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美国学术医疗中心中集落刺激因子使用情况的监测。

Surveillance of colony-stimulating factor use in US academic health centers.

作者信息

Yim J M, Matuszewski K A, Vermeulen L C, Ratko T A, Burnett D A, Vlasses P H

机构信息

Clinical Practice Advancement Center, University Hospital Consortium, Oak Brook, IL 60521, USA.

出版信息

Ann Pharmacother. 1995 May;29(5):475-81. doi: 10.1177/106002809502900504.

Abstract

OBJECTIVE

To characterize and evaluate hematopoietic colony-stimulating factor (CSF) use, including cost implications, in US academic health centers.

DESIGN

An observational study of patients who received granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) from September 1 to October 15, 1993.

SETTING

Thirty academic health centers in the US.

PARTICIPANTS

Five hundred sixty-five patients were evaluated.

MAIN OUTCOME MEASURES

The appropriateness of CSF use was assessed, based on consensus-derived indication guidelines and the Food and Drug Administration-approved product labeling. Indication, type of CSF, and dosage were considered in determining the appropriateness of CSF therapy.

RESULTS

Based on indication evaluation criteria, 71% of CSF use was appropriate, 7% was inappropriate, and 22% was unproven, although the majority of unproven use was deemed promising by the expert panel. Based on dosage evaluation criteria, 51% of CSF use was appropriate, 27% was inappropriate, and 22% was for promising and other unproven indications. More than 90% of the patients studied received G-CSF. Approximately 3.4% of patients who received G-CSF had an adverse event, compared with 22% of those who received GM-CSF. Approximately $791,000 was spent on CSF therapy in the 565 patients: $401,000 (51%) on appropriate indications and doses, $160,000 (20%) on inappropriate doses for appropriate indications, $124,000 (16%) on promising indications, and $106,000 (13%) on unproven or inappropriate indications.

CONCLUSIONS

Substantial costs are incurred currently for CSF therapy without adequate literature support. Further studies are warranted to justify promising but unproven uses of CSFs, as well as to clarify proper dosing, monitoring, and relative safety of CSFs.

摘要

目的

对美国学术医疗中心造血集落刺激因子(CSF)的使用情况进行特征描述和评估,包括成本影响。

设计

对1993年9月1日至10月15日期间接受粒细胞集落刺激因子(G-CSF)或粒细胞-巨噬细胞集落刺激因子(GM-CSF)治疗的患者进行观察性研究。

地点

美国30家学术医疗中心。

参与者

565例患者接受了评估。

主要观察指标

根据共识得出的适应证指南和美国食品药品监督管理局批准的产品标签,评估CSF使用的合理性。在确定CSF治疗的合理性时,考虑适应证、CSF类型和剂量。

结果

根据适应证评估标准,71%的CSF使用是合理的,7%是不合理的,22%是未经证实的,尽管专家小组认为大多数未经证实的使用有前景。根据剂量评估标准,51%的CSF使用是合理的,27%是不合理的,22%是用于有前景和其他未经证实的适应证。超过90%的研究患者接受了G-CSF治疗。接受G-CSF治疗的患者中约3.4%发生了不良事件,而接受GM-CSF治疗的患者中这一比例为22%。565例患者的CSF治疗费用约为79.1万美元:40.1万美元(51%)用于合理的适应证和剂量,16万美元(20%)用于合理适应证的不合理剂量,12.4万美元(16%)用于有前景的适应证,10.6万美元(13%)用于未经证实或不合理的适应证。

结论

目前CSF治疗费用高昂,但缺乏充分的文献支持。有必要进行进一步研究,以证明CSF有前景但未经证实的用途的合理性,并阐明CSF的正确给药、监测和相对安全性。

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