RIF/ATO+ATRA方案联合柔红霉素治疗成人高危急性早幼粒细胞白血病的临床疗效观察

Clinical Efficacy of RIF/ATO+ATRA Regimen Combined with Daunorubicin in the Treatment of High-Risk Acute Promyelocytic Leukemia in Adults

目的探讨复方黄黛片(RIF)/三氧化二砷(ATO)+维甲酸(ATRA)方案联合柔红霉素治疗成人高危急性早幼粒细胞白血病(APL)的临床疗效。方法选取2020年2月—2022年2月收治的成人高危APL患者82例,根据不同治疗方案分组,采用RIF/ATO+ATRA治疗患者44例为对照组,采用RIF/ATO+ATRA联合柔红霉素治疗患者38例为观察组,对比2组近期疗效,白细胞计数(WBC)、血小板计数(PLT)、纤维蛋白降解产物(FDP)、D-二聚体及纤维蛋白原(FIB)变化,早期死亡率、复发率及总生存率,不良反应。结果观察组血液学缓解率、遗传学缓解率、分子学缓解率均高于对照组,诱导分化综合征发生率低于对照组(P<0.05)。观察组诱导期WBC、PLT低于对照组(P<0.05),但巩固期比较差异无统计学意义(P>0.05)。观察组诱导期、巩固期FDP、D-二聚体低于对照组(P<0.05),两组FIB在各阶段比较差异无统计学意义(P>0.05)。两组早期死亡率、复发率、无病生存率及总生存率比较差异无统计学意义(P>0.05)。两组不良反应发生率比较差异无统计学意义(P>0.05)。结论临床针对成人高危APL患者,RIF/ATO+ATRA方案联合柔红霉素可降低WBC峰值,减少诱导分化综合征风险。

Objective To discuss the clinical efficacy of Realgar-Indigo Naturalis Formula(RIF)/Arsenic Trioxide(ATO)+All-trans retinoic acid(ATRA)regimen combined with Daunorubicin in the treatment of high-risk acute promyelocytic leukemia(APL)in adults.Methods Eighty-two adults with high-risk APL from February 2020 to February 2022 were enrolled,and classified into two groups according to different treatment regimens.Control group(n=44)received RIF/ATO+ATRA regimen,while observation group(n=38)received RIF/ATO+ATRA regimen combined with Daunorubicin therapy.Then the clinical efficacy,white blood cell count(WBC),platelet count(PLT),fibrin degradation products(FDP),D-dimer,fibrinogen(FIB),early mortality rate,recurrence rate,overall survival rate and adverse reactions were compared between two groups.Results The hematologic response,cytogenetic response and molecular response rate were all higher in observation group than in control group,with statistical difference(P<0.05).The incidence rate of differentiation syndrome during induction therapy was lower in observation group than in control group(P<0.05).The WBC and PLT during the induction therapy of observation group were lower than those of control group(P<0.05),while the two indicators during the consolidation therapy yielded no statistical difference between two groups(P>0.05).FDP and D-dimer values during both the induction and consolidation therapies were all lower in observation group than in control group(P<0.05).FIB during each treatment period demonstrated no statistical difference between two groups(P>0.05).No statistical difference was found in the early mortality rate,recurrence rate,disease-free survival rate and overall survival rate between two groups(P>0.05).The adverse reaction rate of the two groups had no statistical difference between two groups(P>0.05).Conclusion Application of RIF/ATO+ATRA regimen combined with Daunorubicin in the treatment of high-risk APL in adults can effectively reduce the postoperative peak WBC count and the risk of differentiation syndrome during induction therapy.