| 摘要: |
| 目的:系统梳理儿科中医药临床试验的注册现状及特征,为其规范化设计与高质量实施提供参考。方法:检索中国临床试验注册中心(ChiCTR、ClinicalTrials. gov 和国际临床试验注册平台(ICTRP) 建库至2025 年10 月30 日的儿科中医药临床试验,提取注册时间、地区、机构、经费来源、研究设计、疾病类型、干预措施及结局指标等信息进行描述性统计分析。结果:共纳入285 项临床试验。注册数量呈阶段性增长;地区上以上海、北京、广东等地为集中区,天津中医药大学第一附属医院为主要组长单位;资金多来自地方政府和医药公司;研究类型以干预性研究为主;分期以Ⅳ期临床研究为主;规模多为单/ 双中心、小样本研究;疾病集中于呼吸系统、变态反应性及消化系统疾病;干预措施多采用内治法,阳性对照较常见;结局指标以疾病为导向。结论:儿科中医药临床试验目前是政策引导、资源集中、常见病导向的模式,未来要重视整体设计、理清研究思路、扩大病种范围、促进中医证候与复合评价的统一,以实现儿科中医药临床试验研究的高质量可持续发展。 |
| 关键词: 儿科 疾病 中医药 临床试验 [ |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2026.10.001 |
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| 基金项目:中华中医药学会团体标准立项项目,编号20240108-BZ-CACM;天津市生物医药科技重大专项“中药新药临床试验能力提升”,编号25ZXSWSY00420。 |
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| Current Status and Quantitative Analysis of Clinical Trial Registration of Traditional Chinese Medicine in Pediatrics from the Perspective of Three Major Registration Platforms |
| Chen Yueyue1, Jia Zhichao1, Zeng Jing2, Wang Jixuan1, Li Meifang1, Hu Siyuan1 |
| ((1. The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine / National Clinical Research Center for Chinese Medicine, Tianjin 300381, China; 2. Tianjin Municipal Human Resources and Social Security Bureau, Tianjin 300040, China)) |
| Abstract: |
| Objective: To systematically review the registration status and characteristics of pediatric traditional Chinese medicine clinical trials, providing reference for standardized design and high-quality implementation. Methods: Pediatric traditional Chinese medicine clinical trials registered in Chinese Clinical Trial Register (ChiCTR), ClinicalTrials. gov, and International Clinical Trials Registry Platform (ICTRP) from database establishment to Oct. 30th , 2025 were retrieved. Information on registration time, region, institution, funding source, study design, disease type, intervention, and outcome measures was extracted for descriptive statistical analysis. Results: A total of 285 trials were included. Registrations increased in phases. Studies were concentrated in Shanghai, Beijing, and Guangdong, with the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine as the leading site. Funding mainly came from local government and pharmaceutical companies. Interventional studies predominated, with phase Ⅳ clinical trials being most common. Most were single/ dual-center studies with small sample sizes. Diseases focused on respiratory, allergic, and
digestive system diseases. Internal therapy was the predominant intervention, and positive controls were commonly used. Outcome measures were disease-oriented. Conclusion: At present, pediatric traditional Chinese medicine clinical trials follow a model driven by policy guidance, resource concentration, and orientation towards common diseases. In the future, emphasis should be placed on overall design, clarification of research approaches, expansion of the spectrum of disease types covered, and promotion of the unification of traditional Chinese medicine syndromes and composite outcome assessment, so as to achieve high-quality and sustainable development of pediatric clinical research on traditional Chinese medicine. |
| Key words: Pediatrics diseases traditional Chinese medicine clinical trials |
