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卡铂的剂量分档:基本原理及拟议的分档方案。

Dose-banding of carboplatin: rationale and proposed banding scheme.

作者信息

Kaestner Sabine, Sewell Graham

机构信息

Department of Pharmacy and Pharmacology, University of Bath, Bath BA2 7AY, UK.

出版信息

J Oncol Pharm Pract. 2007 Jun;13(2):109-17. doi: 10.1177/1078155207080801.

Abstract

BACKGROUND

In dose-banding (DB) prescribed doses of cancer chemotherapy are fitted to doseranges or 'bands' and standard doses for each band are provided using a selection of pre-filled infusions or syringes, either singly or in combination. DB is used for several drugs where dose is based on body surface area. No DB-scheme has been reported for carboplatin, which, in clinical practice, is routinely dosed according to renal function.

STUDY OBJECTIVE

To assess the rationale for DB of carboplatin with regards to factors that influence dosing accuracy, develop a DB scheme, and discuss its potential use and limitations.

METHODS

Prospective evaluations of carboplatin area under the plasma concentration -- time curve (AUC) following application of the Calvert-formula were identified by a literature search. A relevant carboplatin dose range for construction of a DB-scheme with Calvert-formula based doses was obtained from published glomerular filtration rate distributions for patients receiving carboplatin.

RESULTS

A DB-scheme was developed for individually calculated carboplatin doses of 358-1232 mg, with 35 mg increments between each standard dose and a maximum deviation of 4.7% from prescribed dose. The proposed DB-scheme covers the GFR-ranges 47-221 mL/min and 26-151 mL/min for patients receiving doses based on the target AUCs of 5 and 7 mg/mL/min, respectively.

CONCLUSION

There is a strong scientific rationale to support DB of carboplatin. The proposed banding scheme could introduce benefits to patients and healthcare staff but, as with other DB schemes, should be validated with prospective clinical and pharmacokinetic studies to confirm safety and efficacy.

摘要

背景

在剂量分档(DB)中,癌症化疗的规定剂量被适配到剂量范围或“档”,并且通过选择单独或组合使用的预填充输液或注射器来提供每个档的标准剂量。DB用于几种基于体表面积给药的药物。尚未有关于卡铂的DB方案的报道,在临床实践中,卡铂通常根据肾功能给药。

研究目的

评估卡铂剂量分档在影响给药准确性因素方面的基本原理,制定一个DB方案,并讨论其潜在用途和局限性。

方法

通过文献检索确定了应用卡尔弗特公式后血浆浓度-时间曲线下卡铂面积(AUC)的前瞻性评估。从已发表的接受卡铂治疗患者的肾小球滤过率分布中获得用于构建基于卡尔弗特公式剂量的DB方案的相关卡铂剂量范围。

结果

制定了一个DB方案,用于单独计算卡铂剂量358 - 1232毫克,每个标准剂量之间增加35毫克,与规定剂量的最大偏差为4.7%。对于分别基于目标AUC为5和7毫克/毫升/分钟接受剂量的患者,拟议的DB方案涵盖肾小球滤过率范围47 - 221毫升/分钟和26 - 151毫升/分钟。

结论

有强有力的科学依据支持卡铂的剂量分档。拟议的分档方案可能会给患者和医护人员带来益处,但与其他DB方案一样,应通过前瞻性临床和药代动力学研究进行验证,以确认安全性和有效性。

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