摘要
目的比较尿激酶原和尿激酶溶栓后的开通率和安全性。方法采用随机、单盲、阳性药对照多中心临床试验。尿激酶原用量为50mg(n=110)和60mg(n=115),尿激酶用量150万U(n=103)。用冠脉造影观察溶栓后90min梗死相关冠状动脉的开通率,并检测患者的各项体征和生化指标,观察14天内病死率、颅内出血率及其他不良反应。结果溶栓后90min,尿激酶原50mg组的TIMI 2+3级开通率为78.50%,TIMI 3级为60.75%;60mg组分别为72.73%和56.36%,均高于尿激酶的开通率51.58%和36.84%,具有显著的统计学差异。50mg组和60mg组之间比较则无统计学差异。同时证明尿激酶原在病死率、颅内出血率及其他不良反应方面均好于尿激酶。结论尿激酶原溶栓后的冠脉开通率和安全性均优于尿激酶,是一种更为理想的溶栓新药。
Objective To compare the efficacy and safety of prourokinase and urokinase on acute myocardial infarction. Methods Totally 328 patients of acute myocardial infarction with symptoms of ST - segment elevation entered the study and randomized to receive prourokinase （50rag, n = 110 ） , （60rag, n = 115 ） or urokinase （ 1.5 x 106U, n = 103 ）. The patency of infarct related coronary ar- tery at 90 min after administration of thrombolytic agents was assessed by coronary angiography. The adverse reaction was also observed by measuring all kind of physical signs and blood, urine biochemical parameters. Results The patency of coronary artery in the prouroki- nase 50rag group was 78.50% （TIMI 2 ＋ 3） and 60.75% （TIMI 3） , in 60mg group was 72.73% and 56.36% respectively. Both of them were higher in the patency than that of the urokinase group（51.56% and 36.84% , respectively）. Safety data including mortality up to 14 days, intracranial hemorrhage and other adverse reaction also showed that security of prourokinase groups were better than the uroki- nase ~roup. Conclusion As an thrombolvtic a^ent. Drourokinase is more effective and safe.
出处
《医学研究杂志》
2013年第10期26-31,共6页
Journal of Medical Research
基金
国家"863"基金资助项目(2004AA2Z3850)
作者简介
尿激酶原临床试验协作组（由李天德肖成祖刘锐刘丽凤整理） 通讯作者：李天德，电子信箱：tedli301@yahoo．com．cn
肖成祖，电子信箱：xiaocz61@yahoo．com．cn
