Faivre R, Neuhart Y, Kieffer Y, Apfel F, Magnin D, Didier D, Toulemonde F, Bassand J P, Maurat J P
Service de Cardiologie, CHU St-Jacques, Besançon.
Presse Med. 1988 Feb 13;17(5):197-200.
Sixty-eight patients with acute deep vein thrombosis were allocated at random to two treatment groups. One group (n = 33) received a fixed dose of 750 anti-Xa units of a low molecular weight heparin (CY 222 Choay Institute); the other group (n = 35) received standard heparin in doses of 500 IU/kg/24 h. Both treatments were given for 10 days in two daily subcutaneous injections. A second phlebography was performed on the last day of treatment. No haemorrhagic complication was observed in the group treated with CY 222, as opposed to three cases of haemorrhage in the group treated with standard heparin. The initial phlebographic score and the location of deep vein thrombotic lesions were the same in both groups. Angiographic improvement, with more than 30% thrombolysis, was obtained at the end of treatment in 64% of patients in the CY 222 group and in 65% of patients in the standard heparin group (NS). In 2 patients treated with standard heparin the second phlebography showed extension of the thrombosis. The initial score remained unchanged in 1/3 of patients in both groups. The activated partial thromboplastin time was prolonged (2 or 3 fold the normal value) in the standard heparin group and unchanged in the CY 222 group. Anti-Xa activity was significantly higher in the CY 222 group than in the standard heparin group. It is concluded that CY 222 and standard heparin were equally effective in patients with deep vein thrombosis. However, haemorrhagic complications were more frequent with standard heparin that with CY 222.
68例急性深静脉血栓形成患者被随机分为两个治疗组。一组(n = 33)接受固定剂量750抗Xa单位的低分子量肝素(法国Choay研究所的CY 222);另一组(n = 35)接受标准肝素,剂量为500 IU/kg/24小时。两种治疗均每日皮下注射2次,持续10天。在治疗的最后一天进行第二次静脉造影。接受CY 222治疗的组未观察到出血并发症,而接受标准肝素治疗的组有3例出血。两组的初始静脉造影评分和深静脉血栓形成病变的部位相同。治疗结束时,CY 222组64%的患者和标准肝素组65%的患者血管造影有改善,血栓溶解超过30%(无显著性差异)。接受标准肝素治疗的2例患者第二次静脉造影显示血栓扩展。两组均有1/3的患者初始评分未改变。标准肝素组活化部分凝血活酶时间延长(为正常值的2或3倍),而CY 222组未改变。CY 222组的抗Xa活性显著高于标准肝素组。结论是,CY 222和标准肝素对深静脉血栓形成患者同样有效。然而,标准肝素组的出血并发症比CY 222组更常见。