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多粘菌素 B 制剂与治疗药物监测专家共识 专家意见小组:多粘菌素 B 长期使用的剂量方案和治疗药物监测

Expert Opinion on Dose Regimen and Therapeutic Drug Monitoring for Long-Term Use of Dalbavancin: Expert Review Panel.

机构信息

Infectious Diseases department, Gustave Dron Hospital, University of Lille, Tourcoing, France.

Department of Infectious Diseases, Hospital Clinic of Barcelona - IDIBAPS, University of Barcelona, Barcelona, Spain.

出版信息

Int J Antimicrob Agents. 2023 Nov;62(5):106960. doi: 10.1016/j.ijantimicag.2023.106960. Epub 2023 Aug 24.

Abstract

BACKGROUND

Dalbavancin is a lipoglycopeptide with a long elimination half-life and is currently licensed for the treatment of acute bacterial skin and skin structure infections in adults. Dalbavancin's potential in treating off-label complex Gram-positive infections is promising and real-world experience in treating such infections is growing. However, clear guidance on extended dosing regimens is lacking.

OBJECTIVES

This study aimed to provide clear expert opinion based on recent pharmacokinetic literature and expert and real-world experience in infection areas that require > 2 weeks of treatment.

METHODS

A single face-to-face meeting was held in September 2022 to collate expert opinion and present safety data of dalbavancin use in these clinical indications. A survey was completed by all authors on their individual experience with dalbavancin, which highlighted the heterogeneity in the regimens that were used.

RESULTS

After review of the survey data and recent literature, this study presents expert panel proposals that accommodate different healthcare settings and resource availability, and centre around the length of treatment duration including up to or exceeding 6 weeks. To achieve adequate dalbavancin concentrations for up to 6 weeks, 3000 mg of dalbavancin should be given over 4 weeks for the agreed complex infections requiring > 2 weeks of treatment. Therapeutic drug monitoring (TDM) is advised for longer treatment durations and in cases of renal failure. Specific dosing recommendations for other special populations require further investigation.

CONCLUSIONS

These proposals based on expert opinion have been defined to encourage best practice with dalbavancin, to optimise its administration beyond the current approved licenced dose across different healthcare settings.

摘要

背景

达巴万星是一种具有长消除半衰期的糖肽类抗生素,目前被批准用于治疗成人急性细菌性皮肤和皮肤结构感染。达巴万星治疗非适应证复杂革兰阳性感染的潜力很有前景,而且在治疗此类感染方面的真实世界经验也在不断增加。然而,目前缺乏关于延长给药方案的明确指导。

目的

本研究旨在根据最近的药代动力学文献以及感染领域的专家和真实世界经验,为需要 >2 周治疗的感染提供明确的专家意见。

方法

于 2022 年 9 月举行了一次面对面会议,以整理专家意见并介绍达巴万星在这些临床适应证中的安全性数据。所有作者都完成了一份关于他们个人使用达巴万星经验的调查,该调查突出了所使用方案的异质性。

结果

在审查了调查数据和最近的文献后,本研究提出了专家小组的建议,这些建议考虑到了不同的医疗保健环境和资源可用性,围绕治疗持续时间展开,包括长达或超过 6 周。为了在长达 6 周的时间内达到足够的达巴万星浓度,对于需要 >2 周治疗的复杂感染,应在 4 周内给予 3000mg 的达巴万星。建议在治疗时间较长和肾功能衰竭的情况下进行治疗药物监测(TDM)。其他特殊人群的特定剂量建议需要进一步研究。

结论

这些基于专家意见的建议旨在鼓励在不同的医疗保健环境中,以最佳实践方式使用达巴万星,在当前批准的许可剂量之外,优化其在不同医疗保健环境中的应用。

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