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目的:观察亚砷酸(AS2O3)联合维甲酸(ATRA)治疗急性早幼粒细胞白血病(APL)的疗效和特点。方法:对APL住院患者随机分为2组,治疗组38例,单纯AS2O3加ATRA,从诱导治疗、巩固治疗到停药观察6年。对照组36例,AS2O3加ATRA加化疗(DA或MA),观察6年。结果:治疗组38例,初治诱导缓解治疗达完全缓解率(CR)为100%。3年复发率为2.6%,6年持续缓解率(CCR)为94.6%。对照组36例初治诱导缓解率为81.3%,3年复发率为30.7%,6年CCR为61.5%。治疗相关不良反应治疗组比对照组较轻而少(P<0.01),3年治疗相关死亡率为0,而对照组为16.7%(6/36)。结论:亚砷酸联合维甲酸治疗APL,具有协同增强作用,疗效高,复发率低,治疗相关不良反应少,未见耐药性产生。
Objective: To observe the efficacy and characteristics of AS2O3 and ATRA in the treatment of acute promyelocytic leukemia (APL). Methods: APL hospitalized patients were randomly divided into two groups, the treatment group 38 cases, simple AS2O3 plus ATRA, from induction therapy, consolidation therapy to withdrawal observed for 6 years. Control group, 36 cases, AS2O3 plus ATRA plus chemotherapy (DA or MA), observed for 6 years. Results: In the treatment group, the complete remission rate (CR) was 38% in the initial treatment group and 100% in the CR group. The 3-year recurrence rate was 2.6%, and the 6-year CCR was 94.6%. Control group, 36 cases of initial treatment induced remission rate was 81.3%, 3-year recurrence rate was 30.7%, 6-year CCR was 61.5%. Treatment-related adverse events in the treatment group were less and less than those in the control group (P <0.01), and the 3-year treatment-related mortality was 0 compared with 16.7% (6/36) in the control group. Conclusion: Arsenite combined with retinoic acid has a synergistic effect in the treatment of APL. It has high curative effect, low recurrence rate, few treatment-related adverse reactions and no drug resistance.