Ishida Hideki, Takahara Shiro, Amada Noritoshi, Tomikawa Shinji, Chikaraishi Tatsuya, Takahashi Kota, Uchida Kazuhiro, Akiyama Takahiro, Tanabe Kazunari, Toma Hiroshi
rom the Department of Urology, Tokyo Women's Medical University Hospital, Tokyo Shinjuku, Japan.
Exp Clin Transplant. 2016 Oct;14(5):518-525.
Our objectives were to compare the clinical outcomes of mizoribine (12 mg/kg/d) and mycophenolate mofetil (2000 mg/d) in combination with tacrolimus, basiliximab, and corticosteroids.
We enrolled 83 recipients of living-donor renal transplant (performed between 2008 and 2013) in this study. This prospective multi-institutional randomized comparative study compared mizoribine (n = 41) and mycophenolate mofetil (n = 42) in combination with tacrolimus, basiliximab, and corticosteroids for living-donor renal transplant recipients. We compared the acute rejection and graft survival rates and adverse event rates within 1 year of renal transplant between the 2 groups using intention-to-treat analyses.
During the 1-year observation period, patient and graft survival rates were 100%. The acute rejection rate was 17.1% in the mizoribine group and 19% in the mycophenolate mofetil group. The incidence rate of cytomegalovirus infection seropositivity (recipient and donor with positive cytomegalovirus antibody status) was higher in the mycophenolate mofetil group than in the mizoribine group, although the difference in these rates was not statistically significant. The incidence of leukopenia was higher in the mizoribine group than in the mycophenolate mofetil group.
High-dose mizoribine at 12 mg/kg/day was a safe and efficacious immunosuppressive alternative to mycophenolate mofetil in living-donor renal transplant recipients. Leukopenia should be closely monitored in the initial period of insufficient kidney function after renal transplant.
我们的目的是比较咪唑立宾(12毫克/千克/天)和霉酚酸酯(2000毫克/天)联合他克莫司、巴利昔单抗和皮质类固醇的临床疗效。
我们在本研究中纳入了83例活体供肾移植受者(于2008年至2013年间进行手术)。这项前瞻性多机构随机对照研究比较了咪唑立宾(n = 41)和霉酚酸酯(n = 42)联合他克莫司、巴利昔单抗和皮质类固醇用于活体供肾移植受者的情况。我们采用意向性分析比较了两组肾移植术后1年内的急性排斥反应、移植物存活率及不良事件发生率。
在1年的观察期内,患者和移植物存活率均为100%。咪唑立宾组的急性排斥反应率为17.1%,霉酚酸酯组为19%。霉酚酸酯组巨细胞病毒感染血清学阳性(受者和供者巨细胞病毒抗体状态均为阳性)的发生率高于咪唑立宾组,尽管这些发生率的差异无统计学意义。咪唑立宾组白细胞减少症的发生率高于霉酚酸酯组。
对于活体供肾移植受者,12毫克/千克/天的高剂量咪唑立宾是一种安全有效的霉酚酸酯免疫抑制替代药物。肾移植术后肾功能不全初期应密切监测白细胞减少症。