Planes A, Vochelle N, Darmon J Y, Fagola M, Bellaud M, Huet Y
Clinique Radio-Chirurgicale du Mall, La Rochelle, France.
Lancet. 1996 Jul 27;348(9022):224-8. doi: 10.1016/s0140-6736(96)01453-5.
The risk of deep-vein thrombosis (DVT) and pulmonary embolism after total hip replacement (THR) surgery may persist after hospital discharge, but the extent of the risk is not known. We carried out a single-centre, prospective, randomised, double-blind trial with the aims of quantifying this risk and assessing the efficacy of continued prophylactic treatment.
At hospital discharge 13-15 days after surgery, we recruited 179 consecutive THR patients who had no DVT visible on bilateral ascending venography of the legs. The patients were randomly assigned subcutaneous enoxaparin (40 mg, once daily; n = 90) or placebo (n = 89) for 21 (19-23) days. The primary endpoint was the occurrence of DVT or pulmonary embolism. Venography was repeated at the end of 21 days' treatment or earlier if necessary.
There were no deaths and no symptomatic pulmonary embolisms during the study or follow-up periods. Of 173 patients with evaluable venograms, intention-to-treat analysis of efficacy showed that the rate of DVT at day 21 after discharge was significantly lower in the enoxaparin group than in the placebo group (6 [7.1%] vs 17 [19.3%], p = 0.018). Distal DVT was detected in one (1.2%) patient in the enoxaparin group and in ten (11.4%) patients in the placebo group (p = 0.006). Proximal DVT was observed in five (5.9%) patients in the enoxaparin group and in seven (7.9%) patients in the placebo group (p = 0.592). A perprotocol analysis of efficacy in 155 patients confirmed these findings. Safety was good; three minor bleeding episodes occurred in the enoxaparin group and one in the placebo group, but none of these episodes necessitated withdrawal from the study.
In patients who have undergone THR surgery, are without venogram-proven DVT at hospital discharge, and do not receive antithrombotic prophylaxis after discharge, the risk of late-occurring DVT remains high at least until day 35 after surgery. Continued prophylaxis with enoxaparin is effective and safe in reducing this risk.
全髋关节置换术（THR）后深静脉血栓形成（DVT）和肺栓塞的风险在出院后可能仍然存在，但风险程度尚不清楚。我们开展了一项单中心、前瞻性、随机、双盲试验，旨在量化这种风险并评估持续预防性治疗的疗效。
在术后13 - 15天出院时，我们招募了179例连续的THR患者，这些患者在双侧下肢上行静脉造影中未见DVT。患者被随机分配皮下注射依诺肝素（40mg，每日一次；n = 90）或安慰剂（n = 89），持续21（19 - 23）天。主要终点是DVT或肺栓塞的发生。在治疗21天结束时或必要时提前重复静脉造影。
在研究期间或随访期间没有死亡病例，也没有症状性肺栓塞。在173例可评估静脉造影的患者中，意向性疗效分析显示，出院后第21天依诺肝素组的DVT发生率显著低于安慰剂组（6 [7.1%] 对17 [19.3%]，p = 0.018）。依诺肝素组有1例（1.2%）患者检测到远端DVT，安慰剂组有10例（11.4%）患者检测到远端DVT（p = 0.006）。依诺肝素组有5例（5.9%）患者观察到近端DVT，安慰剂组有7例（7.9%）患者观察到近端DVT（p = 0.592）。对155例患者进行的符合方案疗效分析证实了这些结果。安全性良好；依诺肝素组发生3次轻微出血事件，安慰剂组发生1次，但这些事件均未导致退出研究。
在接受THR手术、出院时静脉造影未证实有DVT且出院后未接受抗血栓预防的患者中，至少在术后35天内，迟发性DVT的风险仍然很高。持续使用依诺肝素进行预防在降低这种风险方面是有效且安全的。
