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对于囊性纤维化,妥布霉素的处方和监测是否存在跨国共识?对美国/加拿大、英国/爱尔兰和澳大利亚/新西兰目前的治疗药物监测实践的调查。

Is there a multinational consensus of tobramycin prescribing and monitoring for cystic fibrosis? Survey of current therapeutic drug monitoring practices in USA/Canada, UK/Ireland, and Australia/New Zealand.

机构信息

University of South Australia, Adelaide, South Australia, Australia

Flinders Medical Centre, Bedford Park, South Australia, Australia.

出版信息

Eur J Hosp Pharm. 2024 Jun 21;31(4):301-306. doi: 10.1136/ejhpharm-2022-003545.

Abstract

OBJECTIVES

Sophisticated scientific methods have facilitated dose individualisation with substantial advancements in therapeutic drug monitoring (TDM) practice. It is unclear whether these methods have translated to the clinical setting. This study aimed to determine current TDM practice for tobramycin monitoring in cystic fibrosis (CF) centres in the USA and Canada, UK and Ireland, and Australia and New Zealand due to a high prevalence of CF.

METHODS

A web-based survey was developed and circulated via CF specialist groups within the targeted geographical regions. Themes included centre demographics, tobramycin usage, dosing and infusion practices, TDM practices, and blood sampling methods.

RESULTS

In total 77 responses were received from 75 different CF centres over the 3-month evaluation period (October 2019-January 2020). Respondents were from the USA and Canada (60%), Australia and New Zealand (25%), and the UK and Ireland (15%). Tobramycin was used in 97% of sites, with an international variation in practice across all survey aspects including dosing and infusion practice. TDM-based dose adjustment in the UK and Ireland was most commonly based only on trough sample collection for avoidance of toxicity, where use of computer programs for targeting both efficacy and toxicity endpoints were most common in Australia and New Zealand. The underlying pharmacokinetic basis of that program was not known by 33% of sites who utilised a computer program for tobramycin dose individualisation.

CONCLUSION

There remains substantial heterogeneity in tobramycin management worldwide. Despite two decades of research into TDM of tobramycin, there has been a slow uptake of new technologies and evolution of practice. An improved understanding of TDM processes is required for translation of evidence-based research into clinical practice. International guidelines require updating due to the advances in research to support confidence in the changes in clinical practice.

摘要

目的

复杂的科学方法促进了剂量个体化,使治疗药物监测(TDM)实践取得了重大进展。目前尚不清楚这些方法是否已应用于临床环境。本研究旨在确定美国和加拿大、英国和爱尔兰以及澳大利亚和新西兰的囊性纤维化(CF)中心目前监测妥布霉素的 TDM 实践,因为 CF 的患病率很高。

方法

开发了一个基于网络的调查,并通过目标地理区域内的 CF 专家小组进行了分发。主题包括中心人口统计学、妥布霉素使用情况、给药和输注实践、TDM 实践以及血液采样方法。

结果

在 3 个月的评估期(2019 年 10 月至 2020 年 1 月)内,共收到来自 75 个不同 CF 中心的 77 份回复。受访者来自美国和加拿大(60%)、澳大利亚和新西兰(25%)以及英国和爱尔兰(15%)。97%的地点使用妥布霉素,所有调查方面的实践存在国际差异,包括给药和输注实践。在英国和爱尔兰,基于 TDM 的剂量调整最常见的仅基于谷值样本采集以避免毒性,而在澳大利亚和新西兰,最常见的是使用计算机程序针对疗效和毒性终点进行靶向。有 33%的使用计算机程序进行妥布霉素剂量个体化的地点并不知道该程序的潜在药代动力学基础。

结论

全球范围内妥布霉素管理仍存在很大差异。尽管在妥布霉素 TDM 方面进行了 20 年的研究,但新技术的采用和实践的发展仍然缓慢。需要更好地了解 TDM 过程,以便将循证研究转化为临床实践。由于支持临床实践变化的研究进展,国际指南需要更新。

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