伊达比星加强预处理异基因造血干细胞移植治疗难治性急性髓系白血病的临床研究

 　目的　探讨预处理方案中加伊达比星增强预处理的异基因造血干细胞移植（allo-HSCT）治疗难治性急性髓系白血病的疗效和安全性。方法　选择北京军区总医院血液科2010年8月至2012年12月在预处理方案中增加伊达比星的allo-HSCT治疗的27例难治性急性髓系白血病患者，其中男13例，女14例，年龄2～53岁，平均年龄24.6岁；FAB分型包括M1型1例，M2型10例，M3型1例，M4型1例，M5型11例，M6型3例；移植时复发未缓解18例，复发后取得2次或者3次缓解9例；22例采用骨髓加外周血干细胞联合移植，5例仅采用外周血干细胞移植；预处理方案为在以氟达拉滨替代环磷酰胺的改良白消安＋环磷酰胺方案基础上，加用伊达比星（15 mg／m2，连续用3 d），移植后观察患者不良反应、并发症和无病生存等情况。结果　全部患者均获重建造血，能较好耐受此预处理方案，无因预处理相关不良反应而早期死亡者，未发生心脏毒性事件，移植后粒细胞植活平均时间为15 d（11～23 d），植入证据示均为完全供者造血。随访至2013年5月，中位随访时间12个月（5～33个月），13例发生急性GVHD，11例发生慢性GVHD，因急性GVHD死亡2例，发生严重感染的13例中死亡1例，复发的7例中死亡5例；共死亡8例，其余19例患者生存。全组患者治疗相关死亡率、复发相关死亡率和总体生存率分别为11.1 %（3／27）、18.5 %（5／27）和70.4 %（19／27）。结论　allo-HSCT预处理方案中加入伊达比星的增强方案安全可行，患者耐受良好，可降低难治性白血病的复发率，提高长期生存率，移植后并发症并未增加。

Ａllogeneic hematopoietic stem cell transplantation with pretreatment added to idarubicin for treatment of refractory acute myeloid leukemia

Objective　To explore the effect and feasibility with pretreatment added to idarubicin of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the refractory acute myeloid leukemia. Methods　27 patients (13 males and 14 females) with refractory acute myeloid leukemia received allogeneic hematopoietic stem cell transplantation from August 2010 to December 2012 in the Beijing Military Region General Hospital, with the FAB classification of M1 1 case, M2 10 cases, M3 1 case, M4 1 case, M5 11 cases and M6 3 cases. However 18 of the 27 cases were the recurrence, and 9 cases were the second or more remission. 22 cases were treated with transplantation of the bone marrow combining peripheral blood of donors. 5 cases were treated with peripheral blood. All patients were treated with pretreatment consisting of cytarabine, busulfan, fludarabine and added to idarubicin (15 mg/m2, -10, -9, -8 d). Graft-versus-host disease (GVHD) was prevented by combining variety of immunosuppressants including cyclosporin A (CsA), methotrexate (MTX), and anti-thymocyte immunoglobulin (ATG). The regimen-associated side effect, incidence of GVHD and disease-free survival probabilities were observed after HSCT. Results　All of the 27 patients acquired hematopoietic reconstitution. Conditioning regimen was well tolerated and no pre-treatment-related adverse reactions or cardiac toxicity events to early death happened. The bone morrow initial engraftment time was 11 to 23 days, with an average time of 15 days. The median follow up time was 12 months (5-33 months), 13 patients had experience of acute GVHD, and 11 patients had experience of chronic GVHD. 2 patients died of GVHD. 13 cases had serious infection and 1 case died of infection, and 5 of the 7 recurrence cases died of relapse. The rest 19 patients were alive . All patients treatment-related mortality, relapse-related mortality and overall survival rates were 11.1 % (3/27), 18.5 % (5/27) and 70.4 % (19/27), respectively. Conclusion　Ｔhe patient is well tolerated conditioning regimen with pretreatment added to idarubicin, which is feasible and safe. It can reduce the refractory leukemia relapse rate or improve long-term survival after transplantation without incrasing complications.