Guidelines for the Intravenous Application of Recombinant Tissue-type Plasminogen Activator (Alteplase), the Second Edition, October 2012: A Guideline From the Japan Stroke Society
Guidelines for the Intravenous Application of Recombinant Tissue-type Plasminogen Activator (Alteplase), the Second Edition, October 2012: A Guideline From the Japan Stroke Society
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DOI：
10.1016/j.jstrokecerebrovasdis.2013.04.001
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发表时间：
2013-07-01
影响因子：
2.5
通讯作者：
Yamaguchi, Takenori
中科院分区：
文献类型：
--
作者：
Minematsu, Kazuo;Toyoda, Kazunori;Yamaguchi, Takenori
在日本，静脉注射阿替普酶（一种重组组织型纤溶酶原激活剂（rt-PA））于2005年根据药物独特剂量（0.6 mg/kg）的临床试验结果获批用于缺血性卒中适应症。日本卒中学会发布了rt-PA静脉应用指南，并在日本各地组织了适当使用培训课程，以促进静脉阿替普酶的安全、广泛使用。批准后7年，静脉注射阿替普酶的临床经验积累，在日本和海外发现了静脉注射阿替普酶的额外证据，医疗环境发生了实质性变化，包括新药和医疗器械的批准。值得注意的是，2012年8月，在延长的治疗时间窗内（症状发作后4.5小时内）使用阿替普酶已纳入日本的保险范围。为配合这些不断转变的情况，我们决定拟备经修订的指引。在准备第二版时，我们注意通过强调临床实践所需的信息使其内容更加实用。鉴于2005年日本静脉注射阿替普酶的临床经验有限，第一版的开发重点是安全性，而第二版是第一版的实质性修订，主要是在合格性标准方面，基于累积的证据和临床经验。(C)2013年国家中风协会
In Japan, intravenous alteplase, a recombinant tissue-type plasminogen activator (rt-PA), was approved for an indication of ischemic stroke in 2005 on the basis of the results of a clinical trial with a unique dose of the drug (0.6 mg/kg). The Japan Stroke Society published the guidelines for intravenous application of rt-PA and organized training sessions for proper use all over Japan in an effort to promote the safe, widespread use of intravenous alteplase. Seven years following its approval, clinical experience with intravenous alteplase has accumulated, additional evidence of intravenous alteplase has been found in Japan and overseas, and the medical environment has substantially changed, including approvals for new drugs and medical devices. Notably, the use of alteplase in the extended therapeutic time window (within 4.5 hours of symptom onset) became covered by insurance in Japan in August 2012. To address these changing situations, we have decided to prepare the revised guidelines. In preparing the second edition, we took care to make its contents more practical by emphasizing information needed in clinical practice. While the first edition was developed with emphasis on safety in light of limited clinical experience with intravenous alteplase in Japan in 2005, this second edition is a substantial revision of the first edition mainly in terms of eligibility criteria, on the basis of accumulated evidence and the clinical experience. (C) 2013 by National Stroke Association