肾移植术后比较他克莫司缓释剂型与普通剂型的荟萃分析  

Efficacy and safety of extended-release versus standard-release tacrolimus in kidney transplantation： A meta-analysis

作　　者：张艳[1] 刘力玮[1] 王晓硕[1] 张弋[2] 

机构地区：[1]天津医科大学一中心临床学院,300192 [2]天津市第一中心医院

出　　处：《中华器官移植杂志》2016年第9期547-555,共9页Chinese Journal of Organ Transplantation

基　　金：国家高技术研究发展计划（863计划）（2012AA021001）;天津市卫生行业重点攻关项目（12KG102）;局攻关课题：SNPs与肝移植术后他克莫司药代动力学相关性研究（07KY27）

摘　　要：目的比较肾移植术后他克莫司缓释剂型和普通剂型的有效性和安全性。方法检索Pubmed、Embase、Medline、Cochrane图书馆4个英文数据库，收集2016年3月前发表的肾移植术后使用他克莫司缓释剂型和普通剂型的临床随机对照研究，使用Cochrane协作网工具对纳入的随机对照试验进行偏倚风险评估，Jadad评分系统对随机对照试验进行质量评估。用Review Manager和StataSE对纳入研究的数据进行分析。结果共纳入12项研究，含3532例肾移植受者资料。应用他克莫司缓释剂型与普通剂型受者相比，其急性排斥反应发生率ERR=0．93（0．78～1．11），P=0．40]、移植物存活率ERR=1．04（0．79～1．37），P=0．76]、患者死亡率[RR=1．03（0.67～1．57），P=0．90]、患者退出率ERR=1．07（0．95～1．22），P=0．26]、肾小球滤过率EMD=-0．52（-1．95，0．92），P=0．48]、肌酐清除率EMD=-0．94（-1．39，3．28），P=0.43]、感染发生率[RR=0．98（0．90～1．06），P=0．573、新发糖尿病发生率[RR=0．91（0．67～1．23），P=0．533等指标相比较，差异均无统计学意义（P〉0．05）。对其研究对象进行亚组（术后早期或术后晚期使用他克莫司缓释剂型者）分析，得到相似的结果。结论在肾移植术后使用他克莫司缓释剂型与使用普通剂型一样有效、安全。Objective To assess the efficacy and safety of extended-release versus standard- release in kidney transplant recipients. Methods We searched Pubmed, Embase, Medline and Cochrane library databases in English and researched published randomized controlled trials （RCTs） focused on extended-release versus standard-release tacrolimus in renal transplant recipients until March 2016. The risk of bias assessment for RCTs was evaluated using the Cochrane Collaboration＇s tool, and quality of RCTs was assessed by the modified JADAD scale. Meta-analysis was conducted by Review Manager 5. 3 and Stata BE 12. 0. Results A total of 12 RCTs were included, involving 3 532 adult kidney transplant recipients. There was no significant difference between the two treatment groups in the endpoints such as acute rejection rate （RR = 0. 93[0. 78-1.11], P = 0.40）, graft survival （RR = 1.04[0. 79-1.37], P = 0. 76）, patient survival （RR = 1.03[0. 67-1.57], P = 0. 90）, patients withdrawn （RR= 1.07E0. 95-1.22], P= 0. 26）, estimated glomerular filtration rate （eGFR） （MD=- 0. 52[- 1.95,0. 92], P = 0. 48）, creatinine clearance （Ccr） （MD = - 0. 94 [ - 1.39,3. 28], P = 0. 43）, infection （RR= 0. 98[0. 90 - 1.06], P= 0. 57）, and new-onset diabetes rate （RR= 0. 91E0. 67 -1.23], P = 0.53）. Meanwhile, subgroup analysis of different patient population （early after transplantation vs. late after transplantation） showed similar results in the protocol. Conclusion The extended-release tacrolimus has similar efficacy and safety to the standard-release in kidney transplantation.

关 键 词：肾移植 他克莫司 缓释剂型 依从性 

分 类 号：R699.2[医药卫生—泌尿科学]