Borrows Richard, Chusney Gary, Loucaidou Marina, James Anthony, Stichbury Jose, Van Tromp Jen, Cairns Tom, Griffith Megan, Hakim Nadey, McLean Adam, Palmer Andrew, Papalois Vassilios, Taube David
Renal and Transplant Units, St. Mary's Hospital, Paddington, London W2 1NY, United Kingdom.
Ther Drug Monit. 2006 Apr;28(2):269-73. doi: 10.1097/01.ftd.0000177662.11974.f3.
It is suggested that specific methods of Tacrolimus monitoring rather than immunoassays which over-estimate Tacrolimus levels, should be used in transplant recipients. There is limited data, however, comparing clinical outcomes of renal transplantation using each of these techniques. In this study, 40 renal transplant recipients with Tacrolimus monitoring by Microparticle Enzyme Immunoassay (MEIA; target trough level 10-15 ng/ml) were compared with 40 patients monitored by High Performance Liquid Chromatography with Tandem Mass Spectrometry (HPLC-MS; target trough level 8-13 ng/ml). All received anti CD25 antibody induction and Mycophenolate Mofetil in a steroid sparing protocol. No demographic differences were seen between MEIA and HPLC-MS groups. 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 three and six 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 4 patients in the MEIA group and 1 patient in the HPLC-MS group (P = 0.17). Biopsy proven acute Tacrolimus nephrotoxicity occurred in 6 patients in the MEIA group, and 7 in the HPLC-MS group (P = NS). No difference was seen in serum creatinine or estimated creatinine clearance at 3 or 6 months. No difference between groups was seen in systolic or diastolic blood pressure, or total cholesterol at 3 or 6 months. 2 patients in the MEIA group developed CMV disease and 1 developed posttransplantation diabetes mellitus. CMV and posttransplantation diabetes were not seen in the HPLC-MS group. 2 patients in each group developed reversible 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，而不是高估他克莫司水平的免疫测定法。然而，比较使用这些技术中每种技术进行肾移植的临床结果的数据有限。在本研究中，将40例通过微粒酶免疫测定法（MEIA；目标谷浓度10 - 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8 - 13 ng/ml）监测的患者进行比较。所有患者均接受抗CD25抗体诱导治疗，并采用霉酚酸酯进行激素节约方案。MEIA组和HPLC-MS组在人口统计学上无差异。所有患者均随访6个月。两组患者的生存率均为100%；MEIA组的移植物生存率为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没有差异。MEIA组有14例患者发生移植肾功能延迟恢复，HPLC-MS组有12例患者发生移植肾功能延迟恢复（P = 无统计学意义）。MEIA组有4例患者经活检证实发生急性排斥反应，HPLC-MS组有1例患者经活检证实发生急性排斥反应（P = 0.17）。MEIA组有6例患者经活检证实发生急性他克莫司肾毒性，HPLC-MS组有7例患者经活检证实发生急性他克莫司肾毒性（P = 无统计学意义）。在3个月或6个月时，血清肌酐或估计肌酐清除率无差异。在3个月或6个月时，两组患者的收缩压或舒张压以及总胆固醇无差异。MEIA组有2例患者发生巨细胞病毒疾病，1例患者发生移植后糖尿病。HPLC-MS组未出现巨细胞病毒感染和移植后糖尿病。每组有2例患者发生可逆性震颤。本研究表明，采用HPLC-MS监测他克莫司进行肾移植是安全有效的。
