Fosser C, Duczynski G, Agin M, Wicker P, Darpo B
Pfizer Global Research and Development, Pfizer, Inc., New London, Connecticut, USA.
Clin Pharmacol Ther. 2009 Nov;86(5):503-6. doi: 10.1038/clpt.2009.34. Epub 2009 Apr 1.
We analyzed five crossover, thorough QT (TQT) studies to compare automated, manual, and computer-assisted (CA) measurement methods. All the methods detected moxifloxacin-induced, baseline-adjusted, placebo-subtracted mean changes in Fridericia-corrected QT interval (QTcF), with peak effect ranging from 10 to 21 ms. The variability associated with manual and CA measurements was generally 5-28% greater than that associated with automated methods. The performances of automated, manual, and CA measurements were comparable for the purpose of demonstrating assay sensitivity in TQT studies with healthy volunteers.
我们分析了五项交叉、全面QT（TQT）研究，以比较自动、手动和计算机辅助（CA）测量方法。所有方法均检测到莫西沙星诱导的、经基线调整、减去安慰剂后的弗里德里西亚校正QT间期（QTcF）的平均变化，峰值效应在10至21毫秒之间。与手动和CA测量相关的变异性通常比与自动方法相关的变异性大5-28%。在健康志愿者的TQT研究中，为了证明检测灵敏度，自动、手动和CA测量的性能相当。
