当前，药物临床试验面临着两大难题：数据真实性及相关人员操作规范性。现阶段国内外在药物临床试验方面的监管主要以事后监查为主，在数据质量管理以及操作规划标准的监查方面存在一定的时延性。而区块链通过非对称加密、哈希算法及智能合约等技术，可以在保证受试者隐私信息的前提下，提高政府相关监督机构的监管效率，提升药物临床试验数据管理的透明度；同时，与物联网的紧密结合可以实现对标准操作规范的进一步核查，与人工智能的结合有望实现受试者的自动招募。

Clinical drug trials are confronted with two major issues: first, data authenticity, for instance, if any data falsification is conducted during the whole trial; second, whether the standard of procedure is accordingly conducted throughout the whole trial or not. Currently, both domestic and overseas clinical drug trials are not supervised without delay (ex-post inspection). Blockchain technology can improve the efficiency of Food and Drug Administration and the transparency of trials while the rights and safety of human research subjects are guaranteed by the integrated technology such as chained structure, asymmetry key algorithm, hash algorithm, and smart contract. Furthermore, with the assistance of internet of things (IoT) and artificial intelligence (AI), the actual supervision over the whole trial and automatic recruitment of human research subjects are expected to achieve.

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.