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.

目的：分析目前滴眼剂中防腐剂的添加情况，为眼科临床针对不同疾病选择合适的滴眼剂提供参考，倡导合理用药。方法：对临床使用的 194 种滴眼剂说明书中防腐剂成分标注进行统计分析，并对防腐剂的种类、新型防腐剂、眼表毒性研究情况进行归纳综述。结果：滴眼剂中防腐剂大致可分为 5 类，如季铵盐类、醇类、羟苯酯类、有机汞、纯氯氧复合物等。进口滴眼剂的防腐剂以苯扎氯铵为主。国产滴眼剂中新药多以苯扎氯铵为防腐剂，老药则以羟苯乙酯防腐为主；国产药说明书中，有 20.83% 未注明所含防腐剂种类。目前防腐剂中苯扎氯铵抗菌活性虽强，但引起眼表损害的报道也最多，新型防腐剂的研发及无防腐剂滴眼剂可减少眼表的损害。结论：滴眼剂中防腐剂种类繁多、标准不统一，临床医生应熟悉每种眼用制剂防腐剂成分和含量，尤其对青光眼及中重度干眼症使用含防腐剂的滴眼剂时，应关注其对眼表的损害，尽量选择新型防腐剂或不含防腐剂的滴眼剂以减少不良反应的发生。

Objective: To provide guidance for ophthalmologist to choose suitable eye drops for different eye diseases and promote rational drug use by analyzing present situation of preservatives in eye drops. Methods: According to the instructions of 194 kinds of eye drops, statistical analysis was retrospectively carried out on the types, new type, and ocular surface toxicity of preservatives in eye drops. Results: The preservatives of eye drops could be basically divided into 5 categories, such as quaternary ammonium salts, alcohols, hydroxyphenyl esters, organic mercury compounds, pure chlorine oxygen complexes, etc. Besides, most of the preservatives in imported eye drops were benzalkonium chloride, and the new categories of domestic eye drops also utilized benzalkonium chloride as the preservative. However, ethylparaben was used to be considered as preservatives in old-brand domestic eye drops.Moreover, 20.83% domestic drugs’ instructions failed to describe its preservatives. In addition, benzalkonium chloride yielded stronger antibacterial activities compared with other preservatives, but a huge number of animal and in vitro studies demonstrated that benzalkonium chloride may cause or enhance harmful consequences on the eye structures of the anterior segment. Fortunately, preservative-free formulations and new categories would provide clinically benefits. Conclusion: Owing to the various kinds of preservatives and lacking of unified standard of application, clinicians should master the types and content of each preservative in ophthalmic drugs, especially in glaucoma, moderate, and severe dry eyes. Besides, considering ocular surface damage, ophthalmologists should choose new types or preservative-free eye drops to reduce the occurrence of adverse reactions.

目的：分析眼科超说明书用药使用情况，为眼科临床合理用药提供有效、安全的循证参考依据。方法：考察并收集21家爱尔眼科医院集团眼科中心城市及省会级医院备案的超说明书用药情况，同时抽查处方、医嘱用药，对超说明书用药情况进行充分论证评估，参考广东省、山东省等超说明书用药共识、文献，进行统计、分析和归纳，并征求相关眼科临床专家意见。结果：梳理指南、共识及期刊论文等循证医学证据，得出超说明书用药推荐级别1级8项、2级29项、3级24项，并编写了供集团内使用的《眼科医院眼科超药品说明书用药参考目录(2021年版)》，便于临床参考使用。在眼科常用有32种超说明书药品，61项超说明书用药，其中超给药途径32项(52.5%)、超适应证用药13项(21.3%)、超适应证合并超给药途径14项(23.0%)。超说明书品种及超说明用药项目数均以抗菌药物最多，分别为13个(40.6%)品种，26项(42.6%)。结论：眼科因特殊的给药途径，超说明书用药比较普遍，而如抗菌药物注射剂使用眼内注射或滴眼等超说明书用药方式对某些急性眼内感染性疾病起到了很好的治疗效果。规范眼科超说明书用药，是防范医疗风险的必要措施。

