Borrows R, Chusney G, Loucaidou M, Singh S, James A, Stichbury J, Van Tromp J, Cairns T, Griffith M, Hakim N, McLean A, Palmer A, Papalois V, Taube D
Renal and Transplant Units, St. Mary's Hospital, Paddington, London, United Kingdom.
Transplant Proc. 2005 May;37(4):1733-5. doi: 10.1016/j.transproceed.2005.04.007.
It is recommended that specific methods of tacrolimus monitoring rather than immunoassays, which overestimate tacrolimus levels, should be used in transplant recipients. Direct comparison of these techniques, however, has not been conducted in renal transplantation. In this study, 40 renal transplant recipients with tacrolimus monitoring by microparticle enzyme immunoassay (MEIA; target trough level 10 to 15 ng/mL) were compared with 40 patients monitored by high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS; target trough level 8 to 13 ng/mL). All patients received anti CD25 antibody induction and mycophenolate mofetil in a steroid-sparing protocol. No differences were seen between MEIA and HPLC-MS groups in patient demographics. All patients were followed for 6 months. Patient survival was 100% in both groups; graft survival was 100% in the MEIA group and 97.5% in the HPLC-MS group. The groups did not differ in the number of dose changes required in the first 6 months or in the number of patients displaying tacrolimus levels within target range at 3 and 6 months. Delayed graft function occurred in 14 patients in the MEIA group and 12 patients in the HPLC-MS group (P = NS). Biopsy-proven acute rejection occurred in four patients in the MEIA group and one patient in the HPLC-MS group (P < .2). No differences were seen for the following parameters at 3 or 6 months: biopsy-proven tacrolimus nephrotoxicity, serum creatinine or estimated creatinine clearance, systolic or diastolic blood pressure, cholesterol, cytomegalovirus disease, posttransplant diabetes, or tremor. This study suggests that renal transplantation with HPLC-MS monitoring of tacrolimus is safe and effective.
建议在移植受者中使用他克莫司监测的特定方法而非免疫测定法，因为免疫测定法会高估他克莫司水平。然而，这些技术在肾移植中的直接比较尚未进行。在本研究中，将40例通过微粒酶免疫测定法（MEIA；目标谷浓度为10至15 ng/mL）监测他克莫司的肾移植受者与40例通过高效液相色谱串联质谱法（HPLC-MS；目标谷浓度为8至13 ng/mL）监测的患者进行了比较。所有患者均接受抗CD25抗体诱导治疗，并在无激素方案中使用霉酚酸酯。MEIA组和HPLC-MS组在患者人口统计学方面未见差异。所有患者均随访6个月。两组患者生存率均为100%；MEIA组移植物存活率为100%，HPLC-MS组为97.5%。两组在前6个月所需的剂量变化次数或在3个月和6个月时他克莫司水平在目标范围内的患者数量方面无差异。MEIA组有14例患者发生移植肾功能延迟恢复，HPLC-MS组有12例患者发生（P=无统计学意义）。MEIA组有4例患者发生活检证实的急性排斥反应，HPLC-MS组有1例患者发生（P<0.2）。在3个月或6个月时，以下参数未见差异：活检证实的他克莫司肾毒性、血清肌酐或估算的肌酐清除率、收缩压或舒张压、胆固醇、巨细胞病毒病、移植后糖尿病或震颤。本研究表明，采用HPLC-MS监测他克莫司的肾移植是安全有效的。
