Andrade-Sierra J, Rojas-Campos E, Cardona-Muñoz E, Evangelista-Carrillo L A, Gómez-Navarro B, González-Espinoza E, Lugo-Lopez O, Cerrillos-Gutiérrez J I, Medina-Pérez M, Jalomo-Martínez B, Nieves-Hernández J J, Sandoval M, Abundis-Jiménez J R, Ramírez-Robles J N, Villanueva-Pérez M A, Monteón-Ramos F, Cueto-Manzano A M
Medical Research Unit in Renal Diseases, Guadalajara, Jalisco, Mexico; Department of Nephrology and Organ Transplant Unit of the Specialties Hospital, Western National Medical Center, Mexican Social Security Institute (IMSS), Guadalajara, Jalisco, Mexico; Department of Physiology, Centro Universitario de Ciencias de la Salud, University of Guadalajara, Guadalajara, Jalisco, Mexico.
Medical Research Unit in Renal Diseases, Guadalajara, Jalisco, Mexico.
Transplant Proc. 2016 Jan-Feb;48(1):42-9. doi: 10.1016/j.transproceed.2015.12.013.
Early steroid withdrawal (ESW) can improve lipid and hemodynamic profiles without severe acute rejection (AR) events in renal transplant patients. Our objective was to evaluate the effects of ESW on the frequency and severity of AR.
A randomized, open-label, controlled clinical trial was performed on renal transplant recipients with a follow-up of 12 months. In the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth day post transplantation. In the Control group, patients continued with steroid treatment. All patients were over 18 years of age with panel reactive antibody (PRA) class I and II HLA <20%.
In total, 71 patients, 37 in the ESW group (52.1%) and 34 in the Control group (47.9%), had comparable AR incidences at the end of the follow-up (16% vs 15%) (NS) (RR = 1.20, 95% CI = 0.32-3.33). Although renal graft survival was similar between the ESW and Control groups (87% vs 94%), renal function was superior in the ESW group (85 vs 75 mL/min). Additionally, hypertension was less frequent in the ESW group (3% vs 35%), requiring the use of fewer antihypertensives (8% vs 50%).
ESW was also associated with better blood pressure control and similar AR risk. The ESW group exhibited stable renal function.
早期停用类固醇(ESW)可改善肾移植患者的血脂和血流动力学指标,且不会发生严重的急性排斥反应(AR)事件。我们的目的是评估ESW对AR发生频率和严重程度的影响。
对肾移植受者进行了一项随机、开放标签的对照临床试验,随访12个月。在ESW组,患者在移植后第5天被选定停用皮质类固醇治疗。在对照组,患者继续接受类固醇治疗。所有患者年龄均超过18岁,群体反应性抗体(PRA)I类和II类人类白细胞抗原(HLA)<20%。
总共71例患者,ESW组37例(52.1%),对照组34例(47.9%),随访结束时AR发生率相当(16%对15%)(无显著性差异)(相对危险度=1.20,95%置信区间=0.32-3.33)。虽然ESW组和对照组的肾移植存活率相似(87%对94%),但ESW组的肾功能更好(85对75毫升/分钟)。此外,ESW组高血压发生率较低(3%对35%),需要使用的降压药较少(8%对50%)。
ESW还与更好的血压控制和相似的AR风险相关。ESW组肾功能稳定。