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The efficacy and safety of once-daily quetiapine extended release in patients with schizophrenia switched from other antipsychotics: an open-label study in Chinese population

机译:每日一次喹硫平缓释剂从其他抗精神病药转为精神分裂症的疗效和安全性:一项针对中国人群的开放性研究

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Background Non-adherence to antipsychotic medication in schizophrenic patients is common and associated with symptom relapse and poorer long-term outcomes. The risk factors for treatment non-adherence include dosing frequency and complexity. Besides, slower dose titration in an acute schizophrenic episode may lead to attenuated efficacy. Therefore, the convenient dosage regimen and rapid initiation scheme of quetiapine extended release (XR) were expected to provide better effectiveness and promote adherence in patients with schizophrenia. This study was implemented to assess the efficacy and safety of once-daily quetiapine XR in schizophrenic patients with switched from other antipsychotics which were suboptimal due to insufficient efficacy or tolerability. Methods This was a 12-week, open-label study conducted in the Chinese population in Taiwan. Patients who had a score of 4 (moderate) or greater on any of the 7 items of the Positive and Negative Syndrome Scale (PANSS) Positive Symptom Subscale and needed to switch from previous antipsychotics were recruited. Quetiapine XR was administered at 300?mg on day 1, 600?mg on day 2 and up to 800?mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800?mg per day, depending on the clinical response and tolerance of the patients. The variable of the primary outcome was the change from baseline to Week 12 in PANSS total and subscale scores. Secondary outcome was the baseline-to-endpoint difference in the Clinical Global Impression-Severity (CGI-S) scores of the participants. Results Sixty-one patients were recruited and 55.7% of them completed the study. The mean changes in the PANSS total score and CGI-S score showed significant improvement (?18.4, p? Conclusions The results of our investigation implicated that quetiapine XR was an effective and well tolerated alternative for Chinese schizophrenic patients with previous suboptimal treatment. Future large-scale studies are warranted to validate our results. Trial registration ClinicalTrials.gov ID NCT02142556 webcite . Registered 15 May 2014.
机译:背景精神分裂症患者不坚持抗精神病药物治疗很普遍,并伴有症状复发和较差的长期预后。不坚持治疗的危险因素包括给药频率和复杂性。此外,在急性精神分裂症发作中较慢的剂量滴定可能导致疗效减弱。因此,喹硫平缓释(XR)的便捷剂量方案和快速启动方案有望在精神分裂症患者中提供更好的疗效并促进依从性。这项研究的目的是评估喹硫平XR每天一次对精神分裂症患者的疗效和安全性,而精神分裂症患者因疗效或耐受性不足而改用其他抗精神病药,效果欠佳。方法这是在台湾中国大陆人群中进行的为期12周的开放标签研究。招募了在阳性和阴性综合征量表(PANSS)阳性症状子量表的7个项目中的任何一个得分为4(中)或更高且需要从以前的抗精神病药物转换过来的患者。喹硫平XR在第1天以300 mg的剂量给药,第2天以600 mg的剂量给药,第2天后以800 mg的剂量给药。从第8天到研究结束,喹硫平XR的剂量调整为400-800 mg。每天毫克,取决于患者的临床反应和耐受性。主要结果的变量是PANSS总分和分量表得分从基线到第12周的变化。次要结果是参与者临床总体印象严重度(CGI-S)得分的基线到终点差异。结果招募了61例患者,其中55.7%的患者完成了研究。 PANSS总分和CGI-S得分的平均变化显示出显着改善(?18.4,p?)结论我们的研究结果表明,喹硫平XR是先前接受过次优治疗的中国精神分裂症患者的一种有效且耐受性良好的替代方案。我们需要进行大规模研究以验证我们的结果,试验注册ClinicalTrials.gov ID NCT02142556网站c,2014年5月15日注册。

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