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德国实体器官和造血干细胞移植后巨细胞病毒血症及疾病的患者数量和治疗模式:德尔菲共识研究结果

Patient Number and Treatment Patterns in Cytomegalovirus Viremia and Disease Following Solid Organ and Hematopoietic Stem Cell Transplantation in Germany: Results of a Delphi Consensus Study.

作者信息

Teschner Daniel, Knop Jana, Piehl Christian, Schubert Tino, Witzke Oliver

机构信息

Department of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany.

Department of Hematology, and Medical Oncology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.

出版信息

Adv Ther. 2025 May 22. doi: 10.1007/s12325-025-03210-x.

Abstract

INTRODUCTION

Management of cytomegalovirus (CMV) viremia/disease in transplant recipients may be complicated by toxicities and resistance to conventional antivirals, adding to the overall healthcare burden. Despite advances in analyzing real-world data in current years, little is known about refractory and resistant CMV. This study therefore aimed to characterize treatment patterns and patient numbers with special focus on refractory and resistant CMV.

METHODS

Two classical three-round Delphi consensus panels with German clinical experts in CMV following solid organ transplantations (SOT) and hematopoietic stem cell transplantations (HSCT) were held between October and December 2021 using online questionnaires. Consensus was defined as agreement of 75% of participants.

RESULTS

Following SOT, experts agreed that on average 65% of SOT patients are not affected by CMV at all, while 35% of patients experience CMV viremia or disease. Of SOT patients treated with antiviral therapies, experts agreed that 90% respond to their first-line treatment and 10% do not. For HSCT, experts agreed that 62% of patients experience no CMV, while 38% of patients are diagnosed with either CMV viremia or CMV disease. It was further estimated that 23% HSCT patients receiving antiviral treatment do not respond to their first-line CMV treatment. Experts reached consensus on the reasons for non-response, suggesting that among non-responders, 55% were intolerant, while 45% of non-responders were refractory/resistant to first-line treatment.

CONCLUSION

Based on the current incidence of transplantations in Germany, experts estimated that 103 SOT and 225 HSCT patients need second-line CMV treatment annually.

摘要

引言

移植受者巨细胞病毒(CMV)病毒血症/疾病的管理可能因传统抗病毒药物的毒性和耐药性而变得复杂,这增加了整体医疗负担。尽管近年来在分析真实世界数据方面取得了进展,但对于难治性和耐药性CMV仍知之甚少。因此,本研究旨在描述治疗模式和患者数量,特别关注难治性和耐药性CMV。

方法

2021年10月至12月期间,通过在线问卷对德国实体器官移植(SOT)和造血干细胞移植(HSCT)后CMV领域的临床专家进行了两轮经典的三轮德尔菲共识小组调查。共识定义为75%的参与者达成一致。

结果

SOT后,专家们一致认为,平均65%的SOT患者根本不受CMV影响,而35%的患者经历CMV病毒血症或疾病。在接受抗病毒治疗的SOT患者中,专家们一致认为90%对一线治疗有反应,10%没有反应。对于HSCT,专家们一致认为62%的患者没有CMV,而38%的患者被诊断为CMV病毒血症或CMV疾病。进一步估计,接受抗病毒治疗的HSCT患者中有23%对一线CMV治疗无反应。专家们就无反应的原因达成了共识,表明在无反应者中,55%不耐受,而45%的无反应者对一线治疗难治/耐药。

结论

根据德国目前的移植发病率,专家估计每年有103名SOT患者和225名HSCT患者需要二线CMV治疗。

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