基因重组链激酶静脉溶栓治疗急性心肌梗塞临床研究

Intravenous Thrombolysis in Patients with Acute Myocardial Infarction-Comparison of the Efficacy of Gene Recombined Streptokinase

对比分析国产基因重组链激酶和德国链激酶静脉溶栓治疗急性心肌梗塞（ＡＭＩ）的有效性和安全性。方法：１４３例ＡＭＩ患者接受静脉溶栓治疗，其中采用国产ｒＳＫ １５０万单位７３例，德国ＳＫ １５０万单位７０例。结果： ｒＳＫ和ＳＫ总的梗塞相关血管开通率分别为７９．５％和７８．６％，发病≤ ６ｈ血管开通车两组分别为８７．０％和８６．５％，发病＞６ｈ≤１２ｈ血管开通率为５２．６％和５２．９％；住院５周病死率分别为５．５％和５．７％；轻度出血发生率为１６．４％和１４．３％；轻度过敏为５．５％和４．３％，无过敏性休克发生；低血压发生率分别为１１．０％和１７．１％。结论：国产ｒｓｋ １５０万单位与德国ＳＫ１５０万单位静脉溶栓治疗有相同的良好疗效与安全性。虽然有轻度出血，偶有低血压和轻度过敏，但不影响治疗与预后。国产ｒＳＫ的良好疗效和低廉价格更适合我国ＡＭＩ患者选用。

OBJECTIVE: To compare the efficacy and safety of China made gene recombined Streptokinase(rSK)and German made streptokinase(SK)in the treatment of acute myocardial infarction(AMI). METHODS: 143 patients were recruited in the study. 73 patients received rsk 1500 000u and 70 patients received SK 1 500 000u. RESULTS : The total patency rate was 79.5%, 78.6% in the rSK group and in the SK group. In tow groups, the patency rate was 87.0%, 86.5% in ≤ 6 hours after onset of symptom and 52.6%, 52.9% in > 6 hours ≤ 12 hours after onset of symptom; 5 weeks' mortality was 5.5%, 5.7% respectively in the rSK group and SK group, Mild bleeding and allergy occurred in 16.4%, 5.5% in the rSK group, and 14.3%, 4.3 in the SK group; Hypotension occurred in 11 .0% and 17. 1 % of patients in the rSK group and SK group. These adverse effects did not influence the therapy and prognosis. CONCLUSION. China made rSK 1 500 000u and German made SK 1 500 000u has the same good efficacy and safety on the AMI patients. The low cost of China made rSK may be more preferable for the AMI patients of our county.