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日本广岛地区静脉注射重组组织型纤溶酶原激活剂的多中心研究:广岛急性卒中回顾性与前瞻性登记研究

Multicenter Study of Intravenous Recombinant Tissue Plasminogen Activator Infusion around Hiroshima, Japan: The Hiroshima Acute Stroke Retrospective and Prospective Registry Study.

作者信息

Aoki Shiro, Hosomi Naohisa, Sueda Yoshimasa, Kono Tomoyuki, Takamatsu Kazuhiro, Ohyama Hideo, Torii Tsuyoshi, Kitamura Takeshi, Nomura Eiichi, Noda Koichi, Ohtsuki Toshiho, Matsumoto Masayasu

机构信息

Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.

Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.

出版信息

J Stroke Cerebrovasc Dis. 2015 Dec;24(12):2747-53. doi: 10.1016/j.jstrokecerebrovasdis.2015.08.005. Epub 2015 Sep 7.

Abstract

OBJECTIVE

Approximately 10 years have passed since intravenous (IV) recombinant tissue plasminogen activator therapy was approved in Japan. The aim of this retrospective study was to identify the effectiveness and safety of IV alteplase therapy with the Japanese original dose around Hiroshima via consideration of the patients' backgrounds, examination findings, and outcomes.

METHODS

All consecutive patients with ischemic stroke who received IV alteplase therapy between October 2005 and October 2010 were registered.

RESULTS

Four hundred twenty-nine patients with ischemic stroke (172 female [40.1%], mean age 73.7 ± 11.8 years) were registered. The proportion of patients over 75 years old was 51.5% (221 patients). The median National Institutes of Health Stroke Scale (NIHSS) scores at admission were 13 (interquartile range, 9-19), and the NIHSS scores 24 hours after alteplase infusion were 8 (interquartile range, 3-15). The proportion of intracerebral hemorrhage within the initial 36 hours was 20.2% (86 patients). After the multivariate regression analysis, a history of hypertension (odds ratio = 4.14; 95% confidence interval, 1.32-14.79; P = .01) and no recanalization (odds ratio = 10.10; 95% confidence interval, 3.03-39.33; P < .0001) were independently associated with a modified Rankin Scale (mRS) score of 2 or higher at 3 months. Patients over 75 years old were not significantly associated with an intracerebral hemorrhage within the initial 36 hours and an mRS score of 2 or higher at 3 months.

CONCLUSIONS

The results of our study demonstrated that IV alteplase therapy with the Japanese original dose was effective and exhibited a safety profile similar to other studies. Moreover, we should not hesitate to IV alteplase therapy simply because of advanced age.

摘要

目的

自静脉注射重组组织型纤溶酶原激活剂疗法在日本获批以来,大约已过去10年。这项回顾性研究的目的是通过考虑患者背景、检查结果和预后,确定广岛地区使用日本原剂量静脉注射阿替普酶疗法的有效性和安全性。

方法

登记了2005年10月至2010年10月期间接受静脉注射阿替普酶治疗的所有连续性缺血性脑卒中患者。

结果

登记了429例缺血性脑卒中患者(172例女性[40.1%],平均年龄73.7±11.8岁)。75岁以上患者的比例为51.5%(221例患者)。入院时美国国立卫生研究院卒中量表(NIHSS)评分的中位数为13(四分位间距,9-19),阿替普酶输注后24小时的NIHSS评分为8(四分位间距,3-15)。最初36小时内脑出血的比例为20.2%(86例患者)。多因素回归分析后,高血压病史(比值比=4.14;95%置信区间,1.32-14.79;P=0.01)和未再通(比值比=10.10;95%置信区间,3.03-39.33;P<0.0001)与3个月时改良Rankin量表(mRS)评分为2或更高独立相关。75岁以上患者与最初36小时内脑出血以及3个月时mRS评分为2或更高无显著相关性。

结论

我们的研究结果表明,使用日本原剂量静脉注射阿替普酶疗法是有效的,并且显示出与其他研究相似的安全性。此外,我们不应仅仅因为患者年龄较大而对静脉注射阿替普酶疗法犹豫不决。

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