肾移植术后应用他克莫司与西罗莫司为初始免疫抑制剂的荟萃分析

Sirolimus versus Tacrolimus as primary immunosuppressant after renal transplantation： A meta-analysis

目的 系统评价肾移植术后应用他克莫司与西罗莫司为初始免疫抑制剂的临床疗效和安全性.方法 检索PubMed、Embase、MEDLINE、Cochrane controlled trials register、中国知网和维普等数据库（更新至2015年11月）,英文检索词为“sirolimus”或“rapamycin”或“rapamune”,“tacrolimus”或“FK506”或“prograf＆quot;,“kidney transplantation”或“renal transplantation”,中文检索词为“肾移植”,“西罗莫司”,“雷帕霉素”,“他克莫司”,“FK506”,“普乐可复”.提取受者存活率、移植肾存活率、急性排斥反应（AR）发生率、感染发生率、手术切口并发症发生率、GFR水平及失随访或中断率.使用Review Manger 5.3对纳入的研究结果进行数据整理和分析.结果 最终纳入符合标准的文献10篇,共计1 810例肾移植受者.西罗莫司组受者术后1年移植肾存活率、感染发生率均显著低于他克莫司组（RR=0.63,95％可信区间0.45～0.89,P=0.009;RR=4.42,95％可信区间1.73～11.31,P=0.002）,西罗莫司组受者的GFR水平、术后1年AR发生率、手术切口并发症发生率、失随访或中断率均显著高于他克莫司组（SMD=-0.52,95％可信区间为-0.73～-0.31,P＜0.000 01;RR=0.54,95％可信区间0.40～0.73,P＜0.0001;RR=0.17,95％可信区间0.11～0.25,P＜0.000 01;RR=0.44,95％可信区间0.37～0.51,P＜0.000 01）.两组间术后1年受者存活率的差异无统计学意义.结论 他克莫司作为肾移植术后初始免疫抑制剂比西罗莫司更安全,西罗莫司可以作为初始免疫抑制剂的一种选择,但应结合具体的情况,谨慎对待.

Objective To evaluate the efficacy and safety of sirolimus and tacrolimus after renal transplantation.Method PubMed,Web of knowledge,Medline and the Cochrane controlled trials register,Chinese Biomedicaldatabase,and Vip database were searched with the terms and Boolean operators as ＆quot;（kidney transplantation OR renal transplantation） AND （sirolimus OR rapamycin OR rapamune） AND （tacrolimus OR FK506 OR prograf）＆quot;.Results retrieved were updated on November,2015.Data were extracted for patient and graft mortality,acute rejection （AR）,wound complications,infection,GFR,withdrawl.Professional meta analysis software RevMan 5.3 was employed.Result Altogether,1810 patients from 10 randomized controlled trials （RCTs） were included.Patients in the sirolimus group showed a decreased rate of graft mortality and infection （RR =0.63,95% CI,0.45-0.89,P=0.009;RR=4.42,95% CI,1.73-11.31,P=0.002）.Patients in the sirolimus group showed an increased rate of AR,wound complications,GFR,withdrawl （SMD=-0.52,95% CI,-0.73-0.31,P〈0.000 01;RR=0.54,95% CI,0.40-0.73,P〈0.000 1;RR=0.17,95% CI,0.11-0.25,P〈0.000 01;RR =0.44,95% CI,0.37-0.51,P〈0.000 01）.The patient mortality was insignificantly different between two groups.Conclusion This meta-analysis concluded that sirolimus showed advantage over tacrolimus about safety when used early after renal transplantation.The options of immunosuppressive regimens after kidney transplantation should be based on the specific condition.To obtain more reliable and accurate clinical data,the RCTs with more rational design,higher methodological quality,larger sample size,including domestic patients,longer follow-up are still needed.