Leyvraz P, Bachmann F, Bohnet J, Breyer H G, Estoppey D, Haas S, Hochreiter J, Jakubek H, Mair J, Sorensen R
Department of Orthopaedics, Hôpital Orthopédique, Lausanne, Switzerland.
Br J Surg. 1992 Sep;79(9):911-4. doi: 10.1002/bjs.1800790919.
In a prospective, randomized, assessor-blind multicentre study two antithrombotic subcutaneous regimens were compared in patients undergoing total hip replacement. Group 1 (154 patients) received 750 anti-Xa units of a new low molecular weight heparinoid (Lomoparan) subcutaneously twice a day and group 2 (155 patients) received 5000 units heparin and 0.5 mg dihydroergotamine (heparin-DHE 5000) twice a day. The incidence of deep vein thrombosis, assessed by routine bilateral venography on day 10 (+/- 1), was 17 and 32 per cent in groups 1 and 2 respectively (risk reduction 47 per cent; P = 0.007). One patient in each group developed a symptomatic pulmonary embolism confirmed by lung scanning. Major bleeding complications occurred in one patient in each group and no significant difference was observed between the two groups with respect to minor bleeding complications. Subcutaneous Lomoparan appears to be as safe as heparin-DHE 5000 at the above doses with regard to bleeding complications, and is more efficacious with respect to venous thrombosis.
在一项前瞻性、随机、评估者盲法的多中心研究中,对接受全髋关节置换术的患者比较了两种抗血栓皮下给药方案。第1组(154例患者)每天两次皮下注射750抗Xa单位的一种新型低分子肝素类似物(洛莫帕兰),第2组(155例患者)每天两次皮下注射5000单位肝素和0.5毫克双氢麦角胺(肝素 - DHE 5000)。在第10天(±1天)通过常规双侧静脉造影评估深静脉血栓形成的发生率,第1组和第2组分别为17%和32%(风险降低47%;P = 0.007)。每组各有1例患者经肺部扫描确诊发生有症状的肺栓塞。每组各有1例患者发生严重出血并发症,两组在轻微出血并发症方面未观察到显著差异。就出血并发症而言,上述剂量的皮下注射洛莫帕兰似乎与肝素 - DHE 5000一样安全,且在静脉血栓形成方面更有效。