摘要
目的系统评价麦考酚钠肠溶片(EC-MPS)与吗替麦考酚酯(MMF)用于肾移植术后的疗效和安全性。方法计算机检索MEDLINE、EMbase、Pub Med、The Cochrane Library(2013年第9期)、CBM、CNKI、VIP和Wan Fang Data数据库,并追溯纳入研究的参考文献,搜集肾移植术后采用EC-MPS与MMF比较进行免疫抑制治疗的随机对照试验(RCT),检索时限为建库至2013年9月。由两位研究者按纳入与排除标准独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man 5.1软件进行Meta分析。结果共纳入8个RCT,包括2 400例肾移植术后患者。Meta分析结果显示:在不同的随访时间点,EC-MPS组与MMF组的急性排斥反应发生率[4周:RR=0.33,95%CI(0.01,8.05);6个月:RR=0.94,95%CI(0.73,1.22);12个月:RR=0.88,95%CI(0.63,1.24);48个月:RR=0.93,95%CI(0.47,1.84)]、慢性排斥反应发生率[6个月:RR=0.66,95%CI(0.27,1.58);12月:RR=0.57,95%CI(0.29,1.15)]和移植物失功/丢失率[6个月:RR=0.79,95%CI(0.41,1.50);12个月:RR=0.76,95%CI(0.40,1.43);48个月:RR=1.38,95%CI(0.59,3.23)]差异均无统计学意义。在不良反应发生率方面,EC-MPS组除肺炎发生率低于MMF组[RR=0.32;95%CI(0.13,0.79)]外,其余不良反应发生率在两组间差异均无统计学意义。结论当前证据表明,肾移植术后EC-MPS与MMF相比,近期疗效相似,EC-MPS组的肺炎发生率低于MMF组。受纳入研究数量和质量所限,上述结论尚需开展更多高质量研究来验证。
Objective To systematically evaluate the efficacy and safety of enteric-coated mycophenolate sodium（EC-MPS） versus mycophenolate mofetil（MMF） in kidney transplant recipients. Methods We searched MEDLINE, EMbase, PubMed, the Cochrane Library（Issue 9, 2013）, CBM, CNKI, VIP and WanFang Data from their inception to November 2013, to collect randomized controlled trials（RCTs） of EC-MPS versus MMF in kidney transplant recipients. References of included studies were also retrieved. Two reviewers independently screened studies according to the exclusion and inclusion criteria, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed using Rev Man 5.1 software. Results A total of 8 RCTs involving 2 400 patients were included. The results of meta-analysis indicated that there were no significant differences between the two groups at the end of 4-week, 6-month, 12-month and 48-month follow-up in the acute rejection rate（4-weeks： RR=0.33, 95%CI 0.01 to 8.05; 6 months： RR=0.94, 95%CI 0.73 to 1.22; 12 months： RR=0.88, 95%CI 0.63 to 1.24; 4 years： RR=0.93, 95%CI 0.47 to 1.84）. There were no significant differences between the two groups at the end of 6-month and 12-month follow-up in the chronic rejection rate（6 month： RR=0.66, 95%CI 0.27 to 1.58; 12 month： RR=0.57, 95%CI 0.29 to 1.15）. There were no significant differences between the two groups at the end of 6-month, 12-month and 48-month follow-up in the graft loss or death rate（6-month： RR=0.79, 95%CI 0.41 to 1.50; 12-month： RR=0.76, 95%CI 0.40 to 1.43; 48-month： RR=1.38, 95%CI 0.59 to 3.23）. As to the side effect, EC-MPS could significantly reduce the risk of pneumonia compared with MMF（RR=0.32, 95%CI 0.13 to 0.79）. Conclusion Based on current evidences, EC-MPS is comparable with MMF for renal transplant patients in short-term effectiveness, and the incidence of pneumonia in the EC-MPS group is lower than the MMF group. Due to the limited quantity and quality of the studies, the c
出处
《中国循证医学杂志》
CSCD
2015年第6期681-686,共6页
Chinese Journal of Evidence-based Medicine
基金
“十二五”国家科技支撑计划课题“安全合理用药评价和干预技术研究与应用”(编号:2013BAI06B04)
关键词
吗替麦考酚酯
麦考酚钠肠溶片
肾移植
免疫抑制
META分析
系统评价
随机对照试验
Mycophenolate mofetil
Enteric-coated mycophenolate sodium （EC-MPS）
Renal transplantation
Immunosuppression
Meta-analysis
Randomized controlled trial
