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目的 探讨霉酚酸酯( MMF) 防治肾移植术后急性排斥反应(AR) 的效果和安全性。方法 124 例肾移植受者随机分为MMF组(48 例) 及硫唑嘌呤组(Aza 组,76 例), 观察2 个组患者术后3 个月内AR、难治性急性排斥(CRR) 的发生率及并发症。结果 MMF组及Aza 组在患者死亡率、移植肾失功率等方面的差异无显著性; MMF 组的AR 发生率、CRR 发生率明显低于Aza 组; 以MMF3 .0 g/d 治疗CRR, 其效果与单克隆抗体OKT3 类似。MMF组腹泻、全血细胞减少、白细胞减少的发生率明显高于Aza 组, 呕吐、感染和药物性肝损害两组类似。MMF 组58.3 % 的患者至少发生过1 次副作用, 而Aza 组仅有19 .7% ( P<0 .001) , 须中断治疗或减量者分别占25 .0 % 和9 .2% (P<0.05) 。结论 MMF能明显降低肾移植术后早期的AR 和CRR的发生率, 大剂量MMF(3 .0 g/d) 治疗CRR 效果良好。MMF的副作用明显高于Aza, 导致中断治疗或减量者也明显增多。因此, MMF20 ~25 mg·kg-1·d-1 的常规剂量其安全性受到质疑, 需进一步探讨MMF的理想用量。
Objective To investigate the efficacy and safety of mycophenolate mofetil (MMF) in preventing and treating acute rejection (AR) after renal transplantation. Methods 124 renal transplant recipients were randomly divided into MMF group (n = 48) and azathioprine group (n = 76). The AR, refractory acute rejection (CRR) The incidence and complications. Results There was no significant difference in mortality and graft failure between MMF and Aza groups. The incidence of AR and CRR in MMF group was significantly lower than that in Aza group. 0 g / d treatment of CRR, the effect and the monoclonal antibody OKT3 similar. The incidence of diarrhea, pancytopenia and leukopenia in MMF group was significantly higher than that in Aza group, similar to the two groups in vomiting, infection and drug-induced liver damage. 58.3% of patients in the MMF group had at least one adverse event compared with 19 in the Aza group. 7% (P <0 .001), respectively, to be interrupted or reduced treatment accounted for 25. 0% and 9. 2% (P <0.05). Conclusion MMF can significantly reduce the incidence of AR and CRR after renal transplantation. High-dose MMF (3.0 g / d) is effective in treating CRR. The side effects of MMF were significantly higher than those of Aza, resulting in a significant increase in those who discontinued treatment or reductions. Therefore, the safety of conventional doses of 20-25 mg · kg-1 · d-1 MMF was questioned, and the ideal dosage of MMF should be further explored.