Activation Adverse Events Induced by the Selective Serotonin Reuptake Inhibitor Fluvoxamine in Children and Adolescents
Activation Adverse Events Induced by the Selective Serotonin Reuptake Inhibitor Fluvoxamine in Children and Adolescents
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DOI：
10.1089/cap.2008.040
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发表时间：
2009-04-01
影响因子：
1.9
通讯作者：
Riddle, Mark A.
中科院分区：
文献类型：
--
作者：
Reinblatt, Shauna P.;dosReis, Susan;Riddle, Mark A.
目的：本研究的目的是检查使用选择性血清素再摄取抑制剂 (SSRI) 氟伏沙明治疗青少年焦虑症时激活簇不良事件 (AC-AE) 的发生率，以及 AC-AE 与 SSRI 血液水平的关系。 方法：对 45 名青少年（22 名活跃儿童）的儿科精神药理学研究单位 (RUPP) 焦虑研究的数据进行了检查。 氟伏沙明，23 安慰剂）在约翰·霍普金斯大学网站治疗《精神疾病诊断和统计手册》第 4 版 (DSM-IV) 焦虑症，采用为期 8 周的强制灵活滴定计划。作为双盲安慰剂对照试验的一部分，临床医生在每周患者就诊时记录 AC-AE。 AC-AE 被定义为多动、激活和去抑制。检查了人口统计学特征、每日剂量和第 8 周血液水平与 AC-AE 存在的关系。针对那些经历过这种副作用的人确定了 AC-AE 的患病率和首次事件发生的时间。结果：在接受氟伏沙明治疗的 22 名参与者中，有 10 名 (45%) 发现了 AC-AE，而在安慰剂组的 23 名参与者中，只有 1 名 (4%) 发现了 AC-AE。 AC-AE 的发作发生在第 1 周至第 8 周，大多数发生在第 4 周或之前。发生 AC-AE 的受试者在第 8 周时的平均氟伏沙明血液水平高于无 AC-AE 的受试者 (n = 16，t = -2.61，p = 0.04)。发生和未发生 AC-AE 的参与者的年龄以及双相情感障碍或焦虑症家族史都没有差异。结论：AC-AE 是氟伏沙明的常见副作用，通常出现在治疗的前 8 周内，并且与较高的氟伏沙明血液水平相关。建议不仅在开始 SSRI 治疗时而且在整个剂量滴定过程中密切监测 AC-AE，以便及早识别激活。
Objective: The aim of this study was to examine the prevalence of activation cluster adverse events (AC-AEs) in youths treated with the selective serotonin reuptake inhibitor (SSRI) fluvoxamine for anxiety and the relationship of AC-AEs to SSRI blood levels.Methods: Data from the Research Units on Pediatric Psychopharmacology (RUPP) Anxiety Study were examined for 45 youths (22 active fluvoxamine, 23 placebo) treated for Diagnostic and Statistical Manual for Mental Disorders, 4(th) edition (DSM-IV) anxiety disorders at the Johns Hopkins University site with an 8-week forced-flexible titration schedule. As part of the double-blind placebo-controlled trial, AC-AEs were recorded by clinicians at weekly patient visits. AC-AEs were defined as hyperactivity, activation, and disinhibition. Demographic characteristics, daily doses, and week-8 blood levels were examined in relation to the presence of AC-AEs. The prevalence of AC-AE and time to first event were established for those who experienced this side effect.Results: AC-AEs were found in 10 of 22 participants (45%) receiving fluvoxamine and only 1 of 23 in the placebo group (4%). The onset of AC-AEs occurred from week 1 to week 8, with the majority occurring at or before week 4. The mean fluvoxamine blood level at week 8 in subjects with AC-AEs was higher than in subjects without AC-AEs (n = 16, t = -2.61, p = 0.04). Neither the age of the participants nor family history of bipolar or anxiety disorder differed between those who did and did not develop an AC-AE.Conclusions: AC-AEs were common side effects of fluvoxamine, often appeared during the first 8 weeks of treatment, and were associated with higher fluvoxamine blood levels. Close monitoring for AC-AEs, not only when initiating SSRI treatment but also throughout dose titration, is recommended for early identification of activation.