(FDA)美国食品药物管理局2000年12月批准上市    Angiomax 抗凝血药；经证实，该药在不稳定性心绞痛病人预防囊状血管成型术(PTCA)后的血栓疗效好于常规抗凝疗法。大规模临床试验的结果证实：Angiomax可以降低死亡、心脏病发作的概率，使进一步外科手术的必要性减少22%。但这些试验是在ReoPro之类边缘性阻断剂（cutting-edgedrugs）与肝素合用疗法出现之前进行的。该药作为价格更高的ReoPro以及类似药物的替代品的临床试验正在进行当中。除进一步验证该药在血管成型术当中的应用以外，研究者还尝试将其用于心脏病患者，这样就可以打开更广阔的市场。  使用Angiomax每名患者约花费300美元，与5-10美元的非注册肝素类药品相比，显然医生更倾向于选用后者。最初该药只用于5%-10%的血栓高危患者或对肝素过敏的患者。如果它的价格与肝素差不多，该药将会成为首选药物而被更广泛的使用。 Angiomax与肝磷脂的功效相同  2003年9月15日报道，病人服用Medicines Co的血液稀释剂Angiomax六个月之后的效果和使用那些难以服用且成本高的标准药物结合疗法相比，具有相同效果。     这家新泽西制药公司称这些数据支持这些短期所得的结论，即对于标准的非专利注射药肝磷脂和抗血小板药物的混和疗法来说，Angiomax是一种安全有效的替代药品。     当医生们清理堵塞的动脉时，他们使用肝磷脂和抗血小板药物，例如Johnson & Johnsons ReoPro或者Schering-Plough Corp.的Integrilin来防止血液凝结。但是越来越多的医生转向使用Angiomax。该药于2001年初上市，并且能单独使用或者和ReoPro或Integrilin结合使用。     周一Medicines Co.给出了一些最新信息，主要是关于6002名病人如何在进行血管成形术六个月之后康复的。其中一组服用的是肝磷脂和ReoPro或Integrilin，而另一组服用单一的Angiomax或者与两种抗血小板药物中的一种混和服用。 该公司称数据表明Angiomax和肝磷脂具有相似的功效。在两组病人中，都有12％的病人出现了死亡、心脏病和需要再次进行血管成形术的综合症状。该公司称使用Angiomax的病人中没有出现死亡现象，但是统计数字并不是非常重要。       Angiomax的每次治疗费用大约是365美元，给药时间大约为45分钟，通过在血管成形过程中和之后立即进行静脉注射该药。其中在血管形成过程中，医生利用球形导管清除了动脉中的血凝块。通过对比，肝磷脂和抗血小板药物的成本超过800美元。而且，ReoPro的给药时间大约为12小时，Integrilin要18小时。 【原产地英文商品名】ANGIOMAX SDV 250mg/5ml/vial 10vials/box 【原产地英文药品名】BIVALIRUDIN 【中文参考商品译名】 注：以下产品不同规格和不同价格，购买时请以电话咨询为准！ ·ANGIOMAX SDV 250毫克/5毫升/瓶 10瓶/盒 ·ANGIOMAX N+ SDV 250毫克/瓶 10瓶/盒 【中文参考药品译名】比伐卢定 【生产厂家中文参考译名】美国Medicines公司 【生产厂家英文名】Medicines Company Product Overview1 Angiomax® (bivalirudin) is a thrombin-specific antithrombotic with improved clinical outcomes when compared with heparin as a foundation anticoagulant in the contemporary catheterization lab setting ANGIOMAX has been evaluated in 6 randomized trials of over 25,000 patients undergoing percutaneous coronary intervention(PCI).1,2 More than 1 million patients have been treated with ANGIOMAX since 2001.3,4,5 In randomized, double-blind clinical trials, ANGIOMAX with or without provisional glycoprotein (GP) IIb/IIIa: Demonstrated proven efficacy plus fewer bleeding complications for improved outcomes Significantly reduced major hemorrhagic events by 41% to 61% Demonstrated proven antithrombotic effect in low- to high-risk patients Avoided risks and limitations of heparin to reduce need for GP IIb/IIIa Resulted in cost savings which provide better economic outcomes Description The active substance of ANGIOMAX is a short, synthetic, 20-amino acid peptide comprised of an active-site–directed peptide, D-Phe-Pro-Arg-Pro, linked via a tetraglycine spacer to a dodecapeptide analogue of the carboxy-terminal of hirudin   ANGIOMAX is supplied in single-use vials as a white lyophilized cake, which is sterile ANGIOMAX is a potent, highly specific, reversible, bivalent inhibitor of thrombin ANGIOMAX Is Naturally Cleaved by Thrombin ANGIOMAX Is Unique Compared to Heparin Antithrombotic feature ANGIOMAX Heparin Effect 100% bioavailable1 √   Provides a predictable dose response; no continuous ACT monitoring required1 IV, 