Objective: To explore the efficacies of regimens of three-drug induction therapy (ATRA+ATO+anthracyclines) versus two-drug induction therapy (ATRA+ATO) in patients with acute promyelocytic leukemia (APL). Methods: Of 184 patients diagnosed with APL from January 2009 to March 2016, 58 patients underwent three-drug induction therapy, while the rest were treated with two-drug induction therapy. Three-drug induction therapy was of ATRA (20 mg·m(-2)·d(-1), d(1-28)) + ATO (0.16 mg·kg(-1)·d(-1), d(1-28)) + Idarubicin (8 mg·m(-2)·d(-1), d(3-5)) /daunorubicin (40 mg·m(-2)·d(-1), d(3-5)) , while two-drug induction therapy ATRA+ATO with the same doses and methods as above. Of 184 cases, 69 cases accompanied with WBC counts>10×10(9)/L, 115 cases with WBC counts≤10×10(9)/L at onset. Results: ①Short-term efficacy: After one cycle induction therapy, the rates of hematologic remission, genetic remission, molecular remission and induced differentiation syndrome (DS) in three-drug regimen group were 98.3%, 87.9%, 72.4% and 0 respectively, while those in two-drug regimen group were 87.3%, 65.9%, 51.6% and 12.7% respectively. In patients with WBC >10×10(9)/L, DS rate and early mortality in three-drug regimen group were lower than in two-drug regimen group (0 vs 15.6%, 4.2% vs 15.6%, respectively). In patients with WBC≤10×10(9)/L, DS rate in three-drug regimen group was also lower than in two-drug regimen group (0 vs 12.3%) , but there were no statistical differences in terms of relapse and early mortality. ② Long-term efficacy: The relapse rate, overall survival (OS) and disease free survival (DFS) in three-drug regimen group were 0, 98.5%, 96.6% respectively, while those in two-drug regimen group were 8.6%, 86.5% and 84.1% respectively; the advantages of three-drug over two-drug regimen, especially in cases of WBC >10×10(9)/L were observed. ③ Side effects: the incidences of gastrointestinal reaction, liver dysfunction, myocardial damage and headache in three-drug regimen group hardly increased. Conclusion: The efficacies of three-drug induction therapy were superior to two-drug one.
目的： 比较全反式维甲酸（ATRA）、三氧化二砷（ATO）联合蒽环类药物三药诱导方案与ATRA联合ATO双药诱导方案治疗急性早幼粒细胞白血病（APL）的疗效。 方法： 2009年1月至2016年3月确诊并治疗的APL患者184例，随机分为三药诱导组（58例）和双药诱导组（126例）。三药诱导方案为ATRA 20 mg·m(-2)·d(-1)，第1~28天；ATO 0.16 mg·kg(-1)·d(-1)，第1~28天；蒽环类药物去甲氧柔红霉素8 mg·m(-2)·d(-1)或柔红霉素40 mg·m(-2)·d(-1)，第3~5天。双药诱导方案为ATRA联合ATO，剂量用法同上。184例患者中WBC>10×10(9)/L者69例，WBC≤10×10(9)/L者115例。 结果： ①近期疗效：三药诱导组1个疗程的血液学缓解率、遗传学缓解率、分子学缓解率及诱导分化综合征发生率分别为98.3%、87.9%、72.4%和0，双药诱导组分别为87.3%、65.9%、51.6%和12.7%，差异均有统计学意义（P值分别为0.017、0.002、0.008、0.005）；在WBC>10×10(9)/L的患者中，三药诱导组诱导分化综合征的发生率及早期病死率低于双药诱导组（0对15.6%，P=0.042；4.2%对15.6%，P=0.246）；在WBC≤10×10(9)/L的患者中，三药诱导组诱导分化综合征的发生率也低于双药诱导组（0对12.3%，P=0.032），但缓解率及早期病死率两组差异无统计学意义（P值均>0.05）。②远期疗效：三药诱导组的复发率、总生存率及无病生存率分别为0、98.5%、96.6%，双药诱导组分别为8.6%、86.5%、84.1%，差异均有统计学意义（P值分别为0.013、0.018、0.019）；尤其是WBC>10×10(9)/L的患者，三药诱导组优势更加明显。③不良反应：三药诱导组的胃肠道反应、肝功能损害、心肌损伤及头痛的发生率未见明显增加。 结论： 在APL的诱导治疗中，三药诱导方案的疗效优于双药诱导方案。.
Keywords: Antineoplastic combined chemoerapy protocols; Induction therapy; Leukemia, promyelocyte, acute.