在肾移植中使用 LCP-Tacrolimus (LCPT):临床专家德尔菲共识调查。

IF 1.1 4区 医学 Q3 SURGERY Annals of Transplantation Pub Date : 2024-03-12 DOI:10.12659/AOT.943498
Alexander Wiseman, Tarek Alhamad, Rita R Alloway, Beatrice P Concepcion, Matthew Cooper, Richard Formica, Christina L Klein, Vineeta Kumar, Nicolae Leca, Fuad Shihab, David J Taber, Sarah Mulnick, Donald M Bushnell, Monica Hadi, Suphamai Bunnapradist
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引用次数: 0

摘要

背景 LCPT(Envarsus XR®)是肾移植中常用的一种每日一次的缓释口服他克莫司制剂。然而,关于肾移植和肾移植转归中的最佳剂量和治疗方法的循证建议却少之又少。材料和方法 12 位具有 LCPT 经验的肾移植专家采用德尔菲法对现有数据进行了审查,以确定可能达成共识的主题。通过在线德尔菲调查生成了有关 LCPT 使用的关键声明并分发给专家小组。根据共识程度、感知的证据强度以及与临床实践的一致性,对声明进行接受、修改或拒绝。共识的先验定义为≥75%的一致意见。结果 产生了 23 项声明:其中 14 项声明侧重于 LCPT 的重新使用,9 项声明侧重于一般管理或 LCPT 的转换使用。经过两轮讨论,前者的 11/14 份声明和后者的 7/9 份声明达成了共识。与速释他克莫司相比,LCPT 具有安全性和有效性,因此被认为是新用药的一线选择。特别是非裔美国人和快速代谢人群被认为是 LCPT 一线治疗的首选。在转换治疗中,针对速释他克莫司引起的神经系统不良反应以及达到稳态 LCPT 谷值水平所需的时间(约 7 天),患者完全同意转用 LCPT。结论 当随机临床试验无法复制当前的使用模式时,德尔菲流程可以成功地由临床专家达成共识,为肾移植受者使用 LCPT 的临床决策提供依据。
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Use of LCP-Tacrolimus (LCPT) in Kidney Transplantation: A Delphi Consensus Survey of Expert Clinicians.

BACKGROUND LCPT (Envarsus XR®) is a common once-daily, extended-release oral tacrolimus formulation used in kidney transplantation. However, there are minimal evidence-based recommendations regarding optimal dosing and treatment in the de novo and conversion settings. MATERIAL AND METHODS Using Delphi methodology, 12 kidney transplantation experts with LCPT experience reviewed available data to determine potential consensus topics. Key statements regarding LCPT use were generated and disseminated to the panel in an online Delphi survey. Statements were either accepted, revised, or rejected based on the level of consensus, perceived strength of evidence, and alignment with clinical practice. Consensus was defined a priori as ≥75% agreement. RESULTS Twenty-three statements were generated: 14 focused on de novo LCPT use and 9 on general administration or LCPT conversion use. After 2 rounds, consensus was achieved for 11/14 of the former and 7/9 of the latter statements. In a de novo setting, LCPT was recognized as a first-line option based on its safety and efficacy compared to immediate-release tacrolimus. In particular, African Americans and rapid metabolizer populations were identified as preferred for first-line LCPT therapy. In a conversion setting, full consensus was achieved for converting to LCPT to address neurological adverse effects related to immediate-release tacrolimus and for the time required (approximately 7 days) for steady-state LCPT trough levels to be reached. CONCLUSIONS When randomized clinical trials do not replicate current utilization patterns, the Delphi process can successfully generate consensus statements by expert clinicians to inform clinical decision-making for the use of LCPT in kidney transplant recipients.

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来源期刊
CiteScore
2.50
自引率
0.00%
发文量
79
审稿时长
>12 weeks
期刊介绍: Annals of Transplantation is one of the fast-developing journals open to all scientists and fields of transplant medicine and related research. The journal is published quarterly and provides extensive coverage of the most important advances in transplantation. Using an electronic on-line submission and peer review tracking system, Annals of Transplantation is committed to rapid review and publication. The average time to first decision is around 3-4 weeks. Time to publication of accepted manuscripts continues to be shortened, with the Editorial team committed to a goal of 3 months from acceptance to publication. Expert reseachers and clinicians from around the world contribute original Articles, Review Papers, Case Reports and Special Reports in every pertinent specialty, providing a lot of arguments for discussion of exciting developments and controversies in the field.
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