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华法林与阿司匹林预防腹腔镜脾切除和腔静脉-奇静脉吻合术后门静脉血栓形成:一项随机临床试验。

Warfarin versus aspirin prevents portal vein thrombosis after laparoscopic splenectomy and azygoportal disconnection: A randomized clinical trial.

机构信息

Departments of Hepatobiliary Surgery, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, Jiangsu, 225000, China.

Departments of Ultrasound, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, Jiangsu, 225000, China.

出版信息

Int J Surg. 2019 Apr;64:16-23. doi: 10.1016/j.ijsu.2019.02.018. Epub 2019 Mar 6.

Abstract

INTRODUCTION

Portal vein system thrombosis (PVST) is a common, potentially life-threatening complication after splenectomy. The optimal recognized anticoagulation drugs for preventing PVST in cirrhotic patients after splenectomy remain unclear. The aim of this study is to evaluate the safety and efficacy of warfarin in preventing PVST after laparoscopic splenectomy and azygoportal disconnection (LSD).

METHODS

In this randomized controlled single-center study, 80 cirrhotic patients who underwent LSD were randomly assigned to 2 years of treatment with either warfarin (n = 40) or aspirin (n = 40). The primary outcome was prevention of PVST. Sonographers and radiologists who assessed outcomes were blinded to group assignments. Intention-to-treat analysis was performed.

RESULTS

During the first year, excluding two patients withdrawing from the study, 15 of the 39 warfarin-treated patients (38.5%) and five of the 39 aspirin-treated patients (12.8%) did not develop PVST (P = 0.010). The incidence of PVST in the first 2 postoperative years was significantly lower in the warfarin group than in the aspirin group (F = 7.360, P = 0.008). The warfarin group in paired within-group comparisons had significantly greater improvements in total bilirubin and albumin levels at baseline versus at 6 months postoperatively and in creatinine levels at baseline versus at 12, 18, and 24 months postoperatively respectively (all P < 0.05). In contrast, those paired comparisons of the aspirin group showed no significant differences (all P > 0.05).

CONCLUSIONS

Warfarin therapy was safe and effective and significantly reduced the risk of PVST after LSD, compared with aspirin treatment. Warfarin treatment was associated with better liver function protection and renal function improvement than aspirin treatment.

摘要

简介

门静脉系统血栓形成(PVST)是脾切除术后一种常见且可能危及生命的并发症。对于脾切除术后肝硬化患者,预防 PVST 的最佳抗凝药物仍不明确。本研究旨在评估华法林预防腹腔镜脾切除联合门奇静脉断流术(LSD)后 PVST 的安全性和有效性。

方法

在这项随机对照的单中心研究中,80 例接受 LSD 的肝硬化患者被随机分为华法林(n=40)或阿司匹林(n=40)治疗 2 年。主要结局为预防 PVST。评估结果的超声科医生和放射科医生对分组情况不知情。采用意向治疗分析。

结果

在第一年,排除两名退出研究的患者,39 名华法林治疗患者中有 15 名(38.5%)和 39 名阿司匹林治疗患者中有 5 名(12.8%)未发生 PVST(P=0.010)。华法林组在术后 2 年内的 PVST 发生率明显低于阿司匹林组(F=7.360,P=0.008)。华法林组在与自身治疗前相比,术后 6 个月总胆红素和白蛋白水平均显著升高,而术后 12、18 和 24 个月时血肌酐水平也显著升高(均 P<0.05)。相比之下,阿司匹林组的配对比较则无显著差异(均 P>0.05)。

结论

与阿司匹林治疗相比,华法林治疗 LSD 后安全有效,显著降低了 PVST 的风险。与阿司匹林治疗相比,华法林治疗与更好的肝功能保护和肾功能改善相关。

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