阿糖胞苷治疗急性早幼粒细胞白血病疗效随机对照试验的系统评价

目的评价阿糖胞苷治疗急性早幼粒细胞白血病的疗效与安全性。方法查阅国内外已公开发表或未发表的比较含与不含阿糖胞苷治疗方案对急性早幼粒细胞白血病疗效的随机对照试验文献，以无事件生存期、总生存期、无病生存期、完全缓解率、诱导期内死亡率、化疗相关毒副反应、复发率等为评价指标．采用Cochrane协作网RevMan5．0软件进行Meta分析。结果纳入3个随机对照试验，共包括504例受试对象。结果表明，加用阿糖胞苷对急性早幼粒细胞白血病患者的无事件生存期、总生存期和完全缓解率的影响差异无统计学意义。其效应统计量危险比及其95％可信区间分别为1．21（0．93，1．59）、1．02（0．80，1.31）和1．51（0．17，13．45）；加用阿糖胞苷对急性早幼粒细胞白血病患者诱导期内病死率和化疗相关毒副反应的发生率的影响差异也无统计学意义．其效应统计量比值比及其95％可信区间分别为1．26（0．70，2．29）和6．91（0．15，315．6）；对无病生存期的影响亦不明显。而加用阿糖胞苷对复发率的影响尚存在争议。结论根据3篇小样本的随机对照试验结果，在急性早幼粒细胞白血病化疗方案中应用阿糖胞苷并没有显示提高疗效的证据。目前的证据尚不足以推荐阿糖胞苷用于急性早幼粒细胞白血病的常规化疗中。

Cytarabine in the Treatment of Acute Promyelocytic Leukemia: A Systematic Review

Objectives This systematic review assessed the efficacy and safety of cytarabine (Ara-C) for the treatment of acute promyelocytic leukemia (APL). Methods We searched the published or unpublished randomized clinical trial literatures which compare the efficacy and safety of therapeutic regimens with or without cytarabine for the treatment of APL, mainly adopted event-free survival, overall survival, disease-free survival, complete remission, induction death, toxic and adverse reaction and relapse rate as result indicators, and used RevMan5.0 to do meta-analysis. Results Three eligible RCTs were included (N=504). Meta analysis showed that adding Ara-C to the treatment of APL had no statistically significant improvement on event-free survival (HR 1.21,95%CI 0.93～1.59), overall survival (HR1.02,95%CI 0.80～1.31) and disease-free survival. Ara-C for the treatment of APL also had no significant influence on complete remission(CR), induction death, toxic and adverse reaction. The influence of adding Ara-C to relapse rate is still controversial. Conclusion This systematic review found that adding Ara-C for the treatment of APL was not beneficial based on the currently available data.