地西他滨联合CAG治疗中、高危骨髓增生异常综合征及急性髓系白血病的疗效与安全性的Meta分析  

Efficacy and Safety of Decitabine Combined with CAG(Cytarabine,Aclarubicin, G-CSF) for Patients with Intermediate or High Risk Myelodysplastic Syndrome and Acute Myeloid Leukemia: a Meta-Analysis

作　　者：张婧玲 曹颖平[1] 李景岗[2] ZHANG Jing-Ling;CAO Ying-Ping;LI Jing-Gang(Department of Clinical Laboratorial Examination,Fujian Medical University Union Hospital,Fuzhou 350001,Fujian Province,China;Fujian Institute of Hematology,Fujian Provincial Key Laboratory on Hematology,Fujian Medical University Union Hospital,Fuzhou 350001,Fujian Province,China)

机构地区：[1]福建医科大学附属协和医院检验科,福建福州350001 [2]福建省血液病研究所福建省血液病学重点实验室福建医科大学附属协和医院,福建福州350001

出　　处：《中国实验血液学杂志》2019年第2期494-503,共10页Journal of Experimental Hematology

基　　金：福建省卫生计生科研人才培养项目(项目编号2017-CX-20);福建省科技创新联合资金项目(项目编号2017Y9051)

摘　　要：目的:系统评价地西他滨联合CAG方案(DCAG方案)治疗中、高危MDS及AML的临床疗效及安全性。方法:计算机检索PubMed、EMbase、The Cochrane Library、WanFang Data和CNKI等数据库,搜集DCAG方案对比地西他滨单药方案或CAG方案治疗中、高危MDS及AML的随机对照试验(RCT),检索时限从建库至2018年3月。所纳入RCT依据Cochrane风险偏倚评价工具进行质量评价,采用RevMan 5.3进行Meta分析,结果共纳入24个RCT,包括1 557例中、高危MDS及AML患者,其中594名为AML患者,590名为MDS患者。采用DCAG方案治疗的列入DCAG组,采用地西他滨单药方案或CAG方案治疗的列入对照组。结果:Meta分析结果显示:与对照组比较,DCAG方案治疗中、高危MDS及AML患者的完全缓解率高(RR=1.63,95%CI=1.43-1.85,P<0.000 01),总体有效率也高(RR=1. 35,95%CI=1.24-1.46,P<0.000 01);亚组分析结果显示,在完全缓解率方面DCAG方案好于CAG方案(RR=1.71,95%CI=1.49-1.97,P<0.000 01),稍好于地西他滨单药方案(RR=1.43,95%CI=1.08-1.91,P=0.01)。在不良反应方面,两组的肺部感染、消化道反应、骨髓抑制、出血事件发生率等方面无统计学差异(P>0. 05)。结论:DCAG方案治疗中、高危MDS及AML具有切实而显著的疗效,且优于CAG方案和地西他滨单药方案,两者不良反应事件发生无统计学差异。由于缺乏大样本RCT的支持,上述结论尚待更多高质量研究予以验证。Objective:To systematically evaluate the efficacy and safety of DCAG regimen for treating the intermediate or high risk MDS and AML.Methods:PubMed,EMbase,The Cochrane Library,WanFang Data and CNKI databases were searched to collect randomized controlled trials(RCTs)of decitabine combined with CAG regimen for intermediate or high risk MDS and AML from inception to March,2018.The quality of each RCT was evaluated by the Cochrane collaboration′s tool for assessing the risk of bias.Then,the data were analyzed by using RevMan 5.3.Results:Twenty-four RCTs were included in the meta-analysis,containing 1 557 patients with intermediate or high-risk MDS and AML,of whom 594 were AML patients and 590 were MDS patients.The patients treated with the DCAG regimen were enrolled in DCAG group,and the patients treated with single-agent decitabine or CAG regimen were enrolled in control group.Results:The results of meta-analysis showed that compared with other therapies,the complete remission rate of DCAG regimen in patients with intermediate or high-risk MDS and AML was high(RR=1.63,95% CI=1.43-1.85,P<0.000 01),and the overall response rate was also high(RR=1.35,95% CI=1.24-1.46,P<0.000 01);Subgroup analysis results showed that DCAG regimen was better than CAG regimen in the complete remission rate(RR=1.71,95% CI=1.49-1.97,P<0.000 01),and slightly better than single-agent decitabine group(RR=1.43,95%CI=1.08-1.91,P=0.01).In terms of adverse reactions,there was no statistically significant difference in the rates of myelosuppression,pulmonary infection,gastrointestinal reactions,and bleeding events between the 2 groups(P>0.05).Conclusion:DCAG regimen has significant efficacy in the treatment of intermediate or high-risk MDS and AML,and is superior to CAG regimen and single-agent dicitabine regimen.As compared with control group,there was no significant difference in adverse events.Due to limited quantity and quality of the included studies,more high quality studies are needed to verify above mentioned conclusion.

关 键 词：地西他滨 DCAG方案 骨髓增生异常综合征 急性髓系白血病 META分析 

分 类 号：R551.3[医药卫生—血液循环系统疾病] R733.71[医药卫生—内科学]