IPO-V2 - A PROSPECTIVE, MULTICENTER, RANDOMIZED, COMPARATIVE CLINICAL INVESTIGATION OF THE EFFECTS OF SULODEXIDE IN PREVENTING CARDIOVASCULAR ACCIDENTS IN THE 1ST YEAR AFTER ACUTE MYOCARDIAL-INFARCTION
IPO-V2 - A PROSPECTIVE, MULTICENTER, RANDOMIZED, COMPARATIVE CLINICAL INVESTIGATION OF THE EFFECTS OF SULODEXIDE IN PREVENTING CARDIOVASCULAR ACCIDENTS IN THE 1ST YEAR AFTER ACUTE MYOCARDIAL-INFARCTION
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DOI：
10.1016/0735-1097(94)90498-7
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发表时间：
1994-01-01
影响因子：
24
通讯作者：
BIGNAMINI, A
中科院分区：
文献类型：
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作者：
CONDORELLI, M;CHIARIELLO, M;BIGNAMINI, A
目标。本研究旨在评价具有抗血栓特性的糖胺多糖化合物舒洛地特预防急性心肌梗死后死亡和血栓栓塞症事件的效果。抗血栓治疗已被发现在预防急性心肌梗死后心血管事件和死亡方面发挥着重要作用。含有糖胺聚糖的化合物，包括舒洛地特，显示出纤溶和抗血栓的特性，使它们适合用于脑梗塞后的患者。总共3986名从急性心肌梗死中康复的患者被随机分为两组，一组接受每个研究中心常规实施的标准治疗，不包括抗血小板和抗凝药物(对照组，1,970名患者)，另一组接受标准治疗加舒洛地特治疗(治疗组，2,016名患者)。在急性心肌梗死发病后7~10d，给予舒洛地特每日1次肌肉注射600脂蛋白脂肪酶释放单位(LRU)，1个月后口服500LRU胶囊，每日2次。对患者进行大于或等于12个月的评估。研究结束时，对照组有140例死亡(7.1%)，舒洛地特组有97例死亡(4.8%)(风险降低32%，p=0.0022，卡方检验)。对照组中共有90名患者(4.6%)发生了进一步的脑梗塞，相比之下，舒洛地塞组有66名患者(3.3%)(风险降低28%)。P=0.035)。此外，与对照组(n=25；1.3%)(53%的风险降低，p=0.027)相比，舒洛地特组(n=12；0.6%)的左室血栓形成减少(超声心动图评估)。舒洛地特耐受性良好，无明显不良反应。所有有意义的结果都通过“实际治疗”分析得到了证实。这项研究提供的证据表明，在急性心肌梗死发作后早期开始使用舒洛地特的长期治疗与降低总死亡率、再梗死率和壁血栓形成有关。
Objectives. This study was conducted to assess the efficacy of sulodexide, a glycosaminoglycan compound with antithrombotic properties, in preventing death and thromboembolic events after acute myocardial infarction.Background. Antithrombotic therapy has been found to play an important role in the prevention of cardiovascular events and death after acute myocardial infarction. Glycosaminoglycan-containing compounds, including sulodexide, show profibrinolytic and antithrombotic properties that render them suitable for use in patients after infarction.Methods. A total of 3,986 patients who had recovered from acute myocardial infarction were randomized to receive either the standard therapy routinely administered at each study center, excluding antiplatelet and anticoagulant drugs (control group, 1,970 patients), or the standard therapy plus sulodexide (treated group, 2,016 patients). Between 7 and 10 days after the episode of acute myocardial infarction, sulodexide was administered as a single daily 600-lipoprotein-lipase-releasing unit (LRU) intramuscular injection for the 1st month, followed by oral capsules of 500 LRU twice daily. Patients were evaluated for greater-than-or-equal-to 12 months.Results. At the end of the study, 140 deaths (7.1%) were recorded in the control group and 97 (4.8%) in the sulodexide group (32% risk reduction, p = 0.0022, chi-square test). A total of 90 patients (4.6%) in the control group had a further infarction, compared with 66 (3.3%) in the sulodexide group (28% risk reduction. p = 0.035). Furthermore, a reduction in left ventricular thrombus formation (evaluated by echocardiography) was observed in the sulodexide group (n = 12; 0.6%), compared with values in the control group (n = 25; 1.3%) (53% risk reduction, p = 0.027). Sulodexide was well tolerated and devoid of significant adverse events. All significant results were confirmed by ''actual treatment'' analyses.Conclusions. The study provides evidence that long-term therapy with sulodexide started early after an episode of acute myocardial infarction is associated with reductions in total mortality, rate of reinfarction and mural thrombus formation.