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目的 观察全反式维甲酸 (ATRA)联合三氧化二砷 (As2 O3 )治疗初发急性早幼粒细胞白血病 (APL)的完全缓解 (CR)率和融合基因PML RARα转阴情况。方法 ATRA 2 5mg·m- 2 ·d- 1 、As2 O30 .16mg·kg- 1 ·d- 1 联合治疗初发APL直至CR。根据外周血白细胞计数、维甲酸综合征以及肝功能变化调整ATRA和As2 O3 的剂量。观察CR率、获得CR和融合基因PML RARα转阴所需的时间、不良反应及近期缓解时间。结果 31例初发APL患者早期死亡 2例 ,2 9例获CR ,CR率 93.5 %,获得CR的平均时间为 (2 5 .1± 3.9)d。 6 6 .5 %患者在治疗开始后出现白细胞升高 ,6 5 .5 %出现肝功能异常 ,多在As2 O3减量或停用后 1周内恢复。所有患者初发时均为PML RARα阳性 ,CR时 10 .3%转阴 ,巩固治疗后检测的 13例中 10例 (77.0 %)转阴。至今 2 9例获CR的患者仍处CR状态 (1～ 8个月 )。结论 ATRA联合As2 O3 治疗初发APL疗效好 ,不良反应少。长期CR时间需要进一步观察。
Objective To investigate the rate of complete remission (CR) and the gene transfer of PML RARα in patients with acute promyelocytic leukemia (APL) treated with all-trans retinoic acid (ATRA) and arsenic trioxide (As2 O3). Methods ATRA 2 5mg · m-2 · d-1, As 2 O 30 · 16mg · kg -1 · d -1 combined treatment of initial APL until CR. ATRA and As2 O3 doses were adjusted based on peripheral blood leukocyte counts, retinoic acid syndrome, and changes in liver function. Observe the CR rate, obtain CR and fusion gene PML RARα negative time required, adverse reactions and immediate remission time. Results There were 2 early deaths in 31 patients with initial APL. The CR rate was 93.5% in 29 patients and the mean CR time was (2.5 ± 3.9) d. Sixty-five percent of the patients showed leukocytosis after the initiation of treatment, and 65.5% of the patients had abnormal liver function. They recovered more than one week after reduction or discontinuation of As 2 O 3. All patients were positive for PML RARα at the time of initial diagnosis, with 10.3% negative conversion at CR and 10 (77.0%) of 13 patients after consolidation therapy turned negative. To date, 29 CR patients remain in CR status (1 to 8 months). Conclusion ATRA combined with As2 O3 treatment of initial APL good curative effect, less adverse reactions. Long-term CR time needs further observation.