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直接口服抗凝剂可能是下肢骨折创伤患者预防血栓形成的低分子肝素的替代药物。

Direct Oral Anticoagulants Are a Potential Alternative to Low-Molecular-Weight Heparin for Thromboprophylaxis in Trauma Patients Sustaining Lower Extremity Fractures.

机构信息

Division of Trauma, Emergency Surgery and Surgical Critical Care, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Department of Trauma Surgery, Leiden University Medical Center, Leiden University, Leiden, the Netherlands.

Division of Trauma, Emergency Surgery and Surgical Critical Care, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

出版信息

J Surg Res. 2021 Feb;258:324-331. doi: 10.1016/j.jss.2020.10.009. Epub 2020 Nov 11.

Abstract

BACKGROUND

Trauma patients are at a significant risk of venous thromboembolism (VTE), with lower extremity fractures (LEF) being independent risk factors. Use of direct oral anticoagusants (DOACs) for VTE prophylaxis is effective in elective orthopedic surgery, but currently not approved for trauma patients. The primary objective of this study was to compare the effectiveness and safety of thromboprophylaxis of DOACs with low-molecular-weight heparin (LMWH) in trauma patients sustaining LEF.

MATERIALS AND METHODS

We included adult trauma patients admitted to trauma quality improvement program participating trauma centers (between 2013 and 2016), who sustained LEF and were started on DOACs or LMWH for thromboprophylaxis after admission. Propensity score matching was performed to compare symptomatic VTE and bleeding control interventions between the groups.

RESULTS

Of 1,009,922 patients in trauma quality improvement program, 167,640 met inclusion criteria (165,009 received LMWH and 2631 received DOACs). After propensity score matching, 2280 predominantly elderly (median age: 67 y) isolated femur fracture patients (median ISS: 10) were included in each group (4560 patients in total). Symptomatic VTE occurred in 1.4% of patients in both matched groups (P = 0.992). Bleeding control interventions occurred less often in the DOAC group, albeit statistically insignificant (5.8% versus 6.0%, P = 0.772).

CONCLUSIONS

This study found similar rates of VTE and bleeding control measures for thromboprophylaxis with DOACs or LMWH in matched trauma patients with LEF. Further prospective research is warranted to consolidate the safety of DOAC thromboprophylaxis in trauma patients with LEF. Favorable oral administration and likely increased adherence could benefit this high-risk population.

摘要

背景

创伤患者存在静脉血栓栓塞(VTE)的显著风险,下肢骨折(LEF)是独立的危险因素。在择期骨科手术中,使用直接口服抗凝剂(DOAC)进行 VTE 预防是有效的,但目前不批准用于创伤患者。本研究的主要目的是比较 DOAC 和低分子肝素(LMWH)在 LEF 创伤患者中的血栓预防的有效性和安全性。

材料和方法

我们纳入了参加创伤质量改进计划的成人创伤患者(2013 年至 2016 年期间),他们因 LEF 入院,并在入院后开始使用 DOAC 或 LMWH 进行血栓预防。采用倾向评分匹配来比较两组之间的症状性 VTE 和出血控制干预措施。

结果

在创伤质量改进计划的 1009922 名患者中,有 167640 名符合纳入标准(165009 名接受 LMWH,2631 名接受 DOAC)。经过倾向评分匹配后,每组纳入 2280 名主要为老年人(中位年龄:67 岁)的单纯股骨骨折患者(中位 ISS:10)(共 4560 名患者)。在匹配组中,症状性 VTE 的发生率均为 1.4%(P=0.992)。DOAC 组的出血控制干预措施较少,但无统计学意义(5.8%比 6.0%,P=0.772)。

结论

本研究发现,在 LEF 的匹配创伤患者中,DOAC 或 LMWH 进行血栓预防的 VTE 和出血控制措施的发生率相似。需要进一步的前瞻性研究来证实 DOAC 在 LEF 创伤患者中的安全性。口服给药方便且可能增加患者的依从性,这可能使这一高危人群受益。

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