Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands; Department of Clinical Pharmacology, Graduate School of Medicine, University Medical Center Groningen, Groningen, The Netherlands.
Drug Discov Today. 2014 Sep;19(9):1294-7. doi: 10.1016/j.drudis.2014.06.017. Epub 2014 Jun 25.
Prolongation of the QT interval can predispose to fatal ventricular arrhythmias. Differences in QT-labeling language can result in miscommunication and suboptimal risk mitigation. We systematically compared the phraseology used to communicate on QT-prolonging properties of 144 drugs newly approved (1st January 2006 to 1st June 2012) in the European Union (EU) and the United States (US), of which 66 mentioned the term 'QT' (two EU only, 28 US only, 36 both). The agreement between authorities about the message on QT prolongation (does not prolong, unclear, possibly prolongs, prolongs) was moderate (kappa 0.434). However, the agreement in expected clinical decisions based on the product labels was much higher (kappa 0.673). The US drug label tends to be more explicit, especially when it considers absence of QT effects.
QT 间期延长可导致致命性室性心律失常。QT 标注语言的差异可能导致沟通不畅和风险缓解效果不佳。我们系统地比较了在欧盟和美国（2006 年 1 月 1 日至 2012 年 6 月 1 日期间新批准的 144 种药物中用于描述 QT 延长特性的术语，其中 66 种药物提到了“QT”（2 种仅在欧盟使用，28 种仅在美国使用，36 种在欧盟和美国均使用）。监管机构对 QT 延长信息（不延长、不明确、可能延长、延长）的表述的一致性为中等（kappa 值 0.434）。然而，基于产品标签做出的预期临床决策的一致性要高得多（kappa 值 0.673）。美国药物标签往往更明确，尤其是在考虑 QT 效应缺失时。
