全反式维甲酸联合三氧化二砷治疗初发急性早幼粒细胞白血病的临床观察

Clinical observation of the combination of all-trans retinoic acid with arsenic trioxide on newly-diagnosed patients of acute promyelocytic leukemia

目的:观察全反式维甲酸(ATRA)联合三氧化二砷(As2O3)治疗初发急性早幼粒细胞白血病(APL)的疗效和不良反应。方法:对联合应用ATRA和As2O3治疗的55例APL患者的完全缓解(CR)率、达CR所需时间、早期病死率和不良反应进行观察,并与单独应用ATRA组31例和As2O3组26例进行比较。联合用药组治疗方法为ATRA25mg·m-2.d-1,As2O30.16mg·kg-1.d-1直至CR,根据外周血白细胞计数、不良反应调整ATRA和As2O3的剂量。结果:联合用药组与单独应用ATRA、As2O3组相比,CR率无统计学意义(分别为96.3%、83.9%、84.6%,均P>0.05);联合用药组获得CR所需的时间短于单独用药组(平均时间分别为25d、47d、41d,均P<0.05),早期死亡率亦低于单独用药组(分别为3.6%、12.9%、11.5%,均P<0.05),与单独用药组相比,联合用药组的不良反应并未增加。结论:联合用药诱导初发APL缓解的疗效优于单用药组,不良反应少,是一种值得推广应用的方案。

Objective：To observe the therapeutic efficacy and side effect of all-trans retinoic acid（ATRA） combined with arsenic trioxide（As2O3 ）on newly-diagnosed patients with acute promyeloeytic leukemia（APL）. Method： 55 patients of newly-diagnosed APL, underwent ATRA ＋As2O3 therapy. The therapeutic effect was compared with ATRA alone treatment on 31 patients and that of As2O3 alone treatment on 26 patients. The combination group were treated with ATRA 25 mg · m^-2 · d ^-1 and As2O3 0. 16 mg · kg^-1 · d^-1 until complete remission （CR）. The dose were adjusted according to white blood cell（WBC） counts and side effect. CR rate, period to CR, incidence of early death and side effect were observed in three groups. Result：There was no significantly difference in CR rate among the three groups （96.30% for ATRA ＋As2O3 group, 83.9% for ATRA group and 84.6% for As2O3 group respectively, P 〉0.05）. In compared with ATRA and As2O3 respectively, the combination group shortened the period to CR （the medium time to CR was 25 days for the ATRA ＋As2O3 group, 47days for ATRA group and 41 days for As2O3 group respectively, P 〈0. 05）. The combination group showed a lowed incidence of early death （3.6% for ATRA ＋As2O3 group, 12.9% for ATRA group and 11.5% for As2O3 group respectively, P 〈0.05）. The combined use of ATRA with As2O3 did not further enhance toxic side effect as compared to ATRA alone or As2O3 alone. Conclusion.. ATRA ＋ As2O3 regiment is superior to either regiment given alone to patients with APL. It is an efficient therapeutic approach to APL patients using a combination of ATRA with As2O3.