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急性ST段抬高型心肌梗死溶栓治疗后使用普通肝素和低分子肝素。

Use of unfractionated heparin and a low-molecular-weight heparin following thrombolytic therapy for acute ST-segment elevation myocardial infarction.

作者信息

Wang Xu-Kai, Zhang Ye, Yang Cheng-Ming, Wang Yan, Liu Guang-Yao

机构信息

Daping Hospital, Third Military Medical University, Chongqing, China.

出版信息

Clin Drug Investig. 2006;26(6):341-9. doi: 10.2165/00044011-200626060-00005.

Abstract

BACKGROUND

Acute myocardial infarction (AMI) is one of the most serious cardiovascular diseases, with acute ST-segment elevation myocardial infarction (STEMI) showing a higher mortality rate than non-ST-segment elevation myocardial infarction (NSTEMI). There is evidence that low-molecular-weight heparin (LMWH) shows greater efficacy than unfractionated heparin (UFH). This open-label, single-centre, randomised study was conducted to compare the efficacy and safety of parnaparin sodium, a LMWH, with UFH in patients with STEMI.

PATIENTS AND METHODS

Patients with STEMI were randomised to receive either parnaparin sodium (4250IU aXa subcutaneously every 12 hours for 7 days, initiated 12 hours after thrombolysis) or UFH (100 U/kg intravenous bolus, initiated 12 hours after thrombolytic therapy, followed by 1000 U/hour as a continuous infusion for 3 days, then 7500U subcutaneously every 12 hours for 4 days). Patients were followed up for 45 days (> or =14 days in hospital).

RESULTS

In total, 186 patients were randomised to receive parnaparin sodium (n = 96) or UFH (n = 90). A significantly greater reduction in the composite primary endpoint (sum of all deaths, first occurrence of recurrent MI, and first occurrence of emergency revascularisation) was seen with parnaparin sodium compared with UFH at day 45 (27.08% vs 42.22%; p = 0.03). A lower incidence of composite endpoint was seen as early as day 2 with parnaparin sodium, but this did not reach significance versus UFH. The rate of individual endpoint events (death, first occurrence of non-fatal recurrent MI and first occurrence of emergency revascularisation) was lower in the parnaparin sodium group than the UFH group at 2, 7, 14 and 45 days, but the differences were not statistically significant. At day 7, the incidences of any bleeding and heparin-induced thrombocytopenia were also lower in the parnaparin sodium group compared with the UFH group (3.13% vs 10.0%; p = 0.06 and 0% vs 3.33%; p = 0.07, respectively).

CONCLUSION

The results of this study indicate that parnaparin sodium is more effective than UFH in reducing composite cardiac events in patients with STEMI following thrombolytic therapy. There was also a lower incidence of bleeding and heparin-induced thrombocytopenia with parnaparin sodium than with UFH. In view of these findings, parnaparin sodium represents an effective, convenient and well tolerated alternative to UFH.

摘要

背景

急性心肌梗死(AMI)是最严重的心血管疾病之一,急性ST段抬高型心肌梗死(STEMI)的死亡率高于非ST段抬高型心肌梗死(NSTEMI)。有证据表明,低分子量肝素(LMWH)比普通肝素(UFH)疗效更佳。本开放性、单中心、随机研究旨在比较低分子量肝素帕肝素钠与普通肝素对STEMI患者的疗效和安全性。

患者与方法

STEMI患者被随机分为两组,分别接受帕肝素钠(溶栓12小时后开始皮下注射,每12小时4250IU抗Xa,共7天)或普通肝素(溶栓治疗12小时后开始静脉推注100U/kg,随后以1000U/小时持续输注3天,然后每12小时皮下注射7500U,共4天)。对患者进行45天的随访(住院时间≥14天)。

结果

总共186例患者被随机分为接受帕肝素钠组(n = 96)或普通肝素组(n = 90)。在第45天时,与普通肝素相比,帕肝素钠组的复合主要终点(所有死亡、首次复发性心肌梗死和首次紧急血运重建的总和)显著降低(27.08%对42.22%;p = 0.03)。帕肝素钠组早在第2天复合终点发生率就较低,但与普通肝素组相比无统计学意义。在第2、7、14和45天时,帕肝素钠组的各个终点事件(死亡、首次非致命性复发性心肌梗死和首次紧急血运重建)发生率均低于普通肝素组,但差异无统计学意义。在第7天时,帕肝素钠组的任何出血和肝素诱导的血小板减少症发生率也低于普通肝素组(分别为3.13%对10.0%;p = 0.06和0%对3.33%;p = 0.07)。

结论

本研究结果表明,在溶栓治疗后的STEMI患者中,帕肝素钠在降低复合心脏事件方面比普通肝素更有效。帕肝素钠引起的出血和肝素诱导的血小板减少症发生率也低于普通肝素。鉴于这些发现,帕肝素钠是普通肝素的一种有效、方便且耐受性良好的替代药物。

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