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调查注意力缺陷/多动障碍药物批准的差异:比较药物标签的跨国文件分析

Investigating Variations in Medicine Approvals for Attention-Deficit/Hyperactivity Disorder: A Cross-Country Document Analysis Comparing Drug Labeling.

机构信息

School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

University of Nottingham, Nottingham, UK.

出版信息

J Atten Disord. 2024 Sep;28(11):1437-1453. doi: 10.1177/10870547231224088. Epub 2024 Feb 7.

DOI:10.1177/10870547231224088
PMID:38327043
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11328451/
Abstract

OBJECTIVE

This study aimed to compare the approval of medicines for attention deficit/hyperactivity disorder (ADHD) for pediatric patients across five countries.

METHOD

A document analysis was completed, using the drug labeling for ADHD medicines from five countries; United Kingdom, Australia, New Zealand, Canada and United States (US). Comparisons of available formulations and approval information for ADHD medicine use in pediatric patients were made.

RESULTS

The US had the highest number of approved medicines and medicine forms across the studied countries (29 medicine forms for 10 approved medicines). Approved age and dosage variations across countries and missing dosage information were identified in several drug labeling.

CONCLUSIONS

The discrepancies in approval information in ADHD medicine drug labeling and differing availability of medicine formulations across countries suggest variations in the management of ADHD across countries. The update of drug labeling and further research into reasons for variability and impact on practice are needed.

摘要

目的

本研究旨在比较五个国家批准用于治疗儿童注意缺陷多动障碍(ADHD)的药物。

方法

采用文件分析法,使用来自英国、澳大利亚、新西兰、加拿大和美国的 ADHD 药物标签。比较了儿科患者使用 ADHD 药物的可用剂型和批准信息。

结果

在所研究的国家中,美国拥有最多数量的批准药物和药物剂型(10 种批准药物中有 29 种药物剂型)。在多个药物标签中发现了国家间批准年龄和剂量差异以及缺失剂量信息的情况。

结论

ADHD 药物标签中批准信息的差异以及不同国家药物剂型的供应情况表明各国对 ADHD 的管理存在差异。需要更新药物标签,并进一步研究差异的原因及其对实践的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a98/11328451/18ab64eaa5cc/10.1177_10870547231224088-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a98/11328451/18ab64eaa5cc/10.1177_10870547231224088-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a98/11328451/18ab64eaa5cc/10.1177_10870547231224088-fig1.jpg

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Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Preschool Children with Attention-Deficit/Hyperactivity Disorder.盐酸哌甲酯控释胶囊(Aptensio XR)治疗学龄前注意缺陷多动障碍患儿的随机、双盲、安慰剂对照、剂量滴定研究。
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