Divisions of Transplant Surgery and.
Department of Pharmacy Services and.
Clin J Am Soc Nephrol. 2017 Jan 6;12(1):131-139. doi: 10.2215/CJN.04880516. Epub 2016 Dec 15.
There is continued debate whether early steroid withdrawal is safe to use in high-immunologic risk patients, such as blacks. The goal of this study was to use comparative effectiveness methodology to elucidate the safety of early steroid withdrawal in blacks with kidney transplants.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Our cohort study used United Network of Organ Sharing data including all adult black kidney transplant recipients from 2000 to 2009 followed through 2014. Propensity score matching was used to equalize baseline risk between continued steroid and early steroid withdrawal groups. Interaction terms were used to assess if the effect of early steroid withdrawal on outcomes varied by baseline and post-transplant factors. Of 26,582 eligible black patients with kidney transplants (5825 [21.9%] with early steroid withdrawal), 5565 patients with early steroid withdrawal were matched to 5565 blacks on continued steroid use.
Black patients with early steroid withdrawal had similar risk of graft loss (hazard ratio, 0.98; 95% confidence interval, 0.92 to 1.04; P=0.42) and lower risk of death (hazard ratio, 0.91; 95% confidence interval, 0.84 to 0.99; P=0.02), primarily driven by a late mortality advantage (>4 years post-transplant). Delayed graft function, cytolytic induction, tacrolimus, and mycophenolate significantly modified the effect of early steroid withdrawal on outcomes (P<0.05). Acute rejection rates were slightly higher in the continued steroid group (13.0% versus 11.3%, respectively; P<0.01), but this was not associated with graft or patient survival.
Overall, early steroid withdrawal in black kidney transplant recipients was not associated with graft loss but seemed to be associated with better long-term patient survival. Early steroid withdrawal in blacks not receiving cytolytic induction, tacrolimus, and mycophenolate or those with delayed graft function was associated with higher risk of graft loss and death.
对于高免疫风险患者(如黑人),早期停用类固醇是否安全仍存在争议。本研究旨在使用比较效果学方法阐明早期停用类固醇在黑人肾移植患者中的安全性。
设计、地点、参与者和测量方法:我们的队列研究使用了器官共享联合网络的数据,该数据包括 2000 年至 2009 年期间所有接受肾移植的成年黑人患者,并随访至 2014 年。使用倾向评分匹配来平衡继续使用类固醇和早期类固醇停药组之间的基线风险。使用交互项来评估早期类固醇停药对结局的影响是否因基线和移植后因素而异。在 26582 名符合条件的黑人肾移植患者中(5825 名[21.9%]接受早期类固醇停药),5565 名接受早期类固醇停药的患者与 5565 名继续使用类固醇的黑人患者相匹配。
早期接受类固醇停药的黑人患者移植肾丢失的风险相似(风险比,0.98;95%置信区间,0.92 至 1.04;P=0.42),死亡风险较低(风险比,0.91;95%置信区间,0.84 至 0.99;P=0.02),主要是由于晚期死亡率优势(移植后>4 年)。延迟的移植物功能、细胞溶解诱导、他克莫司和霉酚酸酯显著改变了早期类固醇停药对结局的影响(P<0.05)。继续使用类固醇组的急性排斥反应发生率略高(分别为 13.0%和 11.3%;P<0.01),但与移植物或患者存活率无关。
总体而言,黑人肾移植受者早期停用类固醇并不与移植物丢失相关,但似乎与长期患者存活率相关。未接受细胞溶解诱导、他克莫司和霉酚酸酯治疗或延迟移植物功能的黑人患者早期停用类固醇与移植物丢失和死亡风险增加相关。