Bara L, Leizorovicz A, Picolet H, Samama M
Laboratoire Central d'Hématologie, Hôtel-Dieu, Paris.
Thromb Res. 1992 Mar 1;65(4-5):641-50. doi: 10.1016/0049-3848(92)90213-t.
A total of 1290 patients (Pts) undergoing general surgery were enrolled in a randomized, multicentre double-blind study in order to investigate the efficacy and safety of two different doses of a low molecular weight heparin (LMWH) (Logiparin) for the prevention of deep vein thrombosis. Patients were randomized to either 5,000 IU unfractionated heparin twice daily, 2,500 anti-Xa or 3,500 anti-Xa units of Logiparin once daily. Each treatment was given subcutaneously two hours before surgery and continued for seven to ten days. All coagulation tests were performed blindly in a core laboratory. Blood samples were collected before surgery and then 3 hours after injection on Day 3 and 5 after surgery. Anti-Xa amidolytic activities were significantly higher in the two LMW Heparin groups than in the unfractionated heparin group (mean peak levels +/- s.e.m. on Day 3: 0.097 +/- 0.004; 0.152 +/- 0.004 and 0.034 +/- 0.003 IU respectively). As expected a significant correlation was observed between anti-Xa activity and the dose of LMW Heparin injected. The correlation coefficient was higher when the doses were expressed in anti-Xa units/kg body weight. However, the body weight accounts for only 16% of the interindividual variability of anti-Xa activity. Therefore, there is no clear evidence to suggest that weight-adjusted doses should be recommended when this LMW Heparin is used as prophylactic treatment in general surgery. A weak negative correlation was found between anti-Xa activity and thrombosis as demonstrated by a positive radiolabelled fibrinogen uptake test and confirmed by positive phlebography. No significant correlation was demonstrated between anti-Xa activity and the occurrence of postoperative bleeding.
共有1290例接受普通外科手术的患者被纳入一项随机、多中心双盲研究，以调查两种不同剂量的低分子量肝素（LMWH）（洛吉派林）预防深静脉血栓形成的疗效和安全性。患者被随机分为每日两次皮下注射5000 IU普通肝素组、每日一次皮下注射2500抗Xa单位或3500抗Xa单位洛吉派林组。每种治疗均在手术前两小时皮下给药，并持续7至10天。所有凝血试验均在核心实验室进行盲法检测。术前采集血样，然后在术后第3天注射后3小时和术后第5天采集血样。两个低分子量肝素组的抗Xa酰胺水解活性显著高于普通肝素组（第3天的平均峰值水平±标准误分别为：0.097±0.004；0.152±0.004和0.034±0.003 IU）。正如预期的那样，抗Xa活性与注射的低分子量肝素剂量之间存在显著相关性。当剂量以抗Xa单位/千克体重表示时，相关系数更高。然而，体重仅占抗Xa活性个体间变异性的16%。因此，没有明确证据表明在普通外科手术中使用这种低分子量肝素进行预防性治疗时应推荐根据体重调整剂量。通过放射性标记纤维蛋白原摄取试验阳性证明，并经静脉造影证实，抗Xa活性与血栓形成之间存在弱负相关。抗Xa活性与术后出血的发生之间未显示出显著相关性。
