全反式维甲酸联合三氧化二砷治疗177例急性早幼粒细胞白血病患者的临床观察

The clinical efficacy of all-trans retinoic acid plus arsenic trioxide in 177 newly diagnosed acute promyelocytic leukemia patients

目的 探讨全反式维甲酸（ATRA）联合三氧化二砷（ATO）诱导及维持治疗方案对初诊急性早幼粒细胞白血病（APL）的临床疗效.方法 自2004年9月至2013年12月浙江大学附属第一医院血液科收治的298例初发APL患者,177例接受ATRA联合ATO治疗,116例接受ATRA联合化疗方案治疗.回顾性分析两种治疗方案对低中危组（WBC≤10×10^9/L）和高危组（WBC＞ 10×10^9/L）APL患者的临床疗效.结果 在低中危APL患者中,ATRA联合化疗和ARTA联合ATO诱导及维持治疗方案的复发率分别为22.0％（20/91）和6.1％ （6/98） （P=0.004）;3年预计无复发生存（RFS）率分别为78.0％和92.9％（P=0.021）.在高危APL患者中,ATRA联合化疗和ARTA联合ATO诱导及维持治疗方案的复发率分别为25.0％（4/16）和5.2％（3/58） （P=0.035）;3年预计RFS率分别为80.8％和93.0％（P=0.063）.两种方案治疗的低中危和高危患者比较,早期病死率、完全缓解率及总体生存率差异无统计学意义（P＞0.05）.结论 ATRA联合ATO诱导及维持治疗方案可以延长低中危APL患者的无复发生存时间,并能降低低、中、高危患者的复发率.

Objective To investigate the clinical efficacy of all-trans retinoic acid （ATRA） plus arsenic trioxide （ATO） in induction and maintenance therapy in newly diagnosed acute promyelocytic leukemia （APL）.Methods A retrospective analysis of 298 newly diagnosed APL patients from the department of hematology,First Affiliated Hospital of Zhejiang University since September 2004 to December 2013,including 177 cases with ATRA plus ATO and 116 ATRA plus chemotherapy （CT）,was performed to investigate the clinical efficacy between the low-intermediate （WBC≤1 0 × 10^9/L） and high （WBC 〉 10 × 10^9/L） risk APL patients,respectively.Results For the low-intermediate risk patients,the relapse rate in ATRA plus CT and ATRA plus ATO are 22.0% and 6.1% （P=0.004）,respectively;the 3 years estimated relapse-free survival （RFS） are 78.0% and 92.9% （P=0.021）,respectively.For the high risk patients,the relapse rate in ATRA plus CT and ATRA plus ATO are 25.0% and 5.2% （P=0.035）,respectively;the 3 years estimated RFS rate were 80.8% and 93.0% （P=0.021）,respectively.But the rate of early death （ED）,complete remission （CR） and overall survival （OS） between the two therapy protocols had no statistical difference （P〉0.05）.Conclusions ATRA plus ATO in induction and maintenance therapy might prolong the RFS time of the low-intermediate risk APL patients and decrease the relapse rate of the low,intermediate and high risk APL patients.