Spiecker M, Windeler J, Vermeer F, Michels R, Seabra-Gomes R, vom Dahl J, Kerber S, Verheugt F W, Westerhof P W, Bär F W, Nixdorff U, Barth H, Hopkins G R, von Fisenne M J, Meyer J
Department of Cardiology, University of Mainz, Germany.
Am Heart J. 1999 Sep;138(3 Pt 1):518-24. doi: 10.1016/s0002-8703(99)70155-9.
Short-term safety and efficacy of thrombolysis with saruplase in acute myocardial infarction have been shown in several trials. To assess long-term outcome of patients treated with saruplase or streptokinase for myocardial infarction, a 5-year follow-up of patients included in the Pro-Urokinase in Myocardial Infarction Trial was performed.
Follow-up data are available from 8 centers on 255 (92.4%) of 276 included patients. The 5-year mortality rate was comparable with 20.8% of patients in the saruplase group and 16.9% in the streptokinase group (odds ratio 1.29, 95% confidence interval 0.69 to 2.42). In both groups, a considerable number of fatal cardiovascular events occurred more than 1 year after study inclusion. Rates of percutaneous transluminal coronary angioplasty and coronary artery bypass grafting were comparable in both groups. Reinfarction within 5 years occurred in 19.0% of patients in the saruplase group and tended to be less frequent at 10.8% after streptokinase treatment (odds ratio 1.94, 95% confidence interval 0.98 to 3.84). In both groups, the majority of reinfarctions took place more than 3 months after study inclusion. The 5-year stroke rate was 3.6% and 7.2% in the saruplase and streptokinase groups, respectively (odds ratio 0.49, 95% confidence interval 0.16 to 1.47). Subjective symptoms of heart failure and angina pectoris were comparable in both groups.
Our data are consistent with a similar long-term outcome for patients treated with saruplase or streptokinase. Despite the low-risk profile of the patient cohort, there were considerable adverse event rates over a 5-year period.
多项试验已表明，沙芦普酶溶栓治疗急性心肌梗死的短期安全性和有效性。为评估沙芦普酶或链激酶治疗心肌梗死患者的长期预后，对心肌梗死尿激酶原试验纳入的患者进行了5年随访。
来自8个中心的随访数据涉及276例纳入患者中的255例（92.4%）。5年死亡率在沙芦普酶组为20.8%，链激酶组为16.9%，二者相当（比值比1.29，95%置信区间0.69至2.42）。在两组中，相当数量的致命心血管事件发生在研究纳入1年之后。两组经皮腔内冠状动脉成形术和冠状动脉旁路移植术的发生率相当。沙芦普酶组5年内再梗死发生率为19.0%，链激酶治疗后为10.8%，后者发生率较低（比值比1.94，95%置信区间0.98至3.84）。在两组中，大多数再梗死发生在研究纳入3个月之后。沙芦普酶组和链激酶组的5年卒中发生率分别为3.6%和7.2%（比值比0.49，95%置信区间0.16至1.47）。两组心力衰竭和心绞痛的主观症状相当。
我们的数据表明，沙芦普酶或链激酶治疗的患者长期预后相似。尽管患者队列风险较低，但在5年期间仍有相当高的不良事件发生率。
