Alhenc-Gelas M, Jestin-Le Guernic C, Vitoux J F, Kher A, Aiach M, Fiessinger J N
Laboratoire d'Hémostase, Hôpital Broussais, Paris, France.
Thromb Haemost. 1994 Jun;71(6):698-702.
Treatment monitoring based on a laboratory parameter increases the efficacy and safety of standard heparin therapy, but it is not known if this also applies to low-molecular-weight heparin (LMWH) therapy of acute deep vein thrombosis (DVT). In a prospective randomized trial involving 122 consecutive patients, group A (58 patients) received a weight adjusted dose of Fragmin (100 IU/kg) subcutaneously twice a day throughout the treatment period (10 days +/- 1), while in group B (64 patients) the dosage was based on the results of an anti factor Xa (anti Xa) amidolytic assay to obtain a target concentration from 0.5 to 1 IU/ml. AntiXa and antithrombin activities were also measured retrospectively on frozen plasma from all patients. The two regimens were comparable in terms of hemorrhagic complications (4 in group A and 3 in group B). Bilateral ascending phlebography was performed before inclusion and at the end of LMWH treatment. Treatment efficacy, based on Marder's score, did not differ between the two groups (p = 0.3). Dosage adjustment to between 0.5 to 1 IU anti-Xa/ml does not therefore appear to improve the efficacy or safety of LMWH treatment. However, correlations between the change in Marder's score and both anti-Xa (p < 0.001) and antithrombin activity (p < 0.001) were observed, suggesting a relationship between the degree of FXa or thrombin inhibition and antithrombotic activity.
基于实验室参数的治疗监测可提高标准肝素治疗的疗效和安全性，但尚不清楚这是否也适用于急性深静脉血栓形成（DVT）的低分子量肝素（LMWH）治疗。在一项涉及122例连续患者的前瞻性随机试验中，A组（58例患者）在整个治疗期（10天±1天）内每天皮下注射两次按体重调整剂量的速碧林（100 IU/kg），而B组（64例患者）的剂量则根据抗Xa因子（抗Xa）酰胺水解试验的结果来确定，以获得0.5至1 IU/ml的目标浓度。还对所有患者的冷冻血浆进行了抗Xa和抗凝血酶活性的回顾性测量。两组在出血并发症方面具有可比性（A组4例，B组3例）。在纳入研究前和LMWH治疗结束时进行双侧上行静脉造影。基于马德评分的治疗效果在两组之间没有差异（p = 0.3）。因此，将剂量调整至0.5至1 IU抗Xa/ml似乎并不能提高LMWH治疗 的疗效或安全性。然而，观察到马德评分的变化与抗Xa活性（p < 0.001）和抗凝血酶活性（p < 0.001）之间存在相关性，这表明FXa或凝血酶抑制程度与抗血栓活性之间存在关联。
