低剂量rt-PA联合尿激酶静脉溶栓治疗早期急性脑梗死的疗效及安全性评价

目的评价低剂量重组组织型纤溶酶原激活剂(rt-PA)联合尿激酶静脉溶栓治疗对发病6h内急性脑梗死的疗效和安全性。方法选择发病6h内的急性脑梗死患者161例,其中联合溶栓组(A组)44例、单用rt-PA组(B组)37例、单用尿激酶组(C组)32例、对照组(D组)48例。评价4组治疗后28d的疗效,包括神经功能缺损评分(NIHSS)及日常生活能力指数(Barthel),同时观察再梗死率、脑出血发生率及病死率。结果 3个溶栓组与D组在28d有效率及疗效满意率的差异均有统计学意义(P0.01);3个溶栓组之间28d有效率及疗效满意率的差异无统计学意义(P0.05)。4组再发脑梗死率、病死率及非症状性脑出血率的差异无统计学意义(P0.05)。4组脑出血(症状性脑出血+非症状性脑出血)发生率分别为9.0%、27.0%、28.1%、4.2%,A与D组之间差异无统计学意义,A与B、A与C、B与D、C与D组比较差异有统计学意义(P0.05)。结论联合溶栓治疗急性脑梗死远期疗效和单用rt-PA组、单用尿激酶相当,但脑出血发生率低于两组,因此该治疗方法是安全有效的,值得推广应用。

Combined thrombolytic therapy with low-dose recombinant tissue plasminogen activator and urokinase for patients with acute cerebral infarction within 6 hours of onset

Objective To evaluate the efficacy and safety of combined thrombolytic therapy with recombinant tissue plasminogen activator(rt-PA) and urokinase(UK) of patients with acute cerebral infarction within 6 hours of onset. Methods One hundred and sixty-one patients with acute cerebral infarction (<6 hours from onset) were recruited and randomly allocated into 4 groups:combined thrombolysis group (A group)which included 44 patients,the rt-PA group (B group) included 37 patients,the UK group (C group)included 32 patients,and control group (D group)included 48 subjects. The outcome scores were evaluated according to the National Institute of Heath Stroke Scale (NIHSS) and Barthel index before treatment and 28 days after symptom onset,and the hemorrhagic transformation,recurrent infarction and death as the safety indicators were evaluated. Results There were significant differences in efficacy and satisfactory outcome rate between 3 thrombolysis groups and control group at 28 days (P < 0.01). There were no significant differences in the efficacy and satisfactory outcome rate in 3 thrombolysis groups among the 28 days (P > 0.05). There were no significant differences in stroke recurrence rate, mortality and non-symptomatic intracerebral hemorrhage rate (P > 0.05) in 4 groups. The incidence of cerebral hemorrhage (symptomatic and non-symptomatic intracerebral hemorrhage) in each group was 9.0%, 27.0%, 28.1%, 4.2% respectively. There were no significant differences between A and D group (P > 0.05). There were significant differences compared with A and B, A and C, B and D, C and D (P < 0.05). Conclusions The efficacy of combined thrombolytic therapy is noninferior to rt-PA alone or urokinase alone for the treatment of acute cerebral infarction, but the incidence of cerebral hemorrhage is lower than that of the other two groups, so the combined thrombolytic therapy is safe and effective.