肾移植受者应用他克莫司治疗窗浓度的探讨

目的　寻求适合国人肾移植受者他克莫司 (FK5 0 6 )理想治疗窗浓度范围。方法　应用微粒子酶免疫分析法测定 5 8例肾移植患者口服FK5 0 6后 12h的血药谷浓度 ,并观察排斥反应的发生及药物的肾毒性。结果　FK5 0 6的血药浓度 ,术后 1个月为 (13.0± 2 .1) μg/L ,2～ 3个月为 (9.4±1.6 ) μg/L ,3个月以后为 (6 .5± 1.3) μg/L ,比较各时期全血FK5 0 6谷浓度 ,差异均有极显著性 (P <0 .0 1) ;术后发生急性排斥反应 3例次 ,肾毒性 4例次。结论　FK5 0 6具有良好的免疫抑制效果 ,其治疗窗浓度范围 ,术后第 1个月为 11～ 15 μg/L ,第 2～ 3个月为 8～ 11μg/L ;第 3个月后为 5～ 8μg/L ,此浓度范围既能达到满意的免疫抑制效果 ,又能减少FK5 0 6的肾毒性

Clinical research of FK506 therapeutic window concentration in renal transplant recipients

Objective In order to search for the proper therapeutic window concentration of FK506 in Chinese renal transplant recipients.Methods The FK506 trough level 12 h after oral administration in 58 renal transplantation patients was assayed by means of MEIA.The occurrence of rejection and the drug toxicity were observed.Results The blood FK506 trough level was(13.0±2.1)μg/L within the first month,(9.4±1.6)μg/L within second to third months,and(6.5±1.3)μg/L from the third month after transplantation with the difference among the different intervals being very significant(P<0.01).There were 3 case-times of acute rejection and 4 case-times of renal toxicity.Conclusions The whole blood FK506 trough level was 11～15μg/L within the first month,8～11μg/L within the second and third month,5～8μg/L from the fourth month after transplantation.This range of therapeutic window concentration of FK506 trough levels was ideal for Chinese renal transplant recipients with less acute rejection and toxicity effects on kidney.