【摘要】：目的:探討含三氧化二砷(ATO)或復(fù)方黃黛片(RIF)方案治療45例急性早幼粒細(xì)胞白血病(APL)患兒的臨床療效及預(yù)后因素。方法:回顧性分析本院2004年1月至2017年5月收治的45例新診APL患兒的臨床資料。在45例中25例采用含RIF的方案進(jìn)行化療,其余20例采用含ATO的方案治療,對(duì)所有患兒進(jìn)行隨訪;比較2組的預(yù)后及藥物不良反應(yīng)發(fā)生率,探究影響預(yù)后的高危因素。結(jié)果:中位隨訪時(shí)間為49.83個(gè)月。RIF組的25例患兒中,無患兒早期死亡;5例于誘導(dǎo)緩解后未達(dá)CR,CR率為88%;2例骨髓復(fù)發(fā),3例死亡。20例至隨訪結(jié)束時(shí)仍持續(xù)完全緩解(CCR);2例失訪。在ATO組的20名患兒中,2例早期死亡;5例誘導(dǎo)緩解后未達(dá)完全緩解(CR),CR率為90%;2例骨髓復(fù)發(fā)并死亡,15例至隨訪結(jié)束時(shí)仍CCR;1例失訪。預(yù)測全部患兒5年總體生存率(OS)及無事件生存率(EFS)分別為(82.2±6.2)%和(76.4±6.6)%,RIF組的OS及EFS 2值分別為(86.1±7.4)%和(78.4±8.6)%,與ATO組(76.4%±10.6%和74.0%±10.1%)相比無明顯差異(P0.05、P0.05)。至于藥物不良反應(yīng),除心臟損害RIF組發(fā)生率較低外(P0.05),其它藥物不良反應(yīng)發(fā)生率2組未見明顯差異(P0.05)。此外,伴有中樞神經(jīng)系統(tǒng)白血病(CNSL)患兒的5年OS及EFS明顯低于無中樞侵犯的患兒(P0.05、P0.05);誘導(dǎo)治療后未達(dá)M1的患兒5年OS及EFS也明顯低于其余患兒(P0.01);高�；純好黠@低于非高�；純�(P0.05、P0.05),而與年齡、性別無明顯關(guān)系。結(jié)論:復(fù)方黃黛片在兒童APL治療中可達(dá)到與三氧化二砷相近的療效,藥物不良反應(yīng)發(fā)生率未見明顯提高;發(fā)生CNSL、治療反應(yīng)差及臨床分層高危是影響預(yù)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 鹵6.2)% and (76.4 鹵6.6), respectively. The values of OS and EFS 2 in RIF group were (86.1 鹵7.4)% and (78.4 鹵8.6), respectively. There was no significant difference compared with ATO group (76.4% 鹵10.6% and 74.0% 鹵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.
【作者單位】： 中山大學(xué)孫逸仙紀(jì)念醫(yī)院兒科;中山大學(xué)附屬第七醫(yī)院兒科;
【基金】：國家自然科學(xué)基金面上項(xiàng)目(81370625)
【分類號(hào)】：R733.71
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本文編號(hào)：2165981