Arinsoy T, Uslu A, Mir S, Titiz I, Gonenc F, Celik A, Apaydin S, Kacar S, Guvence N, Turkmen A
School of Medicine, Gazi University, Ankara, Turkey.
Transplant Proc. 2011 Apr;43(3):826-32. doi: 10.1016/j.transproceed.2010.11.020.
This study evaluates the effect of enteric-coated mycophenolate sodium (EC-MPS) on patient and graft survivals, the incidence of rejection episodes, and graft function among de novo and maintenance renal transplant recipients.
This open label, multicenter, prospective, post-marketing observational study of 470 renal transplantation patients at 23 centers in Turkey includes 331 de novo patients whose mean age was 29.6 ± 13.2 years and 139 maintenance patients of 34.0 ± 13.0 years. The latter subjects had EC-MPS substituted for mycophenolate mofetil or added to the immunosuppressive therapy. Patients were followed for 12 months to evaluate graft function and treatment failure.
The most common primary disease requiring transplantation was glomerulonephritis (24.3%). De novo and maintenance groups were similar in terms of overall rejection rates and acute rejection incidence whereas chronic rejection was evident only among the latter cohort (P < 0.001). Time to an acute rejection episode was significantly longer among maintenance rather than de novo patients (220.8 versus 18.7 months; P = 0.015). Overall, 12 and 36 month survival rates were 91.6 ± 1.3% and 86.9% ± 0.3% among subjects experiencing acute rejection versus 99.7 ± 0.2% and 50.3% for those displaying chronic rejection. Among maintenance group no deterioration of renal function was observed after conversion from mycophenolate mofetil to EC-MPS. The incidences of leukopenia, new-onset anemia, or liver dysfunction were similar between de novo and maintenance patients. Gastrointestinal discomfort was more prevalent among the maintenance group, reaching a significant level at the fourth visit (P < 0.05). EC-MPS dose reduction was required in only 16.7% of patients at visit, it was more frequent among the de novo group (17.9 versus 13.8%).
EC-MPS was an effective adjunctive therapy for de novo as well as maintenance renal transplant recipients in the Turkish population due to a relatively low incidence of dose reductions necessitated by adverse events as well as with an increased likelihood of long-term graft survival.
本研究评估肠溶型霉酚酸钠（EC-MPS）对初治和维持性肾移植受者的患者及移植物存活率、排斥反应发生率和移植物功能的影响。
这项在土耳其23个中心开展的针对470例肾移植患者的开放标签、多中心、前瞻性上市后观察性研究，包括331例平均年龄为29.6±13.2岁的初治患者和139例平均年龄为34.0±13.0岁的维持性患者。后一组患者用EC-MPS替代霉酚酸酯或添加到免疫抑制治疗方案中。对患者进行12个月的随访以评估移植物功能和治疗失败情况。
需要进行移植的最常见原发性疾病是肾小球肾炎（24.3%）。初治组和维持性组在总体排斥率和急性排斥发生率方面相似，而慢性排斥仅在维持性组中明显（P<0.001）。维持性患者发生急性排斥反应的时间明显长于初治患者（220.8个月对18.7个月；P = 0.015）。总体而言，发生急性排斥反应的患者中12个月和36个月生存率分别为91.6±1.3%和86.9%±0.3%，而发生慢性排斥反应的患者中分别为99.7±0.2%和50.3%。在维持性组中，从霉酚酸酯转换为EC-MPS后未观察到肾功能恶化。初治患者和维持性患者白细胞减少、新发贫血或肝功能障碍的发生率相似。胃肠道不适在维持性组中更为普遍，在第四次随访时达到显著水平（P<0.05）。仅16.7%的患者在随访时需要降低EC-MPS剂量，在初治组中更频繁（17.9%对13.8%）。
在土耳其人群中，EC-MPS是初治和维持性肾移植受者的一种有效辅助治疗方法，因为不良事件导致的剂量减少发生率相对较低，且长期移植物存活的可能性增加。
