Bunnapradist Suphamai, Daswani Adarsh, Takemoto Steven K
Multiorgan Transplant Program, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Transplantation. 2003 Jul 15;76(1):10-5. doi: 10.1097/01.TP.0000079965.62765.1A.
Registry databases offer the statistical power to analyze differences in graft survival rates that may not be detected in randomized clinical trials. This study analyses 2-year graft survival using tacrolimus (tac) or cyclosporine (CsA) with mycophenolate mofetil (MMF) and steroids.
Data reported to the United Network for Organ Sharing Renal Transplant Registry for living-donor kidney patients receiving a transplant during 1998 to 1999 were included. The primary end point was graft survival after adjustment for confounding variables. A Cox model multivariate analysis was used to adjust for potential confounding factors.
Patients receiving CsA-MMF (n=4,686) and tac-MMF (n=2,393) were included. Unadjusted all-cause 2-year graft survival rate was significantly higher with CsA-MMF than tac-MMF (94.3% vs. 92.2%, P=0.0006). After adjustment for potential confounding factors, risk of graft failure at 2 years was significantly higher in patients receiving tac-MMF versus CsA-MMF for both all-cause graft failure (hazards ratio [HR] 1.28, 95% confidence interval [CI] 1.09-1.49, P=0.002) and death-censored graft failure (HR 1.25, 95% CI 1.05-1.49, P=0.013). Other independent risk factors for graft failure were recipient or donor age greater than 55 years, female sex, pretransplant blood transfusions, one or two haplotype mismatches compared with zero haplotype mismatch, and panel reactive antibody (PRA) greater than 30%.
Our findings demonstrate that 2-year renal allograft survival is significantly higher in living-donor recipients receiving CsA compared with tac as initial immunosuppression in combination with MMF.
登记数据库具备强大的统计能力,可分析在随机临床试验中可能无法检测到的移植物存活率差异。本研究分析了使用他克莫司(tac)或环孢素(CsA)联合霉酚酸酯(MMF)和类固醇时的2年移植物存活率。
纳入向器官共享联合网络肾移植登记处报告的1998年至1999年期间接受移植的活体供肾患者的数据。主要终点是在对混杂变量进行调整后的移植物存活率。采用Cox模型多变量分析来调整潜在的混杂因素。
纳入了接受CsA-MMF(n = 4686)和tac-MMF(n = 2393)的患者。未调整的全因2年移植物存活率CsA-MMF显著高于tac-MMF(94.3%对92.2%,P = 0.0006)。在对潜在混杂因素进行调整后,接受tac-MMF的患者在2年时全因移植物失败(风险比[HR] 1.28,95%置信区间[CI] 1.09 - 1.49,P = 0.002)和死亡审查的移植物失败(HR 1.25,95% CI 1.05 - 1.49,P = 0.013)的移植物失败风险显著高于接受CsA-MMF的患者。移植物失败的其他独立风险因素包括受者或供者年龄大于55岁、女性、移植前输血、与零单倍型错配相比有一或两个单倍型错配以及群体反应性抗体(PRA)大于30%。
我们的研究结果表明,在联合MMF作为初始免疫抑制的情况下,活体供肾受者接受CsA时2年肾移植存活率显著高于接受tac时。