基于文献计量学的我国期刊医疗器械风险管理研究热点分析

Bibliometrics Analysis for Near-10-year Literatures on Medical Device Risk Management in Chinese Journals

目的:分析医疗器械风险管理文献的研究要素、聚焦领域及趋向。方法:检索2003—2012年万方、CNKI及维普数据库,从样本文献中提取关键词等参量进行文献计量,运用SPSS17.0构建词篇矩阵、图形聚类工具包(gCLUTO)进行关键词词篇共现分析与聚类可视化分析。结果:检出文献331篇,刊登在114种期刊上,呈逐年上升趋势;关键词双聚类分析为4类。结论:国内医疗器械风险管理研究的热点由21世纪初的国外经验评介、标准法规解读与对策建议,逐步过渡到在用医疗器械不良事件分析与预测、风险分析与评估及控制以及在此基础上整合的安全管理、质量管理技术保障体系建设方面。

Objective To analyze the bibliometric parameters, trend and focal fields on risk management of medical device in the near 10 years of Chinese literatures in China journals. Methods The literatures were sampled from WanFang, CNKI and VIP databases （from 2003 to 2012）, and some parameters such as keywords were extracted for bibliometric analysis. SPSS17.0 was used for constructing article matrix, and gCLUTO was applied for co-occurrence analysis and visualized cluster analysis. Results There were 331 word-paper obtained from 114 journals with an ascending trend, and 4 clusters were gotten by keywords double cluster analysis. Conclusion The research hotspots on medical device risk management in China involve the analysis and prediction of adverse events, risk analysis, evaluation and control, safety management, quality control and etc, which used to be the introduction and assessment of the practices in foreign countries, interpretation of related laws and regulations as well as suggestions.