肾移植12个月时，比较不同KDPI范围供体中他克莫司与霉酚酸酯联用他克莫司与mTOR抑制剂的肾功能。一项使用倾向评分的多中心队列研究。
Renal function at 12 months of kidney transplantation comparing tacrolimus and mycophenolate with tacrolimus and mTORi in donors with different KDPI ranges. A multicenter cohort study using propensity scoring.
作者信息
Rodrigues Arlisson Macedo, Tanno Mariana Tavares, Contti Mariana Moraes, Nga Hong Si, Valiatti Mariana Farina, Costa Silvana Daher, de Sandes-Freitas Tainá Veras, Esmeraldo Ronaldo de Matos, Assunção Camila Marinho, Tassi Juliana Bastos Campos, Ferreira Gustavo Fernandes, Felipe Claudia Rosso, Medina Pestana Jose Osmar, Silva Helio Tedesco, de Andrade Luis Gustavo Modelli
机构信息
Division of Nephrology, Department of Internal Medicine, Universidade Estadual Paulista (UNESP), Botucatu, Brazil.
Transplant Unit, Hospital Geral de Fortaleza, Fortaleza, Brazil.
出版信息
Front Transplant. 2023 Oct 16;2:1279940. doi: 10.3389/frtra.2023.1279940. eCollection 2023.
INTRODUCTION
The combination of tacrolimus/mTORi compared to tacrolimus/mycophenolate (MMF) was shown to be safe in the TRANSFORM trial. For donors with a high KDPI (Kidney Donor Profile Index), however, there are no data to support the effectiveness of this regimen. The main objective of this study was to explore the influence of the KDPI on 12-month renal function (eGFR) in patients receiving mTORi or MMF.
METHODS
Multicenter cohort study of four Brazilian services that use the tacrolimus with mTORi as a protocol. Data from 2008 to 2018 of the tacrolimus/mycophenolate (MMF) and tacrolimus/mTORi (mTORi) regimens in renal transplant recipients over 18 years old were collected. For better homogeneity, the propensity score was used. Afterward, the method used for group selection ("match") was the K-nearest neighbor (KNN) method. New analyses were performed on this new balanced sample, and two different subsamples were constituted based on the median KDPI.
RESULTS
The global analysis ( = 870) showed that the major determinant of worse kidney function was high KDPI. Afterward, the three strata were analyzed. In the first stratum (KDPI up to 50), 242 patients were evaluated, with 121 in each group. The eGFR was 64 ml/min/1.73 m2 in the mTORi group compared to 63 in the MMF group, = 0.4, and when imputed eGFR was evaluated, 61 in the mTORi and 53 in the MMF, = 0.065. In the second stratum (KDPI from 50 to 85), 282 patients were evaluated, with 141 in each group. eGFR was 46 ml/min/1.73 m2 in mTORi compared to 48 in MMF, = 0.4, and when imputed eGFR was evaluated, 40 mTORi and 41 MMF, = 0.8. In the last stratum (KDPI higher than 85) with = 126 and 63 cases per group, eGFR was 36 ml/min/1.73 m2 in mTORi compared to 39 in MMF, = 0.2, and when imputed eGFR was evaluated, 30 mTORi and 34 MMF, = 0.2.
DISCUSSION
The regimen using mTOR inhibitor is an effective and safe regimen when compared to the standard regimen. In addition, the scheme seems to offer additional protection against infections and may be an important ally in cases of high risk for these pathologies.
引言
在TRANSFORM试验中，与他克莫司/霉酚酸酯（MMF）相比，他克莫司/mTOR抑制剂的联合用药被证明是安全的。然而，对于肾脏供体风险指数（KDPI）较高的供体，尚无数据支持该方案的有效性。本研究的主要目的是探讨KDPI对接受mTOR抑制剂或MMF治疗患者12个月肾功能（估算肾小球滤过率[eGFR]）的影响。
方法
对巴西四个将他克莫司与mTOR抑制剂作为方案用药的机构进行多中心队列研究。收集了2008年至2018年18岁以上肾移植受者使用他克莫司/霉酚酸酯（MMF）和他克莫司/mTOR抑制剂（mTORi）方案的数据。为了更好地保证同质性，使用了倾向评分。之后，用于组选择（“匹配”）的方法是K近邻（KNN）方法。对这个新的平衡样本进行了新的分析，并根据KDPI中位数构成了两个不同的子样本。
结果
整体分析（n = 870）显示，肾功能较差的主要决定因素是高KDPI。之后，对三个分层进行了分析。在第一层（KDPI高达50），评估了242例患者，每组121例。mTORi组的eGFR为64 ml/min/1.73 m²，MMF组为63，p = 0.4，当评估估算eGFR时，mTORi组为61，MMF组为53，p = 0.065。在第二层（KDPI为50至85），评估了282例患者，每组141例。mTORi组的eGFR为46 ml/min/1.73 m²，MMF组为48，p = 0.4，当评估估算eGFR时，mTORi组为40，MMF组为41，p = 0.8。在最后一层（KDPI高于85），n = 126，每组63例，mTORi组的eGFR为36 ml/min/1.73 m²，MMF组为39，p = 0.2，当评估估算eGFR时，mTORi组为30，MMF组为34，p = 0.2。
讨论
与标准方案相比，使用mTOR抑制剂的方案是一种有效且安全的方案。此外，该方案似乎能提供额外的抗感染保护，在这些疾病高风险的情况下可能是一个重要的辅助手段。
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