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对现有临床证据的系统评价——非格司亭与来格司亭的比较。

A systematic review of available clinical evidence - filgrastim compared with lenograstim.

作者信息

Sourgens H, Lefrère F

机构信息

University of Münster, Münster, Germany.

出版信息

Int J Clin Pharmacol Ther. 2011 Aug;49(8):510-8. doi: 10.5414/cp201537.

Abstract

BACKGROUND

Filgrastim (Neu-pogen®, Amgen) and lenograstim (Granocyte®, Chugai Pharma) are chemically different granulocyte colony-stimulating factors (G-CSFs). Based on receptor-binding studies and in vitro potency assessment, a clinical superiority of lenograstim versus filgrastim has been postulated together with potential cost savings favouring lenograstim over filgrastim.

OBJECTIVES

To compare the clinical efficacy of filgrastim and lenograstim based on current Summaries of Product Characteristics (SPCs) for both products taking into account published clinical trials in patients and healthy volunteers.

SEARCH STRATEGY AND SELECTION CRITERIA

PubMed and citation lists of published articles were used to identify clinical trials with direct comparisons of filgrastim and lenograstim. All available clinical information directly comparing filgrastim and lenograstim has been accepted for evaluation.

DATA COLLECTION

A total of 16 studies compared filgrastim with lenograstim. Four studies had a randomized, parallel-group design, 4 had a cross-over design and 8 studies were uncontrolled.

RESULTS

Available data do not suggest a clinically remarkable difference between filgrastim and lenograstim in chemotherapy-induced neutropenia and the mobilisation of peripheral blood progenitor cells (PBPC) in patients and healthy donors.

CONCLUSIONS

Both G-CSFs are recommended for clinical use according to instructions in the respective SPCs; there is no reason to prefer lenograstim over filgrastim in any of the approved indications for both. Costs calculations need to consider the advent of biosimilar filgrastim in Europe.

摘要

背景

非格司亭(优保津®,安进公司)和来格司亭(格拉诺赛特®,中外制药)是化学结构不同的粒细胞集落刺激因子(G-CSF)。基于受体结合研究和体外效价评估,推测来格司亭相对于非格司亭具有临床优势,且在成本节约方面可能更有利于来格司亭而非非格司亭。

目的

根据两种产品当前的产品特性摘要(SPC),并考虑已发表的针对患者和健康志愿者的临床试验,比较非格司亭和来格司亭的临床疗效。

检索策略和选择标准

使用PubMed及已发表文章的参考文献列表来识别直接比较非格司亭和来格司亭的临床试验。所有直接比较非格司亭和来格司亭的可用临床信息均被纳入评估。

数据收集

共有16项研究比较了非格司亭和来格司亭。4项研究采用随机平行组设计,4项采用交叉设计,8项研究为非对照研究。

结果

现有数据表明,在化疗引起的中性粒细胞减少以及患者和健康供体外周血祖细胞(PBPC)动员方面,非格司亭和来格司亭之间没有显著的临床差异。

结论

两种G-CSF均按照各自SPC中的说明推荐用于临床;在两者的任何获批适应症中,没有理由更青睐来格司亭而非非格司亭。成本计算需要考虑欧洲生物类似物非格司亭的出现。

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