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对精神分裂症共识缓解标准在临床药物试验中的适宜性进行批判性分析和讨论。

A critical analysis and discussion of the appropriateness of the schizophrenia consensus remission criteria in clinical pharmaceutical trials.

机构信息

Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Munich, Germany.

出版信息

Pharmacopsychiatry. 2010 Nov;43(7):245-51. doi: 10.1055/s-0030-1262788. Epub 2010 Oct 6.

DOI:10.1055/s-0030-1262788
PMID:20927697
Abstract

BACKGROUND

The aim of this paper is to apply the proposed consensus remission criteria to an acutely ill inpatient sample at admission and evaluate their adaptability in this patient population and pharmaceutical trials.

METHODS

The Remission in Schizophrenia Working Group's consensus criteria were applied to 272 acutely ill schizophrenia patients. Patients were examined using the PANSS, HAMD, UKU and SWN-K total scales at admission as well as the GAF, SOFAS and the Strauss-Carpenter Prognostic Scale. Sociodemographic and clinical baseline variables were assessed using a standardized documentation system.

RESULTS

33 patients (12%) fulfilled the symptom severity component of the proposed remission criteria already at baseline. Almost no significant differences were found when comparing patients with achieved and failed symptom severity component that would explain the hospitalization of the patients with achieved criteria despite their apparently mild psychopathological symptoms. The only explainable difference was that patients with an achieved symptom severity component had received significantly more antipsychotics and had suffered from significantly more life events before admission.

CONCLUSION

The present results raise the question whether the symptom severity threshold is adequate to identify patients in remission when applied in clinical trials.

摘要

背景

本文旨在将提出的共识缓解标准应用于入院时的急性住院患者样本,并评估其在该患者人群和药物试验中的适应性。

方法

采用缓解精神分裂症工作组的共识标准对 272 例急性精神分裂症患者进行评估。患者入院时采用 PANSS、HAMD、UKU 和 SWN-K 总评分以及 GAF、SOFAS 和施特劳斯-卡彭特预后量表进行检查。使用标准化文档系统评估社会人口统计学和临床基线变量。

结果

33 名患者(12%)在基线时就已经符合拟议缓解标准的症状严重程度部分。在比较达到和未达到症状严重程度部分的患者时,几乎没有发现任何显著差异,这些差异可以解释为什么尽管达到缓解标准的患者的精神病理症状明显较轻,但仍需要住院治疗。唯一可以解释的差异是,达到症状严重程度部分的患者接受了更多的抗精神病药物治疗,并且在入院前经历了更多的生活事件。

结论

目前的结果提出了一个问题,即在临床试验中应用时,症状严重程度阈值是否足以识别缓解患者。

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Pharmacopsychiatry. 2010 Nov;43(7):245-51. doi: 10.1055/s-0030-1262788. Epub 2010 Oct 6.
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