Department of Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
BMJ Open. 2013 Aug 7;3(8):e003511. doi: 10.1136/bmjopen-2013-003511.
Mycophenolate sodium, an enteric-coated tablet (EC-MPS), is as effective and safe as mycophenolate mofetil (MMF) in preventing transplant rejection. EC-MPS and MMF improve the outcome of severe lupus nephritis (LN) and have fewer side effects than pulsed intravenous cyclophosphamide. Blood concentrations of mycophenolic acid (MPA), the active metabolite of EC-MPS, vary between participants despite fixed dosing. Interpatient variability has been studied in transplantation, but not well documented in LN. The relationship between MPA concentration and its clinical effect on LN has not been described.
This is a prospective, open-label, randomised controlled trial. -32 participants with LN who meet the inclusion and exclusion criteria will be randomised into two groups: one receiving a fixed dose of EC-MPS and the second, a dosing regimen that is titrated with therapeutic drug monitoring. Included participants will have blood sampled over a period of 8-12 h on three different occasions. Pharmacokinetic parameters will be calculated using non-compartmental methods.
The Human Research and Ethics Committee of the Royal Brisbane Women's Hospital have approved this study. The study is registered with Australian and New Zealand Clinical Trials Registry-ACTRN12611000798965 We planned to present the de-identified information at conferences and publish the results in medical journals.
ACTRN12611000798965.
吗替麦考酚酯钠（一种肠溶片）与吗替麦考酚酯（MMF）在预防移植排斥反应方面同样有效且安全。吗替麦考酚酯钠（EC-MPS）和 MMF 可改善严重狼疮肾炎（LN）的预后，且比脉冲式静脉注射环磷酰胺的副作用更少。尽管固定剂量给药，但 EC-MPS 的活性代谢产物麦考酚酸（MPA）在不同参与者之间的血药浓度存在差异。尽管在移植领域已经研究了个体间的变异性，但在 LN 中尚未有充分的记录。MPA 浓度与其对 LN 的临床效果之间的关系尚未描述。
这是一项前瞻性、开放标签、随机对照试验。-32 名符合纳入和排除标准的 LN 患者将被随机分为两组：一组接受固定剂量的 EC-MPS，另一组则采用根据治疗药物监测进行滴定的剂量方案。纳入的参与者将在三个不同时间点采集 8-12 小时的血样。将使用非房室方法计算药代动力学参数。
皇家布里斯班妇女医院人类研究和伦理委员会已批准本研究。该研究在澳大利亚和新西兰临床试验注册中心（ACTRN12611000798965）注册。我们计划在会议上展示去识别信息，并在医学期刊上发表结果。
ACTRN12611000798965。
