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目的 比较马利兰(Bu)和氟达拉滨(Flu)组成的预处理方案(Bu/Flu)与Bu和环磷酰胺(Cy)组成的预处理方案(Bu/Cy)在急性髓性白血病第一次完全缓解(AML-CR1)患者异基因造血下细胞移植(allo-HSCT)中的移植相关毒性和疗效的差异.方法 32例接受allo-HSCT的AML-CR1患者按移植顺序交替分至Bu/Cy组(Bu3.2 mg· kg-1·d-1,移植前第7～4天；Cy 60 mg·kg-1·d-1,移植前第3～2天)或Bu/Flu组(Bu3.2 mg·kg-1·d-1,移植前第5～2天；Flu 30 mg·m-2·d-1,移植前第6～2天).评价两组预处理相关毒性(RRT)、移植物抗宿主病(GVHD)发生率与严重程度、3年累积复发率、非复发死亡率(NRM)、3年无病生存(EFS)率和总生存(OS)率等方面的差异.结果 中位随访时间为617.5(6～ 1261)d.两组中性粒细胞和血小板中位重建时间无明显差异(P=0.121和P=0.171),移植后30 d嵌合状态分析提示两组患者均达到完全植入.Bu/Cy组预处理后中性粒细胞持续＜0.1×109/L和血小板持续＜20×109/L中位时间明显长于Bu/Flu组[6(3 ～14)d比2.5(1 ～9)d,P=0.000;3(1～36)d比1(0 ～4)d,P=0.047].Bu/Cy组与Bu/Flu组Ⅱ～Ⅳ度RRT发生率分别为68.8％和25.0％(P=0.032)；急性GVHD发生率分别为46.7％和75.0％(P=0.149),慢性GVHD发生率分别为46.7％和80.0％(P=0.149)；NRM分别为25.0％和6.3％(P=0.333)；3年累积复发率分别为(17.9±11.7)％和(14.1±9.3)％(P=0.834)；3年EFS率分别为(65.5±12.7)％和(80.2±10.3)％(p=0.362)；3年OS率分别为(68.8±11.6)％和(87.5±8.3)％(P=0.111).结论 Bu/Flu是一种清髓性预处理方案,与Bu/Cy方案比较具有低骨髓抑制毒性及RRT.Bu/Flu作为AML-CR1患者allo-HSCT预处理方案其疗效不低于Bu/Cy.

Objective To compare the transplant-related toxicity and the efficacy of busulfan/fludarabine (Bu/Flu) and busulfan/cyclophosphamide (Bu/Cy) as conditioning regimen in allogeneic hematopoietic stem cell transplantation (allo-HSCT) for acute myeloid leukemia(AML) in the first complete remission (CR1).Methods Totally 32 AML-CR1 patients underwent allo-HSCT were divided into Bu/Cy (Bu 3.2 mg· kg-1 · d-1,7-4 days before transplantation; Cy 60 mg · kg-1 · d-1,3-2 days before transplantation) and Bu/Flu (Bu 3.2 mg · kg-1 · d-1,5-2 days before transplantation; Flu 30 mg · m-2·d-1,6-2 days before transplantation) groups.The regimen-related toxicity (RRT),incidence and severity of graft-versus-host disease (GVHD),3-year cumulative relapse rate,non-relapse mortality (NRM),3-year event-free survival (EFS) rate and overall survival (OS) rate were compared between the two groups.Results The median follow-up duration was 617.5 (6-1261) days.All patients achieved successful engraftment on 30 day after transplantation.There were no significant differences in the median time to neutrophil engraftment (P =0.121) and platelet engraftment (P =0.171) between the two groups.The median duration of neutrophil count under 0.1 × 109/L and platelet count under 20 × 109/L in the Bu/Cy group were significantly longer than those in the Bu/Flu group (P =0.000 and P =0.047).The incidence of grades Ⅱ-Ⅳ RRT were 68.8％ and 25.0％ (P =0.032) in the Bu/Cy and the Bu/Flu groups,respectively.There were no significant differences in the incidence of acute GVHD (P =0.149),chronic GVHD (P =0.149),incidence of NRM (P =0.333),3-year cumulative relapse rates (P =0.834),3-year EFS rate (P =0.362) and OS rate (P =0.111) between the two groups.Conclusion Compared with Bu/Cy,Bu/Flu is a myeloablative condition regimen with milder bone marrow suppression and lower RRT incidence rate in allogeneic HSCT for AML-CR1 patients without compromising the efficacy.