Reimer P, Vosshenrich R
Radiology, Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Moltkestrasse 90, 76133 Karlsruhe, Germany.
Eur Radiol. 2008 Jun;18(6):1096-101. doi: 10.1007/s00330-008-0886-0. Epub 2008 Feb 15.
When contrast agents are approved, the label describes the approved indications and particular circumstances of use such as age, organ function or pregnancy. The use of contrast agents outside their labelled indications is increasing, namely with contrast agents used for MRI. The aim of this paper is to improve the knowledge about this topic. The basis for off-label use is the physician's prerogative, which finds its basis in the "Declaration of Helsinki". Off-label use is allowed under special conditions and might be even the medical state of the art. The necessity for off-label use will continue to increase for MR-contrast agents, as the regulatory requirements for approval of new indications continuously increase, and clinical trials for registration purposes are quite costly and time consuming. As a consequence, manufacturers will concentrate on clinical studies for the essential indications.
当造影剂获得批准时，标签会描述批准的适应症以及特定的使用情况，如年龄、器官功能或妊娠情况。造影剂在其标签适应症之外的使用正在增加，尤其是用于磁共振成像（MRI）的造影剂。本文的目的是增进对这一主题的了解。超说明书用药的依据是医生的特权，其依据来自《赫尔辛基宣言》。在特殊条件下允许超说明书用药，甚至可能是当前的医学技术水平。随着批准新适应症的监管要求不断提高，以及用于注册目的的临床试验成本高昂且耗时，磁共振造影剂超说明书用药的必要性将持续增加。因此，制造商将专注于针对基本适应症的临床研究。
