CAJ | 학술논문

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。
목적：평개타극막사（FK506）여배린선알（CTX）치료난치성신병종합정（RNS）적유효성화안전성。방법계산궤검색 PubMed、CNKI、CBM、만방、유보등전문수거고，사선 FK506여 CTX 치료 RNS 적수궤대조시험，채용 Stata 12.0연건진행통계분석。결과최종납입5편문헌，공포괄308례 RNS 환자，기중시험조155례，대조조153례。Meta 분석결과현시，치료후량조완전완해솔〔 RR ＝1.619，95% CI（1.158，2.363），Z ＝2.82，P ＝0.005〕、부분완해솔〔RR ＝1.272，95% CI（1.024，1.579），Z ＝2.17，P ＝0.030〕간차이균유통계학의의，총완해솔〔RR ＝0.994，95% CI（0.826，1.195），Z ＝0.07，P ＝0.945〕、불량반응발생솔〔RR ＝0.763，95% CI（0.577，1.088），Z ＝1.91，P ＝0.056〕간차이균무통계학의의。3편문헌보도료치료6개월후완전완해솔、부분완해솔、총완해솔급불량반응발생솔，Meta 분석결과현시，량조완전완해솔〔RR ＝1.620，95% CI（0.898，2.923），Z ＝1.60，P ＝0.109〕、부분완해솔〔RR ＝1.051，95% CI（0.649，1.702），Z ＝0.15，P ＝0.878〕、불량반응발생솔〔RR ＝0.712，95% CI（0.424，1.194），Z ＝1.71，P ＝0.087〕간차이균무통계학의의；총완해솔〔 RR ＝1.012，95% CI（0.809，1.265），Z ＝2.18，P ＝0.030〕간차이유통계학의의。결론여경전치료약물 CTX 비교，FK506능제고 RNS 환자적완전완해솔화부분완해솔，치료6개월시，환자총완해솔명현제고，FK506치료 RNS 적유효성교 CTX 고，량자안전성상사。
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 re-markable after 6 months of treatment. FK506 is superior to CTX in effectiveness,similar to safety in RNS treatment.