Tan H P, Donaldson J, Basu A, Unruh M, Randhawa P, Sharma V, Morgan C, McCauley J, Wu C, Shah N, Zeevi A, Shapiro R
The Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Am J Transplant. 2009 Feb;9(2):355-66. doi: 10.1111/j.1600-6143.2008.02492.x. Epub 2008 Dec 15.
Alemtuzumab has been used in off-label studies of solid organ transplantation. We extend our report of the first 200 consecutive living donor solitary kidney transplantations under alemtuzumab pretreatment with tacrolimus monotherapy and subsequent spaced weaning to 3 years of follow-up. We focused especially on the causes of recipient death and graft loss, and the characteristics of rejection. The actuarial 1-, 2- and 3-year patient and graft survivals were 99.0% and 98.0%, 96.4% and 90.8% and 93.3% and 86.3%, respectively. The cumulative incidence of acute cellular rejection (ACR) at the following months was 2%</=6, 9.0%</=12, 16.5%</=18, 19.5%</=24, 23.5%</=30, 24.0%</=36 and 25%</=42. The mean serum creatinine (mg/dL) and glomerular filtration rate (mL/min/1.73 m(2)) at 1 and 3 years were 1.4 +/- 0.6 and 58.7 +/- 21.6 and 1.5 +/- 0.7 and 54.9 +/- 20.9, respectively. Fifty (25%) recipients had a total of 89 episodes of ACR. About 88.7% of ACR episodes were Banff 1, and of those, 82% were steroid-sensitive. Nine (4.5%) recipients had antibody-mediated rejection (AMR). About 76.5% were weaned but only 46% are currently on spaced dose (qod or less) tacrolimus monotherapy, and 94.4% remained steroid-free from the time of transplantation. Infectious complications were uncommon. This experience suggests the 3-year efficacy of this approach.
阿仑单抗已用于实体器官移植的非标签研究。我们扩展了关于前200例连续活体供者单肾移植的报告,这些移植在阿仑单抗预处理、他克莫司单药治疗及随后的间隔撤药方案下进行,并随访3年。我们特别关注受者死亡和移植物丢失的原因以及排斥反应的特征。1年、2年和3年的患者及移植物精算生存率分别为99.0%和98.0%、96.4%和90.8%、93.3%和86.3%。在接下来几个月中急性细胞排斥反应(ACR)的累积发生率分别为:≤6个月时为2%,≤12个月时为9.0%,≤18个月时为16.5%,≤24个月时为19.5%,≤30个月时为23.5%,≤36个月时为24.0%,≤42个月时为25%。1年和3年时的平均血清肌酐(mg/dL)和肾小球滤过率(mL/min/1.73 m²)分别为1.4±0.6和58.7±21.6以及1.5±0.7和54.9±20.9。50例(25%)受者共发生89次ACR发作。约88.7%的ACR发作属于班夫1级,其中82%对类固醇敏感。9例(4.5%)受者发生抗体介导的排斥反应(AMR)。约76.5%的患者已撤药,但目前仅46%接受间隔剂量(隔日或更低)他克莫司单药治疗,94.4%自移植后一直未使用类固醇。感染并发症并不常见。该经验表明了这种方法的3年疗效。