小剂量rt-PA静脉溶栓治疗急性脑梗死临床分析

Clinical analysis of intravenous thrombolysis therapy in acute cerebral infarction with low-dose of rt-PA

目的美国及欧洲缺血性脑卒中治疗指南建议0.9mg.kg-1为重组组织型纤维酶原激活剂(rt-PA)静脉溶栓标准治疗剂量。鉴于国人尤其是我国南方人在种族、体质及脑梗死危险因素等方面的不同,也按0.9mg.kg-1国际标准剂量治疗是否完全适合,有很大争议。本试验比较小剂量rt-PA 0.7mg.kg-1与0.9mg.kg-1标准剂量治疗急性脑梗死的疗效、安全性及预后。方法 28例急性脑梗死患者,发病时间窗为4.5h内,具有溶栓指征,无溶栓禁忌症。随机分为小剂量组rt-PA(0.7mg.kg-1,最高剂量50mg)和对照组(0.9mg.kg-1,最高剂量90mg)。比较两组治疗前、治疗后24h及14d的NIHSS评分,颅内出血率、死亡率以及90d mRS评分。结果两组治疗前的基本临床资料比较差异无统计学意义。各组均能有效改善神经功能,各组治疗后NIHSS评分与治疗前相比有显著差异。但治疗后24h及14d时两组比较差异无统计学意义。两组90d mRS评分比较差异无统计学意义。小剂量0.7mg.kg-1组颅内出血发生率为7.1%,0.9mg.kg-1组为14.3%,两组比较差异无统计学意义。0.9mg.kg-1组死亡1例,小剂量组无死亡病例,两组死亡率比较差异无统计学意义。结论 rt-PA静脉溶栓0.7mg.kg-1剂量安全有效,该剂量可能更适合国人,尤其是南方人。

Objective Guidelines for the management with ischemic stroke from the American Heart Association/American Stroke Association（AHA/ASA） and the European Stroke Organization （ESO） recommended 0.9mg .kg-1 IV rt-PA in intravenous thrombolysis treatment for acute infarction stroke. As the differences in human species, physical and the risk factors of cerebral infarction, especially for the southerners in our country, whether the 0.9mg . kg-1 IV rt-PA was perfectly suitable had been much controversy. To analyze the efficacy, safety and prognosis in the trials were compared 0.7mg. kg-1 IV rt-PA with 0.9mg . kg-1 IV rt-PA. Methods 28 patients were randomly assigned in our study, the stroke onset time was Less than 4.5 hours. The indications for intravenous thrombolysis therapy were clear to 28 patients, without contraindications to thrombolysis therapy. The patients were randomly divided into low-dose group with 0.7mg . kg-1 and control group with 0.9mg . kg-1. To compare between two groups the NIHSS score at 24 hours , 14 day and mRS score at day 90. The intracerebral hemorrhage and mortality were also be compared. Results The two groups were well matched on baseline characteristics. Two groups could be effective in improving neurological function, two groups 24 hours after treatment and 14 day NIHSS score compared with the pre-treatment significantly differences, but within 24 hours after treatment and 14 day after the two groups showed no significant differences. The incidence of the intracerebral hemorrhage from low-dose group and control group was respectively 7.1% and 14.3%. The mortality rate of two groups was no significant difference. Conclusion 0.7mg . kg-1 IV rt-PA is safe and effective in thrombolysis treatment for acute inchemic stroke, and 0.7mg .kg-1 dose may be suitable for Chinese, especially for the southerners in our country.