【摘要】 目的比较亚砷酸(As2O3)与维甲酸(ATRA)治疗急性早幼粒细胞白血病(Acute promyelocytic leukemua,APL)的疗效与安全性。方法采用Cochrane系统评价方法,检索《中国期刊全文数据库》、《中国优秀博硕士论文全文数据库》、《中国重要会议论文全文数据库》、《中国图书全文数据库》、《中国引文数据库》(1994-2010年)。检索时间截至2010年12月。获取比较As2O3和ATRA治疗APL疗效的随机对照试验文献和临床对照试验文献,以完全缓解率(CR)、治疗相关副反应为结局评价指标,使用Cochrane协作网Revman4.2软件进行Meta分析。结果共鉴定并纳入3项随机对照试验研究(RCT)和6项临床对照试验研究(非RCT)共包括614例APL患者。目的均为比较As2O3和ATRA治疗APL的疗效和副反应发生情况。分析结果显示,As2O3和ATRA治疗APL比较,针对CR结局指标差异无统计学意义(P>0.05),其结局指标的比值比(OR)及其95%CI为1.81(0.87,3.77)。针对肝功能异常发生率结局指标比较的OR及其95%CI为1.01(0.25,4.06),提示亚砷酸和维甲酸对肝功能影响无统计学意义。结论 Meta分析结果提示,采用As2O3治疗APL患者与ATRA疗效相当,导致肝功能异常的发生率相当。但需要更多大样本、高质量、双盲的随机对照试验予以证实。更多还原

【Abstract】 Objective To compare the efficacy and safety of arsenic trioxide(As2O3) with all-trans retinoic acid(ATRA) for the treatment of acute promyelocytic leukemia(APL).Methods We searched the database of Chinese journal full text data base,CDMD,CPFD,CBFD,Chinese Citation Database(1994-2010).We included randomized controlled trials and controlled clinical trials which compared As2O3 with ATRA for the treatment of APL.We adopt complete remission rate,and adverse reactions as result indicators.Data were entered and analyzed with the Cochrane review manager software(Revman 4.2).Results Three eligible randomized controlled trials(RCTs) and 6 controlled clinical trials were included(n=614).They all are focusing on the comparison of As2O3 monotherapy with ATRA monotherapy in treating APL patients.Meta analysis showed that effect index for complete remission was 1.81(0.87,3.77).It indicated no statistically significant difference.Effect index for incidence of liver dysfunction was 1.01(0.25,4.06),which showed no statistically significant difference between As2O3 group and ATRA group.Conclusion As2O3 is not superior to ATRA in treating APL patients regarding complete remission.The incidence of liver dysfunction during treatment is not much different between As2O3 group and ATRA group.Due to limitation of included trials,this conclusion need to be validated by further studies.更多还原