CAJ | 학술논문

麦考酚钠肠溶片在肾移植术后早期治疗中的有效性和安全性
맥고분납장용편재신이식술후조기치료중적유효성화안전성
Efficacy and safety of enteric-coated mycophenalate sodium in de novo renal transplant recipients

万方数据

中华器官移植杂志中華器官移植雜誌 중화기관이식잡지
CHINESE JOURNAL OF ORGAN TRANSPLANTATION
2010年 4期 216-219 ,共4页

石炳毅%凌建煜%韩文科%肖序仁%黎磊石%杜林栋%徐达%张炜%陈立中%卢一平%陈忠华%谭建明%朱有华

석병의%릉건욱%한문과%초서인%려뢰석%두림동%서체%장위%진립중%로일평%진충화%담건명%주유화

肾移植%麦考酚钠肠溶片%有效性%安全性腎移植%麥攷酚鈉腸溶片%有效性%安全性
신이식%맥고분납장용편%유효성%안전성
Kidney transplantation%Enteric-coated mycophenolate sodium%Efficacy%Safety

目的评估麦考酚钠肠溶片(EC-MPS)在中国肾移植术后早期免疫抑制治疗中的有效性是否与吗替麦考酚酯(MMF)相当,并对其安全性进行评价.方法采用多中心、前瞻性、随机、双盲、双模拟和平行对照研究.在肾移植术后0～48 h内,将符合标准的受者随机分成EC-MPS组和MMF组.分别用EC-MPS和MMF治疗6个月,观察其有效性和安全性.结果肾移植术后6个月内,EC-MPS组受者发生急性排斥反应、移植肾功能丧失和死亡的总发生率(14.3%)有低于MMF组(20.3%)的趋势,但两组比较,差异无统计学意义(P>0.05).两组不良反应总的发生率(66.7%和66.0%)也较为接近.但EC-MPS组重度感染和重度肺部感染的发生率略低于MMF组,因严重胃肠道不良反应而导致药物减量或停药的受者比例也略低于MMF组,但差异均无统计学意义(P>0.05).结论 EC～MPS在中国肾移植术后早期对受者的免疫抑制治疗中,其有效性与MMF相等.并且具有良好的安全性.
목적 평고맥고분납장용편(EC-MPS)재중국신이식술후조기면역억제치료중적유효성시부여마체맥고분지(MMF)상당,병대기안전성진행평개.방법 채용다중심、전첨성、수궤、쌍맹、쌍모의화평행대조연구.재신이식술후0～48 h내,장부합표준적수자수궤분성EC-MPS조화MMF조.분별용EC-MPS화MMF치료6개월,관찰기유효성화안전성.결과 신이식술후6개월내,EC-MPS조수자발생급성배척반응、이식신공능상실화사망적총발생솔(14.3%)유저우MMF조(20.3%)적추세,단량조비교,차이무통계학의의(P>0.05).량조불량반응총적발생솔(66.7%화66.0%)야교위접근.단EC-MPS조중도감염화중도폐부감염적발생솔략저우MMF조,인엄중위장도불량반응이도치약물감량혹정약적수자비례야략저우MMF조,단차이균무통계학의의(P>0.05).결론 EC～MPS재중국신이식술후조기대수자적면역억제치료중,기유효성여MMF상등.병차구유량호적안전성.
Objective To demonstrate the equivalent efficacy of enteric-coated mycophenolate sodium (EC-MPS) and MMF and to compare their safety profiles in de novo Chinese renal transplant recipients.Methods This randomized, controlled, double-blind, double-simulate, multi-center, parallel-group, prospective study was performed in de novo Chinese renal transplant recipients.After O to 48 h post-transplantation, patients who fulfilled the inclusion/exclusion criteria were randomized equally into EC-MPS or MMF group.Efficacy and safety of EC-MPS and MMF were assessed at the first 6 months.Results Within the first 6 months, there was a trend toward lower incidence of acute rejection, graft loss and death in EC-MPS group than in MMF group but without significant difference.The overall safety profile and incidence of adverse events were similar between two groups.The incidence of severe AEs including serious infection and serious pulmonary infection was slightly lower in EC-MPS group than in MMF group.Serious gastrointestinal adverse events leading to dose reduction or interruption in EC-MPS group were also fewer than in MMF group, nevertheless, with no significant difference.Conclusion During the first 6-months of treatment in de novo Chinese renal transplant recipients, EC-MPS was therapeutically equivalent to MMF with comparable safety profile.