2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.
Acta Neurol Scand. 2010 Oct;122(4):229-36. doi: 10.1111/j.1600-0404.2009.01294.x. Epub 2009 Nov 16.
Intravenous thrombolysis was conditionally approved in the European Union (EU) in 2002, under the requirement of entering all patients into Safe Implementation of Thrombolysis in Stroke - Monitoring Study (SITS-MOST). Countries not belonging to the EU by 2002, i.e. Poland were invited to enter data into the SITS International Stroke Thrombolysis Registry (SITS-ISTR). The aim of this study is to compare the safety and efficacy of thrombolysis in the Polish SITS-ISTR stroke patient population with patients registered in SITS-MOST.
481 patients in Poland were reported between 2003 and 2007. Baseline and outcome data of Polish patients were compared with SITS-MOST.
Most of the baseline characteristics did not differ between the groups. The most important was the onset-to-needle and door-to-needle times were significantly longer in Polish patients, 150 vs 136 min and 82 vs 68 min, respectively (P < 0.001). The symptomatic intracranial haemorrhage and independence rates at 3 months were similar in both populations. Polish patients had a significantly higher 3-month mortality rate, 18.6% vs 11.3% (P < 0.001).
Because of higher mortality the study implies the need to improve the organization of thrombolysis services and provides the rationale to continue the monitoring of treatment in Poland.
2002 年，静脉溶栓在欧盟（EU）有条件获批，条件是所有患者均需进入 Safe Implementation of Thrombolysis in Stroke - Monitoring Study（SITS-MOST）。2002 年不属于欧盟的国家，如波兰，被邀请将数据输入 SITS International Stroke Thrombolysis Registry（SITS-ISTR）。本研究旨在比较波兰 SITS-ISTR 卒中患者人群与 SITS-MOST 登记患者的溶栓安全性和疗效。
2003 年至 2007 年期间，波兰报告了 481 例患者。将波兰患者的基线和结局数据与 SITS-MOST 进行比较。
两组患者的大多数基线特征无差异。最重要的是，波兰患者的发病至溶栓开始时间和门到溶栓开始时间明显更长，分别为 150 分钟和 82 分钟，而 SITS-MOST 组为 136 分钟和 68 分钟（P < 0.001）。两组患者的症状性颅内出血和 3 个月时的独立率相似。波兰患者的 3 个月死亡率明显更高，分别为 18.6%和 11.3%（P < 0.001）。
由于死亡率较高，该研究表明需要改进溶栓服务的组织，并为继续在波兰监测治疗提供了依据。
