Aleu Aitziber, Mellado Patricio, Lichy Christoph, Köhrmann Martin, Schellinger Peter D
Department of Neurology, Neurointensive Care Unit, University of Heidelberg, Heidelberg, Germany.
Stroke. 2007 Feb;38(2):417-22. doi: 10.1161/01.STR.0000254504.71955.05. Epub 2006 Dec 21.
Only 2% to 4% of patients with acute ischemic stroke receive thrombolytic therapy resulting from the current strict inclusion criteria among other issues. Safety of intravenous and intraarterial thrombolysis in off-label situations is controversially discussed. We sought to review the reports on such patients regarding intra- and extracranial hemorrhage.
A MEDLINE search for off-label uses of thrombolysis revealed reports on 273 patients treated with intraarterial or intravenous thrombolysis for ischemic stroke. Symptomatic intracranial hemorrhage occurred in 19 of 273 patients (6.95%) and extracranial hemorrhage in 17 of 273 (6.22%).
These data suggest that the overall bleeding risk in off-label thrombolysis may not be as high as presumed. However, the small number of patients in each group and the likely underreporting of worse outcomes preclude drawing any conclusion as to specific treatment recommendations. Selected patients might benefit, however, from thrombolysis in situations not currently considered in the inclusion criteria. To obtain a meaningful database, a registry for off-label thrombolysis should be created.
由于当前严格的纳入标准及其他因素，仅有2%至4%的急性缺血性卒中患者接受溶栓治疗。静脉溶栓和动脉内溶栓在超说明书情况下的安全性存在争议。我们试图回顾关于此类患者颅内和颅外出血的报告。
对MEDLINE数据库中溶栓超说明书使用情况的检索显示，有关于273例接受动脉内或静脉溶栓治疗缺血性卒中患者的报告。273例患者中有19例（6.95%）发生症状性颅内出血，273例中有17例（6.22%）发生颅外出血。
这些数据表明，超说明书溶栓的总体出血风险可能不像预期的那么高。然而，每组患者数量较少，且可能存在不良结局报告不足的情况，因此无法就具体治疗建议得出任何结论。然而，部分选定患者可能会从目前纳入标准未考虑的情况下的溶栓治疗中获益。为了获得有意义的数据库，应建立一个超说明书溶栓登记系统。
