摘要
目的:系统评价吗替麦考酚酯(MMF)与麦考酚钠肠溶片(EC-MPS)在成人实体器官移植中的有效性与安全性。方法:全面检索PubMed、Embase、Cochrane Library、Clinical trials.gov、中国知网、万方数据知识服务平台及中国生物医学文献数据库中有关两药直接对比的研究,排除涉及替代治疗的文献,检索时限均为自建库至2023年2月。2名研究者独立进行文献筛选、质量评价及数据提取。对2项及以上可合并的效应量采用RevMan 5.4.1软件行Meta分析,无法合并的效应量则行描述性分析。结果:除肾移植外,该研究将心脏、肝脏及胰腺等其他移植类型纳入系统评价,共纳入10项RCTs和4项队列研究。Meta分析结果表明,在霉酚酸(MPA)标准剂量范围内,肾移植1年内EC-MPS与MMF组免疫抑制疗效相当(P>0.05),但EC-MPS能显著降低肾移植术后严重感染的发生风险[RR=0.60,95%CI(0.40,0.89),P=0.01,I2=0%],其余安全性结局两者无显著性差异。受限于研究数量,描述性分析结果表明,肝脏移植3个月内和心脏移植1年内,MMF与EC-MPS的有效性及安全性无显著性差异。结论:现有证据表明,在不同类型的实体器官移植中,术后1年内使用MMF和EC-MPS的免疫抑制疗效均相似,但EC-MPS可能是肾移植术后高感染风险受者的首选。
OBJECTIVE To systematically assess the efficacy and safety of mycophenolate mofetil(MMF)and enteric-coated mycophenolate sodium(EC-MPS)for adult solid organ transplantation.METHODS Comprehensive searches were conducted in the databases of PubMed,Embase,Cochrane Library,Clinical trials.gov,CNKI,Wanfang and China Biology Medicine for the relevant studies directly comparing two medications.The literature of alternative therapies was excluded.The search period started from inceptions to February 2023.Two researchers independently performed literature screening,data extraction and assessment of study bias.Meta-analysis was conducted with RevMan 5.4.1 software and descriptive analysis for studies with unmergable results.RESULTS Besides renal transplantation,10 RCTs and 4 cohort studies included heart,liver and pancreatic transplantation for the first time.Meta-analysis revealed that,within the standard dose of mycophenolic acid(MPA),immunosuppressive efficacy of EC-MPS and MMF was comparable within the first year after renal transplantation(P>0.05).And EC-MPS could significantly lower the risk of severe infections[RR=0.60,95%CI(0.40,0.89),P=0.01,I2=0%].Other safety outcomes displayed no significant differences.Descriptive analysis,limited by the number of studies,showed no significant differences in efficacy or safety between MMF and EC-MPS within 3 months after liver transplantation and 1 year after heart transplantation.CONCLUSION Current evidence indicates that within the first year post-transplantation,immunosuppressive efficacies of MMF and EC-MPS are comparable during solid organ transplantations.However,EC-MPS is recommended for recipients at an elevated risk of infection after renal transplantation.
作者
郭琦
刘爽
陈鸿圣
赵荣生
GUO Qi;LIU Shuang;CHEN Hongsheng;ZHAO Rongsheng(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China;Department of Pharmacy Administration&Clinical Pharmacy,School of Pharmaceutical Sciences,Peking University,Beijing 100191,China)
出处
《中国医院药学杂志》
CAS
北大核心
2024年第10期1205-1211,共7页
Chinese Journal of Hospital Pharmacy
基金
中国药学会科技开发中心药物政策专题研究:临床必需品种使用特点及监测预警研究(编号:CMEI-2020-10-002)。
