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老年肾移植患者低剂量西罗莫司与他克莫司联合应用:一项前瞻性随机对照试验

Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

作者信息

Kojima Cristiane Akemi, Nga Hong Si, Takase Henrique Mochida, Bravin Ariane Moyses, Martinez Garcia Márcia de Fátima Faraldo, Garcia Paula Dalsoglio, Contti Mariana Moraes, de Andrade Luis Gustavo Modelli

机构信息

Department of Internal Medicine, Univ Estadual Paulista, Botucatu, Brazil.

出版信息

Exp Clin Transplant. 2018 Jun;16(3):301-306. doi: 10.6002/ect.2016.0335. Epub 2017 Aug 28.

DOI:10.6002/ect.2016.0335
PMID:28836934
Abstract

OBJECTIVES

There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium.

MATERIALS AND METHODS

In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed.

RESULTS

Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups.

CONCLUSIONS

The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

摘要

目的

对于老年肾移植受者的最佳免疫抑制方案尚无共识。本研究的目的是评估与接受他克莫司/麦考酚钠的老年受者相比,接受低剂量雷帕霉素靶蛋白抑制剂西罗莫司/他克莫司治疗的老年受者的巨细胞病毒感染发生率和肾移植结局。

材料与方法

在这项单中心前瞻性随机研究(试验注册号:NCT02683291)中,60岁以上的肾移植受者被随机分为两组:他克莫司-西罗莫司组(21例患者)和他克莫司-麦考酚酯组(23例患者)。评估巨细胞病毒感染率、患者生存率、活检证实的急性排斥反应以及12个月时的肾功能。

结果

麦考酚酯组的巨细胞病毒感染率(60.9%)高于西罗莫司组(16.7%;P = 0.004)。两组之间活检证实的急性排斥反应率、患者生存率、移植物生存率以及12个月内的估计肾小球滤过率无显著差异。

结论

西罗莫司组的巨细胞病毒感染发生率显著较低。在老年肾移植受者中使用他克莫司联合西罗莫司是安全的。

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引用本文的文献

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Ann Transplant. 2021 Dec 29;26:e933588. doi: 10.12659/AOT.933588.
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Outcomes of sirolimus regimens in 65-year-old and older kidney transplant recipients: a registry-based observational study.65 岁及以上肾移植受者使用西罗莫司方案的结局:基于登记的观察性研究。
Int Urol Nephrol. 2019 Nov;51(11):2063-2072. doi: 10.1007/s11255-019-02251-w. Epub 2019 Aug 5.
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Effect of sirolimus on carotid atherosclerosis in kidney transplant recipients: data derived from a prospective randomized controlled trial.
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Clin Kidney J. 2018 Dec;11(6):846-852. doi: 10.1093/ckj/sfy041. Epub 2018 Jun 6.