比较替奈普酶与阿替普酶治疗发病4.5 h内急性缺血性卒中患者的疗效和安全性研究

To Compare the Efficacy and Safety of Teneplase and Alteplase in the Treatment of Acute Ischemic Stroke within 4.5 h

目的:比较替奈普酶与阿替普酶治疗发病4.5小时内的急性缺血性卒中患者的疗效和安全性。方法:将54例AIS患者按照溶栓药物不同分为对照组和观察组。对照组患者采用0.9 mg/kg阿替普酶(最大量 ≦ 90 mg),初始10%静脉注射,其余90%静脉滴注≦1 h。观察组患者采用0.25 mg/kg替奈普酶(最大量 ≦ 25 mg),5~10 s静脉注射。观察两组患者溶栓后90天时mRS0-2分的比例,24 h、7天时NIHSS评分改善情况,90天时mRS变化情况、90天脑卒中复发率等;以及36小时内症状性颅内出血、任何颅内出血、其他严重的副作用的发生率及90天死亡率。结果:观察组患者24 h NIHSS评分下降 ≥ 4分比例(46.20%)、7天NIHSS评分下降 ≥ 4分比例(68.00%)、90天mRS评分 ≤ 2分比例(92.00%)均高于对照组患者24 h NIHSS评分下降 ≥ 4分的比例(32.10%)、7天NIHSS评分下降 ≥ 4分比例(57.10%)、90天mRS评分 ≤ 2分比例(88.90%),但差异均没有统计学意义(P > 0.05)。两组患者90天均无复发AIS。观察组患者的90天死亡率、36 h症状性颅内出血、36 h任何颅内出血、36 h其他严重副作用与对照组差异没有统计学意义(P > 0.05)。结论:替奈普酶与阿替普酶溶栓治疗发病4.5 h内的AIS患者的疗效和安全性相似,临床可权衡使用TNK。

Objective: To compare the efficacy and safety of teneplase and alteplase in the treatment of acute ischemic stroke patients within 4.5 hours of onset. Methods: Fifty-four AIS patients were divided into control group and observation group according to different thrombolytic drugs. Control group was treated with 0.9 mg/kg alteplase (maximum quantity ≦ 90 mg), the initial 10% was injected intravenously, and the remaining 90% was injected intravenously ≦ 1 h. Observation group received 0.25 mg/kg teneplase (maximum quantity ≦ 25 mg), 5~10 s intravenous injection. The proportion of mRS0-2 score at 90 days after thrombolysis, the improvement of NIHSS score at 24 hours and 7 days, the change of mRS At 90 days, and the recurrence rate of stroke at 90 days were observed in the two groups, and the incidence of symptomatic intracranial hemorrhage within 36 hours, any intracranial hemorrhage, other serious side effects, and 90-day mortality. Results: The proportion of 24 h NIHSS score decreased by ≥4 points (46.20%), the proportion of 7-day NIHSS score decreased by ≥4 points (68.00%), and the proportion of 90-day mRS Score ≤2 points (92.00%) in observation group were higher than those in control group, the proportion of 24 h NIHSS score decreased by ≥4 points (32.10%) and the proportion of 7-day NIHSSThe proportion of scores decreased by ≥4 points (57.10%), and the proportion of 90-day mRS Scores ≤2 points (88.90%), but the differences were not statistically significant (P > 0.05). No AIS recurred in both groups at 90 days. The 90-day mortality, symptomatic intracranial hemorrhage at 36h, any intracranial hemorrhage at 36 h, and other serious side effects at 36 h in observation group were not significantly different from those in control group (P > 0.05). Conclusions: The efficacy and safety of teneplase and alteplase thrombolytic therapy in AIS patients within 4.5 h of onset are similar, and TNK can be used clinically.