摘要
目的系统评价去甲基化药物治疗骨髓增生异常综合征(MDS)的效果和安全性,为该类药物的临床应用提供依据和指导。方法计算机检索PubMed、Web of Science、Embase、Cochrane Library、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普(VIP)数据库2000年1月至2019年12月发表的去甲基化药物治疗MDS的随机对照试验(RCT)。经过筛选,采用RevMan 5.3软件进行疗效及完全性的Meta分析。结果共纳入7项RCT研究的1 172例患者。Meta分析显示,去甲基化药物治疗组在完全缓解率(OR=6.26,95%CI 1.74~22.49,P=0.005)、部分缓解率(OR=4.65,95%CI 1.51~14.29,P=0.007)、总有效率(OR=14.14,95%CI 7.27~27.51,P<0.01)、血液学改善(OR=3.47,95%CI 1.44~8.32,P=0.005)方面均优于支持治疗组。阿扎胞苷治疗组患者总生存得到改善(HR=0.62,95%CI 0.50~0.77,P<0.01)。在不良反应方面,去甲基化药物增加了粒细胞减少性发热的发生(OR=4.19,95%CI 2.26~7.76,P<0.01),但是在粒细胞减少、血小板减少、贫血、感染、恶心、肝损害、疲劳的发生率方面,两组间差异均无统计学意义(均P>0.05)。结论去甲基化药物治疗MDS效果明显,可提高缓解率,阿扎胞苷可延长患者生存时间,但去甲基化药物增加了粒细胞减少性发热的发生。在临床应用该类药物时,需进一步仔细评估其临床安全性。
Objective To systematically evaluate the efficacy and safety of demethylation drugs intreatment of myelodysplastic syndrome(MDS),and to provide reliable basis and guidance for clinical application of these drugs.Methods The randomized controlled trials(RCT)of demethylation drugs for treatment of MDS published in the PubMed,Web of Science,Embase,Cochrane Library,Chinese Journal Full-text Database(CNKI),Chinese Biomedical Literature Database(CBM)and VIP database from January 2000 to December 2019 were searched by computer.RevMan 5.3 software was used for Meta-analysis of the efficacy and safety.Results Seven RCT studies involving 1172 patients were obtained.Meta-analysis showed that the complete remission rate(OR=6.26,95%CI 1.74-22.49,P=0.005),partial remission rate(OR=4.65,95%CI 1.51-14.29,P=0.007),overall response rate(OR=14.14,95%CI 7.27-27.51,P<0.01),hematology improves(OR=3.47,95%CI 1.44-8.32,P=0.005)in the demethylation drug treatment group were better than those in the best supportive treatment group.Meanwhile,the overall survival of patients in azacytidine group was improved(HR=0.62,95%CI 0.50-0.77,P<0.01).In terms of adverse reactions,demethylation drugs increased the incidence of neutropenic fever(OR=4.19,95%CI 2.26-7.76,P<0.01).However,there was no significant difference in the incidence of neutropenia,thrombocytopenia,anemia,infection,nausea,liver damage and fatigue between the two groups(all P>0.05).Conclusions The effect of demethylation drugs in treatment of MDS is obvious,the remission rate can be improved,and azacytidine can prolong the patients'survival,but demethylation drugs increase the incidence of neutropenia fever.In the clinical application of demethylation drugs,it is necessary to further carefully evaluate their clinical safety.
作者
陈明月
谢彦晖
Chen Mingyue;Xie Yanhui(Department of Hematology,Huadong Hospital,Fudan University,Shanghai 200040,China)
出处
《白血病．淋巴瘤》
CAS
2021年第2期99-105,共7页
Journal of Leukemia & Lymphoma
