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在肾移植中使用 LCP-他克莫司(LCPT):专家临床医生的 Delphi 共识调查。

Use of LCP-Tacrolimus (LCPT) in Kidney Transplantation: A Delphi Consensus Survey of Expert Clinicians.

机构信息

AdventHealth Transplant Institute, Porter Adventist Hospital, Denver, CO, USA.

Division of Nephrology, Washington University School of Medicine in St. Louis, Saint Louis, MO, USA.

出版信息

Ann Transplant. 2024 Mar 12;29:e943498. doi: 10.12659/AOT.943498.

Abstract

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.

摘要

背景

LCPT(Envarsus XR®)是一种常用的每日一次、延长释放的口服他克莫司制剂,用于肾移植。然而,在初次使用和转换治疗方面,几乎没有基于证据的推荐意见。

方法

使用 Delphi 方法,12 名具有 LCPT 经验的肾移植专家回顾了可用数据,以确定潜在的共识主题。生成了关于 LCPT 使用的关键陈述,并在在线 Delphi 调查中向专家组分发。根据共识程度、证据的感知强度以及与临床实践的一致性,陈述被接受、修改或拒绝。共识预先定义为≥75%的一致性。

结果

生成了 23 项陈述:14 项侧重于初次使用 LCPT,9 项侧重于一般管理或 LCPT 转换使用。经过两轮,14 项中的前 11 项和 9 项中的后 7 项达成了共识。在初次使用的情况下,LCPT 被认为是一种一线选择,因为它与即时释放的他克莫司相比具有安全性和疗效。特别是,非裔美国人和快速代谢人群被认为是一线 LCPT 治疗的首选人群。在转换治疗方面,对于转换为 LCPT 以解决与即时释放的他克莫司相关的神经不良反应,以及达到 LCPT 稳定状态谷浓度所需的时间(约 7 天),达成了完全共识。

结论

当随机临床试验无法复制当前的使用模式时,Delphi 过程可以通过专家临床医生成功生成共识陈述,为肾移植受者使用 LCPT 提供临床决策依据。

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