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目的观察单纯亚砷酸(AS2O3)联合维甲酸(ATRA)治疗急性早幼粒细胞白血病(APL)的不良反应及预防对策。方法对APL住院患者随机分两组,治疗组38例,单纯AS2O3+ATRA,从诱导治疗,巩固治疗到停药观察6年,对照组36例,AS2O3+ATRA+化疗(DA或MA),观察6年。结果治疗相关不良反应治疗组比对照组,在骨髓抑制,严重感染或败血症,肝肾功能损害,心肌损害,消化道反应等方面均较轻而少(P<0.01)。3年治疗相关死亡率为0,而对照组为16.7%(6/36)。结论治疗组相关不良反应等方面均显示令人满意效果。临床观察表明,单纯亚砷酸联合维甲酸治疗APL,具有协同增强作用,疗效高,治疗相关不良反应少,未见耐药性产生。不必加用化疗。
Objective To observe the adverse reactions and preventive measures of simple arsenic acid (AS2O3) combined with retinoic acid (ATRA) in the treatment of acute promyelocytic leukemia (APL). Methods APL inpatients were randomly divided into two groups: treatment group (38 cases), AS2O3 + ATRA alone, induction therapy, consolidation therapy, withdrawal therapy for 6 years, control group 36 cases, AS2O3 + ATRA + chemotherapy (DA or MA) year. Results Compared with the control group, the treatment-related adverse reactions in the treatment group were lighter and less than those in the control group (P <0.01) in the aspects of bone marrow suppression, severe infection or sepsis, liver and kidney dysfunction, myocardial damage and digestive tract reaction. The 3-year treatment-related mortality was 0, compared with 16.7% (6/36) in the control group. Conclusions The adverse effects of the treatment group showed satisfactory results. Clinical observations show that the combination of arsenic trioxide and tretinoin alone has synergistic enhancement effect, high curative effect and few adverse reactions to treatment. No drug resistance has been found. Do not have to use chemotherapy.