FLAG和MEA方案治疗难治复发性急性髓系白血病的Meta分析

Effectiveness of FLAG regimen and MEA regimen for refractory and relapsed acute myeloid leukemia: A Meta-analysis

目的:系统评价氟达拉滨+阿糖胞苷+重组人粒细胞集落刺激因子(FLAG)和米托蒽醌+依托泊苷+阿糖胞苷(MEA)方案治疗难治复发性急性髓系白血病(RRAML)的疗效及不良反应。方法:计算机检索Pub Med、Cochrane Library、Web of Science、VIP、Wan Fang Data、CNKI、CBM等数据库发表的关于FLAG和MEA方案治疗RRAML的随机对照试验(RCT)。由两位研究者独立进行文献筛选、资料提取和质量评价后,采用Rev Man 5. 0软件进行Meta分析。结果:共纳入6个研究,299例患者。Meta分析结果显示:FLAG方案和MEA方案治疗RRAML时,两者的CR[RR=1. 49,95%CI(0. 92,2. 43),P=0. 11]及PR[RR=1. 38,95%CI(0. 82,2. 32),P=0. 23]无明显差异,但FLAG方案治疗组的总有效率高于MEA方案治疗组,两组的差异有统计学意义[RR=1. 98,95%CI(1. 21,3. 24),P=0. 006],其真菌感染率亦高于MEA组,两组的差异有统计学意义[RR=2. 17,95%CI(1. 09,4. 31),P=0. 03]。结论:FLAG方案治疗RRAML的总有效率高于MEA方案,但其真菌感染率亦高。受纳入研究的数量及质量限制,本系统评价结论仍需进一步开展更多大样本、严格设计的随机对照试验加以验证。

Objective: To systematically evaluate the effectiveness and adverse reaction of FLAG and MEA in the treatment of refractory and relapse acute myeloid leukemia(RRAML). Methods: Such databases as PubMed,Cochrane Library,Web of Science,VIP,WanFang Data,CNKI,CBM were searched to collect the randomized controlled trials(RCTs) on FLAG and MEA in treating refractory and relapse acute myeloid leukemia.Document selection and data fetch and the quality of included studies was evaluated by two reviewers in-dependently,and then Meta-analyses were performed using Review Manager 5.0 software. Results: A total of six studies involving 299 patients were included.Results of Meta-analyses showed that when FLAG and MEA were used in the treatment of refractory and relapse acute myeloid leukemia,significant differences were found in the total effective rate (RR=1.98,95%CI:1.21 to 3.24, P =0.006),but no significant difference was found in complete remission (RR=1.49,95%CI:0.92 to 2.43, P =0.11) and partial remission (RR=1.38,95%CI:0.82 to 2.32, P =0.23).And the fungal infection rate after treatment were also significant differences (RR=2.17,95%CI:1.09 to 4.31, P =0.03). Conclusion: In the total effective rate of treatment for refractory and relapse acute myeloid leukemia,the FLAG regimen is superior to MEA regimen,but the fungal infection rate was also higher.However,all these findings should be further confirmed with more large sample and well-designed RCTs.