Bergqvist D, Benoni G, Björgell O, Fredin H, Hedlundh U, Nicolas S, Nilsson P, Nylander G
Department of Surgery, Academic Hospital, Uppsala, Sweden.
N Engl J Med. 1996 Sep 5;335(10):696-700. doi: 10.1056/NEJM199609053351002.
The risk of venous thromboembolism in patients undergoing total hip replacement is known to be high. However, the optimal duration of prophylaxis with anticoagulant agents after this procedure is unknown. We sought to determine whether one month of anticoagulant therapy with the low-molecular-weight heparin enoxaparin is more effective than enoxaparin therapy given only during the hospitalization for surgery.
Two hundred sixty-two patients undergoing total hip replacement received enoxaparin during their hospitalizations (average stay, 10 to 11 days). They were then randomly assigned to receive enoxaparin or placebo (131 patients each). Blinded outpatient therapy (or placebo) was continued long enough that the total treatment period, inpatient plus outpatient, was one month for each patient. Bilateral ascending phlebography was performed 19 to 23 days after discharge, with deep-vein thrombosis as the primary end point. Distal and proximal thrombosis, pulmonary embolism, and hemorrhage were also recorded, as were deaths.
Venography was adequate in 116 patients in the placebo group and 117 in the enoxaparin group. We observed 43 episodes of deep-vein thrombosis and 2 episodes of pulmonary embolism in the placebo group, but only 21 episodes of deep-vein thrombosis and no episodes of pulmonary embolism in the enoxaparin group (incidence of thromboembolism, 39 percent and 18 percent, respectively; P<0.001). The difference in the incidence of proximal deep-vein thrombosis was also significant (24 percent and 7 percent in the placebo and enoxaparin groups, respectively; P<0.001). Six enoxaparin groups, respectively; P<0.001). Six patients in the enoxaparin group and one patient in the placebo group had hematomas at their injection sites. No patients died or had major complications.
There were significantly fewer venous thromboembolic complications in patients undergoing elective hip replacement when prophylaxis with enoxaparin was given for a total of one month, rather than only during the hospitalization.
全髋关节置换术患者发生静脉血栓栓塞的风险已知较高。然而,该手术后抗凝剂预防的最佳持续时间尚不清楚。我们试图确定使用低分子量肝素依诺肝素进行一个月的抗凝治疗是否比仅在手术住院期间给予依诺肝素治疗更有效。
262例接受全髋关节置换术的患者在住院期间接受了依诺肝素治疗(平均住院时间为10至11天)。然后将他们随机分为接受依诺肝素或安慰剂治疗(每组131例患者)。盲法门诊治疗(或安慰剂)持续足够长的时间,以使每位患者的总治疗期(住院加门诊)为一个月。出院后19至23天进行双侧上行静脉造影,以深静脉血栓形成作为主要终点。还记录了远端和近端血栓形成、肺栓塞和出血情况以及死亡情况。
安慰剂组116例患者和依诺肝素组117例患者的静脉造影结果满意。我们在安慰剂组中观察到43例深静脉血栓形成和2例肺栓塞,但依诺肝素组仅观察到21例深静脉血栓形成且无肺栓塞病例(血栓栓塞发生率分别为39%和18%;P<0.001)。近端深静脉血栓形成的发生率差异也有统计学意义(安慰剂组和依诺肝素组分别为24%和7%;P<0.001)。依诺肝素组有6例患者、安慰剂组有1例患者注射部位出现血肿。无患者死亡或出现重大并发症。
择期髋关节置换术患者进行总共一个月的依诺肝素预防,而不是仅在住院期间进行预防,静脉血栓栓塞并发症明显减少。