Intravenous thrombolytic therapy for acute ischemic stroke (A pilot study in China)
Objective: This paper is the results of an open clinical trial, and also a pilot study of a 5-year National Project “Clinical study of thrombolytic therapy for iscbemic stroke within 6 hours of onset” (19962000). The purpose of this pilot study is to evaluate the efficacy and safety of intravenously administered thrombolytic therapy for isehemic stroke (mostly within 6 hours and partly within 12 hours of onset), using urokinase, produced by Tian Pu Pharmaceutical Company, China. The second phase of this clinical trial, a multicenter, randomized, double blind, placebo-controlled study will be finished by the end of the year 2000.Patients and Methods: The inclusion criteria of this study included 1. The age was between 35 and 80. 2. The time window should be controlled within 6 hours from the onset. If it was an evolved stroke, the consciousness of the patient was clear or only mild drowsy, and the CT scan didn”t show any low density area, the time window could be controlled within 12 houri. 3. The clinical features indicated a carotid territory stroke. 4. CT scan demonstrated no intracranial bleeding or low density area, not including the old lacunes not related to this stroke. 5. The blood pressure should be controlled under 180/100 mmHg. 6 The consciousness of the patient should be clear, or mild drowsy. 7. The severity of the paralytic limbs was between 0 and 3 degrees (with a scale of 0～5degree). 8. An informed consent was required.The patients were assigned to receive the treatment with urokinase (UK) 1.0-l.5million U given over 30 minutes. After UK infusion, 500 ml of low molecular weight dextran will be continued daily for l0 days. 24h after UK infusion, 300 mg aspirin daily will be administered for 10days, andthen l00mgof aspirin daily for 80 days. The neurological deficit was measured by European Stroke Scale (ESS) and was recorded before therapy and at 2h, ld, 3d, 7d, 14d, 30d, and 90d after therapy. Results: The results revealed that 409 cases were recruited into this study. 259 cases (52.64%) were treated within 6 hours of stroke. The mean UK dosage was 1.31 million U. The ESS scores increased rapidly after therapy. The ESS scores increased ＞ 10 in 87.53% of patients within 24 hours after therapy and increased more rapidly m patients treated within 3h than within 3-6h. The ESS score reached ＞ 95 in 46.67% of patients at 90 d after therapy. In our study, 60 cases (14.67%) developed paralysis again after a short period of recovery after therapy, in which 46 crees (76.67%) recurred within 36h after therapy. According to the calculation of Cox ratio model, the risk value of the recurrence of paralysis m patients treated with UK after 6h from the onset of stroke was 1.92 times of patients treated within 6h of stroke. 19 cases (4.65%) deveoped non-symptomatic cerebral hemorrhage, and 16 cases (3.91%) developed symptomatic cerebral hemorrhage. The mortality rate was 12.22% (50/409), in which, 26/409 cases (6.35%) died of large cerebral infarctions and 8/409 cases (1.90%) died of cerebral hemorrhages. Conclusion: We found that the results from this study are favonrable to the thrombolytic therapy with UK according to our protocol (carefully selected patients, especially the time window, the earlier the better, and well controlled blood pressure). The benefit persists over the long term (3 months). The results will be further confirmed by the second phase of the study, the randomized, double-blind, placebo controlled study.
ischemic stroke、thrombolytic therapy、cerebral hemorrhage、time window、clinical trial、blood pressure、pilot study、low density、neurological deficit、low molecular weight、cerebral infarctions、clinical features、mortality rate、CT scan
8
R74;R24
2005-07-07（万方平台首次上网日期，不代表论文的发表时间）
共1页
16