25-minute half-life1 √   Enables fast-on, fast-off activity1 Direct thrombin inhibition1 √   Does not require a binding cofactor to inactivate both circulating and clot-bound thrombin1 Requires antithrombin as a binding cofactor6   √ Inhibits thrombin indirectly and does not effectively inactivate clot-bound thrombin6 Binds reversibly to thrombin1 √   Thrombin is able to resume normal hemostatic functions1 Sheath removal 2 hours after discontinuation in most patients*7,8 √   Reduces access-site bleeding complications and improves throughput7,8,9 No heparin/platelet factor 4 cross-reactivity1 √   No risk of heparin-induced thrombocytopenia or thrombosis syndrome (HIT/HITTS)1 Activates platelets10   √ Promotes more platelet activation and platelet aggregation10 ACT = activated clotting time IV = intravenous *Sheath removal has not been studied in dialysis-dependent patients treated with ANGIOMAX. Follow standard hospital protocol for this population. Safety Considerations ANGIOMAX with provisional use of glycoprotein IIb/IIIa inhibitor is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), and in patients with or at risk for heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. ANGIOMAX is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. ANGIOMAX is contraindicated in patients with active major bleeding or hypersensitivity to ANGIOMAX or its components. The most common (10%) adverse events for ANGIOMAX were back pain, pain, nausea, headache, and hypotension. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of ANGIOMAX administration. Please see complete prescribing information. 1ANGIOMAX Prescribing Information. The Medicines Company, Parsippany, NJ. December 6, 2005. 2Stone GW, McLaurin BT, Cox DA, et al, for the ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355:2203-2216. 3Data on file. The Medicines Company, Parsippany, NJ. 4Source® Non-retail Database, 2002-2006. Conshohocken, Pa: Wolters Kluwer Health. 5ACTracker® Database, 2005. Evanston, Ill: Solucient, LLC. 6Bates SM, Weitz JI. The mechanism of action of thrombin inhibitors. J Invasive Cardiol. 2000;12(suppl F):27F-32F. 7Mehta S, Yebara S, Ibrahim M, et al. Cedars Medical Center's Experience: Early Ambulation post PCI with Use of Direct Thrombin Inhibitor, Bivalirudin Cath Lab Digest 2004;12:1-4. 8Minutello RM, Wong SC, Chou ET, et al. ANGIOMAX Facilitates Early Sheath Removal After Coronary Angioplasty: The AFRICA Study. Am J Cardiol 2003; 6 Suppl 1;146L. 9Schussler JM, Cameron CS, Anwar A, et al. Effect of bivalirudin on length of stay in the recovery area after percutaneous coronary intervention compared with heparin alone, heparin + abciximab, or heparin + eptifibatide. Am J Cardiol. 2004;94:1417-9. 10Xiao Z, Theroux P. Platelet activation with unfractionated heparin at the therapeutic concentrations and comparisons with a low-molecular-weight heparin and with a direct thrombin inhibitor. Circulation. 1998;97:251-256.