Thrombolysis With 0.6 mg/kg Intravenous Alteplase for Acute Ischemic Stroke in Routine Clinical Practice The Japan post-Marketing Alteplase Registration Study (J-MARS)
Thrombolysis With 0.6 mg/kg Intravenous Alteplase for Acute Ischemic Stroke in Routine Clinical Practice The Japan post-Marketing Alteplase Registration Study (J-MARS)
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DOI：
10.1161/strokeaha.110.589606
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发表时间：
2010-09-01
期刊：
影响因子：
8.3
通讯作者：
Yamaguchi, Takenori
中科院分区：
文献类型：
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作者：
Nakagawara, Jyoji;Minematsu, Kazuo;Yamaguchi, Takenori
背景和目的：在日本，日本厚生劳动省(MHLW)于2005年10月批准0.6毫克/公斤的阿尔替普酶用于中风发病后3小时内的使用。日本上市后阿尔替普酶注册研究(J-MARS)的目的是评估0.6 mg/kg阿尔替普酶在日本常规临床实践中的安全性和有效性。方法：2005年10月至2007年10月，来自942个中心的7492名患者参加了J-MARS，这是一项开放的、非随机的观察性研究。主要观察指标为卒中后3个月症状性颅内出血(NIHSS评分较基线恶化4分)和预后良好(改良Rankin量表评分0~1分)。结果：7492例患者中，36小时内症状性颅内出血的比例为3.5%(95%可信区间，3.1%~3.9%)，3月时为4.4%(95%可信区间，3.9%~4.9%)。总病死率为13.1%(95%CI，12.4%~13.9%)，症状性颅内出血致死率为0.9%(95%CI，0.7%~1.2%)。4944例患者3个月的预后良好(疗效分析)为33.1%(95%可信区间，31.8%~34.4%)。基线NIHSS评分在18-80岁之间的患者的亚组分析
Background and Purpose-In Japan, alteplase at 0.6 mg/kg was approved in October 2005 for use within 3 hours of stroke onset by the Ministry of Health, Labor and Welfare (MHLW). The aim of the Japan post-Marketing Alteplase Registration Study (J-MARS), which was requested by MHLW at the time of approval, was to assess the safety and efficacy of 0.6 mg/kg alteplase in routine clinical practice for the Japanese.Methods-A total of 7492 patients from 942 centers were enrolled in the J-MARS, an open-label, nonrandomized, observational study, from October 2005 to October 2007. Primary outcome measures were symptomatic intracranial hemorrhage (a deterioration in NIHSS score >= 4 from baseline) and favorable outcome (modified Rankin Scale score, 0-1) at 3 months after stroke onset.Results-The proportion of patients with symptomatic intracranial hemorrhage in 7492 patients (safety analysis) was 3.5% (95% confidence interval [CI], 3.1%-3.9%) within 36 hours and 4.4% (95% CI, 3.9%-4.9%) at 3 months. The overall mortality rate was 13.1% (95% CI, 12.4%-13.9%) and the proportion of patients with fatal symptomatic intracranial hemorrhage was 0.9% (95% CI, 0.7%-1.2%). The outcomes at 3 months were available for 4944 patients and the proportion of favorable outcome (efficacy analysis) was 33.1% (95% CI, 31.8%-34.4%). The subgroup analysis in patients between 18 and 80 years with a baseline NIHSS score