摘要目的 探讨肾移植后早期应用咪唑立宾( MZR)的有效性和安全性.方法 采用前瞻性临床随机对照研究.将61例首次肾移植受者按随机数字表法分为2组:(1)MZR组:33例,应用他克莫司(Tac)+ MZR+泼尼松(Pred)预防排斥反应；(2)吗替麦考酚酯组(MMF)组:28例,应用Tac+ MMF+ Pred预防排斥反应.MZR的用法为:体重＜50 kg者为150mg/d,早餐后口服；体重≥50kg者为200 mg/d,分早、晚2次口服.MMF、Tac和Pred按常规剂量服用.2组受者均于术前2h和术后4d接受巴利昔单抗(20mg/d)诱导治疗.观察并比较2组受者术后6个月内的急性排斥反应(AR)发生率、移植肾存活率以及高尿酸血症、骨髓抑制、巨细胞病毒感染、胃肠道反应等的发生率.结果 术后6个月内,MZR组AR发生率为15.2％,MMF组AR发生率为10.7％ (P＞0.05)；MZR组移植肾存活率为97.0％,MMF组移植肾存活率为89.3％(P＞0.05).MZR组和MMF组间高尿酸血症、骨髓抑制、胃肠道反应和肺部感染的发生率的差异无统计学意义(P＞0.05).其中,MZR组未发生巨细胞病毒感染,而MMF组则发生4例(36.4％),差异有统计学意义(P＜0.05).结论 在严密监测下,MZR可应用于肾移植术后早期抗排斥反应治疗.

abstractsObjective To evaluate the efficacy and safety of mizroribine (MZR) in early postoperative renal transplantations.Methods A single center, perspective, randomized and controlled clinical study was performed on 61 renal transplant recipients.Forty-eight after operation,patients were randomized into 2 groups as follows:(1) MZR group:33 cases of renal transplant recipients were administrated orally with MZR combined with tacrolimus and prednisone; (2)mycophenolate (MMF) group:28 cases were administrated with MMF combined with tacrolimus and prednisone.The dose of MZR was 150 mg for the weight under 50 kg and 200 mg for the others.The dose of MMF was 1.5～2.0 g/d for the weight above 70 kg,1.5 g/d for 50～70 kg and 1.0 g/d for ＜50 kg.The dose of tacrolimus was 0.1 ～0.15 mg· kg-1 ·day-1.All the patients were given 20 mg basiliximab as induction therapy 2 h preoperation and 4 days post-operation.Acute rejection incidence,renal graft survival rate,morbidity of hyperuricemia,marrow depression,cytomegalovirus infection and severe gastrointestinal side effects were analyzed during a follow-up period of 6 months.Results Acute rejection incidencein two groups was 15.2％ and 10.7％ respectively,and graft survival rate was 97.0％ and 89.3％ respectively.There were no significant differences in acute rejection incidence and renal graft survival rate between two groups.There were also no significant differences in the morbidity of hyperuricemia,marrow depression and gastrointestinal side effects between two groups.Although there were no significant differences in infection morbidity between two groups,more cytomegalovirus infection recipients were observed in the MMF group.Conclusion It demonstrated that under the intensive monitoring,MZR was safe and effective for renal transplant recipients.