Safety and efficacy of low-dose recombinant tissue plasminogen activator in Chinese patients with acute ischemic stroke
10.3760/cma.j.issn.1673-4165.2015.08.003
- VernacularTitle:小剂量重组组织型纤溶酶原激活剂在中国急性缺血性卒中患者中的安全性和有效性
- Author:
Yueming TIAN
;
Xu TONG
;
Yibin CAO
;
Jinghua LIU
;
Nan SHI
- Publication Type:Journal Article
- Keywords:
Stroke;
Brain Ischemia;
Thrombolytic Therapy;
Tissue Plasminogen Activator;
Infusions,Intravenous;
Treatment Outcome;
Dose-Response Relationship,Drug
- From:
International Journal of Cerebrovascular Diseases
2015;(8):588-592
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the safety and efficacy of low-dose recombinant tissue plasminogen activator (rtPA) in Chinese patients with acute ischemic stroke. Methods Consecutive patients with acute ischemic stroke received rtPA intravenous thrombolysis within 4. 5 h after symptom onset were enrol ed retrospectively. According to the dosage of rtPA, they were divided into either a low-dose group (0. 5-0. 8 mg/kg, the maximum dose 50 mg) or a standard dose group (0. 9 mg/kg, the maximum dose 90 mg). The incidences of symptomatic intracranial hemorrhage ( sICH) ( the National Institute of Neurological Disorders and Stroke [NINDS], and European Cooperative Acute Stroke Study Ⅱ [ECASSⅡ] , European Safe Implementation of Thrombolysis in Stroke-Monitoring Study [ SITS-MOST ] ), 90 d mortality, 90 d good outcome (the modified Rankin Scale [mRS] score 0-1), and life self-care ability (mRS score 0-2) were compared between the two groups. Results A total of 163 patients were enrol ed, including 74 patients in the low-dose group and 89 in the standard dose group. The constituent ratios of hypertension (44. 6% vs. 68. 5%; χ2 =9. 490, P=0. 002) and diabetes (5. 4% vs. 28. 1%; χ2 =14. 216, P<0. 001) in the patients of the low-dose group were significantly lower than those of the standard group, while the constituent ratios of smoking (56. 8% vs. 38. 2%; χ2 =5. 590, P=0. 018 ) and smal artery occlusive stroke (21. 6% vs. 10. 1%; χ2 =4. 122, P=0. 042 ) in patients of the low-dose group were significantly higher than those of the standard group. After adjusting for age, National Institutes of Health Stroke Scale (NIHSS) score, hypertension, diabetes, smoking, and ischemic stroke typing, multivariate binary logistic analysis showed that there were no significant differences in NINDS defined sICH (10. 8% vs. 9. 0%, odds ratio [OR] 1. 077, 95%confidence interval [CI] 0. 338-3. 436), ECASS Ⅱdefined sICH ( 9. 5% vs. 9. 0%; OR 0. 976, 95% CI 0. 296- 3. 221 ), SITS-MOST defined sICH (8. 1% vs. 4. 5%; OR 2. 269, 95% CI 0. 522-9. 852), 90 d mortality (17. 6% vs. 14. 6%; OR 1. 720, 95% CI 0. 578-5. 119), 90 d good outcome (35. 1% vs. 32. 6%;OR 0. 780, 95% CI 0. 356-1. 709), and life self-care ability (48. 6% vs. 42. 7%;OR 0. 936, 95% CI 0. 441-1. 987) between the 2 groups (al P>0. 05). Conclusions The program of intravenous thrombolysis for the treatment of Chinese patients with acute ischemic stroke with low-dose rtPA is safe and effective.
