Department of Anesthesia and Intensive Care Medicine, Hôtel Dieu and Cochin University Hospitals, Assistance Publique- Hôpitaux de Paris (AP-HP), Paris Descartes University, Paris, France.
J Thromb Haemost. 2013 Oct;11(10):1833-43. doi: 10.1111/jth.12395.
In several small studies, anticoagulant therapy reduced the incidence of venous thromboembolism (VTE) in patients with isolated lower-limb injuries.
To compare the efficacy and safety of fondaparinux 2.5 mg (1.5 mg in patients with a creatinine clearance between 30 and 50 mL min(-1) ) over nadroparin 2850 anti-factor Xa IU.
In this international, multicenter, randomized, open-label study, patients with an isolated non-surgical unilateral below-knee injury having at least one additional major risk factor for VTE and requiring, in the Investigator's opinion, rigid or semi-rigid immobilization for 21-45 days with thromboprophylaxis up to complete mobilization received subcutaneously once-daily either fondaparinux or nadroparin. The primary efficacy outcome was the composite of VTE (symptomatic or ultrasonographically detected asymptomatic deep vein thrombosis of the lower limb or symptomatic pulmonary embolism) and death up to complete mobilization. The main safety outcome was major bleeding.
We randomized 1349 patients (mean age 46 years): 88.7% had a bone fracture, and 83.8% had a plaster cast fitted (mean duration of immobilization, 34 days). The primary efficacy outcome occurred in 15 of 584 patients (2.6%) in the fondaparinux group and 48 of 586 patients (8.2%) in the nadroparin group (odds ratio, 0.30; 95% confidence interval [CI], 0.15-0.54; P < 0.001). A single major bleed was experienced by fondaparinux-treated patients and none by nadroparin-treated patients. These results were maintained up to the end of follow-up.
Fondaparinux 2.5 mg day(-1) may be a valuable therapeutic option over nadroparin 2850 anti-FXa IU day(-1) for preventing VTE after below-knee injury requiring prolonged immobilization in patients with additional risk factors.
在几项小型研究中，抗凝治疗降低了孤立性下肢损伤患者的静脉血栓栓塞症（VTE）发生率。
比较 2.5mg 磺达肝癸钠（肌酐清除率 30-50mL/min 的患者为 1.5mg）与 2850IU 那屈肝素在预防 VTE 方面的疗效和安全性。
在这项国际性、多中心、随机、开放标签研究中，纳入了因孤立性非手术性单侧膝下损伤而需要至少一项其他 VTE 主要危险因素，且根据研究者的意见需要进行 21-45 天的刚性或半刚性固定，并在完全活动前进行血栓预防的患者，给予每日一次皮下注射磺达肝癸钠或那屈肝素。主要疗效终点是完全活动前的 VTE（症状性或超声检测到的下肢深静脉血栓形成或症状性肺栓塞）和死亡的复合终点。主要安全性终点是大出血。
我们共随机纳入 1349 例患者（平均年龄 46 岁）：88.7%有骨折，83.8%接受了石膏固定（固定时间平均为 34 天）。磺达肝癸钠组有 15 例（2.6%）和那屈肝素组有 48 例（8.2%）患者发生了主要疗效终点事件（比值比，0.30；95%置信区间[CI]，0.15-0.54；P<0.001）。磺达肝癸钠组有 1 例患者发生了单一重大出血事件，而那屈肝素组无此类事件。这些结果在随访结束时仍保持不变。
在需要长期固定且有其他危险因素的膝下损伤患者中，磺达肝癸钠 2.5mg 每日一次可能是优于那屈肝素 2850IU 每日一次的治疗选择，可预防 VTE。
