Gabardi Steven, Tran Jennifer L, Clarkson Michael R
Department of Pharmacy Services, Brigham and Women's Hospital, Boston, MA 02115-6110, USA.
Ann Pharmacother. 2003 Nov;37(11):1685-93. doi: 10.1345/aph.1D063.
To review the pharmacology, pharmacokinetics, efficacy, and safety of mycophenolate sodium.
Primary literature was obtained via a MEDLINE search (1966-June 2003). Abstracts were obtained from the manufacturer and included in the analysis.
All studies and abstracts evaluating mycophenolate sodium in solid organ transplantation were considered for inclusion. English-language studies and abstracts were selected for inclusion, but were limited to those consisting of human subjects.
Mycophenolate sodium, a mycophenolic acid prodrug, is an inhibitor of T-lymphocyte proliferation. Mycophenolic acid reduces the incidence of acute rejection in renal transplantation. Mycophenolate sodium is enteric coated and has been suggested as a potential method to reduce the gastrointestinal adverse events seen with mycophenolate mofetil. Both mycophenolate mofetil and mycophenolate sodium have been shown to be therapeutically equivalent at decreasing the incidence of allograft rejection and loss. The frequency of adverse events is similar between both compounds, with the most common events being diarrhea and leukopenia.
Mycophenolate sodium is effective in preventing acute rejection in renal transplant recipients. At doses of 720 mg twice daily, the efficacy and safety profiles are similar to those of mycophenolate mofetil 1000 mg twice daily. Mycophenolate sodium has been approved in Switzerland; approval in the US is pending.
综述麦考酚钠的药理学、药代动力学、疗效及安全性。
通过MEDLINE检索(1966年至2003年6月)获取原始文献。从生产商处获取摘要并纳入分析。
纳入所有评估麦考酚钠在实体器官移植中应用的研究和摘要。选择英文研究和摘要纳入,但仅限于包含人类受试者的研究。
麦考酚钠是麦考酚酸的前体药物,是T淋巴细胞增殖的抑制剂。麦考酚酸可降低肾移植中急性排斥反应的发生率。麦考酚钠为肠溶包衣制剂,被认为是一种减少麦考酚酯所见胃肠道不良事件的潜在方法。麦考酚酯和麦考酚钠在降低移植物排斥反应和丢失发生率方面已显示出治疗等效性。两种化合物的不良事件发生率相似,最常见的事件为腹泻和白细胞减少。
麦考酚钠对预防肾移植受者的急性排斥反应有效。每日两次剂量为720mg时,其疗效和安全性与每日两次剂量为1000mg的麦考酚酯相似。麦考酚钠已在瑞士获批;在美国的获批尚在等待中。