全反式维甲酸联合三氧化二砷治疗初诊急性早幼粒细胞白血病的疗效及对复发率的影响分析

摘要

目的：探讨应用三氧化二砷（AS2O3）联合全反式维甲酸（ATRA）与单用ATRA对初发急性早幼粒细胞白血病（APL）诱导治疗的临床疗效及对复发率的影响。方法回顾性分析接受规律治疗的初治120例APL患者的临床资料，所有患者按治疗方法不同分为观察组和对照组，每组60例。观察组予ATRA口服联合AS2O3静脉滴注治疗，对照组仅予ATRA口服治疗，根据外周血白细胞数、肝功能以及临床症状调整药物用量，均治疗直至完全缓解（CR）。观察诱导治疗阶段CR率和早幼粒白血病基因和维甲酸受体基因融合基因（PML-RARα）转阴所需时间和不良反应，巩固化疗后3年总生存率（OS）和复发率，同时分析白细胞水平对预后的影响。结果观察组早期病死率、CR率与对照组比较差异无统计学意义（P﹥0.05），达到CR时间少于对照组（P﹤0.05）；观察组PML-RARα转阴率和总生存率高于对照组，复发率低于对照组（P﹤0.05）；选取观察组57例患者分析白细胞水平对预后的影响，WBC≥10×109/L患者复发率、病死率、未缓解（NR）率与WBC﹤10×109/L患者比较，差异无统计学意义（P﹥0.05），CR率与总生存率则低于WBC﹤10×109/L患者。结论 AS2O3联合ATRA治疗初发APL的疗效较好，达到CR时间缩短，预后提高，白细胞水平对APL的预后有一定影响，导致CR率与总生存率降低。%Objective To evaluate the clinical efficacy of induction therapy of arsenic trioxide (AS2O3) in combina-tion with all-trans retinoic acid (ATRA) and ATRA treatment alone and the effect on relapse rate in newly diagnosed acute promyelocytic leukemia (APL). Method The clinical profile of 120 cases of newly diagnosed APL were included in the analysis, all patients were stratified as study group and control group according to respective treatment, with 60 cases in each. Oral ATRA and AS2O3 i.v. were administered in study group, while oral ATRA alone was given in control group, dose adjustment was considered based upon peripheral WBC, liver function and clinical symptoms, until complete re-sponse (CR) was achieved. The CR rate and the time before PML-RARαturned negative, adverse reactions, 3-year over-all survival (OS) and relapse rate after consolidation chemotherapy, as well as the effect of WBC on the prognosis were all analyzed. Result The short-term morality and CR were similar between study group and control group (P>0.05), while the study group took less time to achieve CR than control group (P<0.05);PML-RARαnegative rate and overall survival were both higher, and the recurrence rate was significantly lower in study group than that in control group (P<0.05);57 cases were included in WBC analysis, patients with WBC≥10×109 had comparable relapse rate, mortality rate, NR rate with those with WBC<10×109, and the difference was not statistically significant (P>0.05), but the CR and over-all survival rate was significantly lower in patients with higher WBC levels. Conclusion AS2O3 in combination with ATRA was effective in treating newly diagnosed APL, with less time needed to achieve CR, and improved prognosis, be-sides, white blood cell is associated with the prognosis of APL, leading to lower CR rate and overall survival.