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设计结局研究以确定抗精神病药治疗精神分裂症的“真实世界”疗效和安全性。

Designing outcome studies to determine efficacy and safety of antipsychotics for 'real world' treatment of schizophrenia.

机构信息

Department of Psychiatry, University of Milan, Milan, Italy.

出版信息

Int J Neuropsychopharmacol. 2010 Aug;13(7):971-3. doi: 10.1017/S1461145709991271. Epub 2010 Feb 4.

DOI:10.1017/S1461145709991271
PMID:20128954
Abstract

Over the last 5 years, some studies have questioned the efficacy of second-generation antipsychotics over first-generation neuroleptics in the treatment of schizophrenia. At the same time, these study results have led to re-examination of their design--particularly CATIE and CUtLASS--which essentially measured relatively short-/mid-term outcome and did not always take into account real-world clinical practice and outcome measures (e.g. prevalence of positive acute symptoms, exclusion of comorbidity with substance abuse, predominance of chronic patients, lack of quality of life/wellbeing measures, etc.). In fact, one of the greatest challenges to treatment of schizophrenia is its life-long, multifaceted, functional disability associated with progressive cognitive deterioration after each acute episode. As such, the most important goal of the treatment is not just to deal with acute episodes, but rather to improve long-term outcome. Specifically, we aim for modest improvement and then stabilization of the different clinical dimensions involved in the overall symptomatology (i.e. negative/anergic, impulsive, positive, mood and cognitive impairments), and to achieve 'clinical stabilization' after obtaining a partial or full remission of acute symptoms, thus reducing the risk of a progressive cognitive deterioration. All these aspects need to be properly evaluated in a long-run perspective.

摘要

在过去的 5 年中,一些研究质疑第二代抗精神病药物在治疗精神分裂症方面优于第一代神经阻滞剂。与此同时,这些研究结果促使人们重新审视它们的设计——特别是 CATIE 和 CUtLASS——这些研究本质上衡量的是相对短期/中期的结果,并不总是考虑到现实世界的临床实践和结果衡量标准(例如,阳性急性症状的流行率、排除物质滥用共病、慢性患者为主、缺乏生活质量/幸福感衡量标准等)。事实上,治疗精神分裂症面临的最大挑战之一是其终身的、多方面的、与每次急性发作后认知恶化相关的功能障碍。因此,治疗的最重要目标不仅仅是应对急性发作,而是改善长期预后。具体来说,我们的目标是在涉及整体症状学的不同临床维度(即阴性/无力、冲动、阳性、情绪和认知障碍)上取得适度改善和稳定,然后在获得急性症状部分或完全缓解后实现“临床稳定”,从而降低认知恶化的风险。所有这些方面都需要从长远角度进行适当评估。

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