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低剂量华法林治疗改善永久性动静脉导管寿命的随机临床试验。

A Randomized Clinical Trial of Low-dose Warfarin Therapy for Improving the Longevity of Permanent Arteriovenous Catheters.

机构信息

Assistant Professor of Vascular Surgery, Department of Surgery, School of Medicine Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.

Resident of General Surgery, Department of Surgery, School of Medicine Al-Zahra Hospital Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

Ann Vasc Surg. 2021 May;73:165-170. doi: 10.1016/j.avsg.2020.11.032. Epub 2020 Dec 26.

Abstract

BACKGROUND

The patency of a permanent arteriovenous catheter plays a significant role in the functioning of the catheter among patients dependent on the hemodialysis. Thrombosis formation is one of the most critical reasons for the short-term efficacy of the embedded catheters. The present study aimed to evaluate the efficacy and safety of warfarin for hemodialysis catheter failure prevention.

METHODS

This randomized clinical trial has been conducted on patients under hemodialysis using a permanent arteriovenous catheter. The patients were randomly allocated to the control group and the intervention group. The intervention group was treated with warfarin to achieve a target international normalized ratio (INR) of 1.5-2. The control group did not receive any treatment. The patients were followed for 12 months to assess the efficacy defined as the incidence of catheter clotting and safety defined as warfarin-related hemorrhage.

RESULTS

Eighty-six patients with end-stage renal disease under hemodialysis were included, among which 43 ones were allocated to the intervention group and the latter ones to the control group. The participants of both groups were similar in terms of demographic, clinical, and baseline laboratory characteristics. Four patients (9.3%) presented with warfarin-induced hematoma, among which the warfarin administration stopped for 5.33 ± 1.44 days and then restarted again. None of the patients was forced to cease warfarin therapy because of significant hemorrhages. The mean duration of catheter functioning was 8.30 ± 1.75 months in the intervention group versus 3.90 ± 1.12 months in the controls (P-value<0.001).

CONCLUSIONS

Based on the findings of the present study, the use of warfarin to achieve an INR level of 1.5-2 could effectively lead to a longer duration of permanent hemodialysis catheter functioning.

摘要

背景

永久性动静脉导管的通畅性对依赖血液透析的患者的导管功能起着重要作用。血栓形成是导致嵌入式导管短期疗效不佳的最关键原因之一。本研究旨在评估华法林预防血液透析导管失效的疗效和安全性。

方法

这项随机临床试验是在使用永久性动静脉导管进行血液透析的患者中进行的。患者被随机分配到对照组和干预组。干预组接受华法林治疗,以达到目标国际标准化比值(INR)为 1.5-2。对照组未接受任何治疗。对患者进行了 12 个月的随访,以评估疗效定义为导管血栓形成的发生率和安全性定义为华法林相关出血。

结果

共纳入 86 例终末期肾病血液透析患者,其中 43 例患者被分配到干预组,43 例患者被分配到对照组。两组患者的人口统计学、临床和基线实验室特征相似。4 例患者(9.3%)出现华法林诱导性血肿,其中华法林的给药停止了 5.33±1.44 天,然后重新开始。没有患者因严重出血而被迫停止华法林治疗。干预组导管功能的平均持续时间为 8.30±1.75 个月,而对照组为 3.90±1.12 个月(P 值<0.001)。

结论

根据本研究的结果,使用华法林将 INR 水平控制在 1.5-2 可以有效地延长永久性血液透析导管的功能持续时间。

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