三氧化二砷联合全反式维A酸、柔红霉素治疗小儿急性早幼粒细胞白血病的临床疗效

A Study of Arsenic Trioxide Combined with All-trans Retinoic Acid, Daunorubicin for Treatment of Children with Acute Promyelocytic Leukemia

目的评价全反式维A酸、柔红霉素与三氧化二砷联合方案治疗小儿急性早幼粒细胞白血病(APL)的临床疗效。方法选取2010年10月~2013年10月在我院血液科接受治疗的34例急性APL患儿作为研究对象。采用数字随机法分为对照组和实验组,每组17例。对照组患儿使用维A酸、柔红霉素治疗,实验组在维A酸、柔红霉素基础上联合三氧化二砷静脉注射治疗。对两组患儿的临床治疗效果和长期生存情况进行观察比较。结果经过28天的治疗,试验组患儿完全缓解率显著高于对照组(94.11%vs.82.35%,P<0.05);两组达到完全缓解时间、白细胞峰值、早期死亡率和感染率等指标的差异均有统计学意义(P<0.05);试验组的PML-RARα转阴率较对照组高,但差异无统计学意义(P>0.05)。对患儿跟踪随访36个月,对照组与试验组患儿的总生存时间分别为(21.22±3.78)月、(32.08±4.56)月、无复发生存时间分别为(11.71±4.21)月、(20.27±3.93)月,随访期内死亡率分别为5.88%、17.64%,试验组生存情况均优于对照组,差异有统计学意义(P<0.05)。结论三氧化二砷联合全反式维A酸、柔红霉素治疗方案能够提高APL患儿的完全缓解率并改善长期生存情况,条件许可时,可以作为首选方案。

Objective To evaluate the clinical efficacy of combined regimen of all-trans retinoic acid, dannorubicin and arsenic trioxide for the treatment of children with acute promyeloeytic leukemia （APL）. Methods 34 children with APL who underwent hemodialysis in our hospital between October 2010 and October 2013 were enrolled in this study. They were randomly divided into control group and experi- mental group, 17 cases in each group. In the control group, the children with APL were treated with retinoie acid and daunorubicin. In the experimental group, arsenic trioxide injection was applied intravenously on the basis of retinoie acid and daunorubiein. The clinical thera- peutic effect and long-term survival of the two groups were observed and analyzed. Results After treatment for 28 days, the complete remis- sion rate of the experimental group was significantly higher than that of the control group （94.11% vs. 82.35%, P〈0.05）. There were also significant differences in CR time, white blood cell peak, early death rate and infection rate between the two groups （P〈0.05）. The negative rate of PML-RARct in experimental group was higher than in control group [ （83.50 ± 7.34） vs. （89.54 ± 4.77） ], but the difference was not statistically significant （P〉0.05）. After three years of follow-up, the overall survival time in control group was （21.22 ± 3.78） months, but （32.08 ± 4.56） months in experimental group. The recurrence-free survival time was （11.71 ± 4.21） months in control group, but （20.27 ± 3.93） months in experimental group. During the follow-up period, the mortality in experimental group was significantly lower than in control group （5.88% vs. 17.64%）. The survival rate of experimental group was higher than that of control group, and the difference was statistically significant （P〈0.05）. Conclusion The combination of arsenic trioxide, all-trans retinoic acid and daunorubiein can improve the complete remission rate and long-term survival of children with APL, and it can be taken as the first choice when conditions permit.