眼科学报2025，Vol.40Issue(5)：408-415,8.DOI:10.12419/24122303
基于医院小儿眼科常见病种分析儿童眼科药物临床试验现状
Analysis of the current situation of clinical trials of ophthalmic drugs in children based on the common diseases of pediatric ophthalmology in hospital
摘要
Abstract
Objective:Combined with the common diseases of pediatric ophthalmology in our hospital,the current situation of clinical trials of ophthalmic preparations for children in China was investigated to provide reference for the development of clinical trials of ophthalmic preparations for children in China.Methods:Based on the national drug clinical trial registration and information publicity platform and hospital information system,combined with the pediatric ophthalmic diseases in our hospital,the development of pediatric ophthalmic drug clinical trials was analyzed.Results:Among the outpatients in our hospital,ametropia was the most common(68.49%),followed by conjunctivitis(11.25%)and strabismus(8.60%).A total of 165 clinical trials and 25 clinical trials of pediatric drugs were retrieved from the platform,including 24 trials on delaying juvenile myopia,1 trial on pediatric conjunctivitis,and 0 clinical trial on other diseases.Drug clinical trials were mainly phase I and phase III clinical trials.Eight trials have been completed to delay juvenile myopia,and others are in progress.Conclusions:There is still a huge clinical demand for the drug treatment of children's eye diseases,which is directly related to the protection of children's health rights and life safety.At present,the research and development of children's ophthalmic preparations in China presents the current situation of low enterprise participation and insufficient innovation motivation.The core constraints are fewer projects,greater difficulty,and more ethical issues.It is suggested to systematically promote the research and development of ophthalmic preparations for children through the collaborative innovation of government,industry,university and research,so as to effectively solve the problem of difficult medication for children's eye diseases in China and provide a strong guarantee for children's visual health.关键词
儿童/眼病/近视/药物临床试验Key words
children/eye disease/myopia/drug clinical trials分类
临床医学引用本文复制引用
黄莹莹,王娟,孙惠斌,王静,张颖..基于医院小儿眼科常见病种分析儿童眼科药物临床试验现状[J].眼科学报,2025,40(5):408-415,8.基金项目
郑州市医学科研项目(ZZYK2024020).This work was supported by Zhengzhou Medical Research Project(ZZYK2024020). （ZZYK2024020）
