School of Pharmacy, University of Queensland, Brisbane, QLD, 4102, Australia.
Discipline of Pharmacy, Queensland University of Technology, Gardens Point Campus, Level 9, Q Block, 2 George Street, Brisbane, QLD, 4000, Australia.
Drugs R D. 2018 Dec;18(4):271-282. doi: 10.1007/s40268-018-0254-8.
Globally, enteric-coated mycophenolate sodium (EC-MPS) is replacing mycophenolate mofetil (MMF) in maintenance immunosuppressant regimens. The predominant reason for conversion is the purported improvement in gastrointestinal (GI) quality of life. This paper considers the level of bias associated with studies comparing EC-MPS and MMF for GI-related improvement and provides insight into whether conversion is supported by evidence.
Using a pre-determined protocol, a literature search was conducted. Full-text review, data extraction and risk of bias analysis was conducted by two independent authors using the Cochrane domain-based evaluation of risk of bias. The review was reported according to the preferred reporting items for systematic reviews and meta-analyses.
Twenty-nine studies were included in risk of bias analysis. Of these, only three were deemed a low risk of bias. Across these three studies, there were no statistically significant differences in the proportion of GI-related adverse events nor was there a significant difference in the GI-related quality of life between EC-MPS- and MMF-treated patients in these data.
There was a high risk of bias across the 29 studies investigating conversion from MMF to EC-MPS for potential improvement in GI-related quality of life. The consolidated results of the three studies with low risk of bias suggest no evidence to convert patients stabilised on MMF. If a patient experiences GI-related adverse events whilst taking MMF, other methods should be explored before conversion to EC-MPS.
在全球范围内，肠溶性吗替麦考酚钠（EC-MPS）正在替代吗替麦考酚酯（MMF）用于维持性免疫抑制治疗方案。转换的主要原因是据称胃肠道（GI）生活质量得到了改善。本文考虑了比较 EC-MPS 和 MMF 改善胃肠道相关问题的研究中存在的偏倚程度，并探讨了转换是否有证据支持。
使用预先确定的方案进行文献检索。两名独立作者使用基于 Cochrane 领域的风险偏倚评估对全文进行了审查、数据提取和风险偏倚分析。该综述根据系统评价和荟萃分析的首选报告项目进行了报告。
29 项研究纳入了风险偏倚分析。其中只有三项被认为是低风险的。在这三项研究中，接受 EC-MPS 和 MMF 治疗的患者中，胃肠道相关不良事件的比例或胃肠道相关生活质量均无统计学差异。
29 项研究中存在高风险偏倚，这些研究调查了从 MMF 转换为 EC-MPS 以潜在改善胃肠道相关生活质量的情况。三项低风险偏倚研究的综合结果表明，没有证据表明可以将接受 MMF 稳定治疗的患者转换。如果患者在服用 MMF 时出现胃肠道相关不良反应，应在转换为 EC-MPS 之前探索其他方法。
