阿仑单抗诱导后钙神经蛋白抑制剂单药治疗方案在肾移植中的应用:一项系统评价研究

Application of calcineurin inhibitor monotherapy in renal transplantation after alemtuzumab induction: a Meta-analysis

目的探讨阿仑单抗诱导后钙神经蛋白抑制剂单药治疗（AiCNIm）方案应用于肾移植术后免疫抑制的有效性和安全性。方法应用计算机检索Pubmed、Embase、Web of science、Cochrance library及中国知网（CNKI）等数据库,查找1980年至2014年12月31日发表的有关AiCNIm方案（AiCNIm组）和常规三联方案（Triple组）进行肾移植术后免疫抑制的随机对照临床研究。采用Rev Man 5.2软件进行Meta分析。结果共纳入5项随机对照研究,421例肾移植受者。随访6~12个月结果显示,与Triple组相比,AiCNIm组的急性排斥反应或穿刺活检证实的排斥反应发生率更低[相对风险系数（RR）=0.59,95%可信区间（CI）0.40~0.89],但两组在移植肾失功（RR=0.85,95%CI 0.38~1.87）、受者死亡（RR=0.89,95%CI 0.30~2.67）、感染（RR=1.03,95%CI 0.91~1.17）和移植后新发糖尿病（RR=0.62,95%CI 0.29~1.30）方面比较,差异无统计学意义（均为P〉0.05）。结论基于现有证据,肾移植术后应用阿仑单抗诱导后用钙神经蛋白抑制剂单药治疗,短期免疫抑制效果好且安全。

Objective To evaluate the clinical efficacy and safety of immunosuppression of calcineurin inhibitor monotherapy（ AiCNIm） after alemtuzumab induction following renal transplantation. Methods Randomized control clinical trials related to application of AiCNIm（ AiCNIm group） and conventional triple regimes（ Triple group） for immunosupression after renal transplantation,published from 1980 to December 31 2014,were searched online from Pub Med,Embase,Web of Science,Cochrance library and China National Knowledge Infrastructure（ CNKI） databases.Meta-analysis was performed by Rev Man 5. 2 software. Results Five randomized control studies consisting of 421 renal transplant recipients were included. The results of follow up for 6-12 months revealed that compared with the Triple group,the incidence of rejection response confirmed by acute rejection or aspiration biopsy in the AiCNIm group was significantly lower [relative risk（ RR） = 0. 59,95% confidence interval（ CI） ： 0. 40-0. 89]. However,there was no significant difference in the risk of renal allograft dysfunction（ RR = 0. 85,95% CI： 0. 38-1. 87）,death of recipient（ RR = 0. 89,95%CI： 0. 30-2. 67）,infection（ RR = 1. 03,95% CI： 0. 91-1. 17） and new-onset diabetes after transplantation（ RR = 0. 62,95% CI： 0. 29-1. 30） between two groups（ all in P〉0. 05）. Conclusions According to the existing evidence,application of calcineurin inhibitor monotherapy after renal transplantation exerts short-term immunosuppressive effect and high safety after alemtuzumab induction.