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精神分裂症缓解的有效替代指标:齐拉西酮临床研究数据分析之临床整体印象改善(CGI-I)。

Clinical Global Impression of Improvement (CGI-I) as a valid proxy measure for remission in schizophrenia: analyses of ziprasidone clinical study data.

机构信息

Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.

出版信息

Schizophr Res. 2011 Mar;126(1-3):174-83. doi: 10.1016/j.schres.2010.10.024. Epub 2010 Dec 24.

Abstract

OBJECTIVE

To determine the degree to which a proxy measure of remission in schizophrenia correlates with the criteria identified by the Remission in Schizophrenia Working Group, and how well early treatment response to ziprasidone predicts remission.

METHODS

Data from 10 ziprasidone studies were analyzed to determine rates of remission achieved with ziprasidone using a remission definition of Clinical Global Impression of Improvement (CGI-I) of 1, and compared with rates of remission achieved using the remission working group criteria. Positive and Negative Syndrome Scale (PANSS) and Brief Psychiatric Rating Scale (BPRS) scores were then investigated as predictors of remission.

RESULTS

A CGI-I score of 1 correlated with the remission criteria developed by the remission working group. In the combined ziprasidone arms, BPRS scores at Weeks 1, 3, and 4 successfully predicted PANSS remission (p<0.01) and BPRS remission (p<0.0001) at study endpoint (44-196weeks). PANSS scores (at Weeks 1, 3, and 4) successfully predicted PANSS remission (p<0.01) at study endpoint. PANSS scores at Week 3 successfully predicted BPRS remission (p=0.02) at study endpoint. A CGI-I score of 1 or 2 at Week 1 also successfully predicted remission in schizophrenia.

CONCLUSION

The findings show a correlation between clinical and research scales (remission working group criteria) for the assessment of remission in schizophrenia. This proxy measure for the assessment of remission should be easy to apply in a clinical setting and facilitates the prediction of remission in schizophrenia.

摘要

目的

确定精神分裂症缓解的代理测量与缓解精神分裂症工作组确定的标准的相关性,以及早期齐拉西酮治疗反应对缓解的预测程度。

方法

分析了 10 项齐拉西酮研究的数据,以确定使用缓解定义为临床总体印象改善(CGI-I)1 的齐拉西酮达到缓解的比例,并与使用缓解工作组标准达到缓解的比例进行比较。然后研究阳性和阴性症状量表(PANSS)和简明精神病评定量表(BPRS)评分作为缓解的预测指标。

结果

CGI-I 得分为 1 与缓解工作组制定的缓解标准相关。在联合齐拉西酮组中,BPRS 评分在第 1、3 和 4 周成功预测了 PANSS 缓解(p<0.01)和研究终点(44-196 周)的 BPRS 缓解(p<0.0001)。PANSS 评分(第 1、3 和 4 周)成功预测了研究终点的 PANSS 缓解(p<0.01)。PANSS 评分在第 3 周成功预测了 BPRS 缓解(p=0.02)。第 1 周的 CGI-I 评分为 1 或 2 也成功预测了精神分裂症的缓解。

结论

研究结果表明,精神分裂症缓解的临床和研究量表(缓解工作组标准)之间存在相关性。这种评估缓解的代理测量方法应该易于在临床环境中应用,并有助于预测精神分裂症的缓解。

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