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达比加群酯(普乐沙福)可安全用于胰腺癌手术后的延长静脉血栓栓塞预防。

Dabigatran (Pradaxa) Is Safe for Extended Venous Thromboembolism Prophylaxis After Surgery for Pancreatic Cancer.

机构信息

Division of Gastrointestinal & Endocrine Surgery, Department of Surgery, College of Physicians and Surgeons, Columbia University, 161 Fort Washington Ave - 8th Floor, New York, NY, 10032, USA.

出版信息

J Gastrointest Surg. 2019 Jun;23(6):1166-1171. doi: 10.1007/s11605-018-3936-1. Epub 2018 Sep 5.

Abstract

BACKGROUND

The American College of Chest Physicians and American Hepato-Pancreato-Biliary Association recommend using low-molecular-weight heparin for 28 days postoperatively for venous thromboembolism prophylaxis after cancer surgery. Dabigatran is a once daily oral anticoagulant that is FDA approved for venous thromboembolism prophylaxis after orthopedic surgery, uses fixed dosing, and has an antidote.

METHODS

Patients undergoing surgery for malignant pancreatic tumors (neuroendocrine excluded) from January 2017 to January 2018 were converted to dabigatran 220 mg daily on discharge until postoperative day 28; patients with medical or insurance contraindications were converted to enoxaparin or another direct oral anticoagulant. The primary endpoint was bleeding complications through 90 days.

RESULTS

A total of 134 patients were considered for this study (median age 67 ± 10; 58.9% male). Eighty-seven (82.9%) patients received dabigatran and 18 (17.1%) received another form of anticoagulation. There were 19 (4.2%) patients not prescribed dabigatran due to medical or inpatient contraindications. Four patients experienced bleeding complications after discharge while on dabigatran. Two (2%) were major bleeds (Clavien-Dindo IV and V), and 2 (2%) were minor (Clavien-Dindo I). Patient compliance was excellent, with 93% of prescribed patients fully completing their prophylaxis. There were 2 patients that developed symptomatic deep vein thrombosis.

CONCLUSION

The use of a direct oral anticoagulant as extended venous thromboembolism prophylaxis after major gastrointestinal surgery has not been studied to date. These results show dabigatran to be a safe alternative to low-molecular-weight heparin for extended venous thromboembolism prophylaxis with regard to bleeding complications.

摘要

背景

美国胸科医师学会和美国肝胆胰协会建议,在癌症手术后,使用低分子肝素进行 28 天的静脉血栓栓塞预防。达比加群酯是一种每日一次的口服抗凝剂,经美国食品药品监督管理局批准用于骨科手术后的静脉血栓栓塞预防,采用固定剂量,且有解毒剂。

方法

2017 年 1 月至 2018 年 1 月期间,接受恶性胰腺肿瘤(排除神经内分泌肿瘤)手术的患者在出院时转换为每日 220mg 达比加群酯,直至术后第 28 天;有医学或保险禁忌证的患者转换为依诺肝素或其他直接口服抗凝剂。主要终点是 90 天内的出血并发症。

结果

共有 134 名患者符合本研究条件(中位年龄 67±10 岁;58.9%为男性)。87 名(82.9%)患者接受了达比加群酯治疗,18 名(17.1%)患者接受了其他形式的抗凝治疗。由于医学或住院禁忌,有 19 名(4.2%)患者未开达比加群酯。在服用达比加群酯后出院的 4 名患者中发生了出血并发症。2 例(2%)为大出血(Clavien-Dindo IV 和 V 级),2 例(2%)为小出血(Clavien-Dindo I 级)。患者依从性极好,93%的处方患者完全完成了预防治疗。有 2 例患者发生症状性深静脉血栓形成。

结论

迄今为止,尚未研究直接口服抗凝剂作为胃肠道大手术后的扩展静脉血栓栓塞预防药物。这些结果表明,在出血并发症方面,达比加群酯是低分子肝素用于扩展静脉血栓栓塞预防的安全替代药物。

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