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 调查眼科万古霉素使用情况，并对超说明书用药进行评价，为临床提供参考。方法 采用回顾性分析法，选取郑州市第二人民医院2022年1月1日—2024年12月眼科使用万古霉素的159例住院患者为研究对象，对患者基本信息、万古霉素的使用情况、微生物送检情况及超说明书用药情况等进行评价分析。结果159例患者中男性占比76.1%，主要分布在眼底病病区，致病因素主要为眼外伤（102/159，64.15%），其次为手术源性（36/159，22.64%）。给药途径主要为玻璃体注射，以治疗用药为主，多联合头孢他啶治疗眼内感染。病原菌送检率为75.47%，标本检出率为35.07%。其中革兰阳性菌33例，占80.49%，主要为表皮葡萄球菌；革兰阴性菌5例，占12.20%，有大肠埃希菌、铜绿假单胞菌等；真菌4例，占9.76%，主要为曲霉菌。超说明书用药包括玻璃体注射、眼内灌洗及超适应证用于眼内炎的预防。玻璃体注射超说明书用药推荐等级及证据强度高于眼内灌洗和超适应证。结论 万古霉素在眼科临床应用广泛，应严格掌握适应证和用法用量。对于超说明书用药，应在充分评估其合理性和安全性后谨慎使用。本研究对万古霉素的规范化使用及药品说明书修订和个体化治疗具有重要的临床价值和现实意义。
Objective: To investigate the use of vancomycin in ophthalmology department and evaluate its off-label drug use, thereby providing references for clinical practice. Methods: A retrospective analysis was conducted, selecting 159 inpatients who received vancomycin treatment in the Department of Ophthalmology of our hospital from January 1, 2022 to December 31, 2024. The basic information of the patients, details of vancomycin, microbial testing results, and off-label drug use were evaluated and analyzed. Results Among the 159 patients, male patients accounted for 76.1%, and there were mainly distributed in the fundus disease area. The primary pathogenic factor was ocular trauma (102/159,64.15%), followed by surgical causes (36/159,22.64%). The main route of vancomycin administration was intravitreal injection, primarily for therapeutic purposes. It was often combined with ceftazidime to treat intraocular infections. The submission rate of pathogenic bacteria was 75.47%, and the specimen detection rate was 35.07%. There were 33 cases of gram-positive bacteria, accounting for 80.49%, mainly Staphylococcus epidermidis; 5 cases of gram-negative bacteria, accounting for 12.20%, including Escherichia coli, Pseudomonas aeruginosa, etc.; and 4 cases of fungi, accounting for 9.76%, mainly Aspergillus. Off-label drug use included intravitreal injections, intraocular lavage, and the use of drugs highly suitable for the preventing endophthalmitis. Endogenous infections were mainly caused by gram-negative bacteria. The evidence-based medicine support for vancomycin intravitreal injection in the treatment of endophthalmitis is strong. The recommended grade and evidence strength of off-label use of intravitreal injection are higher than those of intraocular lavage and off-label use. Conclusions: Vancomycin is widely used in ophthalmology, and its indications, usage, and dosage should be strictly controlled. Off-label drug use should be used with caution after a comprehensive evaluation of its rationality and safety. This study holds significant clinical value and practical significance for the standardized use of vancomycin, the revision of drug instructions, and individualized treatment.
