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磺达肝癸钠:新研究结果的最新进展。

Fondaparinux: an update on new study results.

作者信息

Bauersachs R M

机构信息

Vascular Medicine, Medical Department IV, Klinikum Darmstadt, Germany.

出版信息

Eur J Clin Invest. 2005 Mar;35 Suppl 1:27-32. doi: 10.1111/j.0960-135X.2005.01454.x.

DOI:10.1111/j.0960-135X.2005.01454.x
PMID:15701145
Abstract

Fondaparinux (Arixtra) is the first selective factor Xa inhibitor approved for use in thromboprophylaxis after orthopaedic surgery. New recently completed trials have also demonstrated the potential of fondaparinux in the prevention of venous thromboembolism (VTE) in other surgical and medical settings and in the treatment of established VTE. In the randomized double-blind PEGASUS study in high-risk abdominal surgery patients, fondaparinux reduced the incidence of VTE from 6.1% with dalteparin to 4.6% (odds ratio reduction = 25.8%, P = 0.14), without increasing the bleeding risk. In the randomized double-blind ARTEMIS trial in acutely ill medical patients, fondaparinux reduced the incidence of VTE from 10.5% with placebo to 5.6% (odds ratio reduction = 49.5%, P = 0.029), without increasing the bleeding risk; there was no pulmonary embolism in the fondaparinux group compared with five, all fatal, in the placebo group (P = 0.029). In the two MATISSE trials, both the efficacy and safety of once daily fondaparinux were at least as good as enoxaparin in the treatment of deep-vein thrombosis (MATISSE-DVT) and unfractionated heparin in the treatment of pulmonary embolism (MATISSE-PE). In patients with coronary artery disease, promising results were obtained in phase II trials and large phase III trials are ongoing. In conclusion, fondaparinux may further improve and simplify the prevention and treatment of thrombosis in a large range of medical and surgical settings.

摘要

磺达肝癸钠(安卓)是首个被批准用于骨科手术后血栓预防的选择性Xa因子抑制剂。最近完成的新试验也证明了磺达肝癸钠在其他外科和内科环境中预防静脉血栓栓塞(VTE)以及治疗已形成的VTE方面的潜力。在针对高危腹部手术患者的随机双盲PEGASUS研究中,磺达肝癸钠使VTE的发生率从达肝素组的6.1%降至4.6%(优势比降低 = 25.8%,P = 0.14),且未增加出血风险。在针对急性病内科患者的随机双盲ARTEMIS试验中,磺达肝癸钠使VTE的发生率从安慰剂组的10.5%降至5.6%(优势比降低 = 49.5%,P = 0.029),且未增加出血风险;磺达肝癸钠组未发生肺栓塞,而安慰剂组有5例,均为致命性肺栓塞(P = 0.029)。在两项MATISSE试验中,每日一次使用磺达肝癸钠在治疗深静脉血栓形成(MATISSE - DVT)方面的疗效和安全性至少与依诺肝素相当,在治疗肺栓塞(MATISSE - PE)方面至少与普通肝素相当。在冠心病患者中,II期试验取得了有前景的结果,大型III期试验正在进行中。总之,磺达肝癸钠可能会进一步改善并简化在广泛的内科和外科环境中血栓的预防和治疗。

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