Lopez-Solis Roberto, DeVera Michael, Steel Jennifer, Fedorek Sheila, Sturdevant Mark, Hughes Christopher, Humar Abhinav
Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Clin Transplant. 2014 Jul;28(7):783-8. doi: 10.1111/ctr.12379. Epub 2014 Jun 1.
In the setting of liver transplantation, mycophenolate mofetil (MMF) may be used as an adjuvant therapy for immunosuppression to prevent graft rejection; however, its use may be limited due to severe gastrointestinal (GI) side effects. In contrast, enteric-coated mycophenolate sodium (EC-MPS) may be associated with less severe side effects and hence better tolerability. We compared the side effects of EC-MPS to MMF in liver transplant patients in a de novo study (Study I-randomized, prospective, double-blinded) and a conversion study (Study II). In both studies, the severity of GI symptoms was assessed at various time points using the Gastrointestinal Symptoms Rating Scale (GSRS) survey, a validated survey of GI symptoms (abdominal pain, reflux, indigestion, diarrhea, and constipation). In Study I, the symptoms of 30 recipients receiving EC-MPS (n = 15) were compared to 15 recipients receiving MMF. A multivariate analysis of variance (MANOVA) of the total GSRS scores and symptom syndrome subscores revealed no significant difference (p > 0.05) between the two medications over time. A conversion study (Study II) with 29 participants, however, showed that over time, all GI symptoms improved significantly (p < 0.001) when the patients were treated with EC-MPS instead of MMF.
在肝移植的背景下,霉酚酸酯(MMF)可作为免疫抑制的辅助治疗药物以预防移植物排斥反应;然而,由于严重的胃肠道(GI)副作用,其应用可能受到限制。相比之下,肠溶型霉酚酸钠(EC-MPS)的副作用可能没那么严重,因此耐受性更好。我们在一项起始研究(研究I——随机、前瞻性、双盲)和一项转换研究(研究II)中比较了EC-MPS与MMF在肝移植患者中的副作用。在这两项研究中,均使用胃肠道症状评定量表(GSRS)调查在不同时间点评估胃肠道症状的严重程度,GSRS是一项经过验证的胃肠道症状(腹痛、反流、消化不良、腹泻和便秘)调查。在研究I中,将30名接受EC-MPS治疗的受者(n = 15)的症状与15名接受MMF治疗的受者的症状进行了比较。对GSRS总评分和症状综合征子评分进行的多变量方差分析(MANOVA)显示,随着时间推移,两种药物之间无显著差异(p>0.05)。然而,一项有29名参与者的转换研究(研究II)表明,随着时间推移,当患者接受EC-MPS而非MMF治疗时,所有胃肠道症状均有显著改善(p<0.001)。