重组人尿激酶原治疗急性ST段抬高性心肌梗死的多中心Ⅲ期临床试验  

Multicenter Phase Ⅲ Study of Recombinant Prourokinase for Acute Myocardial Infarction with ST-segment Elvation

作　　者：尿激酶原临床试验协作组 李天德[1] 肖成祖[2] 刘锐 刘丽凤 

机构地区：[1]解放军总医院 [2]军事医学科学院生物工程研究所 [3]上海天士力药业有限公司

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)

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.

关 键 词：尿激酶原尿激酶冠脉开通率安全性 Ⅲ期临床试验 

分 类 号：R972[医药卫生—药品]