全反式维甲酸联合高三尖杉酯碱治疗急性早幼粒细胞白血病的临床研究  

Treatment of acute promyelocytic leukemia by all-trans retinoic acid plus homoharringtonine

作　　者：傅明伟[1] 秘营昌[1] 白洁[1] 井丽萍[1] 李大鹏[1] 秦铁军[1] 孙秀娟[1] 林冬[1] 卞寿庚[1] 王建祥[1] 

机构地区：[1]中国医学科学院中国协和医科大学血液学研究所血液病医院血二科,天津300020

出　　处：《白血病．淋巴瘤》2007年第5期337-340,343,共5页Journal of Leukemia & Lymphoma

基　　金：天津市科技发展计划资助项目(05YFSZSF02400)

摘　　要：目的研究全反式维甲酸(ATRA)联合高三尖杉酯碱(HHT)治疗急性早幼粒细胞白血病(APL)的可行性、疗效及不良反应。方法选择初诊的 APL 患者26例随机分为研究组和对照组,分别给予 ATRA 或柔红霉素(DRN)/米托蒽琨(Mit)联合 HHT 诱导治疗,HA 或 DA/MA 方案巩固治疗。在诱导及巩固治疗各疗程结束时分别对比两组病例的 CR 率、融合基因情况、不良反应及无病生存期(DFS),并进行统计学分析。结果研究组在诱导结束时全部病例获血液学缓解,缓解率为100%,融合基因转阴率为63.6%。巩固第一疗程结束时融合基因转阴率为100%(至随访截止时间)。累计生存率为85.7%。诱导治疗期间中位累计血浆输注量为670 ml,中位累计血小板输注量32 U。对照组1例患者早期死亡,诱导结束时其余病例获血液学缓解。融合基因转阴率为38.5%,巩固第一疗程结束时融合基因转阴率为91.7%,累计生存率为75.6%。诱导治疗期间中位累计血浆输注量为760 ml,中位累计血小板输注量32U。两组比较,在疗效、融合基因转阴率、累计生存率(85.7%/75.6%)及不良反应等方面均相似,在诱导治疗融合基因转阴率方面研究组似有优势,差异无统计学意义。结论 ATRA 联合 HHT 治疗 APL 在疗效、融合基因转阴率、血浆及血小板输注量及不良反应方面差异无统计学意义,作为新诊断APL 治疗的新选择,也可取得分子生物学缓解。Objective To evaluate the feasibility,efficacy and side-effect of regimen combine all- trans retinoic acid with homoharringtonine in new diagnosis acute promyelocytic leukemia(APL)in a random- ized comparison.Methods 26 patients with new diagnosis APL were randomized in two groups,which re- ceived an induction therapy with ATRA/daunorubicin or mitoxantrone plus homoharringtonine until CR,fol- lowed by two courses of consolidation therapy with HA/DA or MA regimen,respectively.Statistical analysis the expression of fusion gene,the rate of complete remission,side-effect and disease-free survival after in- duction and consolidation therapy,respectively.Results In HHT group all patients achieved hematological complete remission after induction therapy,the rate of CR is 100%,there is a same result in control group except one early death,the rate of CR is 92%.In HHT group the rate of fusion gene negative after induction therapy is 63.6% and 100% after 1 course consolidation therapy,in contrast to control group is 38.5% and 91.7%,respectively.The cumulative overall survival in HHT group and control group is 85.7% and 75.6%, respectively.There is no significance in toxicity.Conclusion The result in randomized comparison suggests regimen ATRA plus homoharringtonine followed by consolidation therapy with HA has no significance with control group in new diagnosis acute promyelocytic leukemia.This regimen can be a new choice in treatment of APL and can also achieve a molecular remission.

关 键 词：白血病 早幼粒细胞 急性 药物疗法 联合 维甲酸 三尖杉酯碱 

分 类 号：R733.71[医药卫生—肿瘤]