儿童用药安全性评价指标体系构建探索

doi:10.19803/j.1672-8629.20250768

中国药物警戒 ›› 2026, Vol. 23 ›› Issue (3): 285-289.
DOI: 10.19803/j.1672-8629.20250768

儿童用药安全性评价指标体系构建探索

罗强¹, 邓彬², 熊慧瑜², 王春婷³, 黄彦^2#, 刘佐仁^1,4,*

¹广东药科大学药学院,广东广州 510006;
²广东省药品不良反应监测中心,广东广州 510080;
³国家药品监督管理局药品评价中心,国家药品监督管理局监管科学创新研究基地,北京 100163;
⁴国家药品监督管理局药物警戒技术研究与评价重点实验室,广东广州 510006

收稿日期:2025-10-31 出版日期:2026-03-15 发布日期:2026-03-17
通讯作者: ^*刘佐仁,男,硕士,教授,药事管理。E-mail: gdpc1223@163.com。^#为共同通信作者。
作者简介:罗强,男,在读硕士,药学。
基金资助:
药品监管科学全国重点实验室支持项目（2024SKLDRS0232）

Construction of an Indicator System for Evaluating Safety of Pediatric Medication

LUO Qiang¹, DENG Bin², XIONG Huiyu², WANG Chunting³, HUANG Yan^2#, LIU Zuoren^1,4,*

¹School of Pharmacy, Guangdong Pharmaceutical University, Guangzhou Guangdong 510006, China;
²Center for ADR Monitoring of Guangdong, Guangzhou Guangdong 510080, China;
³Center for Drug Reevaluation, NMPA/NMPA Center for Innovation and Research in Regulatory Science, Beijing 100163, China;
⁴NMPA Key Laboratory for Pharmacovigilance Technology Research and Evaluation, Guangzhou Guangdong 510006, China

Received:2025-10-31 Online:2026-03-15 Published:2026-03-17

1. 儿童用药安全性评价指标体系构建探索_附加材料.docx(33KB)

摘要/Abstract

摘要： 目的构建能反映儿童用药安全风险的指标体系,为儿童用药的安全性评价提供参考。方法通过文献研究法、头脑风暴法构建儿童用药安全性评价初步框架,运用德尔菲法分析、筛选和优化指标,结合层次分析法确定指标权重,构建儿童用药安全性评价指标体系。结果形成包含3个一级指标、10个二级指标、37个三级指标的儿童用药安全性评价指标体系,并确定各级指标相应的权重值。结论本研究提示“药品固有风险”占比高,说明儿童用药风险关键在于药品本身,建议应加强药品全生命周期的风险管理,强化儿童用药上市前研究并完善上市后监测,从源头到终端全面控制风险。构建的指标体系具有一定的科学性,可为评价儿童用药安全性提供参考。

关键词: 儿童用药, 指标体系, 安全性评价, 德尔菲法, 层次分析法, 界值法

Abstract: Objective To construct an indicator system for evaluating the safety of pediatric medication in order to contribute to children’s health. Methods A tentative framework was established via literature review and brainstorming. The Delphi method was used to analyze, screen, and refine the indicators. The Analytic Hierarchy Process (AHP) was applied to determine the weight of each indicator before the indicator system for evaluation of safety of pediatric medication was established. Results The final system comprised 3 first-level indicators, 10 second-level indicators, and 37 third-level indicators, with corresponding weights assigned to each indicator. Conclusion The significant weight of “inherent medication risks” underscores that the risk to pediatric medication lies in the drug itself. It is recommended that risks be managed throughout medication, pre-market research upgraded, and post-market surveillance enhanced. The constructed indicator system is well-grounded and can serve as a reference for evaluating the safety of pediatric medication.

Key words: Pediatric Medication, Indicator System, Safety Evaluation, Delphi Method, Analytic Hierarchy Process (AHP), Boundary Value Method

中图分类号:

R951
R994.11

罗强, 邓彬, 熊慧瑜, 王春婷, 黄彦, 刘佐仁. 儿童用药安全性评价指标体系构建探索[J]. 中国药物警戒, 2026, 23(3): 285-289.

LUO Qiang, DENG Bin, XIONG Huiyu, WANG Chunting, HUANG Yan, LIU Zuoren. Construction of an Indicator System for Evaluating Safety of Pediatric Medication[J]. Chinese Journal of Pharmacovigilance, 2026, 23(3): 285-289.

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儿童用药安全性评价指标体系构建探索

Construction of an Indicator System for Evaluating Safety of Pediatric Medication

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