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首页> 外文期刊>Stroke: A Journal of Cerebral Circulation >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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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).

机译：在常规临床实践中，采用0.6 mg / kg静脉阿替普酶溶栓治疗急性缺血性中风：日本上市后阿替普酶注册研究（J-MARS）。

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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 >or=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 <25 demonstrated that favorable outcome at 3 months was 39.0% (95% CI, 37.4%-40.6%). CONCLUSIONS: These data suggest that 0.6 mg/kg intravenous alteplase within 3 hours of stroke onset could be safe and effective in routine clinical practice for the Japanese.
机译：背景与目的：在日本，厚生劳动省（MHLW）于2005年10月批准以0.6 mg / kg的阿替普酶在中风发作后3小时内使用。 MHLW在批准时要求进行的日本上市后阿替普酶注册研究（J-MARS）的目的是评估0.6 mg / kg阿替普酶在日本人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（一项开放标签，非随机，观察性研究）。主要预后指标为有症状的颅内出血（NIHSS评分恶化>或>中风发作后3个月，基线水平= 4）和良好的结局（改良的Rankin量表评分，0-1）。结果：7492例有症状性颅内出血的患者比例（安全性分析）在36小时内为3.5％（95％置信区间[CI]，3.1％-3.9％）和4.4％（95％CI，3.9％-4.9） ％）在3个月时。总死亡率为13.1％（95％CI，12.4％-13.9％），致命性症状性颅内出血患者的比例为0.9％（95％CI，0.7％-1.2％）。 3944个月的患者可获得3个月的预后，良好预后（疗效分析）的比例为33.1％（95％CI，31.8％-34.4％）。在基线NIHSS得分<25的18至80岁患者中进行的亚组分析表明，3个月时的有利结局为39.0％（95％CI，37.4％-40.6％）。结论：这些数据表明，在日本人的常规临床实践中，卒中发作后3小时内0.6 mg / kg静脉阿替普酶可能是安全有效的。

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