Bonate P L, Russell T
Quintiles, Inc. Clinical Pharmacokinetics, Kansas City, Missouri 64134, USA.
J Clin Pharmacol. 1999 Apr;39(4):349-58. doi: 10.1177/00912709922007912.
It is increasingly likely that non-cardiac-related drugs will need to be routinely analyzed for their ability to prolong cardiac repolarization. This leads to potential problems for drug companies in general and statisticians in particular. A number of issues immediately arise in regard to answering the question, "Does drug X prolong cardiac repolarization?" These include identifying what is the desired outcome, what is the dependent variable, and what analysis method should be used. The purpose of this article is bring to to light some of the issues regarding the analysis of QTc data, the advantages and disadvantages of these analysis methods, and some general recommendations.
越来越有可能需要对非心脏相关药物延长心脏复极化的能力进行常规分析。这给制药公司，尤其是统计学家带来了潜在问题。关于回答“药物X是否会延长心脏复极化？”这个问题，立刻出现了许多问题。这些问题包括确定期望的结果是什么、因变量是什么以及应该使用什么分析方法。本文的目的是揭示一些关于QTc数据分析的问题、这些分析方法的优缺点以及一些一般性建议。
