Noninferiority of perphenazine vs. three second-generation antipsychotics in chronic schizophrenia.
Noninferiority of perphenazine vs. three second-generation antipsychotics in chronic schizophrenia.
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DOI：
10.1097/nmd.0000000000000065
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发表时间：
2014-01
期刊：
影响因子：
--
通讯作者：
Lin H
中科院分区：
文献类型：
--
作者：
Rosenheck R;Lin H
非劣效性分析是一种在比较有效性研究中越来越重要的统计方法，但很少在精神药理学中使用。使用临床抗精神病药物干预有效性试验（CATIE）的数据，本方法用于评估第一代抗精神病药物在临床上是否不逊于第二代抗精神病药物（SGAs）。阳性和阴性综合征量表（PANSS）的保守非劣效性边际（NIM）来自最小临床重要差异的最小公布值，进一步减少25%。该NIM基于平均PANSS结果差异的95%置信区间（N = 1049）来评估奋那嗪是否优于奥氮平、利培酮和喹硫平。在18个月的意向治疗分析和几个亚分析中，奋那嗪不低于所有三种SGAs。非劣效性可以通过设计为优势试验的研究来评价。CATIE有能力进行非劣效性分析。
Noninferiority analysis is a statistical method of growing importance in comparative effectiveness research that has rarely been used in psychopharmacology. This method is used here to evaluate whether first-generation antipsychotics are clinically not inferior to second-generation antipsychotics (SGAs) using data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE). A conservative noninferiority margin (NIM) on the Positive and Negative Syndrome Scale (PANSS) was derived from the smallest published value for the minimal clinically important difference, further reduced by 25%. This NIM was used to assess whether perphenazine is noninferior to olanzapine, risperidone, and quetiapine on the basis of the 95% confidence intervals of differences in mean PANSS outcomes (N = 1049). Perphenazine was noninferior to all three SGAs during 18 months of intentionto- treat analysis and in several subanalyses. Noninferiority can be evaluated from studies designed as superiority trials. Power was available in the CATIE to conduct noninferiority analysis.