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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Expanded Indication for Recombinant Tissue Plasminogen Activator from 3 to 4.5 h after Onset of Stroke in Japan
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Expanded Indication for Recombinant Tissue Plasminogen Activator from 3 to 4.5 h after Onset of Stroke in Japan

机译：在日本卒中开始后3至4.5小时的重组组织纤溶酶原激活剂的扩展指示

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Objective: We examined the impact of expansion of the time window (from 3 to 4.5 hours) in the labeled indication for recombinant tissue-plasminogen activator (rt-PA) in August 2012 on the use of rt-PA for patients with acute ischemic stroke (AIS) and the outcomes of patients treated with rt-PA. Materials and Methods: Using a Japanese nationwide inpatient claims database, we identified patients with AIS who admitted to hospitals that consecutively participated in the database from 2010 to 2014. We defined the pre-expansion period as before August 2012 and the post-expansion period as after August 2012. We conducted an interrupted time-series analysis using patient-level data to examine the association between the expansion and use of rt-PA. We also assessed the association of the expansion with outcomes in patients treated with rt-PA. Results: Among 257,778 patients with AIS, 4.5% patients (5,796/129,326) were treated with rt-PA in the pre-expansion period and 5.8% patients (7,483/128,452) were treated with rt-PA in the post-expansion period. The expansion was associated with greater use of rt-PA (adjusted odds ratio [aORI, 1.35; 95% confidence interval [CI], 1.24-1.48). Among patients treated with rt-PA, the expansion was associated with functional independence (modified Rankin scale of <2) at discharge (aOR, 1.26; 95% CI, 1.03-1.54), but not with in-hospital mortality (aOR, 0.92; 95% CI, 0.68-1.24). Conclusions: This study showed that expansion of the time window for rt-PA was associated with increased use of rt-PA in patients with AIS, while the functional outcome at discharge was improved after the expansion in patients treated with rt-PA.
机译：目的：我们研究了2012年8月重组组织型纤溶酶原激活剂（rt-PA）标记适应症中时间窗（从3小时到4.5小时）扩大对急性缺血性卒中（AIS）患者使用rt-PA的影响，以及rt-PA治疗患者的预后。材料和方法：使用日本全国性住院患者索赔数据库，我们确定了2010年至2014年间连续参与数据库的AIS患者。我们将扩张前阶段定义为2012年8月之前，扩张后阶段定义为2012年8月之后。我们使用患者层面的数据进行了中断时间序列分析，以检查rt-PA的扩展和使用之间的关联。我们还评估了rt-PA治疗患者的扩展与预后之间的关联。结果：在257778例AIS患者中，4.5%的患者（5796/129326）在扩张前接受了rt PA治疗，5.8%的患者（7483/128452）在扩张后接受了rt PA治疗。扩大与rt-PA的更多使用有关（调整后的优势比[aORI，1.35；95%可信区间[CI]，1.24-1.48）。在接受rt PA治疗的患者中，扩张与出院时的功能独立性（改良Rankin评分<2）相关（aOR，1.26；95%可信区间，1.03-1.54），但与住院死亡率无关（aOR，0.92；95%可信区间，0.68-1.24）。结论：本研究表明，在AIS患者中，rt-PA时间窗的扩大与rt-PA的使用增加有关，而在接受rt-PA治疗的患者中，扩大时间窗后出院时的功能结果得到改善。

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