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首页> 外文期刊>The journal of clinical psychiatry >Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study.
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Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study.

机译：每日一次缓释富马酸喹硫平在急性精神分裂症中的疗效和耐受性：一项随机，双盲，安慰剂对照研究。

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OBJECTIVE: To evaluate the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) in a 6-week, double-blind, randomized study. METHOD: Patients with a DSM-IV diagnosis of acute schizophrenia were randomly assigned to fixed-dose quetiapine XR 400, 600, or 800 mg/day (once daily in the evening), quetiapine immediate release (IR) 400 mg/day (200 mg twice daily), or placebo. Dual-matched placebo was used to maintain blinding. Quetiapine XR target doses were reached by day 2 (400 and 600 mg) and day 3 (800 mg). The primary endpoint was least squares mean change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score. PANSS response rate (percentage of patients with > or = 30% reduction in total score), Clinical Global Impressions-Improvement scale (CGI-I) response rate (percentage of patients with score < or = 3), change in CGI-Severity of Illness (CGI-S), and adverse events (AEs) were also assessed. The study was conducted from November 2004 to December 2005. RESULTS: 588 patients were enrolled and 446 (76%) completed the study. Improvement in PANSS total score at week 6 was significant versus placebo (-18.8) in all groups: -24.8 (p = .03), -30.9 (p < .001), and -31.3 (p < .001) for quetiapine XR 400, 600, and 800 mg, respectively, and -26.6 (p = .004) for quetiapine IR. There were also statistically significant differences in PANSS and CGI-I response rates for all active treatments versus placebo (all p < .05). The most common AEs in all quetiapine groups were somnolence and dizziness; there were no unexpected AEs with quetiapine XR. Incidence of AEs potentially related to extrapyramidal symptoms was similar to placebo. CONCLUSION: Once-daily quetiapine XR (400-800 mg/day) was effective versus placebo in patients with acute schizophrenia. Treatment, including rapid dose escalation, was well tolerated, with a therapeutically effective dose reached by day 2. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00206115.
机译：目的：在一项为期六周的双盲随机研究中，评估延缓释放富马酸喹硫平（喹硫平XR）的疗效和耐受性。方法：将DSM-IV诊断为急性精神分裂症的患者随机分配至固定剂量喹硫平XR 400、600或800 mg /天（晚上一次，每天一次），喹硫平立即释放（IR）400 mg /天（200每日两次）或安慰剂。双匹配安慰剂用于维持致盲。在第2天（400和600 mg）和第3天（800 mg）达到了Quetiapine XR目标剂量。主要终点是阳性和阴性综合征量表（PANSS）总分从基线到第6周的最小二乘均值。 PANSS反应率（总得分降低>或= 30％的患者百分比），临床总体印象改善量表（CGI-I）响应率（得分<或= 3的患者百分比），CGI严重度变化还评估了疾病（CGI-S）和不良事件（AE）。该研究于2004年11月至2005年12月进行。结果：招募了588位患者，其中446位（76％）完成了该研究。在所有组中，与安慰剂（-18.8）相比，第6周PANSS总评分的改善显着：喹硫平XR分别为-24.8（p = .03），-30.9（p <.001）和-31.3（p <.001）。喹硫平IR分别为400、600和800 mg，-26.6（p = .004）。所有积极治疗组与安慰剂组的PANSS和CGI-I反应率也存在统计学上的显着差异（所有p <.05）。在所有喹硫平组中最常见的不良事件是嗜睡和头晕。喹硫平XR没有意外的不良事件。可能与锥体束外症状相关的AE发生率与安慰剂相似。结论：每日一次喹硫平XR（400-800 mg /天）对安慰剂治疗急性精神分裂症有效。包括快速剂量递增在内的治疗耐受性良好，到第2天达到治疗有效剂量。临床试验注册：ClinicalTrials.gov标识符NCT00206115。

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