静脉低剂量重组组织型纤溶酶原激活物治疗短暂性脑缺血发作的临床对照研究

A Clinical Controlled Study of Intravenous Low Dose Recombinant Tissue Plasminogen Activator(rt-PA)Treatment for Patients with Transient Ischemic Attack(TIA)

目的观察短暂性脑缺血发作(TIA)患者采用静脉低剂量重组组织型纤溶酶原激活物(rt-PA)治疗后血浆t-PA、PAI-1在不同时间点的变化特点,评价其疗效及安全性。方法纳入试验的TIA住院患者42例,根据患者是否接受静脉低剂量rt-PA治疗分为rt-PA治疗组和阿司匹林对照组(每组21人),治疗组患者入院第1 d、2 d、3 d给予rt-PA 20 mg,静滴,1次/d,3 d后改为阿司匹林100 mg,口服,1次/d;对照组患者入院后即给予阿司匹林100 mg,口服,1次/d。两组患者均住院观察2周,有卒中危险因素者给予相应治疗。结果(1)治疗组与对照组患者血浆t-PA水平均高于正常,但治疗组患者的t-PA在第1 d和第3 d明显高于入院时水平和对照组,差别均有显著性意义(P＜0．05);治疗组与对照组血浆PAI-1水平间差别无显著性意义,但均高于正常水平。(2)治疗组患者第1 d TIA发作控制率为80．96%,对照组为66．67%。治疗组有效控制率为95．24%,对照组为90．48%。(3)治疗组未见主要不良事件发生。结论(1)静脉低剂量rt-PA治疗TIA可有效提高纤溶系统活性,抑制血栓形成;(2)静脉应用低剂量rt-PA是控制TIA急性发作的有效方法之一,且起效快、副作用小、安全性高。

Objective To observe the characteristics of plasma tPA and PAI-1 in patients with TIA,and to assess the clinical efficacy and safety of intravenous low-dose recombinant tissue plasminogen activator (rt-PA) treatment for TIA. Methods The study included 42 subjects with TIA who was excluded intracranial hemorrhage by computer tomography (CT) and new cerebral infarction by magnetic resonance imaging (MRI).The subjects were divided into rt-PA treatment and aspirin con- trol groups,according to receiving rt-PA therapy or not.The subjects'sex and age matched.In treatment group rt-PA 20mg was adopted once daily in first 3d and aspirin was used 100mg once daily after 3d;in control group,aspirin 100mg was applied once daily at the beginning of admission.All subjects were observed for 2 weeks in hospital,then regularly secondary preventions were administrated.Results (1) Plasma level of tPA was higher than normal value in both groups,and plasma tPA level in treatment group at 1d and 3d was significantly higher than control and start point (P＜0.05).There was no significant differ- ence in plasma level of PAI-1 between the 2 groups,but both higher than normal value.(2) 95.24% of TIA patients returned to their normal status in hospitalization after administration of low-dose rt-PA.Among of them,80.96% of the patients re- covered to normal only on first day.In control cases,the above rates were 90.48% and 66.67%,respectively.(3) No major adverse events were observed in the treatment group compared with the control group.Conclusion (1) Applying intravenous low-dose rt-PA may raise effectively fibrinolytic system activity.(2) Our findings show that intravenous low-dose rt-PA is efficient and safe for the treatment of TIA.