剂通常被认为是激活抗抑郁药。为了评估激活和镇静的发生率和时间模式以及剂量-效应关系，从一项比较安慰剂和氟西汀每天5、20和40毫克/天治疗重度抑郁障碍的固定剂量研究(N=363)和将安慰剂和氟西汀每天20、40和60毫克/天治疗重度抑郁障碍(N=746)进行比较的两项固定剂量研究中对不良事件数据进行了评估。不良事件紧张、焦虑、烦躁和失眠被认为是激活的指示；嗜睡和虚弱被认为是镇静的指示。激活和镇静都有统计学意义(p小于或等于0.05)的治疗紧急现象，但剂量-效应关系不同。激活率在5-40 mg/d之间相对稳定，然后在60 mg/d时增加。镇静速率线性增加到40 mg/d，然后与40 mg/d和60 mg/d相当。任何一种现象的停产都是罕见的。首次发作的时间模式和激活和镇静持续的时间模式不同。第一次激活出现的时间很早就达到顶峰，随着时间的推移，所有剂量的激活都会下降。第一次出现镇静的次数也在所有剂量下提前达到顶峰，但随着时间的推移，较低剂量的镇静首次出现可能有更大的变异性。随着时间的推移，持续出现镇静的情况可能比持续出现的激活情况下降得更少。
Serotonin uptake inhibitors are generally considered activating antidepressants. To assess rates and temporal patterns of activation and sedation as well as dose-effect relationships, adverse event data were evaluated from a fixed-dose study comparing placebo and fluoxetine 5, 20, and 40 mg/day in the treatment of major depressive disorder (N = 363) and two fixed-dose studies pooled together comparing placebo and fluoxetine 20, 40, and 60 mg/day in the treatment of major depressive disorder (N = 746). The adverse events nervousness, anxiety, agitation, and insomnia were considered indicative of activation; somnolence and asthenia were considered indicative of sedation. Activation and sedation were both statistically significant (p less than or equal to 0.05) treatment-emergent phenomena, but dose-effect relationships differed. Activation rates were relatively stable between 5 and 40 mg/day, and then increased at 60 mg/day. Sedation rates increased linearly to 40 mg/day and then were comparable at 40 and 60 mg/day. Discontinuations for either phenomenon were uncommon. The temporal patterns of first occurrences and persistence of activation and sedation differed. First occurrences of activation peaked early and declined over time with all doses. First occurrences of sedation also peaked early with all doses, but there may have been greater variability in first occurrences of sedation over time with lower doses. Persistent occurrences of sedation may decline less over time than persistent occurrences of activation.