Hakimi Zalmai, Aballéa Samuel, Ferchichi Sameh, Scharn Micky, Odeyemi Isaac A, Toumi Mondher, Saliba Faouzi
HEOR, Astellas Pharma Global Development, Leiden, The Netherlands.
HEOR, Creativ-Ceutical, Paris, France.
Transpl Infect Dis. 2017 Oct;19(5). doi: 10.1111/tid.12732. Epub 2017 Jul 21.
We investigated the impact of early- (E-CMV) and late onset (L-CMV) cytomegalovirus disease on the probability of graft rejection, graft failure, mortality, and healthcare resource use, following solid organ transplantation (SOT) in France.
A retrospective analysis of data from the French 'Programme de Médicalisation des Systèmes d'Information' database (2007-2011) was conducted to identify SOT recipients who developed CMV disease in an inpatient setting. Recipients were stratified by time to CMV disease onset: E-CMV (≤3 months), L-CMV-3M (>3-24 months), and L-CMV-6M (>6-24 months). Data were analyzed by comparing recipients with CMV disease or without (controls) in a 1:2 ratio, matched according to age, gender, target organ, and previous/simultaneous occurrence of graft rejection. Graft failure, graft rejection, all-cause in-hospital mortality, and resource utilization (including hospitalization costs) were assessed over 12 months following CMV disease diagnosis.
Among 20 473 SOT recipients, 2430 (11.86%) were reported to have CMV disease within 24 months after transplantation. CMV disease was significantly associated with an increased risk of graft rejection and mortality, as indicated by logistic regression analysis. Odd ratios (ORs) for the risk of graft rejection were E-CMV=1.43, L-CMV-3M=1.50, and L-CMV-6M=1.61 (all P<.05), while ORs for mortality were E-CMV=2.85, L-CMV-3M=4.22, and L-CMV-6M=4.77 (all P<.0001). Only L-CMV was significantly correlated with a higher risk of graft failure: E-CMV=1.18 (P=.1906), L-CMV-3M=1.77 (P=.0013), and L-CMV-6M=3.12 (P<.0001). Hospitalization costs increased by €7078 (range €6270-€22 111), €6523 (range €5328-€10 295), and €6311 (range €5295-€9184) in recipients with E-CMV, L-CMV-3M, and L-CMV-6-M, respectively.
This study, based on French national data, demonstrates the considerable burden of CMV disease in SOT recipients and highlights the importance of developing new strategies to prevent and manage CMV disease and improve clinical outcomes for SOT patients.
我们调查了法国实体器官移植(SOT)后早期(E-CMV)和迟发性(L-CMV)巨细胞病毒病对移植排斥、移植失败、死亡率及医疗资源利用可能性的影响。
对法国“信息系统医疗化计划”数据库(2007 - 2011年)的数据进行回顾性分析,以确定在住院环境中发生巨细胞病毒病的SOT受者。受者按巨细胞病毒病发病时间分层:E-CMV(≤3个月)、L-CMV-3M(>3 - 24个月)和L-CMV-6M(>6 - 24个月)。通过以1:2的比例比较患有巨细胞病毒病的受者与未患该病的受者(对照组)进行数据分析,根据年龄、性别、目标器官以及既往/同时发生的移植排斥情况进行匹配。在巨细胞病毒病诊断后的12个月内评估移植失败、移植排斥、全因住院死亡率及资源利用情况(包括住院费用)。
在20473名SOT受者中,有2430名(11.86%)报告在移植后24个月内发生了巨细胞病毒病。逻辑回归分析表明,巨细胞病毒病与移植排斥和死亡率风险增加显著相关。移植排斥风险的比值比(OR)分别为:E-CMV = 1.43,L-CMV-3M = 1.50,L-CMV-6M = 1.61(均P <.05),而死亡率的OR分别为:E-CMV = 2.85,L-CMV-3M = 4.22,L-CMV-6M = 4.77(均P <.0001)。仅L-CMV与移植失败风险较高显著相关:E-CMV = 1.18(P = 0.1906),L-CMV-3M = 1.77(P = 0.0013),L-CMV-6M = 3.12(P <.0001)。E-CMV、L-CMV-3M和L-CMV-6M受者的住院费用分别增加了7078欧元(范围为6270 - 22111欧元)、6523欧元(范围为5328 - 10295欧元)和6311欧元(范围为5295 - 9184欧元)。
这项基于法国国家数据的研究表明,SOT受者中巨细胞病毒病负担较重,并强调了制定新策略以预防和管理巨细胞病毒病并改善SOT患者临床结局的重要性。