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依诺肝素用于胰腺手术患者术后抗凝预防的疗效及安全性:一项前瞻性试验与文献综述

Efficacy and safety of postoperative anticoagulation prophylaxis with enoxaparin in patients undergoing pancreatic surgery: A prospective trial and literature review.

作者信息

Hashimoto Daisuke, Nakagawa Shigeki, Umezaki Naoki, Yamao Takanobu, Kitano Yuki, Yamamura Kensuke, Kaida Takayoshi, Arima Kota, Imai Katsunori, Yamashita Yo-Ichi, Chikamoto Akira, Baba Hideo

机构信息

Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan.

Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan.

出版信息

Pancreatology. 2017 May-Jun;17(3):464-470. doi: 10.1016/j.pan.2017.03.010. Epub 2017 Mar 29.

Abstract

BACKGROUND

/Objectives: Enoxaparin is low-molecular-weight heparin that is used for postoperative thromboprophylaxis. The purpose of this study was to evaluate the efficacy and safety of enoxaparin after pancreatic resection. We additionally carried out a literature review regarding venous thromboembolism (VTE) and postoperative bleeding mainly after hepatobiliary-pancreatic surgery.

METHODS

This was a prospective, single-arm study. Patients aged 20-79 years who planned to undergo pancreatic resection followed by postoperative anticoagulation therapy with enoxaparin were enrolled from 2013 to 2016. The exclusion criteria were low renal function, active bleeding, clinical signs of VTE at screening, or evidence of thromboembolic disease before surgery. The primary endpoint was the incidence of postoperative VTE. The secondary endpoint was the incidence of postoperative complications. For the literature review, PubMed was searched for relevant articles and the PRISMA guidelines were used.

RESULTS

In total, 103 patients were analyzed. Two patients (1.9%) developed asymptomatic VTE, and no patients developed symptomatic VTE. No in-hospital mortality occurred. Morbidities (Clavien-Dindo grade ≥ IIIa) occurred in 29 patients (28.1%). Three patients (2.9%) developed intra-abdominal hemorrhage due to pseudoaneurysm formation after pancreaticoduodenectomy or distal pancreatectomy. The literature review included nine articles, and all indicated that the results of this study were feasible.

CONCLUSION

This is the first prospective trial to focus on pharmacologic prophylaxis with enoxaparin after pancreatic surgery. Postoperative anticoagulant therapy with enoxaparin was used in patients who underwent pancreatic surgery with a low incidence of VTE and no increase in postoperative bleeding events compared with existing evidence.

摘要

背景

/目的:依诺肝素是一种用于术后血栓预防的低分子量肝素。本研究的目的是评估胰腺切除术后使用依诺肝素的疗效和安全性。我们还对主要是肝胆胰手术后的静脉血栓栓塞(VTE)和术后出血进行了文献综述。

方法

这是一项前瞻性单臂研究。2013年至2016年纳入了计划接受胰腺切除术后用依诺肝素进行抗凝治疗的20-79岁患者。排除标准为肾功能低下、活动性出血、筛查时VTE的临床体征或术前有血栓栓塞性疾病的证据。主要终点是术后VTE的发生率。次要终点是术后并发症的发生率。对于文献综述,在PubMed上搜索相关文章并使用PRISMA指南。

结果

总共分析了103例患者。2例患者(1.9%)发生无症状VTE,无患者发生有症状VTE。无院内死亡发生。29例患者(28.1%)发生了并发症(Clavien-Dindo分级≥Ⅲa级)。3例患者(2.9%)在胰十二指肠切除术或远端胰腺切除术后因假性动脉瘤形成发生腹腔内出血。文献综述纳入了9篇文章,所有文章均表明本研究结果是可行的。

结论

这是第一项关注胰腺手术后使用依诺肝素进行药物预防的前瞻性试验。与现有证据相比,接受胰腺手术的患者使用依诺肝素进行术后抗凝治疗,VTE发生率低且术后出血事件未增加。

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