Jeon Kina, Kim Darae, Choi Jin-Oh, Cho Yang Hyun, Sung Kiick, Oh Jaewon, Cho Hyun Jai, Jung Sung-Ho, Lee Hae-Young, Park Jin Joo, Choi Dong-Ju, Kang Seok-Min, Kim Jae-Joong, Jeon Eun-Seok
Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Front Cardiovasc Med. 2022 Aug 23;9:957299. doi: 10.3389/fcvm.2022.957299. eCollection 2022.
Mycophenolate mofetil (MMF) is a prodrug of mycophenolic acid (MPA) and a key immunosuppressant for improving graft survival in patients with heart transplantation (HTx). However, dose reduction or interruption is occasionally needed due to gastrointestinal (GI) side effects. Enteric-coated mycophenolate sodium (EC-MPS) is an alternative form of MPA delivery to improve GI tolerability. In the present study, the efficacy of EC-MPS compared with MMF in HTx patients was investigated.
In this retrospective study, the Korean Organ Transplant Registry (KOTRY) data were used to analyze the efficacy and rejection rate of MMF and EC-MPS. A total of 611 patients was enrolled from 2014 to February of 2021. Patients were divided based on the use of MMF or EC-MPS at 6 months post-HTx. Patients who were not prescribed MMF or EC-MPS were excluded. Graft survival, all-cause mortality, and treated rejection were compared between the two groups. All statistical analyses were performed using SPSS; characteristics were compared using Pearson chi-square test and survival rate with Kaplan-Meier plot and log-rank test.
A total of 510 HTx patients was analyzed (mean age: 51.74 ± 13.16 years, males: 68.2%). At 6 months after HTx, 78 patients were taking EC-MPA (12.8%) and 432 patients were taking MMF (70.7%). The median follow-up was 42.0 months (IQR: 21.7-61.0 months). Post-HTx outcomes including overall survival, all cause mortality, acute cell mediated rejection (ACR), acute antibody mediated rejection (AMR), treated rejection, and cardiac allograft vasculopathy (CAV) were comparable between the two groups during follow-up.
Notable differences were not observed in overall survival, all cause mortality, ACR, AMR, treated rejection, and CAV between MMF and EC-MPS groups. Efficacy of EC-MPS was similar to that of MMF in HTx patients during mid-term follow up after HTx.
霉酚酸酯（MMF）是霉酚酸（MPA）的前体药物，是改善心脏移植（HTx）患者移植物存活的关键免疫抑制剂。然而，由于胃肠道（GI）副作用，偶尔需要减少剂量或中断用药。肠溶型霉酚酸钠（EC-MPS）是一种替代的MPA给药形式，可提高胃肠道耐受性。在本研究中，对HTx患者中EC-MPS与MMF的疗效进行了研究。
在这项回顾性研究中，韩国器官移植登记处（KOTRY）的数据用于分析MMF和EC-MPS的疗效和排斥率。2014年至2021年2月共纳入611例患者。根据HTx术后6个月时使用MMF或EC-MPS的情况对患者进行分组。未使用MMF或EC-MPS的患者被排除。比较两组之间的移植物存活、全因死亡率和治疗的排斥反应。所有统计分析均使用SPSS进行；使用Pearson卡方检验比较特征，使用Kaplan-Meier图和对数秩检验比较生存率。
共分析了510例HTx患者（平均年龄：51.74±13.16岁，男性：68.2%）。HTx术后6个月时，78例患者服用EC-MPA（12.8%），432例患者服用MMF（70.7%）。中位随访时间为42.0个月（四分位间距：21.7-61.0个月）。随访期间，两组之间的HTx术后结局，包括总生存、全因死亡率、急性细胞介导的排斥反应（ACR）、急性抗体介导的排斥反应（AMR）、治疗的排斥反应和心脏移植物血管病变（CAV）相当。
MMF组和EC-MPS组在总生存、全因死亡率、ACR、AMR、治疗的排斥反应和CAV方面未观察到显著差异。HTx术后中期随访期间，EC-MPS在HTx患者中的疗效与MMF相似。
