Objective To evaluate the clinical efficacy and safety of reduced-dose tacrolimus (FK506 )in combination with increased-dose mycophenolate mofetil (MMF)after renal transplantation.Methods In this prospective study,52 patients undergoing renal transplantation for over 1 2 months in the Department of Organ Transplantation,Anhui Provincial Hospital from January 201 1 to January 201 3 were recruited.All participants were randomly divided into the intervention group and control group (n =26 in each group).In the intervention group,blood trough concentration of FK506 was adjusted to 2.0-4.5 ng/ml and oral dose of MMF was adjusted to 1 .5 g/d during 1 5 d after study.And in control group, blood trough concentration of FK506 was kept in 5.5-1 0.0 ng/ml and oral dose of MMF was 1 .0 g/d constantly.The changes of the glomerular filtration rate (GFR)and serum creatinine (Scr)at 0 d,1 5 d,and 2-,4-,6-,8-,1 0-,1 2-month after corresponding treatment were statistically compared between two groups.At 1 year after therapy,triglyceride, total cholesterol and 24 h urinary protein levels were measured and compared between two groups.Moreover,the incidence of adverse reactions was also statistically compared.Results During the period from 0 d to 1 2 months after treatment,GFR did not significantly change in the control group (P >0.05),whereas the value in the intervention group was considerably elevated (P <0.05).The changes in terms of the GFR at 8-,1 0-and 1 2-month after treatment significantly differed between two groups (all in P <0.05).From 0 d to 1 2 months after therapy,the levels of Scr were significantly decreased in two groups (both in P <0.05),and more apparent decline was noted in the intervention group.The changes in the Scr levels at 1 0 and 1 2 months after corresponding treatment significantly differed between two groups (both in P <0.05).At 1 2 months after therapy,there was no significant difference in the levels of total cholesterol,triglyceride and mean 24 h urinary protein between the control and intervention groups (all in P >0.05).No acute rejection or renal allograft dysfunction occurred in two groups.And there was no significant difference in the incidence of adverse reactions between the intervention and control groups (P >0.05).Conclusions Combined therapy of reduced-dose FK506 and increased-dose MMF is an efficacious and safe immunosuppressive therapy.%目的：评价肾移植术后予以减量他克莫司（FK506）联合加量吗替麦考酚酯（MMF）方案的疗效及安全性评价。方法本前瞻性研究中收集2011年1月至2013年1月期间在安徽省立医院器官移植科接受肾移植手术超过12个月的受者52例，随机分为干预组和对照组各26例。干预组在入组后15 d 内将 FK506血药谷浓度调整为2.0～4.5 ng／ml，MMF 的口服剂量调整为1.5 g／d；对照组入组后 FK506血药谷浓度保持不变，维持在5.5～10.0 ng／ml，MMF 的口服剂量仍保持1.0 g／d。比较两组治疗0、15 d，2、4、6、8、10、12个月的肾小球滤过率（GFR）、血清肌酐（Scr）的变化；比较两组治疗1年的甘油三酯、总胆固醇、24 h 尿蛋白定量的变化；比较两组治疗后相关不良反应发生率。结果治疗0 d 至12个月，对照组的 GFR 波动不大（P ＞0.05），而干预组 GFR 明显升高（P ＜0.05），且治疗8、10、12个月时两组的 GFR 变化值比较差异均有统计学意义（均为P ＜0.05）。治疗0 d 至12个月，干预组和对照组的 Scr 水平均下降，其中前者下降幅度更明显（P ＜0.05），且治疗10、12个月时两组的 Scr 变化值比较差异均有统计学意义（均为 P ＜0.05）。治疗12个月，干预组和对照组的总胆固醇、甘油三酯、平均24 h 尿蛋白定量比较，差异均无统计学意义（均为 P ＞0.05）。干预组和对照组均未发生急性排斥反应和移植肾失功。两组的不良反应发生率比较差异无统计学意义（P ＞0.05）。结论减量FK506联合加量 MMF 是安全有效的免疫抑制方案。
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