Randomized, Double-Blind, Placebo-Controlled Study of Paliperidone Extended-Release and Quetiapine in Inpatients With Recently Exacerbated Schizophrenia
Randomized, Double-Blind, Placebo-Controlled Study of Paliperidone Extended-Release and Quetiapine in Inpatients With Recently Exacerbated Schizophrenia
复制标题
DOI：
10.1176/appi.ajp.2009.08040613
复制
发表时间：
2009-06-01
影响因子：
17.7
通讯作者：
Mahmoud, Ramy
中科院分区：
文献类型：
--
作者：
Canuso, Carla M.;Dirks, Bryan;Mahmoud, Ramy
目的：作者比较了帕利哌酮缓释和奎替利嗪在最近加重的精神分裂症患者需要hospitalization.Method：在一项为期6周的双盲研究，住院患者最近加重的精神分裂症随机分配到帕利哌酮缓释，奎替利嗪，或安慰剂治疗。为期2周的单药治疗阶段之后是为期4周的添加治疗阶段。目标剂量为推荐范围的上限：帕利哌酮缓释剂，9或12 mg/天，喹替鲁胺，600或800 mg/天。主要终点是帕利哌酮缓释剂和奎替利汀在2周单药治疗阶段终点时阳性和阴性症状量表（PANSS）的平均总变化评分的差异：帕利哌酮缓释剂的6周完成率为77.5%（124/160），奎替利汀为66.7%（106/159），安慰剂为63.8%（51/80）。从第5天（-11.4 vs.-8.2）至单药治疗阶段终点（-23.4 vs.-17.1），帕利哌酮缓释剂组的平均PANSS总变化评分改善大于喹替鲁酮组。仅帕利哌酮缓释剂在2周时显示PANSS改善显著大于安慰剂。在6周研究终点时，尽管添加治疗（主要是其他抗精神病药）的使用相似，但帕利哌酮缓释剂的改善显著大于喹替鲁。帕利哌酮缓释剂、奎替鲁和安慰剂的常见不良事件分别为震颤（13.9%、5.0%、7.5%）、嗜睡（8.9%、11.9%、1.3%）、失眠（10.1%、9.4%、11.3%）和头痛（12.0%、7.5%、13.8%）。帕潘立酮缓释剂组、奎硫平组和安慰剂组的六周不良事件相关停药率分别为6.3%、10.1%和6.3%。结论：与奎硫平相比，帕潘立酮缓释剂可以更早、更大程度地改善近期病情恶化、需要住院治疗的精神分裂症患者的症状，并且没有意外的耐受性发现。
Objective: The authors compared paliperidone extended-release and quetiapine in patients with recently exacerbated schizophrenia requiring hospitalization.Method: In a 6-week double-blind study, inpatients with a recent exacerbation of schizophrenia were randomly assigned to treatment with paliperidone extended-release, quetiapine, or placebo. A 2-week monotherapy phase was followed by a 4-week additive-therapy phase. Target doses were at the upper end of recommended ranges: paliperidone extended-release, 9 or 12 mg/day, and quetiapine, 600 or 800 mg/day. The primary endpoint was the difference in mean total change score on the Positive and Negative Syndrome Scale (PANSS) between paliperidone extended-release and quetiapine at the 2-week monotherapy phase endpoint.Results: Six-week completion rates were 77.5% (124/160) with paliperidone extended-release, 66.7% (106/159) quetiapine, and 63.8% (51/80) placebo. Improvement in mean PANSS total change score was greater with paliperidone extended-release than with quetiapine from day 5 (-11.4 versus -8.2) through the monotherapy phase endpoint (-23.4 versus -17.1). Only paliperidone extended-release showed significantly greater PANSS improvement compared with placebo at 2 weeks. At the 6-week study endpoint, there was a significantly greater improvement with paliperidone extended-release compared with quetiapine despite similar use of additive therapy (predominantly other antipsychotics). Common adverse events with paliperidone extended-release, quetiapine, and placebo, respectively, were tremor (13.9%, 5.0%, 7.5%), somnolence (8.9%, 11.9%, 1.3%), insomnia (10.1%, 9.4%, 11.3%), and headache (12.0%, 7.5%, 13.8%). Six-week adverse event-related discontinuation rates were 6.3%, 10.1%, and 6.3%, respectively, in the paliperidone extended-release, quetiapine, and placebo groups.Conclusions: Compared with quetiapine, paliperidone extended-release improved symptoms earlier and to a greater degree in patients with recently exacerbated schizophrenia requiring hospitalization, with no unexpected tolerability findings.