人尿激肽原酶对高危非致残性缺血性脑血管事件的临床疗效

Efficacy of human urinary kallidinogenase in treating the patients with high risk non-disabling ischemic cerebrovascular events

目的观察人尿激肽原酶与阿司匹林、氯吡格雷双抗血小板在降低高危非致残性缺血性脑血管事件(HR-NICE)患者90d内出现缺血性卒中风险的作用。方法 HR-NICE患者305例随机分为两组,分别采用单纯双抗治疗(A组,156例)和双抗联合人尿激肽原酶治疗(B组,149例),观察其90d内主要终点事件(新发缺血性卒中)和次要终点事件(短暂性脑缺血发作、心肌梗死或血管性死亡)的发生情况。检测治疗前后凝血功能[凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)和纤维蛋白原(Fib)]变化。结果B组患者主要终点事件发生率低于A组(7.4%vs.16.0%)(P<0.05),两组次要终点事件发生率相仿(3.4%vs.7.4%)(P>0.05)。两组患者治疗前后PT、APTT和Fib均无明显变化(P>0.05)。149例高血压患者在应用人尿激肽原酶治疗期间血压无明显波动(P>0.05)。结论与单纯双抗治疗比较,双抗血小板联合人尿激肽原酶治疗能有效地降低HR-NICE患者新发缺血性卒中事件的发生,且不影响患者凝血功能和血压。

Objective To observe the efficacy and safety of human urinary kallidinogenase （HUK） and dual antiplatelets with aspirin and clopidogrel to reduce the ischemic stroke crisis in the patients with high risk non-disabling ischemic cerebrovascular events （HR-NICE） within 90 days. Methods Three hundred and five patients with HR-NICE were randomly assigned into two groups of A（treated with dual antiplatelets, 156 cases） and B（treated with dual antiplatelets and HUK, 149 cases）. The incidences of primary end point events （new ischemic stroke） and secondary end point events（transient ischemic attack, myocardial infarction and vascular death） were observed within 90 days. The changes of coagulation indicators including prothrombin time （PT）, activated partial thromboplastin time（APTT） and fibrinogen（Fib） were detected before and after treatment. Results The incidence of primary end point events was lower in group B than that in group A（7. 4%vs. 16.0%） （P〈0. 05） ,while the incidence of secondary end point events in group B was not significantly different from that in group A（3.4%vs. 7.4%） （P〉0. 05）. The PT, APTT and Fib in both groups were not significantly changed before and after treatment（P〉0. 05）. The blood pressure was stable during HUK treatment in 149 patients with hypertension（P〉0. 05）. Conclusion Compared to dual antiplatelets therapy, combined use of dual antiplatelets and HUK can reduce the incidence of new ischemic stroke without effects on the coagulation function or blood pressure in the patients with HR-NICE.