Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients
Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients
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DOI：
10.1046/j.1600-6143.2003.00337.x
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发表时间：
2004-02-01
影响因子：
8.8
通讯作者：
Hall, M
中科院分区：
文献类型：
--
作者：
Salvadori, M;Holzer, H;Hall, M
霉酚酸酯（MMF）的引入代表了移植医学的重大进步，尽管最佳使用可能受到胃肠道（GI）副作用的限制。为了改善麦考酚酸的上消化道耐受性，开发了麦考酚酸钠肠溶包衣制剂（EC-MPS; myfortic（R））。EC-MPS（720 mg B. I. d.）和MMF（1000 mg MMF B. I. d.），在423名新肾移植患者中评估了联合环孢素微乳剂（Neoral（R））和皮质类固醇的治疗效果，这些患者参加了一项为期12个月的双盲研究。6个月时的疗效失败（活检证实的急性排斥反应[BPAR]、移植物丢失、死亡或失访）（EC-MPS 25. 8% vs. MMF 26. 2%; 95% CI：[-8. 7，+ +8. 0]）证明了治疗等效性。12个月时，EC-MPS和MMF的BPAR、移植物丢失或死亡的发生率分别为26.3%和28.1%，单独BPAR的发生率分别为22.5%和24.3%。在BPAR组中，EC-MPS组严重急性排斥反应的发生率为2.1%，MMF组为9.8%（p = ns）。两组的安全性特征和GI不良事件的发生率相似。在12个月内，15.0%的EC-MPS患者和19.5%的MMF患者因GI不良事件需要改变剂量（p = = ns）。肠溶-MPS 720 mg B。I. D.在治疗上等同于MMF 1000 mg B。I. D.安全性相当
The introduction of mycophenolate mofetil (MMF) represented a major advance in transplant medicine, although optimal use may be limited by gastrointestinal (GI) side-effects. An enteric-coated formulation of mycophenolate sodium (EC-MPS; myfortic(R)) has been developed with the aim of improving the upper GI tolerability of mycophenolic acid. Therapeutic equivalence of EC-MPS (720 mg b. i. d.) and MMF (1000 mg MMF b. i. d.), with concomitant cyclosporine microemulsion (Neoral(R)) and corticosteroids, was assessed in 423 de novo kidney transplant patients recruited to a 12-month, double-blind study. Efficacy failure (biopsy-proven acute rejection [BPAR], graft loss, death or loss to follow up) at 6 months (EC-MPS 25.8% vs. MMF 26.2%; 95% CI: [-8.7, + + 8.0]) demonstrated therapeutic equivalence. At 12 months, the incidence of BPAR, graft loss or death was 26.3% and 28.1%, and of BPAR alone was 22.5% and 24.3% for EC-MPS and MMF, respectively. Among those with BPAR, the incidence of severe acute rejection was 2.1% with EC-MPS and 9.8% with MMF (p = ns). The safety profile and incidence of GI adverse events were similar for both groups. Within 12 months, 15.0% of EC-MPS patients and 19.5% of MMF patients required dose changes for GI adverse events (p = = ns). Enteric-coated-MPS 720 mg b. i. d. is therapeutically equivalent to MMF 1000 mg b. i. d. with a comparable safety profile.