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Tbo-非格司亭与非格司亭用于自体造血干细胞移植患者干细胞动员和植入的回顾性研究

Tbo-filgrastim versus filgrastim for stem cell mobilization and engraftment in autologous hematopoietic stem cell transplant patients: A retrospective review.

作者信息

Potter Ashley, Beck Bradley, Ngorsuraches Surachat

机构信息

Mayo Clinic, Rochester, MN, USA.

Avera McKennan Hospital and University Health Center, Sioux Falls, SD, USA.

出版信息

J Oncol Pharm Pract. 2020 Jan;26(1):23-28. doi: 10.1177/1078155219833444. Epub 2019 Mar 9.

DOI:10.1177/1078155219833444
PMID:30854925
Abstract

INTRODUCTION

Filgrastim, a granulocyte colony-stimulating factor, is commonly used in autologous hematopoietic stem cell transplants (HSCTs) to assist with peripheral blood progenitor cell (PBPC) collection and to support stem cell engraftment. In the United States, tbo-filgrastim is approved under its own Biologic License Application and is limited to a single indication excluding the HSCT population.

METHODS

Approximately one year after a system-wide formulary change to tbo-filgrastim for all on- and off-label indications, our institution conducted an IRB-approved retrospective comparison of tbo-filgrastim to filgrastim in the autologous HSCT setting. The study included 71 patients who received an autologous HSCT from 1 January 2013 to 31 December 2016 with a documented administration of tbo-filgrastim or filgrastim.

RESULTS

There were no statistically significant differences noted on CD34 + counts during stem cell mobilization, neutrophil engraftment, infection rates during the engraftment phase, nor duration of hospitalization during the engraftment phase. More patients in the tbo-filgrastim group received plerixafor per protocol resulting in more patients meeting their PBPC collection goal in one day with fewer collection days overall, a result potentially confounded by institutional protocol changes. Utilizing tbo-filgrastim offered an average cost savings per patient of $2664.26 ($1907.33 for PBPC mobilization and $756.93 for stem cell engraftment) when comparing dollars spent on granulocyte colony-stimulating factor products only.

CONCLUSION

Tbo-filgrastim demonstrates comparable efficacy with a cost savings benefit compared to filgrastim for autologous PBPC mobilization and stem cell engraftment.

摘要

引言

非格司亭,一种粒细胞集落刺激因子,常用于自体造血干细胞移植(HSCT),以辅助外周血祖细胞(PBPC)采集并支持干细胞植入。在美国,替勃非格司亭根据其自身的生物制品许可申请获得批准,且仅限于单一适应症,不包括HSCT人群。

方法

在全系统将所有适应症(包括标签外适应症)的处方药物变更为替勃非格司亭大约一年后,我们机构在自体HSCT环境下对替勃非格司亭与非格司亭进行了一项经机构审查委员会批准的回顾性比较。该研究纳入了71例在2013年1月1日至2016年12月31日期间接受自体HSCT且有替勃非格司亭或非格司亭用药记录的患者。

结果

在干细胞动员期间的CD34 +细胞计数、中性粒细胞植入、植入期感染率以及植入期住院时间方面,均未发现统计学上的显著差异。替勃非格司亭组中更多患者按照方案接受了普乐沙福治疗,从而使更多患者在一天内达到PBPC采集目标,且总体采集天数减少,这一结果可能因机构方案变更而受到干扰。仅比较在粒细胞集落刺激因子产品上的花费时,使用替勃非格司亭可为每位患者平均节省2664.26美元(PBPC动员节省1907.33美元,干细胞植入节省756.93美元)。

结论

在自体PBPC动员和干细胞植入方面,与非格司亭相比,替勃非格司亭显示出相当的疗效且具有成本节约效益。

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引用本文的文献

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Use of Biosimilar Granulocyte Colony-Stimulating Factor for Mobilization in Autologous and Allogeneic Hematopoietic Stem Cell Transplantation.生物类似物粒细胞集落刺激因子在自体和异基因造血干细胞移植中用于动员的应用
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