司莫司汀在异基因造血干细胞移植预处理方案应用中的短期疗效和安全性分析  

Analysis of short-term efficacy and safety of semustine in the application of preconditioning regimen for allogeneic hematopoietic stem cell transplantation

作　　者：王磊 王红春 张建平 肖然 周洁 刘红星 WANG Lei;WANG Hong-chun;ZHANG Jian-ping;XIAO Ran;ZHOU Jie;LIU Hong-xing(Hebei Yanda Lu Daopei Hospital,Hebei Langfang 065201,China;Beijing Lu Daopei Hospital,Beijing 100176,China;Beijing Lu Daopei Institute of Hematology,Beijing 100176,China)

机构地区：[1]河北燕达陆道培医院,河北廊坊065201 [2]北京陆道培医院,北京100176 [3]北京陆道培血液病研究院,北京100176

出　　处：《中国医院药学杂志》2021年第18期1886-1890,共5页Chinese Journal of Hospital Pharmacy

基　　金：河北省医学科学研究课题(编号:20210319)。

摘　　要：目的:回顾性分析司莫司汀用于异基因造血干细胞移植预处理方案的短期疗效和安全性。方法:收集103例燕达陆道培医院异基因造血干细胞移植患者移植后8周内的临床资料,包括使用司莫司汀预处理方案(司莫司汀组)的患者54例,非司莫司汀预处理方案(非司莫司汀组)的患者49例,比较2组患者的造血重建时间、各系造血细胞植入、骨髓抑制、肝肾毒性以及其他移植预处理相关不良反应。结果:2组患者造血重建时间无显著差异(P>0.05),司莫司汀组达到完全供者细胞嵌合的中位时间相对延长(P=0.02),司莫司汀组Ⅰ+Ⅱ级骨髓抑制发生率较低(P<0.05)。司莫司汀组在移植后2周内肝损伤发生率明显低于非司莫司汀组,而在移植后5周后肝损伤发生率又明显高于非司莫司汀组;2组肾损伤发生率在移植后4周内无显著差异,司莫司汀组从移植后6周起肾损伤发生显著较低(P<0.05)。司莫司汀组易发生Ⅰ度和Ⅱ度急性移植物抗宿主病(acute graft versus host disease, aGVHD),但不易发生Ⅲ度aGVHD;司莫司汀组较易发生感染性发热和口腔溃疡;其他移植预处理相关不良反应发生率无显著差异。结论:在异基因造血干细胞移植预处理方案中使用司莫司汀组的患者骨髓抑制和重度aGVHD发生率较低,肝肾损害及其他移植预处理相关不良反应无显著增加,对造血重建时间无显著影响。OBJECTIVE To explore the short-term efficacy and safety of semustine for allogeneic hematopoietic stem cell transplantation(allo-HSCT).METHODS At Week 8 post-transplantation, clinical data were reviewed for 103 patients undergoing allo-HSCT.They were divided into two groups of semustine preconditioning(n=54)and non-semustine preconditioning(n=49).Hematopoietic reconstruction time, hematopoietic cell implantation of each line, myelosuppression, hepatorenal toxicity and other adverse reactions related to transplantation preconditioning were compared between two groups.RESULTS No significant inter-group difference existed in hematopoietic reconstruction time(P>0.05).The median time to complete donor cell chimerism was relatively longer in semustine group(P=0.02).The rate of bone marrow suppressionⅠ-Ⅱ level was lower in semustine group(P<0.05).The incidence of liver injury was significantly lower in semustine group than that in non-semustine group at Week 2 and significantly higher than that in non-semustine group at Week 5 post-transplantation.No significant inter-group difference existed in the incidence of renal injury at Week 4 post-transplantation.However, the incidence of renal injury was significantly lower in semustine group at Week 6 post-transplantation(P<0.05).Acute graft versus host disease(aGVDH)Ⅰ-Ⅱ level was prone to occur in semustine group and aGVHD was infrequent in semustine group.Patients in semustine group were more prone to infectious fever and oral ulcer.No significant difference existed in the incidence of other adverse reactions related to transplantation preconditioning.CONCLUSION Semustine in allo-HSCT pretreatment regimen has a lower incidence of bone marrow suppression and severe aGVHD.And there is no marked increase in hepatorenal damage and other transplant-related adverse reactions and it has no significant effect on hematopoietic reconstruction time.

关 键 词：司莫司汀 异基因造血干细胞移植 骨髓抑制 肝肾毒性 预处理方案 

分 类 号：R969.4[医药卫生—药理学]