他克莫司与环磷酰胺治疗难治性肾病综合征有效性和安全性的Meta分析

Tacrolimus and Cyclophosphamide in Treatment of Refractory Nephrotic Syndrome Efficacy and Safety:A Meta-analysis

目的评价他克莫司(FK506)与环磷酰胺(CTX)治疗难治性肾病综合征(RNS)的有效性和安全性。方法计算机检索PubMed、CNKI、CBM、万方、维普等全文数据库,筛选FK506与CTX治疗RNS的随机对照试验,采用Stata 12.0软件进行统计分析。结果最终纳入5篇文献,共包括308例RNS患者,其中试验组155例,对照组153例。Meta分析结果显示,治疗后两组完全缓解率〔RR=1.619,95%CI(1.158,2.363),Z=2.82,P=0.005〕、部分缓解率〔RR=1.272,95%CI(1.024,1.579),Z=2.17,P=0.030〕间差异均有统计学意义,总缓解率〔RR=0.994,95%CI(0.826,1.195),Z=0.07,P=0.945〕、不良反应发生率〔RR=0.763,95%CI(0.577,1.088),Z=1.91,P=0.056〕间差异均无统计学意义。3篇文献报道了治疗6个月后完全缓解率、部分缓解率、总缓解率及不良反应发生率,Meta分析结果显示,两组完全缓解率〔RR=1.620,95%CI(0.898,2.923),Z=1.60,P=0.109〕、部分缓解率〔RR=1.051,95%CI(0.649,1.702),Z=0.15,P=0.878〕、不良反应发生率〔RR=0.712,95%CI(0.424,1.194),Z=1.71,P=0.087〕间差异均无统计学意义;总缓解率〔RR=1.012,95%CI(0.809,1.265),Z=2.18,P=0.030〕间差异有统计学意义。结论与经典治疗药物CTX比较,FK506能提高RNS患者的完全缓解率和部分缓解率,治疗6个月时,患者总缓解率明显提高,FK506治疗RNS的有效性较CTX高,两者安全性相似。

Objective To evaluate the efficacy and safety of tacrolimus（FK506） and cyclophosphamide（CTX） in the treatment of refractory nephrotic syndrome（RNS）.Methods PubMed,CNKI,CBM,VIP and other ful-text databases were searched for randomized controlled trials for RNS treatment with FK506 and CTX.Stata 12.0 software was used to perform statistical analysis.Results A total of 5 literatures were enrolled,including 308 RNS patients（155 in study group,153 in control group）.Meta-analysis showed that there was significant difference between 2 groups in complete remission rate 〔RR =1.619,95% CI（1.158,2.363）,Z=2.82,P=0.005〕,partial response rate 〔RR=1.272,95% CI（1.024,1.579）,Z=2.17,P=0.030〕,there was no difference in total remission rate 〔RR=0.994,95% CI（0.826,1.195）,Z=0.07,P= 0.945〕,adverse reaction rate 〔RR=0.763,95% CI（0.577,1.088）,Z=1.91,P=0.056〕.There were into 3 articles reported the complete remission rate,partial remission,total remission rate and adverse reaction rate after 6 months of treatment.Meta analysis showed that there was no significant difference between 2 groups in complete remission rate 〔RR=1.620,95% CI（0.898,2.923）,Z =1.60,P =0.109〕,partial remission rate 〔RR =1.051,95%CI（0.649,1.702）,Z =0.15,P =0.878〕,adverse reaction rate 〔RR=0.712,95% CI（0.424,1.194）,Z=1.71,P=0.087〕,and that there was in total remission rate 〔RR=1.012,95% CI（0.809,1.265）,Z=2.18,P=0.030 〕.Conclusion As compared with CTX,FK506 can improve RNS patients＇ complete remission rate and partial remission rate,and the total remission rate increases remarkable after 6 months of treatment.FK506 is superior to CTX in effectiveness,similar to safety in RNS treatment.