三氧化二砷联合全反式维甲酸治疗初发急性早幼粒细胞白血病50例疗效观察

 目的　观察三氧化二砷（ATO）联合全反式维甲酸（ATRA）治疗初发急性早幼粒细胞白血病（APL）的疗效。方法　98例初发APL患者分为对照组和治疗组，对照组48例，治疗组50例。对照组采用常规ATRA+DA双诱导方案治疗；治疗组采用ATRA每天25 mg／m2，ATO每天0.15 mg／kg（ATRA后第10天开始）联合治疗，直至完全缓解（CR），CR后接受ATO和ATRA联合巩固治疗。比较两组CR率、PML-RARα融合基因转阴时间及5年无病生存率。结果　对照组和治疗组CR率分别为89.5 %（43／48）和90.0 %（45／50），获得CR时间分别为（30.0±5.1）d和（28.1±4.4）d，两组CR率（χ2＝-0.068，P＝0.946）及获得CR时间（t＝1.757，P＝0.083）相比差异均无统计学意义。在所有获得CR的患者中，3例分别在CR后第276、385和394天复发。所有患者发病时PML-RARα融合基因均阳性，对照组和治疗组CR时分别有25.0 %（5／20）和29.4 %（5／17）转阴，巩固后分别有92.5 %（37／40）和97.6 %（41／42）转阴。对照组和治疗组5年无病生存率分别为（85.3±5.9）%和（87.6±5.6）%，差异无统计学意义（χ2＝0.232，P＝0.630）。结论　ATO联合ATRA能有效治疗初发APL患者，可以作为常规化疗方案外的另一选择。

Clinical observation on the efficacy of the treatment with combination of all-trans retinoic acid and arsenic trioxide in 50 cases of newly diagnosed acute promyelocytic leukemia

Objective To study the efficacy of arsenic trioxide （ATO） combined all-trans retinoic acid （ATRA） in primary acute promyelocytic leukemia （APL） patients. Methods 98 patients with newly diagnosed APL were randomly divided into control （48 cases） and treatment group （50 cases）. Control group received conventional ATRA＋DA dual induction regimen and the treatment group received ATRA 25 mg·kg^-2·d^-1 and ATO 0.15 mg·kg^-2·d^-1 beginning from 10 days later after administration of ATRA. After complete remission （CR）, ATO and ATRA treatment were received. CR rate for consolidation, time of reaching clinical and molecular remission and 5-year disease-free survival were observed. Results CR rates were 89.6 % （43/48） and 90.0 % （45/50） in control group and treatment group, respectively, and the time of obtaining CR was （30.0_＋5.1） and （28.1_＋4.4） days, respectively. CR rates （X^2 =-0.068, P =0.946） and time of reaching CR （t =1.757, P =0.083） in two groups showed no significant difference. In patients obtaining CR, 3 patients relapsed in 276, 385 and 394 days after CR, respectively. PML-RARct fusion gene was positive at diagnosis in all patients. The rate of negative of fusion gene at CR in conwol and treatment group was 25.0 % （5/20） and 29.4 % （5/17）, respectively. The rate of negative of fusion gene after consolidation in control and treatment group was 92.5 % （37/40） and 97.6 % （41/42）, respectively. 5-year disease-free survival rates of the control and treatment group was （85.3±5.9） % and （87.6±5.6） %, respectively. The difference was not statistically significant （X^2 =0.232, P =0.630）. Conclusion The regimen of ATO combined ATRA is effective in treating newly diagnosed APL patients, and can be used as an alternative regimen.