Fiessinger J N, Lopez-Fernandez M, Gatterer E, Granqvist S, Kher A, Olsson C G, Söderberg K
Hôpital Broussais, Paris, France.
Thromb Haemost. 1996 Aug;76(2):195-9.
The aim of the study was to compare the efficacy and safety of once-daily subcutaneous injection of dalteparin, a low molecular weight heparin, with that of intravenous unfractionated heparin in the treatment of deep venous thrombosis (DVT). Patients were included if they had deep venous thrombosis distal to inguinal ligament and were randomised either before, if it was considered necessary, or after phlebographic verification of the diagnosis. There was no pre-inclusion treatment with unfractionated heparin. One hundred and twenty patients received dalteparin, administered subcutaneously once-daily at a fixed dose of 200 IU anti-factor Xa/kg, and 133 patients received a continuous intravenous infusion of unfractionated heparin (UFH). Oral anticoagulation was started on the first or second day, and initial treatment with dalteparin or UFH discontinued when the prothrombin time was in the therapeutic range (2 < INR < 3) on two consecutive days. Control phlebograms were taken within 4 days, thereafter. There were no significant differences between the two initial treatment groups in improvements in Marder score. Two major bleeding events occurred in the UFH group versus none in the dalteparin group. One patient in each group experienced clinically significant pulmonary embolism. During a mean follow-up period of 6.9 +/- 1.5 months, recurrent DVT occurred in four patients in the dalteparin group and in two of the UFH group. These results confirm those of a previous study on dalteparin in the initial treatment of DVT, and suggest that dalteparin administered once-daily at a fixed dose of 200 UI/kg is as effective and well-tolerated as UFH in patients with DVT below the inguinal ligament. The present study also demonstrates that dalteparin can be started as soon as the diagnosis of DVT is suspected and without pre-treatment with UFH. Given that the administration of once-daily subcutaneous injections needs not require a patient to be hospitalised, studies to investigate the possibility of using dalteparin for the initial treatment of DVT in the outpatient setting are warranted.
本研究旨在比较低分子量肝素达肝素每日一次皮下注射与静脉注射普通肝素治疗深静脉血栓形成（DVT）的疗效和安全性。若患者腹股沟韧带远端存在深静脉血栓形成，且在必要时于静脉造影确诊前或确诊后被随机分组，则纳入研究。患者未接受普通肝素的预治疗。120例患者接受达肝素治疗，每日一次皮下注射，固定剂量为200 IU抗Xa因子/千克，133例患者接受普通肝素（UFH）持续静脉输注。在第一天或第二天开始口服抗凝治疗，当连续两天凝血酶原时间处于治疗范围（2<国际标准化比值<3）时，停用达肝素或UFH的初始治疗。此后在4天内进行对照静脉造影。两个初始治疗组在Marder评分改善方面无显著差异。UFH组发生2例严重出血事件，而达肝素组无严重出血事件。每组各有1例患者发生具有临床意义的肺栓塞。在平均随访期6.9±1.5个月期间，达肝素组有4例患者复发DVT，UFH组有2例患者复发DVT。这些结果证实了先前一项关于达肝素初始治疗DVT的研究结果，并表明对于腹股沟韧带以下DVT患者，每日一次固定剂量200 UI/千克的达肝素治疗与UFH同样有效且耐受性良好。本研究还表明，一旦怀疑DVT诊断即可开始使用达肝素，无需先用UFH进行预处理。鉴于每日一次皮下注射无需患者住院，有必要开展研究以探讨在门诊环境中使用达肝素进行DVT初始治疗的可能性。
