Park Man Young, Kim Eun Yeob, Lee Young Ho, Kim Woojae, Kim Ku Sang, Sheen Seung Soo, Lim Hong Seok, Park Rae Woong
Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, Korea.
Healthc Inform Res. 2011 Mar;17(1):58-66. doi: 10.4258/hir.2011.17.1.58. Epub 2011 Mar 31.
The aim of this study was to examine whether or not levofloxacin has any relationship with QT prolongation in a real clinical setting by analyzing a clinical data warehouse of data collected from different hospital information systems.
Electronic prescription data and medical charts from 3 different hospitals spanning the past 9 years were reviewed, and a clinical data warehouse was constructed. Patients who were both administrated levofloxacin and given electrocardiograms (ECG) were selected. The correlations between various patient characteristics, concomitant drugs, corrected QT (QTc) prolongation, and the interval difference in QTc before and after levofloxacin administration were analyzed.
A total of 2,176 patients from 3 different hospitals were included in the study. QTc prolongation was found in 364 patients (16.7%). The study revealed that age (OR 1.026, p < 0.001), gender (OR 0.676, p = 0.007), body temperature (OR 1.267, p = 0.024), and cigarette smoking (OR 1.641, p = 0.022) were related with QTc prolongation. After adjusting for related factors, 12 drugs concomitant with levofloxacin were associated with QTc prolongation. For patients who took ECGs before and after administration of levofloxacin during their hospitalization (n = 112), there was no significant difference in QTc prolongation.
The age, gender, body temperature, cigarette smoking and various concomitant drugs might be related with QTc prolongation. However, there was no definite causal relationship or interaction between levofloxacin and QTc prolongation. Alternative surveillance methods utilizing the massive accumulation of electronic medical data seem to be essential to adverse drug reaction surveillance in future.
本研究旨在通过分析从不同医院信息系统收集的数据组成的临床数据仓库，探讨在实际临床环境中左氧氟沙星与QT间期延长是否存在关联。
回顾了过去9年中3家不同医院的电子处方数据和病历，并构建了一个临床数据仓库。选择同时接受左氧氟沙星治疗并进行了心电图（ECG）检查的患者。分析了各种患者特征、合并用药、校正QT（QTc）间期延长以及左氧氟沙星给药前后QTc间期差异之间的相关性。
本研究共纳入了来自3家不同医院的2176例患者。364例患者（16.7%）出现QTc间期延长。研究表明，年龄（比值比1.026，p<0.001）、性别（比值比0.676，p=0.007）、体温（比值比1.267，p=0.024）和吸烟（比值比1.641，p=0.022）与QTc间期延长有关。在对相关因素进行校正后，12种与左氧氟沙星联用的药物与QTc间期延长有关。对于住院期间在使用左氧氟沙星前后均进行了心电图检查的患者（n=112），QTc间期延长无显著差异。
年龄、性别、体温、吸烟及各种合并用药可能与QTc间期延长有关。然而，左氧氟沙星与QTc间期延长之间不存在明确的因果关系或相互作用。利用大量积累的电子医疗数据的替代监测方法似乎对未来的药物不良反应监测至关重要。
