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一项随机对照试验,旨在确定早期从万古霉素换用万古霉素替代药物作为预防具有多种不良肾脏结局风险因素患者发生肾毒性的策略的疗效(STOP-NT)。

Randomized Controlled Trial to Determine the Efficacy of Early Switch From Vancomycin to Vancomycin Alternatives as a Strategy to Prevent Nephrotoxicity in Patients With Multiple Risk Factors for Adverse Renal Outcomes (STOP-NT).

作者信息

Carreno Joseph J, Kenney Rachel M, Divine George, Vazquez Jose A, Davis Susan L

机构信息

1 Henry Ford Hospital Department of Pharmacy Services, Detroit, MI, USA.

2 Wayne State University, Detroit, MI, USA.

出版信息

Ann Pharmacother. 2017 Mar;51(3):185-193. doi: 10.1177/1060028016673858. Epub 2016 Nov 13.

DOI:10.1177/1060028016673858
PMID:27838680
Abstract

BACKGROUND

Use of alternative antimicrobials to vancomycin is a potential strategy to reduce acute kidney injury (AKI) in high-risk patients, but current data do not support widespread adoption of this practice.

OBJECTIVE

To determine the efficacy of early switch to a nonnephrotoxic alternative for prevention of AKI in high-risk patients who receive vancomycin.

METHODS

This was an IRB-approved, prospective randomized controlled trial in a single, tertiary care academic medical center. Patients initially prescribed vancomycin between October 2011 to April 2013 with at least 2 risk factors for AKI were included. Treatment randomization was stratified by indication for therapy. Patients were randomized to continuation of dose-optimized vancomycin or early switch to an alternative antimicrobial agent. The primary end point was nephrotoxicity by consensus guideline definition adjudicated by blinded review; the secondary end point was AKI network-defined AKI.

RESULTS

A total of 103 patients were randomized; 100 were included in the modified intent-to-treat population, 51 in the vancomycin group and 49 in the alternative group. The incidence of nephrotoxicity was 6.1% in the alternative therapy arm and 9.8% in the vancomycin group ( P = 0.72). The incidence of AKI was 32.7% in the alternative therapy group and 31.4% in the vancomycin group ( P = 0.89).

CONCLUSIONS

No significant difference in nephrotoxicity or AKI was detected among patients treated with alternative antimicrobials compared with vancomycin. The use of alternative antimicrobial therapy instead of vancomycin solely for the purpose of preventing AKI in high-risk patients does not appear to be warranted.

摘要

背景

使用万古霉素以外的其他抗菌药物是降低高危患者急性肾损伤(AKI)的一种潜在策略,但目前的数据并不支持广泛采用这种做法。

目的

确定在接受万古霉素治疗的高危患者中,早期换用非肾毒性替代药物预防AKI的疗效。

方法

这是一项经机构审查委员会批准的前瞻性随机对照试验,在一家单一的三级医疗学术医学中心进行。纳入2011年10月至2013年4月期间最初开具万古霉素且至少有2个AKI危险因素的患者。治疗随机分组按治疗指征分层。患者被随机分为继续使用剂量优化的万古霉素或早期换用另一种抗菌药物。主要终点是根据共识指南定义经盲法审查判定的肾毒性;次要终点是急性肾损伤网络定义的AKI。

结果

共103例患者被随机分组;100例纳入改良意向性治疗人群,万古霉素组51例,替代组49例。替代治疗组肾毒性发生率为6.1%,万古霉素组为9.8%(P = 0.72)。替代治疗组AKI发生率为32.7%,万古霉素组为31.4%(P = 0.89)。

结论

与万古霉素治疗的患者相比,使用替代抗菌药物治疗的患者在肾毒性或AKI方面未检测到显著差异。仅为预防高危患者的AKI而使用替代抗菌治疗而非万古霉素似乎没有依据。

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