Niaudet Patrick, Charbit Marina, Loirat Chantal, Lapeyraque Anne-Laure, Tsimaratos Michel, Cailliez Mathilde, Foulard Michel, Dehennault Maud, Marquet Pierre, Chaouche-Teyara Kamel, Lemay Djamila
Pediatric Nephrology, Necker Hospital, 161 rue de Sevres, 75743, Paris, Cedex, France.
Pediatr Nephrol. 2009 Feb;24(2):395-402. doi: 10.1007/s00467-008-1031-7. Epub 2008 Nov 5.
Data on the use of enteric-coated mycophenolic acid (EC-MPS) in pediatric transplantation cases are scarce. We undertook a 12-month, multicenter, open-label pilot study in which 16 de novo renal transplant patients aged 5-16 years received EC-MPS with cyclosporine A microemulsion (CsA-ME), steroids, and anti-interleukin-2 receptor antibody induction. The mean dose of EC-MPS was 916 +/- 93 mg/m(2) per day during weeks 1-2, 810 +/- 193 mg/m(2) per day during months 3-6, and 827 +/- 153 mg/m(2) per day during months 6-12. The mean CsA C(2) level exceeded target range up to month 6 post-transplant. Efficacy failure (biopsy-proven acute rejection, graft loss, death or loss to follow-up) occurred in two patients: one patient with primary non-function underwent nephrectomy, and one patient experienced biopsy-proven acute rejection (Grade 1B, day 344) following EC-MPS dose reduction. There were no deaths. Creatinine clearance (Schwartz) was 103 +/- 30 mL/min per 1.73 m(2) at month 6 and 100 +/- 16 mL/min per 1.73 m(2) at month 12. The majority of adverse events were mild or moderate (101/126, 80.2%). In this pilot study, EC-MPS 450 mg/m(2) administered twice daily with CsA, steroids, and interleukin-2 antibody induction resulted in a low rate of rejection with good renal function in a pediatric population. However, a larger, controlled trial is required to confirm these results.
关于肠溶包衣霉酚酸（EC-MPS）在儿科移植病例中的使用数据稀缺。我们开展了一项为期12个月的多中心、开放标签的试点研究，16例年龄在5至16岁的初发肾移植患者接受了EC-MPS联合环孢素A微乳剂（CsA-ME）、类固醇以及抗白细胞介素-2受体抗体诱导治疗。在第1至2周，EC-MPS的平均剂量为916±93mg/m²/天，第3至6个月为810±193mg/m²/天，第6至12个月为827±153mg/m²/天。移植后直至第6个月，CsA的平均C₂水平均超过目标范围。两名患者出现疗效失败（活检证实的急性排斥反应、移植物丢失、死亡或失访）：一名原发性无功能患者接受了肾切除术，一名患者在EC-MPS剂量减少后出现活检证实的急性排斥反应（1B级，第344天）。无死亡病例。第6个月时肌酐清除率（施瓦茨公式）为103±30mL/min/1.73m²，第12个月时为100±16mL/min/1.73m²。大多数不良事件为轻度或中度（101/126，80.2%）。在这项试点研究中，EC-MPS 450mg/m²每日两次联合CsA、类固醇以及白细胞介素-2抗体诱导治疗，在儿科人群中导致排斥反应发生率较低且肾功能良好。然而，需要更大规模的对照试验来证实这些结果。
