基于CiteSpace的吸入制剂安全性与风险控制研究  

Safety and Risk Control Study of Inhalation Preparation Based on CiteSpace

作　　者：魏正然 姜雁琼 史天资 蔡沅璇 赵宇航 上官小芳 黄锐[2] 李克 WEI Zhengran;JIANG Yanqiong;SHI Tianzi;CAI Yuanxuan;ZHAO Yuhang;SHANGGUAN Xiaofang;HUANG Rui;LI Ke(School of Medicine and Health Management,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;School of Pharmacy,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Wuhan Institute for Drug and Medical Device Control,Wuhan 430073,China)

机构地区：[1]华中科技大学同济医学院医药卫生管理学院,武汉430030 [2]华中科技大学同济医学院药学院,武汉430030 [3]武汉药品医疗器械检验所,武汉430073

出　　处：《医药导报》2024年第6期993-999,共7页Herald of Medicine

基　　金：药物制剂质量研究与控制重点实验室开放课题资助项目(YWZJZD-202202);湖北省药品监督管理局药品安全监管科研项目(20220112)。

摘　　要：目的分析近20年国内外吸入制剂安全性研究的热点、规律和分布情况,并对吸入制剂安全性与风险控制研究现状进行总结。方法以Web of Science核心合集数据库中有关吸入制剂安全性与风险管理的文献为对象,借助Excel 2021、CiteSpace6.1.R3软件对年度发文量、国家、机构、作者以及关键词共现、聚类、突现情况进行可视化处理并分析。结果共纳入文献365篇,吸入制剂的安全性与风险控制领域在2002-2018年期间内发文量均在每年30篇以下,2019年后年发文量突破30篇。通过分析国家、机构合作网络可知,发文量前四的国家是美国、英国、德国、中国,发文量前3的机构是阿斯利康公司、葛兰素史克公司、辉瑞公司。通过分析作者合作网络可知,欧美作者间的合作网络形成较早,2002年就已经出现一定的研究团体,而我国在2020年才形成较集中的合作网络。结论近20年来,关于吸入制剂的研究主要集中在安全性与功效方面,关于其风险控制的研究较少,存在安全评估与风险评估相脱节的现象,未来的关注点可能集中吸入制剂不良反应评估和风险管理研究方面。Objective To analyze the hot spots,rules and distribution on safety research of inhalation preparations at home and abroad in the past 20 years,and to summarize the current status of safety and risk control research on inhalation preparations.Methods This reaserch is based on the literature related to the safety and risk control of inhalation preparations in the core collection database of the Web of Science.With the help of Excel 2021 and CiteSpace6.1.R3,visualized processing and analysis were carried out on the annual number of publications,countries,institutions,authors,co-occurrence of keywords,clustering and prominence.Results A total of 365 articles were included,the annual publication number in the field of the safety and risk control of inhalation preparations was less than 30 per year from 2002 to 2018.But since 2019,the number of articles published this year has exceeded 30.Through the analysis of the cooperation network of countries and institutions,the top four countries in terms of publication volume are the United States,the United Kingdom,Germany,and China,and the top three institutions are AstraZeneca,GlaxoSmithKline and Pfizer.Through the analysis of the author cooperation network,the cooperation network between European and American authors was formed earlier,and a certain research group has appeared in 2002.In contrast,a more concentrated cooperation network has been formed in China in 2020.Conclusions In the past 20 years,the research on inhalation preparations has mainly focused on their safety and efficacy,while there are few studies on their risk control.There is a disconnect between safety assessment and risk assessment,and the future focus maybe focused on the adverse reaction assessment and risk management research of inhalation preparations.

关 键 词：吸入制剂 安全性 风险控制 

分 类 号：R944.9[医药卫生—药剂学]