Department of Social and Clinical Pharmacy, Charles University in Prague, Faculty of Pharmacy in Hradec Kralove, Heyrovskeho 1203, 500 05 Hraddec Kralove, Czech Republic; Department of Social Pharmacy, Pharmacopidemiolgy and pharmacotherapy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.
Expert Rev Pharmacoecon Outcomes Res. 2007 Feb;7(1):49-58. doi: 10.1586/14737167.7.1.49.
This paper reviews the clinical and pharmacoeconomic studies that have been conducted within Europe for patients undergoing elective hip-replacement surgery. Additionally, we offer a perspective on the possible future clinical use of new agents in orthopedic surgery, such as dabigatran and BAY 59-7939 (rivaroxban). Low-molecular weight heparins are standard therapy for patients requiring thromboprophylaxis and, therefore, we compare these with the other agents: vitamin K antagonists, fondaparinux and the direct oral inhibitors (thrombin or factor Xa inhibitors). The most evidence on the cost-effectiveness and efficacy is available for the low-molecular weight heparins and fondaparinux. Their major limitation is that they require parenteral administration. Only fondaparinux has undergone an extensive pharmacoeconomic evaluation. The direct thrombin inhibitors and direct factor Xa inhibitors are possibly the drugs of the future, but it must be borne in mind that they are still in Phase III clinical trials and, therefore,their safety and efficacy profile is not completely understood, neither are the pharmacoeconomic aspects.
本文回顾了在欧洲进行的择期髋关节置换手术患者的临床和药物经济学研究。此外，我们还对骨科手术中新型药物（如达比加群和 BAY 59-7939[利伐沙班]）的未来临床应用提供了一些看法。低分子肝素是需要预防血栓形成的患者的标准治疗方法，因此，我们将其与其他药物进行了比较：维生素 K 拮抗剂、磺达肝素和直接口服抑制剂（凝血酶或因子 Xa 抑制剂）。关于成本效益和疗效的最有证据是低分子肝素和磺达肝素。它们的主要局限性是需要进行胃肠外给药。只有磺达肝素经过了广泛的药物经济学评估。直接凝血酶抑制剂和直接因子 Xa 抑制剂可能是未来的药物，但必须注意的是，它们仍处于 III 期临床试验阶段，因此，其安全性和疗效谱尚不完全清楚，药物经济学方面也不清楚。
