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抗癌药物的剂量标准化。

Dose standardisation of anticancer drugs.

机构信息

Pharmacy Department, Hôpital Saint-Louis, AP-HP, Paris, France.

出版信息

Int J Clin Pharm. 2011 Apr;33(2):221-8. doi: 10.1007/s11096-010-9478-6. Epub 2011 Jan 14.

DOI:10.1007/s11096-010-9478-6
PMID:21369959
Abstract

OBJECTIVE OF THE STUDY

Body size based dosing is often used for prescribing anticancer drugs. However the scientific and the clinical rationales of this historical method have recently been criticized. As a result, alternative dosing strategies have been suggested, as flat-fixed dosing regimens, but not implemented in routine practice. Dose standardisation is a first step in order to rationalise chemotherapy dose calculation. A new method, derived from dose-banding, was developed, taking into account prescription and economic criteria.

SETTING

Feasibility and interest of this concept were studied in two French cancer centres Institut Curie and Hôpital Saint-Louis.

MAIN OUTCOME MEASURES

The aim of our study was to assess dose standardisation of expensive anticancer drugs in objectives of quality and economy.

METHOD

Nine candidate drugs were selected and standardized rounded doses (SRD) were proposed. To determine the specific standard doses of these two centres, two theoretical and practical methods were applied, and then, their results were compared. For each anticancer drug the objective was to fix SRD in order to cover all the doses most frequently prescribed.

RESULTS

It has been possible to propose SRD for six of the nine drugs. These SRD have been implemented with the agreement of the medical staff. These doses are, whenever possible, rounded to the nearest vial size, or correspond to a combination of the different strength of the commercial drug.

CONCLUSION

Our study shows that dose standardisation is a help to optimise the productivity and improve the organisation of the preparation unit.

摘要

研究目的

基于体表面积的剂量给药法常用于开具抗癌药物。然而,这种历史方法的科学和临床合理性最近受到了批评。因此,已经提出了替代剂量策略,例如平坦固定剂量方案,但尚未在常规实践中实施。剂量标准化是合理化化疗剂量计算的第一步。考虑到处方和经济标准,开发了一种源自剂量分组的新方法。

设置

在两个法国癌症中心居里研究所和圣路易医院研究了这一概念的可行性和兴趣。

主要观察指标

我们的研究旨在评估昂贵抗癌药物在质量和经济目标方面的剂量标准化。

方法

选择了 9 种候选药物,并提出了标准化整剂量(SRD)。为了确定这两个中心的特定标准剂量,应用了两种理论和实际方法,然后比较了它们的结果。对于每种抗癌药物,目的是固定 SRD,以覆盖最常开具的所有剂量。

结果

已经能够为九种药物中的六种药物提出 SRD。这些 SRD 已经在医务人员的同意下实施。这些剂量尽可能地舍入到最近的小瓶尺寸,或者对应于商业药物不同强度的组合。

结论

我们的研究表明,剂量标准化有助于优化生产力并改善制剂单位的组织。

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Comparison of toxicity and effectiveness between fixed-dose and body surface area-based dose capecitabine.固定剂量与基于体表面积剂量的卡培他滨的毒性和有效性比较。
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Investigating the potential impact of dose banding for systemic anti-cancer therapy in the paediatric setting based on pharmacokinetic evidence.基于药代动力学证据研究系统抗肿瘤治疗在儿科人群中进行剂量分组的潜在影响。
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Dose-Banding of Intravenous Piperacillin-Tazobactam in Pediatric Surgical Inpatients.小儿外科住院患者静脉注射哌拉西林-他唑巴坦的剂量分组
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Fixed Dosing of Monoclonal Antibodies in Oncology.肿瘤学中的单克隆抗体固定剂量。
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Physiologically based pharmacokinetic modelling of methotrexate and 6-mercaptopurine in adults and children. Part 1: methotrexate.基于生理学的甲氨蝶呤和 6-巯基嘌呤在成人和儿童中的药代动力学模型。第 1 部分:甲氨蝶呤。
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