| Along with the development of thrombolytic drugs and the study of some large scale clinical trials, some new thromblytic drugs and novel therapy are clinically used either domestic or abroad. As a mutant of tPA, RhTNK-tPA has long half-life time, and it is allowed to impulsingly administer intravenous. Moreover, its fibrin specificity is elevated 14 times and 80 times increasing in the resistance to PAI-I. As far as its side effect of thrombus, this is lesser than any other plasminogen activator. As a matter of fact, the congener products have attained validation of FDA to use in STEMI patients. So we can see the potential clinic value of this product. This study is main to estimate the therapeutic effect and safety in STEMI patients treated with rhTNK-tPA and offer the evidence for the clinical application of this product. 41 patients who had diagnosed first time AMI without taboo of thrombolysis according to the ACC/AHA criteria were randomized to rhTNK-tPA group (20 cases) and rt-PA group (21 cases), were intravenously injected with rhTNK-tPA and rt-PA for thrombolysis respectively. After assignment to rhTNK-tPA group, 20mg rhTNK-tPA diluted up to 3ml with sterile water for injection before administration, bolus for 5 to 10 seconds, followed by an infusion of 2ml sterile water. While in rt-PA group, 50mg rt-PA diluted up to 50ml with sterile water, first 8ml bolus, then 42ml pumped in a90min period. Before doing these, patients were administered impulsing dose of heparin intravenous (70IU/kg, total amount is less than 5000IU). The patients who didn't get PCI in 90min, were pumped heparin intravenous 15min after thrombolysis with the speed of 1000IU/h for 24h persistently. We adjusted the dosage of heparin to keep APTT between 50 to 70 seconds. When it reached to 1200IU/h and still couldn't keep APTT to that range, we did not increase the dosage and check APTT in 6h, 12h, 18h and 24h. Heparin should be stopped when there is obvious bleeding or suspect of hemorrhagic apoplexy and/or bleeding in the puncture vessels. As for the patients with PCI in 90min, heparin was given due to their condition during the operation and adjusted it according to APTT, not more than 5000IU in total and stopped after operation. Sheathing canal was pulled out 4h later. Patients should take Asp 300mg and clopidogrel 300mg, before thrombolysis, clopidogrel 75mg/d after that and Asp 100mg/d three days later. CAG were performed at 90 min of thrombolysis, IRA flow was evaluated by TIMI grades. However, for the patients who didn't perform CAG, IRA flow was evaluated through the decline of ST, the peak of creatase, the relief of pain and the reperfusion arrhythmia. Adverse events and acute complications were recorded during 30 days after thrombolysis. There was no significant difference about sex, age, diastolic blood pressure, heart rate and coronary heart disease risk factors between two groups. TheIRA repatency rate in rhTNK-tPA group is higher than that in rt-PA group (80.0%VS76.2%, P>0.05), but no statistic significance. 7 patients in each group were performed CAG, TIMI 0 flow (28.6%vs28.6%, P>0.05), TIMI 1flow (0.0%vs0.0%, P>0.05), TIMI 2flow (14.3%vs28.6%, P>0.05), TIMI 3flow (57.1%vs42.9%, P>0.05), but the differences did not reach statistical significance. No intracranial hemorrhage patients were seen in rhTNK-tPA group, while 1 patient died of this in rt-PA group (14.3%), P>0.05, no statistic significance between these two groups. In rhTNK-tPA group there are a little more cases with bleeding in other places than in rt-PA group (25.0%VS19.0%, P>0.05), but no statistic difference either. Between these two groups, whether slight complications (25.0% VS 19.0%, P>0.05), or midrange complications (5.0% VS 0.0%, P>0.05), or severe complications (0.0% VS 4.8%, P>0.05), there is no difference in statistic significance. The complications including allergic reaction, persistence hypotension, severe and unexpected complications were not seen in these cases. There is no difference of statistic significance in these two groups in cardiac failure (15% VS 19%, P>0.05) and postinfarction angina pectoris (10.0% VS 14.3%, P>0.05). No cardiac shock was occurred in each group. The result showed that rhTNK-tPA (20mg) is effective, safe and convenient in the therapy of thrombolysis intravenous, while with the adjunctive therapy of clopidogrel, Asp and satis quantum heparin. Due to limitedsamples in this research, we still need to find more evidence of the effect and safety of rhTNK-tPA in the thrombolysis for expanding its clinical application by large scale and multicentre clinical control study.
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