Zhang Jing-Ling, Cao Ying-Ping, Li Jing-Gang
Department of Clinical Laboratorial Examination, Fujian Medical University Union Hospital, Fuzhou 350001, Fujian Province, China.
Department of Clinical Laboratorial Examination, Fujian Medical University Union Hospital, Fuzhou 350001, Fujian Province, China,E-mail:
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2019 Apr;27(2):494-503. doi: 10.19746/j.cnki.issn.1009-2137.2019.02.030.
To systematically evaluate the efficacy and safety of DCAG regimen for treating the intermediate or high risk MDS and AML.
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.
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.
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).
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.
系统评价地西他滨联合CAG(DCAG)方案治疗中高危骨髓增生异常综合征(MDS)及急性髓系白血病(AML)的疗效及安全性。
检索PubMed、EMbase、Cochrane图书馆、万方数据和中国知网数据库,收集自数据库建库至2018年3月期间,关于地西他滨联合CAG方案治疗中高危MDS及AML的随机对照试验(RCT)。采用Cochrane协作网偏倚风险评估工具对各RCT质量进行评价。然后,使用RevMan 5.3软件进行数据分析。
Meta分析共纳入24项RCT,包含1557例中高危MDS及AML患者,其中AML患者594例,MDS患者590例。接受DCAG方案治疗的患者纳入DCAG组,接受单药地西他滨或CAG方案治疗的患者纳入对照组。
Meta分析结果显示,与其他治疗方法相比,DCAG方案治疗中高危MDS及AML患者的完全缓解率较高(RR = 1.63,95%CI = 1.43 - 1.85,P<0.00001),总缓解率也较高(RR = 1.35,95%CI = 1.24 - 1.46,P<0.00001);亚组分析结果显示,DCAG方案在完全缓解率方面优于CAG方案(RR = 1.71,95%CI = 1.49 - 1.97,P<0.00001),且略优于单药地西他滨组(RR = 1.43,95%CI = 1.08 - 1.91,P = 0.01)。在不良反应方面,两组间骨髓抑制、肺部感染、胃肠道反应及出血事件发生率比较,差异无统计学意义(P>0.05)。
DCAG方案治疗中高危MDS及AML疗效显著,优于CAG方案及单药地西他滨方案。与对照组相比,不良事件差异无统计学意义。由于纳入研究的数量和质量有限,尚需更多高质量研究验证上述结论。