为药物安全性研究，对突出药物引起的T波形态微小变化的参数进行研究。

Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies.

作者信息

Baas Tobias, Gräfe Ksenija, Khawaja Antoun, Dössel Olaf

机构信息

Karlsruhe Institute of Technology, Institute of Biomedical Engineering, 76131 Karlsruhe,

出版信息

Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:3796-9. doi: 10.1109/IEMBS.2011.6090769.

DOI:10.1109/IEMBS.2011.6090769

PMID:22255166

Abstract

In guideline E14, the American Food and Drug Administration (FDA) requests for clinical studies to investigate the prolongation of the heart rate corrected QT-interval (QTc) of the ECG. As drug induced QT-prolongation can be caused by changes in the repolarisation of the ventricles, it is so far a thorough ECG biomarker of risk for ventricular tachyarrhythmias and Torsade de Pointes (TdP). Ventricular repolarisation changes not only change QT but also influence the morphology of the T-wave. In a (400 mg single dose) Moxifloxacin positive control study both, QTc and several descriptors describing the T-wave morphology have been measured. Moxifloxacin is changing two shape dependent descriptors significantly (P<0.05) about 3 to 4 hours after a 400 mg oral single dose of Moxifloxacin.

摘要

在指南E14中，美国食品药品监督管理局（FDA）要求进行临床研究，以调查心电图中心率校正QT间期（QTc）的延长情况。由于药物诱导的QT延长可能由心室复极化的变化引起，因此它是目前用于评估室性快速心律失常和尖端扭转型室速（TdP）风险的一种全面的心电图生物标志物。心室复极化变化不仅会改变QT，还会影响T波形态。在一项（400mg单剂量）莫西沙星阳性对照研究中，测量了QTc以及几个描述T波形态的指标。口服400mg单剂量莫西沙星后约3至4小时，莫西沙星会使两个与形状相关的指标发生显著变化（P<0.05）。