FLAG与FLAG联合蒽环类药物方案对复发难治性急性髓系白血病疗效比较的Meta分析

Comparative Effects Between FLAG and FLAG Combined with Anthracyclines in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia: a Mata-Analysis

目的系统评价FLAG与FLAG联合蒽环类药物方案对复发难治性急性髓系白血病(AML)的疗效、不良反应及预后。方法计算机检索包括Pub Med,SCI,Cochrane,Elsevier,Embase,Ovid,外文医学信息检索平台(FMJS),CNKI,CBM数据库,检索时间从建库至2017年6月的关于单纯FLAG与FLAG联合蒽环类药物方案比较的临床病例对照试验,评价纳入研究的方法学质量并提取数据后,采用Rev Man 5.3软件进行Meta分析。结果共纳入11篇临床对照研究,包含998例复发难治性AML患者。Meta分析结果显示,FLAG联合蒽环类药物方案对复发难治性AML的完全缓解率及总有效率均高于单纯FLAG组,差异均有统计学意义[RR=1.24,95%CI(1.09,1.42),P=0.001;RR=1.40,95%CI(1.25,1.57),P<0.000 01];FLAG联合蒽环类药物组血清转氨酶升高率低于FLAG组,差异有统计学意义[RR=0.28,95%CI(0.14,0.57),P=0.000 4];口腔溃疡、恶心呕吐、感染的发生率两组间差异均无统计学意义(P>0.05),两者的预后也无明显统计学差异(P>0.05)。结论 FLAG+蒽环类药物方案对复发难治性AML的疗效明显高于单纯FLAG方案,且未明显增加不良反应发生率,两者预后也无明显统计学差异。

Objective To systematically evaluate the clinical effect, adverse reactions and prognosis between FLAG and FLAG combined anthracyclines in the treatment of relapsed or refi＇actory acute myeloid leukemia（R/R AML）. Methods Clinical case-control trials about FLAG and FLAG combined anthracycline in the treatment of R/R AML were collected through retrieving pubMed, SCI, Cochrane, Elsevier, Embase, Ovid, FMJS, CNKI, CBM on line from database building to June 2017. After evaluating the methodological quality of the included studies and extracting data, the literature data were carried out Meta- analysis by RevMan 5.3 software. Results Eleven trials involving 998 patients with R/R AML were retrieved. Meta-analysis results showed that the clinical remission rate and total effective rate of FLAG combined anthracycline group were higher than those of FLAG group[RR = 1.24, 95% CI（1.09, 1.42）, P=0.001; RR = 1.40, 95% CI（1.25, 1.57）, P 〈 0. 000 01], and the increase rate of serum transaminase in FLAG combined anthracycline group was lower than that of FLAG group[ RR =0. 28, 95% CI（0. 14, 0. 57）, P = 0. 000 4]. However, there was no significant difference in the inci- dence rate of oral ulcer, nausea, vomiting and infection between the two groups（ P 〉 0.05）. There was no significant difference in the prognosis between the two groups（P 〉 0.05）. Conclusion The clinical effect of FLAG combined anthracycline was better than that of FLAG alone, but there was no significant increase in the incidence rate of adverse reactions, and there was no significant difference in prognosis between the two groups.