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富马酸喹硫平缓释片(喹硫平 XR)单药治疗广泛性焦虑障碍的维持治疗:一项长期、随机、安慰剂对照试验。

Extended release quetiapine fumarate (quetiapine XR) monotherapy as maintenance treatment for generalized anxiety disorder: a long-term, randomized, placebo-controlled trial.

机构信息

START Clinic for Mood and Anxiety Disorders, Toronto, Ontario, Canada.

出版信息

Int Clin Psychopharmacol. 2011 Jan;26(1):11-24. doi: 10.1097/YIC.0b013e32833e34d9.

Abstract

The objective of this study was to evaluate the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) as maintenance monotherapy for patients with generalized anxiety disorder (GAD). Time-to-event (anxiety symptom recurrence; maximum 52 weeks) multicenter, randomized-withdrawal, parallel-group, double-blind, placebo-controlled study of quetiapine XR (50-300 mg/day) following open-label run-in (4-8 weeks) and open-label stabilization (≥ 12 weeks). Primary variable: time from randomization to anxiety event. Secondary variables included: Hamilton Anxiety Rating Scale (HAM-A) total, HAM-A psychic/somatic anxiety factors, Clinical Global Impression-Severity of Illness (CGI-S), and Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scores; adverse events (AE) reporting. Four hundred and thirty-two patients, stabilized on quetiapine XR, were randomized to continue quetiapine XR (N=216) or switch to placebo (N=216). Risk of anxiety symptom recurrence was significantly reduced by 81% for quetiapine XR versus placebo: hazard ratio=0.19 (95% confidence interval 0.12-0.31; P<0.001). Fewer patients receiving quetiapine XR (N=22, 10.2%) than placebo (N=84, 38.9%) experienced anxiety symptom recurrence. Significant differences were observed between quetiapine XR and placebo in: HAM-A total, psychic/somatic, CGI-S (all P<0.001) and Q-LES-Q (P<0.05) scores. AEs (>10%) during open-label treatment were dry mouth, sedation, somnolence, dizziness, fatigue, and constipation. During randomized treatment, the most common AEs for quetiapine XR were headache and nasopharyngitis. Quetiapine XR monotherapy reduced the risk of anxiety symptom recurrence in patients with GAD stabilized on quetiapine XR, with tolerability results consistent with the known profile of quetiapine.

摘要

本研究的目的是评估富马酸喹硫平缓释片(喹硫平 XR)作为广泛性焦虑障碍(GAD)患者维持单药治疗的疗效和耐受性。这是一项多中心、随机停药、平行组、双盲、安慰剂对照的研究,在开放标签导入期(4-8 周)和开放标签稳定期(≥12 周)后,对喹硫平 XR(50-300mg/天)进行评估。主要变量:从随机分组到焦虑事件的时间。次要变量包括:汉密尔顿焦虑量表(HAM-A)总分、HAM-A 精神/躯体焦虑因子、临床总体印象-严重程度(CGI-S)和生活质量、享受和满意度问卷(Q-LES-Q)评分;不良事件(AE)报告。432 例稳定服用喹硫平 XR 的患者被随机分为继续服用喹硫平 XR(n=216)或换用安慰剂(n=216)。与安慰剂相比,喹硫平 XR 可显著降低 81%的焦虑症状复发风险:风险比=0.19(95%置信区间 0.12-0.31;P<0.001)。接受喹硫平 XR 治疗的患者(n=22,10.2%)中,焦虑症状复发的患者少于接受安慰剂治疗的患者(n=84,38.9%)。与安慰剂相比,喹硫平 XR 在 HAM-A 总分、精神/躯体、CGI-S(均 P<0.001)和 Q-LES-Q(P<0.05)评分方面均有显著差异。在开放标签治疗期间,最常见的 AE 为口干、镇静、嗜睡、头晕、疲劳和便秘。在随机治疗期间,喹硫平 XR 最常见的 AE 是头痛和鼻咽炎。在稳定服用喹硫平 XR 的 GAD 患者中,喹硫平 XR 单药治疗可降低焦虑症状复发的风险,且耐受性结果与喹硫平的已知特征一致。

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