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精神分裂症、临床抗精神病药物干预有效性试验(CATIE)与治疗所需人数:CATIE如何为临床医生提供信息?

Schizophrenia, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and number needed to treat: how can CATIE inform clinicians?

作者信息

Citrome L, Stroup T Scott

机构信息

Department of Psychiatry, New York University School of Medicine, New York, NY, USA.

出版信息

Int J Clin Pract. 2006 Aug;60(8):933-40. doi: 10.1111/j.1742-1241.2006.01044.x.

Abstract

The schizophrenia medication study conducted as part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) provided a large quantity of data. However, placing these data into a clinically meaningful context for the individual practitioner has been challenging. Effectiveness and safety outcome data were extracted from the three principal publications that documented the results of phases 1 and 2 of the CATIE schizophrenia study. Number needed to treat (NNT) and number needed to harm (NNH) were calculated from the categorical results, together with their confidence intervals. Olanzapine and clozapine demonstrated advantages over comparators in terms of all-cause discontinuation, largely driven by efficacy advantages. NNT for olanzapine compared with perphenazine, quetiapine, risperidone and ziprasidone ranged from 5.5 to 10.1 in phase 1. NNT for clozapine compared with risperidone or quetiapine was approximately 3 in phase 2. There were marked differences in association with weight gain and metabolic effects, with olanzapine demonstrating a NNH ranging from 12.4 to 17.7 in terms of discontinuation of treatment in phase 1 because of these effects. Results from phase 2 reflect phase 1 in this regard, and demonstrated an advantage for ziprasidone in terms of discontinuation because of weight gain or metabolic effects, with NNT ranging from 10.6 to 20.8. However, these notable differences in association with weight gain and metabolic effects did not seem to drive the differences in overall time to all-cause discontinuation. NNT and NNH can help place the wide array of CATIE results into clinical context, and permits quantification of the differences observed between the antipsychotics that were tested.

摘要

作为干预有效性临床抗精神病药物试验(CATIE)一部分的精神分裂症药物研究提供了大量数据。然而,将这些数据置于个体从业者有临床意义的背景下一直具有挑战性。有效性和安全性结果数据是从记录CATIE精神分裂症研究第1阶段和第2阶段结果的三篇主要出版物中提取的。从分类结果及其置信区间计算出治疗所需人数(NNT)和伤害所需人数(NNH)。在全因停药方面,奥氮平和氯氮平相对于对照药物显示出优势,这主要是由疗效优势驱动的。在第1阶段,奥氮平与奋乃静、喹硫平、利培酮和齐拉西酮相比的NNT范围为5.5至10.1。在第2阶段,氯氮平与利培酮或喹硫平相比的NNT约为3。在体重增加和代谢影响方面存在显著差异,在第1阶段,由于这些影响,奥氮平在治疗停药方面的NNH范围为12.4至17.7。在这方面,第2阶段的结果反映了第1阶段的情况,并且在因体重增加或代谢影响而停药方面,齐拉西酮显示出优势,NNT范围为10.6至20.8。然而,与体重增加和代谢影响相关的这些显著差异似乎并未推动全因停药总时间的差异。NNT和NNH有助于将CATIE的广泛结果置于临床背景中,并允许对所测试的抗精神病药物之间观察到的差异进行量化。

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