咪唑啉
医学
霉酚酸酯
泌尿科
他克莫司
移植
入射(几何)
置信区间
肾移植
免疫抑制剂
不利影响
霉酚酸
内科学
随机对照试验
光学
物理
作者
Man Ki Ju,Kyu Ha Huh,K.T. Park,S.J. Kim,B.H. Cho,C.D. Kim,Byung Jun So,Chong Myung Kang,S. Lee,Dong Jin Joo,Y.S. Kim
标识
DOI:10.1016/j.transproceed.2012.12.028
摘要
The present study compared the efficacy and safety of mizoribine (MZR) with mycophenolate mofetil (MMF) in kidney transplantation. This multicenter, randomized clinical trial. Employed doses of study drug tailored to the immunosuppressive need. The primary efficacy outcome was the incidence of biopsy-proven acute rejection episodes (BPAR). The safety of the study drug was assessed using the incidences of adverse events, drug discontinuations, and abnormal laboratory results. The 7 (6.4%) BPARs above grade II were observed in the MZR group noninferior to the 2 (1.8%) in the MMF group (95% confidence interval, −0.007–0.097 > noninferiority limit [−0.2]). BPAR was significantly decreased in the MZR group after the dose change (17/41 [41.4%] vs 8/69 [11.6%]; P < .0001) and the incidence of BPAR was similar between the MZR and MMF groups after the dose change (P = .592). The uric acid level was significantly elevated in the MZR group (P = .002). In conclusion, the efficacy and safety of MZR were similar and statistically noninferior to MMF in combination therapy with tacrolimus.
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