Rosenheck Robert, Lin Haiqun
*VA New England Mental Illness Research and Education Center, West Haven, CT; and †Department of Psychiatry, and ‡Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT.
J Nerv Ment Dis. 2014 Jan;202(1):18-24. doi: 10.1097/NMD.0000000000000065.
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 intention-to-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.
非劣效性分析是一种在比较疗效研究中日益重要的统计方法，在精神药理学中很少使用。本文使用此方法，利用干预有效性临床抗精神病药物试验（CATIE）的数据，评估第一代抗精神病药物在临床上是否不劣于第二代抗精神病药物（SGA）。阳性和阴性症状量表（PANSS）的保守非劣效性界值（NIM）源自已发表的最小临床重要差异值，并进一步降低25%。该NIM用于根据平均PANSS结果差异的95%置信区间（N = 1049）评估奋乃静是否不劣于奥氮平、利培酮和喹硫平。在18个月的意向性分析和几个亚分析中，奋乃静不劣于所有三种SGA。非劣效性可从设计为优效性试验的研究中进行评估。CATIE具备进行非劣效性分析的效能。
