吡柔比星为主联合化疗方案治疗初治急性髓系白血病疗效观察——一项前瞻、开放、随机、多中心临床研究  

Analysis of outcome of pirarubicin-based combination chemotherapy regimen in the treatment of newly diagnosed acute myeloid leukemia a prospective, open, randomized and multicenter clinical trial

作　　者：王彦艳[1] 沈晓梅[2] 张荣艳[3] 郭晓楠[4] 孙慧[5] 王欣[6] 张晋林[7] 李军民[1] 沈志祥[1] 

机构地区：[1]上海血液学研究所、上海交通大学医学院附属瑞金医院,200025 [2]云南省第一人民医院 [3]江西医学院第一附属医院 [4]河北医科大学第二附属医院 [5]郑州大学第一附属医院 [6]山东省立医院 [7]四川省人民医院

出　　处：《中华血液学杂志》2010年第11期748-751,共4页Chinese Journal of Hematology

摘　　要：目的 比较吡柔比星＋阿糖胞苷（TA）方案与柔红霉素＋阿糖胞苷（DA）方案治疗初治急性髓系白血病（AML）的疗效及不良反应.方法 全国72个血液病治疗中心于2006年10月至2009年7月共入组207例初治AML患者,随机分为DA或TA方案组,观察并评价1个或2个疗程后完全缓解（CR）率、总体反应（RR）率及不良反应.结果 207例患者中可评价198例,TA组126例,DA组72例,比例1.75∶1,符合方案设定2∶1范围.TA组CR率69.8%,RR率（CR＋PR）81.8%;DA组CR率63.9%,RR率80.9%,二者疗效之间差异无统计学意义.对于AML-M2亚型,TA组CR率（77.1%）明显高于DA组（60%）.两组之间不良反应差异无统计学意义.结论 TA方案与DA方案治疗初治AML患者的疗效相当,但对于AML-M2亚型,TA显示出了较好的疗效.而不良反应两组间差异无统计学意义.Objective To compare the effectiveness and side effects of two chemotherapy regimens [pirarubicin ＋ cytarabine （TA） and daunorubicin ＋ cytarabine （DA）] in patients with acute myeloid leukemia（AML）. Methods From Oct 2006 to Jul 2009, there were 207 newly diagnosed AML patients randomized into DA or TA group from 72 centers all over the country. The aim of this clinical trial is to observe and evaluate complete remission rate （CR）, total remission rate （TRR） , and side effect after one or two circles of therapy. Results In 198 evaluable patients, 126 cases in TA group and 72 in DA group were evalvable,in DA group, correspondingly（ P 〉 0.05 ）. For patients with subtype M2, CR （77.1% ） in TA group was higher than that in DA （60%）. There was no difference in side effect between the two groups. Conclusion There is no difference of the effect between TA and DA chemotherapy for newly diagnosed AML patients. But for subtype M2, TA is more efficacy. And there is no difference in side effect between the two regimens.

关 键 词：吡柔比星 白血病 非淋巴细胞 急性 疗效 不良反应 

分 类 号：R686[医药卫生—骨科学]