生物仿制药 Filgrastim 与创新药 Fligrastim 在自体和异体干细胞移植患者外周血干细胞动员、CD34+ 干细胞收集和移植方面的比较:单中心经验。

IF 1.1 4区 医学 Q3 SURGERY Annals of Transplantation Pub Date : 2023-03-03 DOI:10.12659/AOT.938585
Maha M Islami, Mansoor Ahmed Khan, Mohammed A Aseeri, Majed A Alshamrani, Abdelmajid Alnatsheh, Sameer Alamoudi, Ahmed A Alzahrani
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引用次数: 0

摘要

背景 在中东地区,缺乏使用生物仿制药filgrastim动员外周血CD34+干细胞的数据。自2014年2月以来,我们一直使用Neupogen和生物仿制药G-CSF)Zarzio®(作为动员剂,用于异体和自体干细胞移植。材料与方法 这是一项单中心回顾性研究。所有接受生物类似物G-CSF(Zarzio®)或原始G-CSF(Neupogen®)动员CD34+干细胞的患者和健康捐献者均纳入研究。主要目的是确定并比较Zarzio®组和Neupogen®组在成年癌症患者或健康捐献者中的成功采集率和CD34+干细胞采集量。结果 共有114名患者,包括97名癌症患者和17名健康捐献者,在自体移植中使用G-CSF配合化疗(35人使用Zarzio®+化疗,39人使用Neupogen®+化疗)或G-CSF作为单一疗法(14人使用Zarzio®,9人使用Neupogen®)成功进行了CD34+干细胞动员。在异体干细胞移植中,使用G-CSF单药治疗(8例使用Zarzio®,9例使用Neupogen®)可成功收获干细胞。Zarzio®和Neupogen®在白细胞分离时收集的CD34+干细胞数量上没有差异。在次要结果方面,两组之间没有差异。结论 我们的研究表明,生物仿制药G-CSF(Zarzio®)在自体干细胞移植和异体干细胞移植中用于动员时,疗效与原始G-CSF(Neupogen®)相当,并可显著节约成本。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Comparison of Biosimilar Filgrastim with Innovator Fligrastim for Peripheral Blood Stem Cells Mobilization, Collection of CD34+ Stem Cells, and Engraftment in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation: A Single-Center Experience.

BACKGROUND In the Middle East, there is lack of data on peripheral blood CD34+stem cells mobilization by using biosimilar filgrastim. We have been using both Neupogen and a biosimilar G-CSF) Zarzio® (as a mobilizing agent since February 2014 for both allogenic and autologous stem cell transplantations. MATERIAL AND METHODS This was a single-center retrospective study. All patients and healthy donors who received either the biosimilar G-CSF (Zarzio®) or original G-CSF (Neupogen®) for mobilization of CD34+ stem cells were included in the study. The primary goal was to determine and compare the rate of successful harvest and amount of CD34+ stem cells collected in either adult cancer patients or healthy donors between Zarzio® and Neupogen® groups. RESULTS A total of 114 patients, including 97 cancer patients and 17 healthy donors, underwent successful CD34+ stem cell mobilization using G-CSF with chemotherapy (35 with Zarzio® +chemotherapy, 39 with Neupogen® +chemotherapy) or G-CSF as monotherapy (14 with Zarzio®, 9 with Neupogen®) in autologous transplantation. In an allogeneic stem cell transplantation, successful harvest was achieved by using G-CSF monotherapy (8 with Zarzio®, 9 with Neupogen®). There was no difference between Zarzio® and Neupogen® in the amount of CD34+ stem cells collected at leukapheresis. There was no difference with regards to secondary outcomes between the 2 groups. CONCLUSIONS Our study showed that biosimilar G-CSF (Zarzio®) has comparable efficacy to the original G-CSF (Neupogen®) when used for mobilization in both autologous and allogenic stem cell transplantation and was associated with significant cost saving.

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来源期刊
CiteScore
2.50
自引率
0.00%
发文量
79
审稿时长
>12 weeks
期刊介绍: Annals of Transplantation is one of the fast-developing journals open to all scientists and fields of transplant medicine and related research. The journal is published quarterly and provides extensive coverage of the most important advances in transplantation. Using an electronic on-line submission and peer review tracking system, Annals of Transplantation is committed to rapid review and publication. The average time to first decision is around 3-4 weeks. Time to publication of accepted manuscripts continues to be shortened, with the Editorial team committed to a goal of 3 months from acceptance to publication. Expert reseachers and clinicians from around the world contribute original Articles, Review Papers, Case Reports and Special Reports in every pertinent specialty, providing a lot of arguments for discussion of exciting developments and controversies in the field.
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