复方黄黛片与三氧化二砷在45例儿童急性早幼粒细胞白血病中的疗效比较
发布时间：2018-08-05 13:48
【摘要】：目的:探讨含三氧化二砷(ATO)或复方黄黛片(RIF)方案治疗45例急性早幼粒细胞白血病(APL)患儿的临床疗效及预后因素。方法:回顾性分析本院2004年1月至2017年5月收治的45例新诊APL患儿的临床资料。在45例中25例采用含RIF的方案进行化疗,其余20例采用含ATO的方案治疗,对所有患儿进行随访;比较2组的预后及药物不良反应发生率,探究影响预后的高危因素。结果:中位随访时间为49.83个月。RIF组的25例患儿中,无患儿早期死亡;5例于诱导缓解后未达CR,CR率为88%;2例骨髓复发,3例死亡。20例至随访结束时仍持续完全缓解(CCR);2例失访。在ATO组的20名患儿中,2例早期死亡;5例诱导缓解后未达完全缓解(CR),CR率为90%;2例骨髓复发并死亡,15例至随访结束时仍CCR;1例失访。预测全部患儿5年总体生存率(OS)及无事件生存率(EFS)分别为(82.2±6.2)%和(76.4±6.6)%,RIF组的OS及EFS 2值分别为(86.1±7.4)%和(78.4±8.6)%,与ATO组(76.4%±10.6%和74.0%±10.1%)相比无明显差异(P0.05、P0.05)。至于药物不良反应,除心脏损害RIF组发生率较低外(P0.05),其它药物不良反应发生率2组未见明显差异(P0.05)。此外,伴有中枢神经系统白血病(CNSL)患儿的5年OS及EFS明显低于无中枢侵犯的患儿(P0.05、P0.05);诱导治疗后未达M1的患儿5年OS及EFS也明显低于其余患儿(P0.01);高危患儿明显低于非高危患儿(P0.05、P0.05),而与年龄、性别无明显关系。结论:复方黄黛片在儿童APL治疗中可达到与三氧化二砷相近的疗效,药物不良反应发生率未见明显提高;发生CNSL、治疗反应差及临床分层高危是影响预后的高危因素。
[Abstract]:Objective: to investigate the clinical effect and prognostic factors of 45 children with acute promyelocytic leukemia (APL) treated with arsenic trioxide (ATO) or compound Huangdai tablets (RIF). Methods: the clinical data of 45 newly diagnosed children with APL from January 2004 to May 2017 were retrospectively analyzed. In the 45 cases, 25 cases were treated with RIF regimen, the other 20 cases were treated with ATO regimen, all the children were followed up, the prognosis and incidence of adverse drug reactions were compared between the two groups, and the high risk factors affecting prognosis were explored. Results: the median follow-up time was 49.83 months. Among the 25 children in the RIF group, no early death was found in 5 cases. The CR rate of 882 cases was not reached after induction of remission. 2 cases died of bone marrow recurrence. 20 cases still had complete remission of (CCR) loss in 2 cases until the end of follow-up. Among the 20 children in ATO group, 2 cases died early and 5 cases did not reach complete remission after induced remission. The CR rate of 2 cases of bone marrow recurrence and death of 15 cases of bone marrow recurrence and death was 90%, and 1 case was still missing at the end of follow-up. The 5-year overall survival rate (OS) and non-event survival rate (EFS) were (82.2 卤6.2)% and (76.4 卤6.6), respectively. The values of OS and EFS 2 in RIF group were (86.1 卤7.4)% and (78.4 卤8.6), respectively. There was no significant difference compared with ATO group (76.4% 卤10.6% and 74.0% 卤10.1%) (P 0.05). As for adverse drug reactions, there was no significant difference in the incidence of other adverse drug reactions between the two groups (P0.05) except for the lower incidence of cardiac injury in RIF group (P0.05). In addition, The 5-year OS and EFS in children with CNS leukemia (CNSL) were significantly lower than those without central nervous system invasion (P0.05P 0.05), and the 5-year OS and EFS in children without M1 after induction therapy were significantly lower than those in other children (P0.01), and those at high risk were significantly lower than those in non-high-risk children (P0.01). Children (P0. 05, P 0. 05), but with age, There is no obvious relationship between sex. Conclusion: the curative effect of compound Huangdai tablet in the treatment of children with APL is similar to that of arsenic trioxide, and the incidence of adverse drug reactions is not obviously increased, the poor response to treatment and the high risk of clinical stratification are the high risk factors affecting the prognosis.
【作者单位】： 中山大学孙逸仙纪念医院儿科;中山大学附属第七医院儿科;
【基金】：国家自然科学基金面上项目(81370625)
【分类号】：R733.71
，
本文编号：2165981
[Abstract]:Objective: to investigate the clinical effect and prognostic factors of 45 children with acute promyelocytic leukemia (APL) treated with arsenic trioxide (ATO) or compound Huangdai tablets (RIF). Methods: the clinical data of 45 newly diagnosed children with APL from January 2004 to May 2017 were retrospectively analyzed. In the 45 cases, 25 cases were treated with RIF regimen, the other 20 cases were treated with ATO regimen, all the children were followed up, the prognosis and incidence of adverse drug reactions were compared between the two groups, and the high risk factors affecting prognosis were explored. Results: the median follow-up time was 49.83 months. Among the 25 children in the RIF group, no early death was found in 5 cases. The CR rate of 882 cases was not reached after induction of remission. 2 cases died of bone marrow recurrence. 20 cases still had complete remission of (CCR) loss in 2 cases until the end of follow-up. Among the 20 children in ATO group, 2 cases died early and 5 cases did not reach complete remission after induced remission. The CR rate of 2 cases of bone marrow recurrence and death of 15 cases of bone marrow recurrence and death was 90%, and 1 case was still missing at the end of follow-up. The 5-year overall survival rate (OS) and non-event survival rate (EFS) were (82.2 卤6.2)% and (76.4 卤6.6), respectively. The values of OS and EFS 2 in RIF group were (86.1 卤7.4)% and (78.4 卤8.6), respectively. There was no significant difference compared with ATO group (76.4% 卤10.6% and 74.0% 卤10.1%) (P 0.05). As for adverse drug reactions, there was no significant difference in the incidence of other adverse drug reactions between the two groups (P0.05) except for the lower incidence of cardiac injury in RIF group (P0.05). In addition, The 5-year OS and EFS in children with CNS leukemia (CNSL) were significantly lower than those without central nervous system invasion (P0.05P 0.05), and the 5-year OS and EFS in children without M1 after induction therapy were significantly lower than those in other children (P0.01), and those at high risk were significantly lower than those in non-high-risk children (P0.01). Children (P0. 05, P 0. 05), but with age, There is no obvious relationship between sex. Conclusion: the curative effect of compound Huangdai tablet in the treatment of children with APL is similar to that of arsenic trioxide, and the incidence of adverse drug reactions is not obviously increased, the poor response to treatment and the high risk of clinical stratification are the high risk factors affecting the prognosis.
【作者单位】： 中山大学孙逸仙纪念医院儿科;中山大学附属第七医院儿科;
【基金】：国家自然科学基金面上项目(81370625)
【分类号】：R733.71
，
本文编号：2165981
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