Post-licensed 1-year experience of systemic thrombolysis with tissue plasminogen activator for ischemic stroke in a Japanese neuro-unit
Introduction
In Japan, according to the results of an open clinical trial [1], intravenous thrombolysis with tissue plasminogen activator (tPA) for ischemic stroke within 3 h of onset was officially approved in October, 2005. The dose of alteplase has been set at 0.6 mg/kg in Japan [1], whereas it has been set at 0.9 mg/kg internationally [2], [3]. We herein report a post-approval initial year clinical experience of intravenous alteplase in a Japanese neuro-unit.
Section snippets
Methods
Our hospital with 340 beds has two divisions of a tertiary emergency section (Hyogo Emergency Medical Center) and a secondary emergency and outpatient clinic section (Kobe Red Cross Hospital). Kobe city has about one and half million inhabitants, and our hospital covers the central and eastern area of the Kobe city. According to an official approval of tPA for ischemic stroke on October 11, 2005, we initiated to offer intravenous tPA in patients with ischemic stroke within 3 h of onset on
Results
During the 12-month period, 166 patients with ischemic stroke within 7 days of onset were hospitalized. Of those, 122 (73%) patients arrived within 24 h of onset and 52 (31%) patients arrived within 3 h. Finally, 20 patients received tPA, corresponding to 12% of all ischemic strokes and 38% of ischemic strokes within 3 h of onset.
The mean age was 68 years old, of whom 4 (20%) patients were over 80 years old (Table 1). Six patients (30%) had pre-morbid disability, 3 (15%) of whom had been dependent
Discussion
In Japan, dose of alteplase in ischemic stroke has been set at 0.6 mg/kg, because previous clinical trials with different type of tPA (duteplase) in ischemic stroke and coronary thrombolysis with alteplase in Japan have shown similar efficacy and safety at nearly two thirds of tPA dose for the international guidelines [1].
In this study, the proportion of excellent outcome (mRS = 0, 1) at 3 months was 25%, which was lower than 37% in the Japanese tPA trial [1] and 39% in the NINDS trial [2] with
Acknowledgments
We would thank all staffs in the emergency department for their help.
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