Objective: To investigate off-label ophthalmic medications, and provide an effective and safe evidence-based reference for the rational use of ophthalmic drugs. Methods: On the basis of collecting the off-label drug use recorded in 21 Aier Eye Hospital Group which including ophthalmic central cities and provincial capital level hospitals, and spot checking the prescription and doctor’s order drug use, this article conducted full demonstration and evaluation of off-label drug use which referred to the off-label drug used consensus of Guangdong and Shandong, and other literature on the off-label drug use in ophthalmology. The paper conducted statistics, analysis and induction, and solicited the opinions of relevant ophthalmology clinical experts. Results: Sorting out the evidence of the guides,consensus, journal papers and other evidence-based medicine in ophthalmic medication, recommending 8 items of level 1, 29 items of level 2, and 24 items of level 3, we compiled the “Reference catalogue for the off-label drug use in ophthalmic hospital (2021 edition)” within the group which can providing reference for clinical use. There were 61 off-label drugs commonly used in ophthalmology, involving 32 drugs. Among them, 32 items (52.5%) were used by over administration route, 13 items (21.3%) were used by over indication, and 14 items (23.0%) were used by over indication and administration route. Antibacterial drugs were the most frequently used in the varieties and items of off-label drug use, accounting for 13 (40.6%) and 26 (42.6%) respectively. Conclusion: Ophthalmic off-label medications are common owing to the special route of administration. Such as intraocular injection or eye drop have played a good role in the treatment of some ocular infectious diseases. Standardizing the off-label drug use of ophthalmology is an effective measure to reducing medical risks.

目的：分析眼科超说明书用药使用情况，为眼科临床合理用药提供有效、安全的循证参考依据。方法：考察并收集21家爱尔眼科医院集团眼科中心城市及省会级医院备案的超说明书用药情况，同时抽查处方、医嘱用药，对超说明书用药情况进行充分论证评估，参考广东省、山东省等超说明书用药共识、文献，进行统计、分析和归纳，并征求相关眼科临床专家意见。结果：梳理指南、共识及期刊论文等循证医学证据，得出超说明书用药推荐级别1级8项，2级29项，3级24项，并编写了供集团内使用的《眼科医院眼科超药品说明书用药参考目录(2021年版)》，便于临床参考使用。在眼科常用有32种超说明书药品，61项超说明书用药，其中超给药途径32项(52.5%)、超适应证用药13项(21.3%)、超适应症合并超给药途径14项(23.0%)。超说明书品种及超说明用药项目数均以抗菌药物最多，分别为13个(40.6%)品种，26项(42.6%)。结论：眼科因特殊的给药途径，超说明书用药比较普遍，而如抗菌药物注射剂使用眼内注射或滴眼等超说明书用药方式对某些急性眼内感染性疾病起到了很好的治疗效果。规范眼科超说书用药，是降低医疗风险的必要措施。

Objective: To investigate off-label ophthalmic medications, and provide an effective and safe evidence-based reference for the rational use of ophthalmic drugs. Methods: On the basis of collecting the off-label drug use recorded in 21 Aier Eye Hospital Group which including ophthalmic central cities and provincial capital level hospitals, and spot checking the prescription and doctor’s order drug use, this article conducted full demonstration and evaluation of off-label drug use which referred to the off-label drug used consensus of Guangdong and Shandong, and other literature on the off-label drug use in ophthalmology. The paper conducted statistics, analysis and induction, and solicited the opinions of relevant ophthalmology clinical experts. Results: Sorting out the evidence of the guides, consensus, journal papers and other evidence-based medicine in ophthalmic medication, recommending 8 items of level 1, 29 items of level 2, and 24 items of level 3, we compiled the “Reference catalogue for the off-label drug use in ophthalmic hospital (2021 edition)” within the group which can providing reference for clinical use. There were 61 off-label drugs commonly used in ophthalmology, involving 32 drugs. Among them, 32 items (52.5%) were used by over administration route, 13 items (21.3%) were used by over indication, and 14 items (23.0%) were used by over indication and administration route. Antibacterial drugs were the most frequently used in the varieties and items of off-label drug use, accounting for 13 (40.6%) and 26 (42.6%) respectively. Conclusion: Ophthalmic off-label medications are common owing to the special route of administration. Such as intraocular injection or eye drop have played a good role in the treatment of some ocular infectious diseases. Standardizing the off-label drug use of ophthalmology is an effective measure to reducing medical risks.