Ueda Kimi, McCague Kevin M, Wiland Anne, Peddi V Ram
Department of Transplantation, California Pacific Medical Center, San Francisco, USA.
Novartis Pharmaceuticals Corporation, East Hanover, USA.
Ann Transplant. 2014 Feb 17;19:84-92. doi: 10.12659/AOT.889706.
Prospective, long-term data on corticosteroid withdrawal (CSW) versus corticosteroid continuation (CSC) following kidney transplantation are scarce.
MATERIAL/METHODS: The Mycophenolic Renal Transplant (MORE) Registry was a prospective, observational study of de novo kidney transplant patients receiving mycophenolic acid (MPA) and standard of care. Adult patients receiving tacrolimus and enteric-coated mycophenolate sodium (EC-MPS) or mycophenolate mofetil (MMF) at time of transplant were analyzed to 4 years according to CSW by month 3 (n=363) or CSC (n=509).
In the CSW and CSC groups, 3.3% and 13.0% had undergone retransplantation (p<0.001), 89.9% and 77.0% had panel reactive antibodies <30% (p<0.001), and 72.5% and 87.2% received pretransplant dialysis (p<0.001), respectively. Rabbit antithymocyte induction was used in 62.3% of CSW patients and 58.6% of CSC patients (p=0.015), and alemtuzumab in 23.7% and 4.7%, respectively (p=0.002). At all time points to 3 years post-transplant, significantly fewer CSW patients were maintained on the full recommended dose of MPA versus CSC patients. Biopsy-proven acute rejection occurred in 10.1% and 14.3% of CSW and CSC patients (p=0.12), graft survival was 96.9% versus 93.7% (p=0.030), and patient survival was 95.6% versus 95.0% (p=0.65), respectively. Adverse events were similar except for leukopenia (CSW 60.6%, CSC 29.9%; p<0.001) and neutropenia (CSW 17.4%, CSC 11.4%; p=0.013), with infections in 24.8% and 30.8% of CSW and CSC patients, respectively (p=0.057).
CSW patients were less likely to receive the full dose of MPA than CSC patients, possibly due to induction-related hematological toxicity. Graft survival to 4 years post-transplant was superior in CSW patients.
关于肾移植后皮质类固醇撤减（CSW）与皮质类固醇持续使用（CSC）的前瞻性长期数据稀缺。
材料/方法：霉酚酸肾移植（MORE）注册研究是一项对接受霉酚酸（MPA）和标准治疗的初发肾移植患者进行的前瞻性观察性研究。对移植时接受他克莫司和肠溶包衣的霉酚酸钠（EC-MPS）或霉酚酸酯（MMF）的成年患者，根据第3个月时的CSW（n = 363）或CSC（n = 509）情况进行4年分析。
在CSW组和CSC组中，分别有3.3%和13.0%的患者接受了再次移植（p<0.001），89.9%和77.0%的患者群体反应性抗体<30%（p<0.001），以及72.5%和87.2%的患者在移植前接受了透析（p<0.001）。62.3%的CSW患者和58.6%的CSC患者使用了兔抗胸腺细胞诱导剂（p = 0.015），分别有23.7%和4.7%的患者使用了阿仑单抗（p = 0.002）。在移植后至3年的所有时间点，与CSC患者相比，维持全推荐剂量MPA的CSW患者显著更少。活检证实的急性排斥反应在CSW组和CSC组患者中的发生率分别为10.1%和14.3%（p = 0.12），移植肾存活率分别为96.9%和93.7%（p = 0.030），患者存活率分别为95.6%和95.0%（p = 0.65）。除白细胞减少（CSW组60.6%，CSC组29.9%；p<0.001）和中性粒细胞减少（CSW组17.4%，CSC组11.4%；p = 0.013）外，不良事件相似，CSW组和CSC组患者的感染率分别为24.8%和30.8%（p = 0.057）。
与CSC患者相比，CSW患者接受全剂量MPA的可能性较小，可能是由于诱导相关的血液学毒性。移植后4年CSW患者的移植肾存活率更高。
