Baas Tobias, Gräfe Ksenija, Khawaja Antoun, Dössel Olaf
Karlsruhe Institute of Technology, Institute of Biomedical Engineering, 76131 Karlsruhe,
Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:3796-9. doi: 10.1109/IEMBS.2011.6090769.
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.
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）。
