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老年内科患者中使用磺达肝素钠预防静脉血栓栓塞的安全性:一项单中心回顾性研究的结果。

Safety of fondaparinux in the prevention of venous thromboembolism in elderly medical patients: results of a single-center, retrospective study.

机构信息

Division of Internal Medicine General Hospital, Latisana, Udine, Italy -

出版信息

Minerva Med. 2014 Jun;105(3):221-8.

PMID:24988087
Abstract

AIM

Venous thromboembolism (VTE) is one of the leading causes of morbidity and mortality in acutely ill medical patients. Fondaparinux is recommended for the prevention of VTE in this setting, but little information is available on its safety and effectiveness in unselected, "real world" patients. The aim of this paper was to assess the safety and efficacy of fondaparinux in elderly acutely ill medical patients.

METHODS

Single center, retrospective study. All patients >60 years, admitted for acute medical disease, bedridden for at least four days and treated with fondaparinux were evaluated. Occurrence of objectively documented, symptomatic VTE, and of bleeding events during the treatment period and follow-up were reported.

RESULTS

Two hundred and ten patients (median age 81 years) were treated with fondaparinux. Seventy patients received fondaparinux 1.5 mg daily, 140 received the 2.5 mg daily dose. However, 29 patients in the first group (with a CrCl≥50 mL/min) and 84 patients in the last group (with a CrCl<50 mL/min) did not receive the correct dose of fondaparinux. During treatment, one episode (0.48%, 95% CI 0.1% to 2.6%) of major bleeding and 6 episodes (2.86%, 95% CI 1.3% to 6.1%) of clinically relevant non major bleeding were recorded. Only one thromboembolic event (0.48%, 95% CI 0.1% to 2.6%) was documented. Thirty-nine patients died; no death was related to VTE, unlike one death was due to major bleeding. Cancer was the only significant predictor of bleeding at statistical analysis.

CONCLUSION

In elderly acutely ill hospitalized medical patients, thromboprophylaxis with fondaparinux 2.5 or 1.5mg daily is safe and effective in preventing VTE without increasing bleeding risk.

摘要

目的

静脉血栓栓塞症(VTE)是急性重病患者发病率和死亡率的主要原因之一。在这种情况下,推荐使用磺达肝素钠预防 VTE,但关于其在未选择的“真实世界”患者中的安全性和有效性的信息很少。本文旨在评估磺达肝素钠在老年急性重病患者中的安全性和疗效。

方法

单中心回顾性研究。所有年龄>60 岁、因急性内科疾病入院、卧床至少 4 天并接受磺达肝素钠治疗的患者均进行评估。报告治疗期间和随访期间发生的客观记录的、有症状的 VTE 和出血事件。

结果

210 例患者(中位年龄 81 岁)接受磺达肝素钠治疗。70 例患者接受磺达肝素钠 1.5mg 每日一次,140 例患者接受 2.5mg 每日一次。然而,第一组中有 29 例(CrCl≥50ml/min)和最后一组中有 84 例(CrCl<50ml/min)未接受磺达肝素钠的正确剂量。在治疗期间,记录到 1 例(0.48%,95%CI 0.1%至 2.6%)主要出血事件和 6 例(2.86%,95%CI 1.3%至 6.1%)临床相关非主要出血事件。仅记录到 1 例血栓栓塞事件(0.48%,95%CI 0.1%至 2.6%)。39 例患者死亡;没有死亡与 VTE 相关,而有 1 例死亡与大出血有关。癌症是唯一在统计学分析中出血的显著预测因素。

结论

在老年急性住院内科患者中,磺达肝素钠 2.5 或 1.5mg 每日预防血栓栓塞症是安全有效的,不会增加出血风险。

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