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欧洲三份儿科处方集里的抗感染药物给药建议有多一致?

How Consistent are Anti-Infective Drug Dosing Recommendations Across Three European Paediatric Formularies?

作者信息

Higi Lukas, Carydias Elisabeth, Burden Andrea M, Vonbach Priska

机构信息

Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland.

PEDeus Ltd, Zurich, Switzerland.

出版信息

Paediatr Drugs. 2025 Mar;27(2):221-232. doi: 10.1007/s40272-024-00674-2. Epub 2024 Dec 14.

Abstract

BACKGROUND

Drug dosing recommendations in paediatrics are mainly based on the age and bodyweight of the child. Because of the limited amount of label information, several paediatric drug formularies have been developed. This study compares anti-infective drug dosing recommendations across three European formularies.

METHODS

Recommendations from three paediatric formularies (German Pediatric Formulary [GPF], SwissPedDose [SPD] and the British National Formulary for Children [BNF]) were collected. Using population growth curves, we simulated one child for each month from 1 month up to 18 years of age. The recommendations from each formulary were used to calculate doses for each simulated child. Equivalence and difference in calculated doses were analysed.

RESULTS

In total, dosing recommendations for 34 anti-infective substances were collected with 74 corresponding indications, which resulted in 47,154 calculated doses. The mean (± standard deviation) proportion of equivalent doses (difference ≤10%) across all three formularies was 40% (±16), while for pairwise comparisons it was 53% (±19) for GPF versus BNF, 67% (±14) for GPF versus SPD and 52% (±19) for SPD versus BNF. The median [25th quantile, 75th quantile] differences in daily doses across all three formularies were 0%, [0, 26] while for pairwise comparisons it was 4% [0, 32] for GPF versus BNF, 0% [0, 17] for GPF versus SPD and 7% [0, 33] for SPD versus BNF.

CONCLUSIONS

The majority of recommended anti-infective drug doses were consistent, with the highest equivalence found between GPF and SPD. Maintaining formularies is resource intensive; therefore, a common standard in Europe could prove beneficial when moving towards digitalisation of the healthcare systems.

摘要

背景

儿科用药剂量建议主要基于儿童的年龄和体重。由于药品标签信息有限,已制定了多种儿科药物处方集。本研究比较了三种欧洲处方集中抗感染药物的剂量建议。

方法

收集了三种儿科处方集(德国儿科处方集[GPF]、瑞士儿科剂量[SPD]和英国国家儿童处方集[BNF])的建议。利用人口增长曲线,我们模拟了从1个月到18岁每个月的一个儿童。每个处方集的建议用于计算每个模拟儿童的剂量。分析计算剂量的等效性和差异。

结果

总共收集了34种抗感染药物的剂量建议,有74种相应适应症,共计算出47154个剂量。所有三种处方集中等效剂量(差异≤10%)的平均(±标准差)比例为40%(±16),而两两比较时,GPF与BNF为53%(±19),GPF与SPD为67%(±14),SPD与BNF为52%(±19)。所有三种处方集每日剂量的中位数[第25百分位数,第75百分位数]差异为0%,[0, 26],而两两比较时,GPF与BNF为4% [0, 32],GPF与SPD为0% [0, 17],SPD与BNF为7% [0, 33]。

结论

大多数推荐的抗感染药物剂量是一致的,GPF和SPD之间的等效性最高。维护处方集资源密集;因此,在医疗系统向数字化迈进时,欧洲采用统一标准可能会有好处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2541/11829927/8089784769b8/40272_2024_674_Fig1_HTML.jpg

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