Department of Neurology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Int J Stroke. 2012 Jun;7(4):289-92. doi: 10.1111/j.1747-4949.2011.00709.x. Epub 2011 Dec 14.
Thrombolysis with intravenous alteplase has been proven an effective treatment for patients with acute ischemic stroke in randomized clinical trials. In daily practice, the effect of thrombolysis may be less, and complications may occur more often.
The aim of this study was to assess effectiveness and safety of thrombolysis in an unselected observational cohort of patients.
During a two-year period, all patients over 18 years with acute stroke who were admitted within four-hours from onset of symptoms in 12 centers were registered. We compared outcomes in patients who were treated with alteplase with patients who were not treated with alteplase. The primary outcome was good functional outcome at three-months measured with the modified Rankin Scale ≤2). The safety end point was symptomatic intracranial hemorrhage and mortality. We used a multivariable logistic regression model to adjust for baseline imbalances and multilevel analysis to take into account within center correlations.
Overall, 1657 patients with ischemic stroke were admitted within four-hours from onset of symptoms and 696 (42%) were treated with alteplase. Treatment with alteplase was associated with a favorable outcome (adjusted odds ratio 1·3; 95% confidence interval 1·0 to 1·7). After further adjustment for potential clustering effects, the adjusted odds ratio for good outcome was 1·4 (95% confidence interval 1·0 to 1·8). Thirty-six (5%) of the 696 patients treated with alteplase had a symptomatic intracranial bleeding complication.
Thrombolysis for ischemic stroke with intravenous alteplase is an effective treatment also in an unselected observational cohort of patients.
静脉注射阿替普酶溶栓治疗已被随机临床试验证明对急性缺血性脑卒中患者有效。但在日常实践中，溶栓的效果可能较差，且并发症可能更常见。
本研究旨在评估溶栓治疗在未经选择的观察性队列患者中的有效性和安全性。
在为期两年的时间里，在 12 个中心，所有发病 4 小时内的 18 岁以上急性脑卒中患者都被登记。我们比较了接受阿替普酶治疗和未接受阿替普酶治疗的患者的结局。主要结局是采用改良 Rankin 量表（mRS）评分≤2 分的 3 个月时的良好功能结局。安全性终点是症状性颅内出血和死亡率。我们使用多变量逻辑回归模型来调整基线不平衡，使用多层次分析来考虑中心内相关性。
共有 1657 例缺血性脑卒中患者在发病 4 小时内入院，其中 696 例（42%）接受了阿替普酶治疗。阿替普酶治疗与良好结局相关（调整后的优势比 1.3；95%置信区间 1.0 至 1.7）。在进一步调整潜在聚类效应后，良好结局的调整优势比为 1.4（95%置信区间 1.0 至 1.8）。接受阿替普酶治疗的 696 例患者中有 36 例（5%）发生症状性颅内出血并发症。
在未经选择的观察性队列患者中，静脉注射阿替普酶治疗缺血性脑卒中也是一种有效的治疗方法。
