小剂量地西他滨治疗中高危骨髓增生异常综合征的Meta分析

目的 系统评价小剂量地西他滨治疗中高危骨髓增生异常综合征（MDS）疗效和安全性。方法 计算机检索PubMed、Cochrane Library、Embase、中国期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）1995-2012年间发表的关于小剂量地西他滨治疗MDS的文献资料。并纳入随机对照试验（RCT）,采用Review manager5.0软件进行Meta分析。结果 共纳入3篇随机对照试验（RCT），共894例患者。Meta分析结果显示，地西他滨与支持治疗相比，总生存率（OR）OR=22.9,95%CI(7.51，69.85)，P＜0.00001]、部分缓解率(PR) OR=17.23,95%CI(2.27，130.76)，P=0.006]、血液学改善（HI）OR=3.21,95%CI(1.53，6.75)，P=0.002]、中位生存期（MST）13.5月 vs. 7.3月，P＜0.05]、Ⅲ/Ⅳ级发热伴中性粒细胞减少OR=4.85,95%CI(2.55,9.21)，P＜0.00001] 差异有统计学意义。完全缓解率（CR）OR=6.39,95%CI(0.25,166.49)，P=0.26] 、Ⅲ/Ⅳ级血小板减少症OR=2.35,95%CI(0.63,8.69)，P=0.20]差异无统计学意义。结论 小剂量地西他滨可提高骨髓增生异常综合征患者总体生存率和部分缓解率，有助于血液学改善。但是增加Ⅲ/Ⅳ级中性粒细胞减少症的发生，部分患者也会出现血小板减少症、恶心呕吐、腹泻等不良反应。

Effectiveness and Safety of Low-dose Decitabine for Intermediate-or High-risk Myelodysplastic Syndrome (MDS) : A Systematic Review

Objective To assess the clinical effectiveness and safety of low-dose decitabine compared with best supportive care for intermediate- or high-risk myelodysplastic syndrome (MDS).Methods The related documents were searched on the PubMed, Embase, Cochrane Library, CNKI, and CBM databases from 1995 to 2012. Randomized controlled trials (RCTs) about Low-dose decitabine alone or combined with best supportive care for MDS were retrieved. The methodological quality of theincluded studies was assessed according to the Cochrane Reviewer's Handbook. Meta-analyses were performed using RevMan 5.0 software.Results Three RCTs involving 984 patients with MDS were included. Results of Meta-analysis showed that significant differences were found in overall response（OR）OR=22.9,95%CI(7.51，69.85)，P＜0.00001], partial response (PR)OR=17.23,95%CI(2.27，130.76)，P=0.006]，hematology improve（HI） OR=3.21，95%CI(1.53，6.75)，P=0.002]，median survival time 13.5 vs. 7.3 months, P＜0.05], grade 3 or 4 febrile neutropenia OR=4.85,95%CI(2.55，9.21)，P＜0.00001]，but not in complete remission （CR）OR=6.39，95%CI(0.25，166.49)，P=0.26], grade 3 or 4 thrombocytopenia OR=2.35，95%CI(0.63， 8.69)，P=0.2] between DEC and BSC regimen.Conclusion The low-dose decitabine can improve overall response, partial response and Hematologyimprove；however，it also increases grade 3 or 4 febrile neutropenia.