后置环磷酰胺预处理方案对异基因造血干细胞移植后移植物抗宿主病的预防效果

Preventive effect of post-cyclophosphamide conditioning regimen on graft-versus-host disease in patients after allogeneic hematopoietic stem cell transplantation for acute leukemia

目的观察后置环磷酰胺预处理方案对异基因造血干细胞移植后移植物抗宿主病(GVHD)的预防效果。方法29例拟行异基因造血干细胞移植的急性白血病患者,其中15例患者采用后置环磷酰胺预处理方案(观察组)、14例患者采用经典白消安/环磷酰胺方案预处理(对照组)。观察组患者移植前第3~7天氟达拉滨30 mg/(m^(2)·d)静脉滴注,移植前第3~6天白消安注射液0.8 mg/kg静脉滴注(6 h一次),移植第3、4天环磷酰胺50 mg/(m^(2)·d)静脉滴注;对照组移植前第3~6天白消安注射液0.8 mg/kg静脉滴注(6 h一次),移植前第3、4天环磷酰胺60 mg/(kg·d)静脉滴注。主要观察指标为移植后急慢性GVHD及移植相关并发症发生情况,次要观察指标为细胞移植所需时间、患者总生存期与无进展生存期。结果观察组患者移植后急性GVHD3例、慢性GVHD1例,对照组患者移植后急性GVHD5例,两组急、慢性GVHD发生情况间差异无统计学意义。两组中性粒细胞、血小板植入时间及移植相关并发症发生情况间差异无统计学意义。观察组1、2年的总生存率分别为93.33%、71.29%,1、2年的无进展生存率分别为92.85%、70.93%;对照组1、2年的无进展生存率分别为53.84%、38.46%,1、2年的总生存率分别为53.83%、38.46%。与对照组比较,观察组总生存率、无进展生存率高(P均<0.05)。结论后置环磷酰胺预处理可有效预防急性白血病患者异基因造血干细胞移植后GVHD,且患者的预后较好。

Objective To investigate the efficacy of post-cyclophosphamide conditioning regimen transplantation in the prevention of graft-versus-host disease(GVHD)after allogeneic hematopoietic stem cell transplantation(allo-HSCT)for acute leukemia.Methods Twenty-nine cases of acute leukemia patients undergoing allogeneic hematopoietic stem cell transplantation were selected,among whom,15 patients were treated with post-cyclophosphamide conditioning regi⁃men(observation group)and 14 patients were treated with classic busulfan/cyclophosphamide conditioning regimen(con⁃trol group).Patients in the observation group received fludarabine 30 mg/(m^(2)·d)by intravenous infusion from day 3 to day 7 before transplantation,and busulfan injection 0.8 mg/kg by intravenous infusion(once every 6 hours)from day 3 to day 6 before transplantation,and cyclophosphamide 50 mg/(m^(2)·d)by intravenous infusion on day 3 and day 4 after trans⁃plantation.Patients in the control group received busulfan injection 0.8 mg/kg by intravenous infusion(once every 6 hours)from day 3 to day 6 before transplantation,and cyclophosphamide 60 mg/(kg·d)by intravenous infusion on day 3 and day 4 before transplantation.The main observation indicators were the incidence of acute and chronic GVHD and transplantation-related complications after transplantation,and the secondary observation indicators were the time required for cell implantation,and the overall survival(OS)and progression-free survival(PFS)of the patients.Results In the observation group,there were 3 cases of acute GVHD and 1 case of chronic GVHD after transplantation,while in the con⁃trol group,there were 5 cases of acute GVHD after transplantation.There was no statistically significant difference in the incidence of acute and chronic GVHD between the two groups.There were no statistically significant differences in neutro⁃phil and platelet engraftment time and transplantation-related complications between the two groups.The 1-year and 2-year OS rates of the observation group were 93.33%and 71.29%,respectively,the 1-year and 2-year PFS rates were 92.85%and 70.93%,respectively,and the 1-year and 2-year relapse-free survival rates were 53.84%and 38.46%,respectively.The 1-year and 2-year OS rates of the control group were 53.83%and 38.46%,respectively,and the observation group had longer OS and PFS rates than the control group(both P<0.05).Conclusion Post-cyclophosphamide condi⁃tioning regimen can effectively prevent GVHD after allogeneic hematopoietic stem cell transplantation in acute leukemia pa⁃tients,and the prognosis of the patients is better.