基于知识图谱的我国儿童用药真实世界研究发展现状与前沿分析

Analysis of Current Status and Frontier of Real-World Studies on Pediatric Medication in China Based on Knowledge Mapping

目的:了解我国儿童用药领域真实世界研究的现状、热点与前沿,为儿童用药研发提供综合信息。方法:检索中国知网、万方、维普数据库中与儿童用药相关的真实世界研究文献,包括观察性研究和试验性研究等,利用CiteSpace5.8.R3分析文献信息,并绘制可视化知识图谱。结果:最终纳入文献1665篇,发文时间跨度为1999-2021年,46.13%为观察性研究,以描述性研究类型为主;其次为试验性研究(16.67%),以实用性随机对照研究类型为主。我国儿童用药真实世界研究领域总体发文量呈递增趋势,发文作者及机构较集中,研究热点为药物不良反应、合理用药。研究内容主要为真实世界儿童用药综合评价(抗菌药物最常见),关注度最高的疾病是感染性疾病,研究数据来源以医院信息系统为主。研究趋势为超说明书用药现象与真实世界研究。结论:我国儿童用药领域真实世界研究备受关注,研究者及机构间合作较少。研究者应运用真实世界研究完善儿童药品临床综合评价,重视实用性临床研究,重视慢性病用药数据库建立,扩大真实世界研究数据来源。超说明书用药是未来该领域真实世界研究值得深入的研究方向。

Objective:To review the current situation,hot spots and frontiers of pediatric medication research and provide comprehensive information for the research and development of pediatric medication.Methods:Chinese literatures related to the real world research in pediatric medication were retrieved from CNKI,Wanfang and VIP databases,including observational studies and experimental studies,etc.Citespace5.8.R3 was used to analyze the literature information and draw the visualization maps.Results:1665 articles were included,covering the period from 1999 to 2021.Observational studies accounted for 46.13%,and were mainly descriptive studies.Experimental studies accounted for 16.67%,and were mainly practical randomized controlled studies.The overall number of articles published in the real world research field of pediatric medication in China showed an increasing trend,and the authors and institutions were more concentrated.The research hotspots were adverse reactions and retrospective analysis.The main content of the study was the comprehensive evaluation of medication for children in the real world(antibiotics were the most common).Diseases of the highest concern are infectious diseases.The data source is mainly hospital information system.The research trend is the phenomenon of off-label drug use and real world study.Conclusion:The real world study on pediatric medication is attracting more and more attention in China,and there is a lack of cooperation between researchers and institutions.Researchers should use real world research to improve the comprehensive clinical evaluation of children′s drugs,pay attention to the types of practical clinical studies,pay attention to the establishment of chronic medicine database,and expand data sources for real-world research.Off-label drug use is worthy of further research in the real world in the future.