两种rhG-CSF制剂用于自体外周造血干细胞移植的效果比较

Comparison of effects of two rhG-CSF preparations used in auto-transplantation of peripheral blood stem cell

目的探讨两种重组人粒细胞集落刺激因子吉赛欣(国产rhG-CSF)和惠尔血(进口rhG-CSF)在外周造血干细胞(PBSC)动员及移植后造血恢复中的效能差异。方法选择2000-01～2003-05在本院进行自体外周造血干细胞动员的47例血液肿瘤患者,随机分为两组,在化疗后白细胞降至最低点时分别接受国产rhG-CSF和进口rhG-CSF进行干细胞动员,比较rhG-CSF使用时间及采集所得CD34+细胞数量,其中接受干细胞回输的41例再随机分组,在预处理和干细胞回输后,外周WBC达到0×109/L时分别接受两种rhG-CSF促进造血恢复,比较外周血中性粒细胞绝对计数(ANC)恢复至≥1.5×109/L的天数及rhG-CSF使用时间。结果47例进行干细胞动员的患者中,24例应用进口rhG-CSF,23例应用国产rhG-CS,使用时间分别为6.17±2.64d和5.78±1.83d,所得采集物CD34+细胞总数分别为(5.90±5.06)×106/kg体重和(5.13±6.07)×106/kg体重,两者比较无显著性差异。41例接受自体干细胞回输的患者,22例应用进口rhG-CSF,19例应用国产rhG-CSF,使用时间分别为10.86±2.41d和10.83±4.75d,ANC恢复至≥1.5×109/L的时间分别为9.07±1.50d和10.00±4.20d,两者比较亦无显著性差异。结论两种rhG-CSF制剂在PBSC动员、PBSC回输后造血恢复等方面无明显差异,均可供临床上选择使用。

Objective To explore the difference of efficacy between two kinds of recombinant human granulocyte colony stimulating factor(rhG-CSF) preparations in peripheral blood stem cell(PBSC) mobilization process and hematopoiesis recovery after auto-PBSC transplantation.Methods From Jan, 2000 to May, 2003, 47 patients with hematological malignancies were received PBSC mobilization in our hospital. They were divided into two groups at random and treated with GRAN(rhG-CSF of Kirin Kunpeng Bio-Pharm) and JISAIXIN (rhG-CSF of North China Pharm) separately when their peripheral WBC reduced to the minimum after chemotherapy. The time of using rhG-CSF and the number of CD34+ cell in the stem cell collection between the two groups were compared. The 41 of patients who received PBSC reinfusion were again divided into two groups at random again; treated with GRAN and JISAIXIN separately when peripheral WBC decreased to 0×109/L after preparative regimens and PBSCT;the time of using rhG-CSF and of ANC increased to ≥1.5×109/L between two groups were compared. Results Two groups that had underwent mobilization used rhG-CSF for 6.17±2.64 days and 5.78±1.83 days and obtained 5.90±5.06×106/kg and 5.13±6.07×106/kg CD34+ cell respectively. No significant differences were found between the two groups. Also the two groups that had received PBSC reinfusion used GRAN and JISAIXIN for 10.86±2.41days and 10.83±4.75 days respectively. And it took 9.07±1.50 days and 10.00±4.20 days separately for ANC to increase to ≥1.5×109/L. Also no significant differences were found between them. Conclusion There is no significant difference in PBSC mobilization and hematopoiesis recovery after PBSC reinfusion between these two kinds of rhG-CSF( GRAN and JISAIXIN).