小剂量环磷酰胺预防异基因造血干细胞移植后急性移植物抗宿主病的临床研究  

Clinical study of low-dose cyciophosphamide in prevention of acute graft versus host disease after allogeneic hematopoietic stem cell transplantation

作　　者：黄晓兵[1] 祝彪[1] 李成龙[1] 代景莹[1] 王春森[1] 

机构地区：[1]四川省医学科学院·四川省人民医院血液科,成都610072

出　　处：《国际输血及血液学杂志》2017年第4期282-288,共7页International Journal of Blood Transfusion and Hematology

基　　金：四川省卫生计生委基金项目（150225）

摘　　要：目的评估小剂量环磷酰胺替代甲氨蝶呤的急性移植物抗宿主病（aGVHD）预防新方案的疗效及安全性。方法选择2013年1月至2015年5月于四川省人民医院血液科接受异基因造血干细胞移植（allo—HSCT）的75例血液系统疾病患者为研究对象，其中43例患者接受亲缘全相合allo—HSCT，32例接受亲缘单倍体相合atlo—HSCT。按照研究对象接受aGVHD预防方案不同分为，研究组（n=32，接受小剂量环磷酰胺联合环孢素A、吗替麦考酚酯的aGVHD预防新方案），对照组（n=43，接受甲氨蝶呤联合环孢素A、吗替麦考酚酯的aGVHD预防经典方案）。对2组患者的性别构成比、年龄、不同疾病种类构成比、不同allo～HSCT类型构成比、移植后中性粒细胞及血小板植活时间、aGVHD及慢性移植物抗宿主病（cGVHD）发生率、移植相关性口腔黏膜炎及出血性膀胱炎（HC）发生率、复发率、总体生存（OS）率等指标进行回顾性分析，并进行统计学比较。本研究遵循的程序符合四川省人民医院人体试验委员会制定的伦理学标准，得到该委员会批准，征得患者知情同意，并签署知情同意书。结果①2组患者的性别构成比、年龄、不同疾病种类构成比、不同allo—HsCT类型构成比等一般临床资料分别比较，差异均无统计学意义（P〉0．05）。②全部患者接受allo—HSCT后均获得造血干细胞植入，均达到完全嵌合状态，并且获得造血重建。研究组患者中性粒细胞植活时间为（13．9±1．6）d，对照组患者为（14．6±1．2）d，二者相比，差异无统计学意义（t=0．559，P=0．606）；研究组患者血小板植活时间为（15．1±1．3）d，对照组患者为（17．2±1．4）d，二者相比，差异亦无统计学意义（t=1．512，P=0．374）。③2组中接受亲缘全相合allo-HSCT的患者，allo—HSCT后100d内Ⅰ～Ⅳ度aGVHD的累积发生率相比，差异无统计学意Objective To evaluate efficacy and safety of a novel prevention regimen for acute graft versus host disease （aGVHD） with low-dose cyclophosphamide in place of methotrexate. Methods From January 2013 to May 2015, a total of 75 patients with hematological diseases underwent allogeneic hematopoietie stem cell transplantation （allo HSCT） in Department of Hematology, Sichuan Provincial People＇s Hospital were selected as study subjects. Among them, 43 patients received related matched allo-HSCT, 32 patients received haploidentical allo-HSCT. According to different regimens of aGVHD prevention, study subjects were divided into study group （n=32） who received a novel aGVHD prevention regimen with low-dose cyclophosphamide combined with cyclosporine A and mycophenolate mofetil, and control group （n=43） who received a classic aGVHD prevention regimen with methotrexate combined with cyclosporine A and mycophenolate mofetil. The constituent ratio of gender, age, constituent ratio of different diseases, constituent ratio of different allo-HSCT types, the time of neutrophil and platelet engraftment, incidences of aGVHD and chronic graft versus host disease （cGVHD）, incidences of oral mucositis associated with transplantation and hemorrhagic cystitis （HC）, recurrence rate, overall survival （OS） rate between two groups were analyzed retrospectively, and compared statistically. The study protocol was approved by the Ethical Review Board of Investigation in Human at Sichuan Provincial People＇s Hospital. Informed consents were obtained from all participants. Results （1） There were no significant differences in constituent ratio of gender, age, constituent ratio of different diseases and constituent ratio of different alIo-HSCT types between two groups （P〈0.05）. （2） All patients achieved hematopoietic stem cell engrafted, complete chimerism states after allo-HSCT, and obtained hematopoietic reconstitution. Time of neutrophils engraftment of patients in study group and control gr

关 键 词：环磷酰胺 造血干细胞移植 移植物抗宿主病 

分 类 号：R457.7[医药卫生—治疗学]