Thrombolytic therapy within 3 to 6 hours after onset of ischemic stroke - Useful or harmful?
Thrombolytic therapy within 3 to 6 hours after onset of ischemic stroke - Useful or harmful?
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DOI：
10.1161/01.str.0000015555.21285.db
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发表时间：
2002-05-01
期刊：
影响因子：
8.3
通讯作者：
Hacke, W
中科院分区：
文献类型：
--
作者：
Ringleb, PA;Schellinger, PD;Hacke, W
背景-缺血性卒中发作后3小时内使用重组组织纤溶酶原激活剂（rtPA）是一种既定的治疗方法。由于在卒中发作后3小时的时间窗内使用静脉rtPA仍然是一个有争议的问题，我们试图审查在缺血性卒中症状发作后6小时的时间窗内使用溶栓治疗的证据。（国家神经疾病和卒中研究所rtPA卒中研究，欧洲急性卒中合作研究[ECASS] I，ECASS II）显示，即使在缺血性卒中症状发作后6小时内，静脉rtPA溶栓治疗也有获益。与3小时时间窗相比，6小时时间窗的脑出血发生率略有增加（比值比，3.23 vs 2.68），但由于置信区间较宽，因此无统计学意义。在改良兰金量表上使用小于或等于2与大于或等于3的二分法时，rtPA治疗6小时内仍具有相对优势降低37%的积极作用。然而，阿替普酶溶栓用于缺血性卒中急性非介入性治疗（ATLANTIS）研究（使用3- 5小时时间窗）未能显示rtPA的获益。尽管如此，当ATLANTIS的结果被纳入荟萃分析（如科克伦图书馆）时，rtPA治疗在6小时时间窗内的积极作用仍然存在，“需要治疗的人数”值为11。仅在3- 6小时的时间窗内治疗患者将导致治疗值为25所需的数量。结论-因此，从我们的观点来看，将溶栓治疗限制在3小时似乎是不合理的。由于缺乏3至6小时的批准，在此时间窗内的溶栓治疗应仅作为从患者和患者亲属获得广泛信息后的机构方案的一部分进行。需要更好的患者选择方法，特别是更新的MRI技术，如扩散和灌注加权成像，可以发挥关键作用。其目的是根据每个患者的成像结果中的发现来限定和个性化时间窗，而不是使用严格的时间定义的治疗窗。
Background-The use of recombinant tissue plasminogen activator (rtPA) within 3 hours after onset of an ischemic stroke is an established therapy. Because the use of intravenous rtPA beyond a time window of 3 hours after stroke onset is still a matter of debate, we sought to review, the evidence for the use of thrombolytic therapy in a time window up to 6 hours after onset of symptoms of ischemic stroke.Summary of Review-The meta-analyses of the major trials (National Institute of Neurological Disorders and Stroke rtPA Stroke Study, European Cooperative Acute Stroke Study [ECASS] I, ECASS II) showed a benefit of thrombolytic therapy with intravenous rtPA even within 6 hours after onset of symptoms of ischemic stroke. The rate of intracerebral hemorrhage was slightly increased in the 6-hour time window compared with the 3-hour time window, (odds ratio, 3.23 versus 2.68), but this was without statistical significance because of wide confidence intervals. A positive effect of 37% relative odds reduction with the use of a dichotomization of less than or equal to2 versus greater than or equal to3 on the modified Rankin Scale remains for rtPA treatment within 6 hours. However, the Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke (ATLANTIS) Study, in which a 3- to 5-hour time window was used, failed to show a benefit of rtPA. Still, when the results of ATLANTIS are included into meta-analyses such as the Cochrane Library, the positive effect of rtPA treatment in the 6-hour time window remains, with a "number needed to treat" value of 11. Treating patients only within a 3- to 6-hour time window would lead to a number needed to treat value of 25.Conclusions-Consequently, from our point of view it appears unjustified to limit thrombolytic therapy to 3 hours. Because of lack of approvals for 3 to 6 hours, thrombolytic therapy within this time window should be done only as part of an institutional protocol after extensive information is obtained from the patient and the patient's relatives. Better methods for patient selection are required in particular, newer MRI techniques, such as diffusion- and perfusion-weighted imaging, can play a key role. The aim is to qualify and individualize the time window according to the findings in each patient's imaging results rather than to use a strictly time-defined therapeutic window.