A pilot study of a new thrombolytic agent for acute ischemic stroke in Taiwan within a five-hour window

Han Hwa Hu, Michael Mu Huo Teng, Li Chi Hsu, Wen Jang Wong, Lee Min Wang, Yun On Luk, Chang Ming Chern, Bing Wen Soong, Wen Yung Sheng

研究成果: 雜誌貢獻文章同行評審

14 引文 斯高帕斯(Scopus)

摘要

Background and Purpose - This study was the first clinical trial in Taiwan of a new thrombolytic agent human tissue urokinase type plasminogen activator (HTUPA) in patients with acute ischemic stroke. Methods - Patients were treated with a single bolus intravenous HTUPA under an open-label dose escalation design within 5 hours after symptom onset. Safety outcomes were assessed by symptomatic and asymptomatic intracerebral hemorrhage (ICH) as well as other bleeding episodes. Preliminary efficacy was measured by National Institutes of Health Stroke Scale (NIHSS). Results - Three doses of HTUPA (0.3 mg/kg, 0.35 mg/kg, and 0.4 mg/kg) were administered to 33 patients, with the majority of patients (n=29) receiving 0.3 mg/kg. Two cases of fatal ICH occurred: 1 in the patient who received 0.4 mg/kg and the other in the 0.3 mg/kg group. Asymptomatic ICH occurred in 6 patients. Other treatment-related serious adverse events were ecchymosis, hematuria, and upper gastrointestinal bleeding, which were completely recovered. At day 90, in patients treated with 0.3 mg/kg within a 0- to 5-hour window, 34% reached NIHSS scores 0 to 1, whereas of those treated within 0 to 3 hours, 86% reached this score. Conclusion - Intravenous HTUPA, given at 0.3 mg/kg as a bolus injection within 5 hours after symptom onset, had an acceptable safety and efficacious profile in patients with acute ischemic stroke.
原文英語
頁(從 - 到)918-919
頁數2
期刊Stroke
37
發行號3
DOIs
出版狀態已發佈 - 三月 1 2006
對外發佈

ASJC Scopus subject areas

  • 神經病學(臨床)
  • 心臟病學與心血管醫學
  • 高級和專業護理

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