富马酸喹硫平缓释剂治疗重性抑郁障碍：伴焦虑抑郁患者的分析。
Extended release quetiapine fumarate in major depressive disorder: analysis in patients with anxious depression.
机构信息
Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA.
出版信息
Depress Anxiety. 2012 Jul;29(7):574-86. doi: 10.1002/da.21970. Epub 2012 Jul 2.
BACKGROUND
A pooled analysis was performed on data from two studies evaluating the efficacy of once-daily extended-release quetiapine fumarate (quetiapine XR) monotherapy for patients with major depressive disorder. Through these analyses (based on Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) measures), we aim to further evaluate the efficacy of quetiapine XR in depressed patients with high levels of anxiety symptoms.
METHODS
Secondary analyses were conducted of pooled individual patient data from two 8-week (6-week randomized phase, 2-week drug discontinuation phase), double-blind, placebo-controlled studies of quetiapine XR (50-300 mg/day). Outcomes included change from randomization at Week 6 in Montgomery Åsberg Depression Rating Scale (MADRS) total score for patients with anxious and nonanxious depression.
RESULTS
Of 968 patients included in the analysis, 788 (81.4%) were classified as anxious depressed (defined as HAM-D anxiety/somatization factor score ≥ 7) and 180 (18.6%) were nonanxious. For patients with anxious depression and nonanxious depression, statistically significant differences versus placebo in MADRS total score were recorded for quetiapine XR 150 mg/day (-3.24, P < .001 and -4.82, P < .01, respectively) and 300 mg/day (-3.57, P < .001 and -3.39, P < .05, respectively) at Week 6. In the second analysis using an alternate definition of anxious depression (baseline HAM-A total score ≥ 20), quetiapine XR 150 and 300 mg/day resulted in significant differences versus placebo in MADRS total score reduction in patients with high and lower levels of anxiety. The adverse event (AE) profile was similar irrespective of baseline anxiety levels, although patients with anxious depression reported a somewhat greater incidence of AEs.
CONCLUSION
Quetiapine XR monotherapy improved symptoms of depression in patients with higher and lower levels of anxiety.
背景
对评估每日一次的富马酸喹硫平缓释片（喹硫平 XR）单药治疗重度抑郁症患者疗效的两项研究的数据进行了汇总分析。通过这些分析（基于汉密尔顿抑郁量表（HAM-D）和汉密尔顿焦虑量表（HAM-A）测量），我们旨在进一步评估喹硫平 XR 对伴有较高焦虑症状的抑郁患者的疗效。
方法
对两项为期 8 周（6 周随机阶段，2 周停药阶段）、双盲、安慰剂对照的喹硫平 XR（50-300mg/天）研究的汇总个体患者数据进行了二次分析。主要结局为随机分组后第 6 周时伴有焦虑和不伴焦虑的抑郁患者在蒙哥马利抑郁评定量表（MADRS）总分上的变化。
结果
在纳入分析的 968 例患者中，788 例（81.4%）被归类为伴焦虑的抑郁（定义为 HAM-D 焦虑/躯体化因子评分≥7），180 例（18.6%）为不伴焦虑的抑郁。与安慰剂相比，伴焦虑抑郁的患者接受喹硫平 XR 150mg/天和 300mg/天治疗时，MADRS 总分在第 6 周时有统计学显著差异（分别为-3.24，P<0.001 和-4.82，P<0.01），不伴焦虑抑郁的患者接受喹硫平 XR 150mg/天和 300mg/天治疗时，MADRS 总分在第 6 周时也有统计学显著差异（分别为-4.82，P<0.001 和-3.39，P<0.05）。在第二项分析中，采用基线 HAM-A 总分≥20 作为伴焦虑抑郁的替代定义，结果显示，喹硫平 XR 150mg/天和 300mg/天治疗时，与安慰剂相比，在伴有较高和较低焦虑水平的患者中，MADRS 总分的降低有显著差异。无论基线焦虑水平如何，不良反应（AE）谱均相似，尽管伴焦虑抑郁的患者报告 AE 发生率略高。
结论
喹硫平 XR 单药治疗可改善伴有较高和较低焦虑水平的抑郁患者的症状。
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