Bergmann J F, Neuhart E
Clinique thérapeutique, Hôpital Lariboisière, Paris, France.
Thromb Haemost. 1996 Oct;76(4):529-34.
A multicenter, randomized double-blind study compared in two parallel groups the efficacy and safety of a low molecular weight heparin (LMWH) enoxaparin 20 mg once daily, with unfractionated heparin (UFH) 5000 IU twice daily, administered subcutaneously for 10 days, in the prevention of venous thrombosis disease in 442 hospitalized elderly patients bedridden for an acute medical illness. The main efficacy endpoint was defined as the occurrence of venous thrombosis, diagnosed by a daily fibrinogen uptake test, and/or documented clinical pulmonary embolism. Intention-to-treat analysis of efficacy showed that the incidence of venous thromboembolic events was low: 4.8% (10/207) in the LMWH group (9 episodes of isotopic venous thrombosis and one of scintigraphic pulmonary embolism), and 4.6% (10/216) in the UFH group (10 episodes of isotopic venous thrombosis). The two treatments were equivalent, where equivalence was defined as a maximum difference of 7% between the two groups (p = 0.0005). There were no significant differences in terms of safety between the 216 patients in the LMWH group and the 223 patients in the UFH group who received at least one injection of the randomized treatment. During the study period, 15 patients (3.4%) died (7 in the LMWH group and 8 in the UFH group): 2 sudden deaths, one in each group including one case in which pulmonary embolism could not be excluded since no autopsy was performed, and 13 others deaths unrelated to the study treatments. Six patients (1.4%) presented a bleeding complication: 2 (0.9%) in the enoxaparin group (one major and one minor hemorrhage), and 4 (1.8%) in the UFH group (2 major and 2 minor hemorrhages). These results indicate that subcutaneous enoxaparin 20 mg once daily for 10 days is as effective and well tolerated as subcutaneous UFH 5000 IU twice daily in the prevention of venous thromboembolic disease in bedridden elderly in-patients presenting an acute medical illness.
一项多中心随机双盲研究将442例因急性内科疾病而卧床的老年住院患者分为两个平行组，比较低分子量肝素（LMWH）依诺肝素每日一次20mg与普通肝素（UFH）每日两次5000IU皮下注射10天预防静脉血栓形成疾病的疗效和安全性。主要疗效终点定义为通过每日纤维蛋白原摄取试验诊断的静脉血栓形成和/或记录在案的临床肺栓塞。疗效的意向性分析表明，静脉血栓栓塞事件的发生率较低：LMWH组为4.8%（10/207）（9例同位素静脉血栓形成和1例闪烁扫描肺栓塞），UFH组为4.6%（10/216）（10例同位素静脉血栓形成）。两种治疗方法等效，等效性定义为两组之间的最大差异为7%（p = 0.0005）。LMWH组的216例患者和UFH组的223例至少接受一次随机治疗注射的患者在安全性方面无显著差异。在研究期间，15例患者（3.4%）死亡（LMWH组7例，UFH组8例）：2例猝死，每组各1例，其中1例因未进行尸检无法排除肺栓塞，其他13例死亡与研究治疗无关。6例患者（1.4%）出现出血并发症：依诺肝素组2例（0.9%）（1例大出血和1例小出血），UFH组4例（1.8%）（2例大出血和2例小出血）。这些结果表明，对于患有急性内科疾病的卧床老年住院患者，每日一次皮下注射依诺肝素20mg共10天在预防静脉血栓栓塞疾病方面与每日两次皮下注射UFH 5000IU一样有效且耐受性良好。
