目的：结合医院小儿眼科常见病种调研国内儿童眼用制剂药物临床试验开展现状，为儿童眼用制剂药物临床试验的发展提供参考。方法：基于国家药物临床试验登记与信息公示平台和医院信息系统，结合郑州市第二人民医院儿童眼科病种，分析儿童眼科药物临床试验开展情况。 结果：医院门诊就诊患者以屈光不正最多（占68.49% ），其次是结膜炎（占11.25%），再次是斜视（占8.60%）。平台共检索到相关临床试验165项，儿科专用药物临床试验25项，其中延缓青少年近视方面试验24个，小儿结膜炎试验1个，其他病种药物临床试验检测结果为0；药物临床试验中以I期和Ⅲ期临床试验为主；延缓青少年近视方面试验已完成试验8项，其他都在进行中。结论：儿童眼科疾病的药物治疗尚有巨大的临床需求未满足，直接关系到了儿童健康权益保障与生命安全维护。当前国内儿童眼用制剂研发呈现企业参与度低、创新动力不足的现状，其核心制约因素在于项目少、难度大、涉及更多的伦理问题。建议通过政产学研协同创新，系统性推进儿童眼用制剂的研发进展，切实解决我国儿童眼病治疗用药难的问题，为儿童视觉健康提供有力保障。

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.

目的：利用美国食品药品监督管理局公共数据开放项目（OpenFDA）检索并分析盐酸环喷托酯滴眼液药品不良反应（adverse drug reactions，ADRs）的报告情况，为临床安全用药提供参考。 方法： 以“盐酸环喷托酯滴眼液”作为检索词，在OpenFDA数据库中检索2004年1月1日至2024年8月1日期间盐酸环喷托酯滴眼液相关ADRs的所有信息，对检索到的数据进行分析。 结果：共检索到盐酸环喷托酯滴眼液相关ADRs 1185例。1185例患者中，剔除性别不详后，女性和男性分别为516例和483例（43.54% vs 40.76%）；剔除年龄不详后，ADRs发生率较高的是65~<80岁患者（221例，18.65%）、50~<65岁患者（176例，14.85%）、3~<13岁患者（140例，11.81%）。盐酸环喷托酯滴眼液发生率较高的ADRs为眼器官疾病（767例，64.73%）、神经系统疾病（254例，21.43%）及胃肠系统疾病（228例，19.24%）。 结论：盐酸环喷托酯滴眼液可发生眼局部和全身ADRs，临床在使用时应详细询问患者疾病史和用药史，加强用药监护，提高患者用药的安全性。

Objective: To retrieve and analyze adverse drug reactions (ADRs) of cyclopentolate hydrochloride eye drops on the US Food and drug Administration Public Data Open Project (OpenFDA), so as to provide reference for clinical rational drug use. Methods: Using "Cyclopentolate hydrochloride eye drops" as the search term, retrieve all information related to ADRs of cyclopentolate hydrochloride eye drops from the OpenFDA database from January 1, 2004 to August 1, 2024, and analyze the retrieved data  Results: A total of 1 185 cases of ADRs associated with cyclopentolate hydrochloride eye drops were found. Among the 1185 patients, 516 were female and 483 were male ( 43.54 % vs 40.76 % ) after excluding the unknown gender. After excluding patients with unknown age, the incidence of ADRs was higher in patients aged 65~ < 80 years old ( 221 cases, 18.65 % ), 50~< 65 years old ( 176 cases, 14.85 % ), and 3~ < 13 years old ( 140 cases, 11.81 % ). The ADRs with high incidence of cyclopentolate hydrochloride eye drops were ocular organ diseases ( 767 cases, 64.73 % ), nervous system diseases ( 254 cases, 21.43 % ) and gastrointestinal system diseases ( 228 cases, 19.24 % ). Conclusions: Cyclopentolate hydrochloride eye drops can cause local and systemic adverse reactions. In clinical use, the patient 's disease history and medication history should be asked in detail, and medication monitoring should be strengthened to improve the safety of patient medication.