Department of Neurology, AZ Sint-Jan Brugge-Oostende, Brugge, Belgium.
Acta Neurol Belg. 2010 Jun;110(2):157-62.
We report the Belgian results of the Safe Implementation of Thrombolysis in Stroke - International Stroke Thrombolysis Register (SITS-ISTR). This prospective observational register evaluates the safety and efficacy of intravenous thrombolysis with rtPA (recombinant tissue Plasminogen Activator) for ischemic stroke in routine clinical practice.
We compared the baseline characteristics, treatment delay, rate of symptomatic intracerebral hemorrhage and functional outcome at 90 days after treatment between patients enrolled in centres in Belgium and the non-Belgian SITS-registry population. We performed a multivariate analysis to adjust for differences in demographic and baseline characteristics.
743 patients were enrolled in 42 centers in Belgium between December 2002 and December 2007. These patients were older, had more severe stroke were more frequently female and more frequently had hyperlipidemia and atrial fibrillation. The median stroke onset-to-treatment delay was 140 min vs. 145 min. More patients died and were disabled 3 months after the stroke. A slight, non-significant, increase of symptomatic intracerebral hemorrhage (SICH) as per SITS protocol was observed (2.4 vs. 1.6%, p = 0.15). After adjustment for differences in baseline characteristics, functional independence (mRS < or = 2) at 3 months (OR 0.95, 95% CI 0.86-1.05, p = 0.31) was not different from non-Belgian patients, nor was the rate of SICH. However mortality at 3 months in Belgian patients was slightly higher (OR 1.15, 95% CI 1.02-1.29, p = 0.02).
Intravenous thrombolysis for ischemic stroke is safe and effective in the routine clinical use in Belgium. The higher mortality we observed is not related to a higher rate of SICH.
我们报告了 Safe Implementation of Thrombolysis in Stroke - International Stroke Thrombolysis Register（SITS-ISTR）在比利时的研究结果。这个前瞻性观察性注册研究评估了重组组织型纤溶酶原激活剂（rtPA）静脉溶栓治疗缺血性脑卒中的安全性和有效性，该研究在常规临床实践中进行。
我们比较了在比利时的中心注册的患者和非比利时 SITS 注册人群的基线特征、治疗延迟、症状性颅内出血发生率和治疗 90 天后的功能结局。我们进行了多变量分析，以调整人口统计学和基线特征的差异。
2002 年 12 月至 2007 年 12 月期间，在比利时的 42 个中心共纳入了 743 名患者。这些患者年龄更大，卒中更严重，女性更多，高脂血症和心房颤动更多。中位卒中发病至治疗的时间延迟为 140 分钟，而非比利时患者为 145 分钟。更多的患者在卒中后 3 个月死亡和残疾。按照 SITS 方案，观察到症状性颅内出血（SICH）略有增加（2.4%比 1.6%，p = 0.15）。调整基线特征的差异后，3 个月时功能独立性（mRS<或=2）（OR 0.95，95%CI 0.86-1.05，p = 0.31）与非比利时患者没有差异，SICH 的发生率也没有差异。然而，比利时患者的 3 个月死亡率略高（OR 1.15，95%CI 1.02-1.29，p = 0.02）。
在比利时的常规临床实践中，静脉溶栓治疗缺血性卒中是安全有效的。我们观察到的较高死亡率与 SICH 发生率较高无关。
