title: Post-licensed 1-year experience of systemic thrombolysis with tissue plasminogen activator for ischemic stroke in a Japanese neuro-unit.
abstract: OBJECTIVE
  In Japan, intravenous thrombolysis with tissue plasminogen activator (tPA) for ischemic stroke within 3h of onset was officially approved in October 2005.
  
  
  METHODS
  We report initial 1-year clinical experience of intravenous alteplase at 0.6mg/kg in a Japanese neuro-unit.
  
  
  RESULTS
  Twenty patients received intravenous tPA, corresponding to 12% of all ischemic strokes (n=166) and 38% of ischemic strokes within 3h of onset (n=52). The mean age was 68 years old and 15% had pre-morbid dependency with modified Rankin Scale (mRS) of 3 or 4. The median baseline National Institute of Health Stroke Scale score was 19 points (range; 5-37). Average time from stroke onset to tPA delivery was 136 min (range; 87-180). Of 18 (90%) patients receiving pretreatment vascular imaging, 16 (80%) patients had a large arterial occlusion. At 3 months, excellent outcome with mRS of 0 or 1 was 25%, and good outcome with mRS of 0-2 was 35%. One patient (5%) developed symptomatic intracranial hemorrhage within 36 h. Mortality rate was 15%.
  
  
  CONCLUSIONS
  Intravenous tPA within 3h was safe and feasible, and possibly effective in clinical practice. The higher stroke severity in our cohort precluded to compare the sufficient effectiveness with clinical trials. In Japan, a post-licensed national surveillance is currently under way.
authors.affiliation: Division of Neurology, Kobe Red Cross Hospital and Hyogo Emergency Medical Center, 1-3-1 Wakinohama Bay Street, Chuo Ward, Kobe 651-0073, Japan. y-yoneda@kobe.jrc.or.jp
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Yoneda
authors.forename: Shinji
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Yoshie
authors.initials: Y
authors.lastname: Hara
authors.forename: Kohei
authors.initials: K
authors.lastname: Ohta
authors.forename: Makoto
authors.initials: M
authors.lastname: Matsushita
authors.forename: Daisuke
authors.initials: D
authors.lastname: Yamamoto
authors.forename: Haruo
authors.initials: H
authors.lastname: Yamashita
authors.forename: Kohkichi
authors.initials: K
authors.lastname: Hosoda
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002544:Cerebral Infarction / Q000188:drug therapy* / Q000401:mortality; D004185:Disability Evaluation; D017277:Drug Approval; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D007564:Japan; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D012720:Severity of Illness Index; D016019:Survival Analysis; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator