Husian Sadik, Jeyaraman Preethi, Gupta S K, Rai Reeta, Pathak Sangeeta, Dayal Nitin, Naithani Rahul
Department of Pharmacology, Pharmaceutical Sciences and Research University, New Delhi, India.
Division of Hematology and Bone Marrow Transplant, Saket, New Delhi, India.
South Asian J Cancer. 2021 Sep 4;10(3):172-174. doi: 10.1055/s-0041-1729446. eCollection 2021 Sep.
This is a retrospective study. G-CSF was administered in the dose of 10 μg/kg subcutaneous as a single dose for 4 days. On day 5, peripheral blood stem cell (PBSC) apheresis was performed using Haemonetics MCS plus or COBE Spectra apheresis machine through a double-lumen central venous catheter. Primary outcome parameters were the total number of CD34+ HSCs/kg of recipient weight mobilized in peripheral blood and the number of days required for neutrophil and platelets engraftment, respectively. We compared the effectiveness and safety of innovator filgrastim versus generic filgrastim in patients who underwent hematopoietic stem cell transplantation (HSCT). A total of 91 stem cell mobilizations was analyzed. There were 58 normal healthy donors for allogeneic HSCT and 33 patients for autologous HSCT. There was no statistically significant difference among groups in terms of total collected CD34+ cells value ( = 0.609). The mean time to neutrophil engraftment was 13.7 days in the innovator group and 13.2 days in the Grafeel group ( = 0.518). The mean time to platelet engraftment was 16.2 days in the innovator group and 14.8 days in the generic group ( = 0.435). The patient who received generic filgrastim had more febrile episodes during the course of transplantation ( = 0.020). Generic filgrastim was found to be comparable to original filgrastim for peripheral blood stem cell mobilization in normal healthy donors for allogeneic HSCT and patients for autologous HSCT.
这是一项回顾性研究。给予粒细胞集落刺激因子（G-CSF），剂量为10μg/kg，皮下注射，单剂量给药4天。在第5天，通过双腔中心静脉导管，使用血液学MCS plus或COBE Spectra血细胞分离机进行外周血干细胞（PBSC）采集。主要结局参数分别为受者体重每千克外周血中动员的CD34+造血干细胞总数以及中性粒细胞和血小板植入所需的天数。我们比较了创新型非格司亭与仿制药非格司亭在接受造血干细胞移植（HSCT）患者中的有效性和安全性。共分析了91次干细胞动员情况。有58名正常健康供者进行异基因HSCT，33名患者进行自体HSCT。各组间在总采集的CD34+细胞值方面无统计学显著差异（P = 0.609）。创新型组中性粒细胞植入的平均时间为13.7天，格拉非组为13.2天（P = 0.518）。创新型组血小板植入的平均时间为16.2天，仿制药组为14.8天（P = 0.435）。接受仿制药非格司亭的患者在移植过程中发热发作更多（P = 0.020）。发现仿制药非格司亭在异基因HSCT的正常健康供者和自体HSCT患者的外周血干细胞动员方面与原研非格司亭相当。
