连续静脉输注依诺肝素和皮下注射依诺肝素预防危重症患者血栓形成的血浆抗 FXa 浓度。一项随机临床试验。

Plasma anti-FXa concentration after continuous intravenous infusion and subcutaneous dosing of enoxaparin for thromboprophylaxis in critically ill patients. A randomized clinical trial.

机构信息

Tampere University Hospital, Critical Care Medicine Research Group, PO Box 2000, 33521 Tampere, Finland.

Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

出版信息

Thromb Res. 2017 Oct;158:71-75. doi: 10.1016/j.thromres.2017.08.014. Epub 2017 Aug 24.

DOI:10.1016/j.thromres.2017.08.014

PMID:28846877

Abstract

INTRODUCTION

In intensive care unit (ICU) patients, subcutaneous low-molecular weight heparin thromboprophylaxis results in lower plasma anti-factor Xa (anti-FXa) levels compared to general ward patients. The aim of this study was to examine whether enoxaparin thromboprophylaxis given as a continuous intravenous infusion (CII) results in more constant and predictable anti-FXa concentration than standard subcutaneous bolus (SCB) administration.

MATERIALS AND METHODS

This was a prospective, single-blind, multicenter, randomized controlled trial where ICU patients requiring thromboprophylaxis received enoxaparin either 40mg as a SCB once daily or 40mg as a CII over 24h for three consecutive days. The primary outcome was maximum serum anti-FXa concentration (C) within the first 24h; the secondary outcome was anti-FXa area under the curve (AUC). Trough level was measured at 72h.

RESULTS

Thirty-nine patients were included in the intention to treat analysis. The median anti-FXa C was 0.05 (interquartile range, IQR, 0.05-0.18) IU/ml in the CII group and 0.18 (IQR, 0.12-0.33) IU/ml in the SCB group (p=0.05). Median anti-FXa AUC was 1.20 (IQR, 0.98-2.88) in the CII and 1.54 (IQR, 1.22-4.12) in the SCB group (p=0.095). After 72h, 66.7% of patients in the CII group had a detectable anti-FXa concentration of >0.1IU/ml, compared with 16.7% in the SCB group (p=0.019).

CONCLUSIONS

Continuous infusion of enoxaparin led to lower anti-FXa C than standard SCB administration. No difference in anti-FXa AUC was detected.

摘要

简介

在重症监护病房（ICU）患者中，与普通病房患者相比，皮下给予低分子肝素进行血栓预防可导致较低的血浆抗因子 Xa（anti-FXa）水平。本研究的目的是检查依诺肝素作为连续静脉输注（CII）给药是否会比标准皮下注射（SCB）给药产生更稳定和可预测的抗-FXa 浓度。

材料和方法

这是一项前瞻性、单盲、多中心、随机对照试验，其中需要进行血栓预防的 ICU 患者接受依诺肝素 40mg 作为每日一次的 SCB 或连续 3 天 24 小时内输注 40mg 的 CII。主要结局是前 24 小时内的最大血清抗-FXa 浓度（C）；次要结局是抗-FXa 曲线下面积（AUC）。在 72 小时测量谷底水平。

结果

39 名患者被纳入意向治疗分析。CII 组的中位抗-FXa C 为 0.05（四分位距，IQR，0.05-0.18）IU/ml，SCB 组为 0.18（IQR，0.12-0.33）IU/ml（p=0.05）。CII 组的中位抗-FXa AUC 为 1.20（IQR，0.98-2.88），SCB 组为 1.54（IQR，1.22-4.12）（p=0.095）。72 小时后，CII 组 66.7%的患者抗-FXa 浓度>0.1IU/ml 可检测到，而 SCB 组为 16.7%（p=0.019）。