肾移植受者FK506治疗窗浓度的临床观察

CLINICAL INVESTIGATION ON THE THERAPEUTIC WINDOW CONCENTRATION OF FK506 IN RENAL ALLOGRAFT RECIPIENTS

目的 :寻求适合国人肾移植受者FK5 0 6理想治疗窗浓度范围。 方法 :应用MEIA法测定口服FK5 0 6 1 2h后全血谷浓度。 结果 :统计资料显示 ,术后第 1个月应为 1 2～ 1 8μg/L ,第 2～ 3个月为 8～ 1 3μg/L ;第 4个月后为 5～ 8μg/L。 结论 :此浓度范围既能达到满意的免疫抑制效果 ,又能减少排斥反应和FK5 0

OBJECTIVE To find a reference therapeutic window concentration of FK506 in anti rejection regime for Chinese renal allograft recipients. METHODOLOGY Between Mar 1998 and May 1999,28 cases of renal recipients (male/female 23/5)administered FK506 in the anti rejection regime.Regular sampling of early morning blood was collected in the first 3 months after transplantation for the determination of FK506 concentration.After the 3rd month,irregular sampling for FK506 whole blood concentration was performed.Trough level of FK506 was assayed with MEIA.Serum creatinine,urine volume,renal graft ultrasound image were also monitored regularly. RESULTS The whole blood FK506 trough level was 12～18 μg/L within the first month,8～12 μg/L within the second and third month,5～8 μg/L after the 4th month after transplantation.One in 28 patients developed acute renal graft rejection at a trough FK506 concentration at 4 30 μg/L 41 days after transplantation.Another two patients developed acute nephrotoxicity within one month after transplantation with FK506 whole blood concentration above 20 μg/L. CONCLUSION A reference window concentration of FK506 for anti rejection in renal allograft recipients is established,with the trough concentration at 15 4±2 30 μg/L in the first month,10 3±1 80 μg/L between the 2nd and the 3rd month,and 6 70±0 90 μg/L after the 3rd month of renal transplantation.