肾移植后应用西罗莫司和他克莫司的有效性与安全性的荟萃分析  

Efficacy and safety of sirolimus and tacrolimus after renal transplantation： a meta-analysis

作　　者：周静怡[1] 沈毅[1] 程军[1] 江艳[1] 黄洪锋[1] 陈江华[1] 

机构地区：[1]浙江大学医学院附属第一医院肾脏病中心,杭州310003

出　　处：《中华器官移植杂志》2014年第10期584-589,共6页Chinese Journal of Organ Transplantation

摘　　要：目的系统评价西罗莫司（SRL）和他克莫司（Tac）作为肾移植术后免疫抑制剂的有效性和安全性。方法以“kidneytransplantation”或“renaltransplantation”，“Sirolimus”或“Rapamy—cin”，“taerolimus”或“FKS06”，“肾移植”，“西罗莫司”，“雷帕霉索”，“他克莫司”，以及“FK506”为关键词，在PubMed、Web of knowledge、Medline、Cochrane Library及中国知网和维普数据库中检索2014年6月之前发表的相关文献，筛选1980年以来的以中文和英文发表的随机对照研究，剔除因SRL和Tae合用、多次肾移植、胰肾联合移植等原因不符合纳入标准的文献后，提取受者存活率、移植肾存活率、急性排斥反应（AR）发生率、不良事件发生率等数据作为主要评价指标，提取肾小球滤过率（GFR）作为肾功能指标，使用RevMan5．1软件分析，以危险比（I水）或平均差（MD）进行比较，并进行亚组分析和敏感性分析。结果共15篇文献2480例受者纳入分析。SRL组受者术后1年AR发生率和不良事件发生率均显著高于Tac组（RR=2．02，95％可信区间1.37～2.99，P〈O．05；RR：1．31，95％可信区间1．02～1．68，P〈0．05），其中高脂血症发生率显著增高（RR=1．75，95％可信区间1．17～2．61，P〈0．01）。两组间术后1年受者和移植肾存活率、术后2年受者和移植肾存活率、高血压和移植后糖尿病等不良事件发生率以及GFR水平均无显著差异。根据亚组分析，当使用抗胸腺细胞球蛋白（ATG）作为免疫诱导或血SRL浓度高于4～8μg／L时，两组间术后1年AR发生率无显著差异（P〉0．05）。结论肾移植术后早期应用SRL较Tae无明显优势，甚至术后1年AR发生率和脂质代谢方面不良事件发生率更高；使用ATG作为免疫诱导、增加血SRL浓度可能会避免这些风险，但需更多临床试验证据支持。Objective To evaluate the efficacy and safety of sirolimus and tacrolimus after renal transplantation. Method PubMed, Web of knowledge, Medline and the Cochrane Library were searched with the terms and Boolean operators as ＂（kidney transplantation OR renal transplantation） AND （sirolimus OR rapamycin） AND （tacrolimus OR FK506）＂. Results retrieved were last updated on June 9, 2014. Language limit of English and Chinese only was applied. Trials were excluded if enrolling recipients of organs other than kidneys, reporting none of the outcomes in point or combining sirolimus with tacrolimus. Patient and graft survival, acute rejection and adverse events were evaluated as primary outcomes and glomerular filtration rate （GFR） was an additional surrogate for renal function. Professional meta-analysis software RevMan 5. 1 was employed to analyze the pooled risk ratio （RR） and mean difference （MD） followed by subgroup analysis and sensitivity analysis. Result Fifteen studies were included with 2480 patients. Patients in the sirolimus group showed an increased rate of acute rejection within one-yeats follow-up 2. 02 （95% CI 1.37-2. 99, P〈0. 05） and also a higher risk of adverse events 1. 31 （95% CI 1.02-1.68, P〈0.05）. The incidence of hyperlipidaemia was significantly higher with RR = 1.75 （95% CI 1. 17-2. 61, P 〈 0. 01 ） in the sirolimus group. The other outcomes were insignificantly different between two groups. In subgroups with ATG as immunity induction and higher sirolimus concentration （〉4-8/ag/L）, the difference was insignificant （ P 〉0. 05 ）. Conclusion advantage over tacrolimus when used concentrations, or with ATG as immunity evidence is needed. This meta-analysis concluded that sirolimus showed no early after transplantation. When used with higher induction, the disadvantages may be avoided. More clinical

关 键 词：肾移植 免疫抑制剂 西罗莫司 他克莫司Meta分析 

分 类 号：R699.2[医药卫生—泌尿科学]