Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study

Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study
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DOI:
10.1503/cmaj.1041561
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发表时间:
2005-05-10
影响因子:
14.6
通讯作者:
Buchan, AM
Buchan, AM
中科院分区:
医学1区
文献类型:
--
作者:
Hill, MD;Buchan, AM

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背景:急性缺血性卒中的溶栓治疗一直存在争议。加拿大阿替普酶中风有效性研究,一个国家的前瞻性队列研究,进行了评估阿替普酶治疗缺血性中风在实际practice.Methods的有效性:这项研究是由联邦政府授权的阿替普酶在加拿大治疗中风的许可证的条件。建立了一个登记处,收集从1999年2月17日至2001年6月30日接受此类治疗的中风患者2.5年的数据。所有能够根据加拿大指南进行溶栓治疗的中心都有资格向登记研究提交患者数据。数据收集是前瞻性的,随访在卒中后90天完成。在基线和治疗开始后24-48小时获得的头部CT扫描副本提交给中央小组进行review.Results:共有1135例患者在加拿大所有主要医院的60个中心入组。该登记处收集了该国所有接受治疗的缺血性中风患者中估计84%的数据。在37%的患者中观察到极好的临床结局。仅4.6%的患者发生症状性颅内出血(95%置信区间[CI] 3.4%-6.0%);然而,这些患者中有75%在医院死亡。另外1.3%(95%CI 0.7%-2.2%)的患者有hemiorolingual血管性edema.Conclusions:在加拿大接受溶栓治疗的中风患者的结果是相称的临床试验的结果。症状性颅内出血的发生率较低。脑卒中溶栓治疗是一种安全有效的治疗方法。
Background: Thrombolysis for acute ischemic stroke has remained controversial. The Canadian Alteplase for Stroke Effectiveness Study, a national prospective cohort study, was conducted to assess the effectiveness of alteplase therapy for ischemic stroke in actual practice.Methods: The study was mandated by the federal government as a condition of licensure of alteplase for the treatment of stroke in Canada. A registry was established to collect data over 2.5 years for stroke patients receiving such treatment from Feb. 17, 1999, through June 30, 2001. All centres capable of administering thrombolysis therapy according to Canadian guidelines were eligible to submit patient data to the registry. Data collection was prospective, and follow-up was completed at 90 days after stroke. Copies of head CT scans obtained at baseline and at 24-48 hours after the start of treatment were submitted to a central panel for review.Results: A total of 1135 patients were enrolled at 60 centres in all major hospitals across Canada. The registry collected data for an estimated 84% of all treated ischemic stroke patients in the country. An excellent clinical outcome was observed in 37% of the patients. Symptomatic intracranial hemorrhage occurred in only 4.6% of the patients (95% confidence interval [CI] 3.4%-6.0%); however, 75% of these patients died in hospital. An additional 1.3% (95% CI 0.7%-2.2%) of patients had hemiorolingual angioedema.Conclusions: The outcomes of stroke patients undergoing thrombolysis in Canada are commensurate with the results of clinical trials. The rate of symptomatic intracranial hemorrhage was low. Stroke thrombolysis is a safe and effective therapy in actual practice.