非格司亭（Neupogen™）与聚乙二醇化非格司亭（Nivestim™）在化疗引起的发热性中性粒细胞减少症一级预防中的有效性和安全性：一项观察性队列研究。
Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study.
作者信息
Al-Rabayah Abeer A, Al Mashni Ola, Hanoun Esraa, Al Qasem Weam, Al Momani Deema, Al Froukh Rawan Fawzi, Sawalha Razan, Hammoudeh Suzan S
机构信息
Department of Pharmacy, Center for Drug Policy and Technology Assessment, King Hussein Cancer Center, Queen Rania Street, Al-Jubeiha, PO Box 1269, Amman, 11941, Jordan.
Department of Pharmacy, King Hussein Cancer Center, Queen Rania Street, Al-Jubeiha, PO Box 1269, Amman, 11941, Jordan.
出版信息
Drugs Real World Outcomes. 2022 Dec;9(4):589-595. doi: 10.1007/s40801-022-00312-8. Epub 2022 Sep 7.
BACKGROUND
Despite the demonstrated efficacy and safety of biosimilar filgrastim-aafi (Nivestim™), few studies have compared its use in real-life clinical practice to the originator filgrastim (Neupogen™).
OBJECTIVES
This study aimed to compare the effectiveness and safety of filgrastim and filgrastim-aafi for the primary prophylaxis of chemotherapy induced-febrile neutropenia in the real-life setting.
PATIENTS AND METHODS
A retrospective cohort study included all adult cancer patients at the King Hussein Cancer Centre requiring primary prophylaxis for chemotherapy-induced febrile neutropenia between 2014 and 2016. Two cohorts were selected: patients who received filgrastim and those who received filgrastim-aafi. The primary endpoint was the incidence of febrile neutropenia; the secondary endpoints were the incidence of adverse drug reactions (ADRs), hospital admissions due to febrile neutropenia, and the mean length of hospitalization. Chi-squared tests were performed to evaluate differences between groups. Logistic regression was conducted to adjust for confounding factors.
RESULTS
A total of 268 patients were identified, with 88 in the filgrastim cohort and 180 in the filgrastim-aafi cohort; 64%were females. The mean age was 47 (±15) years. The incidence of febrile neutropenia was 21.6% in the filgrastim cohort and 15% in the filgrastim-aafi cohort (P = 0.179). No statistically significant differences were detected in the incidence of hospital admission (P = 0.551) or ADRs (P = 0.623) between the two cohorts. Upon adjusting for the confounding factors, results remained statistically insignificant.
CONCLUSION
Filgrastim and filgrastim-aafi had comparable effectiveness and safety as primary prophylaxis for chemotherapy-induced febrile neutropenia. More extensive prospective studies with additional insight on the cost implications are required.
背景
尽管生物类似药非格司亭-aafi（Nivestim™）已证实其有效性和安全性，但很少有研究在实际临床实践中将其与原研非格司亭（Neupogen™）的使用情况进行比较。
目的
本研究旨在比较非格司亭和非格司亭-aafi在实际临床环境中对化疗引起的发热性中性粒细胞减少症进行一级预防的有效性和安全性。
患者和方法
一项回顾性队列研究纳入了2014年至2016年间在侯赛因国王癌症中心需要对化疗引起的发热性中性粒细胞减少症进行一级预防的所有成年癌症患者。选择了两个队列：接受非格司亭的患者和接受非格司亭-aafi的患者。主要终点是发热性中性粒细胞减少症的发生率；次要终点是药物不良反应（ADR）的发生率、因发热性中性粒细胞减少症住院的情况以及平均住院时间。进行卡方检验以评估组间差异。进行逻辑回归以调整混杂因素。
结果
共识别出268例患者，非格司亭队列中有88例，非格司亭-aafi队列中有180例；64%为女性。平均年龄为47（±15）岁。非格司亭队列中发热性中性粒细胞减少症的发生率为21.6%，非格司亭-aafi队列中为15%（P = 0.179）。两个队列之间在住院率（P = 0.551）或药物不良反应发生率（P = 0.623）方面未检测到统计学上的显著差异。在调整混杂因素后，结果在统计学上仍无显著性差异。
结论
非格司亭和非格司亭-aafi作为化疗引起的发热性中性粒细胞减少症的一级预防措施，其有效性和安全性相当。需要进行更广泛的前瞻性研究，并对成本影响有更多深入了解。
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