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欧洲移植组织内关于在高度致敏患者中启用依姆利菲酶进行脑死亡供者肾移植的比利时共识指南。

Belgian Consensus Guidelines Within Eurotransplant on Imlifidase-enabled Deceased Donor Kidney Transplantation in Highly Sensitized Patients.

作者信息

Kuypers Dirk R J, Claas Frans H J, Bouquegneau Antoine, Buemi Antoine, de Fijter Johan W, Emonds Marie-Paule, Gambino Giuseppe, Gervais Thibaut, Gothot André, Holovska Vanda, Le Moine Alain, Massart Annick, Mikhalski Dimitri, Naesens Maarten, Pipeleers Lissa, Schmitt Justine, Streel Corentin, Van Laecke Steven, Weekers Laurent, Wissing Karl Martin, Kanaan Nada

机构信息

Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium.

Department of Microbiology, Immunology and Transplantation, University Hospitals Leuven, Belgium.

出版信息

Transplantation. 2025 Aug 1;109(8):1274-1283. doi: 10.1097/TP.0000000000005388. Epub 2025 May 5.

DOI:10.1097/TP.0000000000005388
PMID:40320582
Abstract

Highly sensitized (HS) kidney transplant (KTx) candidates, that is, typically considered internationally as those with panel-reactive antibody levels of >85%, remain a substantial subpopulation of patients with low chance of receiving a compatible organ. Among its many objectives, Eurotransplant-an international transplant organ allocation network serving 8 European countries-aims to improve the management of HS KTx candidates through its prioritized "acceptable mismatch" (AM) program. However, despite this program, some HS patients within the Eurotransplant network who have panel-reactive antibodies >85% still cannot access donor kidneys. For patients who remain in the AM program for ≥3 y without undergoing transplantation, an additional prioritization strategy has been implemented. This involves defining further AMs to allow for desensitization with imlifidase within the AM program. While the AM desensitization program was being developed, the Belgian Imlifidase Scientific Expert Group within the Eurotransplant network independently recognized the need for guidelines on imlifidase desensitization for real-world use in HS KTx candidates (including both AM and Eurotransplant Kidney Allocation System patients). This article describes the consensus guidelines they subsequently developed, which represent a model that any center within the Eurotransplant region could adapt or apply in clinical practice when treating HS KTx candidates who require imlifidase desensitization. The consensus guidelines include patient eligibility criteria for imlifidase treatment that align with Eurotransplant allocation rules and incorporate posttransplant management strategies for HS patients. These guidelines are dynamic and will be reviewed and updated regularly as Eurotransplant rules change and imlifidase experience grows.

摘要

高度致敏(HS)肾移植(KTx)候选人,即在国际上通常被视为群体反应性抗体水平>85%的患者,仍然是接受相容性器官机会较低的大量患者亚群。在其众多目标中,欧洲移植组织(一个为8个欧洲国家服务的国际移植器官分配网络)旨在通过其优先的“可接受错配”(AM)计划改善对HS KTx候选人的管理。然而,尽管有这个计划,欧洲移植网络中一些群体反应性抗体>85%的HS患者仍然无法获得供体肾脏。对于在AM计划中停留≥3年而未接受移植的患者,已实施了额外的优先排序策略。这涉及定义进一步的AM,以便在AM计划中使用依姆利酶进行脱敏。在开发AM脱敏计划时,欧洲移植网络内的比利时依姆利酶科学专家组独立认识到需要针对HS KTx候选人(包括AM和欧洲移植肾脏分配系统患者)实际应用依姆利酶脱敏的指南。本文描述了他们随后制定的共识指南,这些指南代表了欧洲移植区域内任何中心在治疗需要依姆利酶脱敏的HS KTx候选人时可在临床实践中采用或应用的模型。共识指南包括与欧洲移植分配规则一致的依姆利酶治疗患者资格标准,并纳入了HS患者的移植后管理策略。这些指南是动态的,将随着欧洲移植规则的变化和依姆利酶经验的增加而定期审查和更新。

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