真实世界研究主题与研究能力的可视化分析
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摘要
真实世界研究作为临床研究中的一种新理念,以其独特的优势,受到国内外研究者的关注。该研究主要通过可视化的方法对其进行分析。首先,通过检索中国生物医学文献数据库、中国知网、万方数据库、Medline和EMbase等数据库,纳入中文文献414篇和英文文献2 158篇。其次,采用BICOMS 2软件提取和整理纳入文献的主要信息,并生成共现矩阵;利用NetDraw软件绘制网络关系图和g CLUTO软件进行聚类分析,生成可视化矩阵图。最终研究结果显示,国内外的发文量整体上呈现增长的趋势,但是相对于国外,我国真实世界的研究起步较晚,且研究整体实力与国外有一定的差距;国内外关于真实世界研究均存在地区间的不均衡,国内主要集中于北京、广东、上海等发达省市,且省市之间缺乏紧密合作;国外主要集中于美国、英国、德国等发达国家,国家间合作比较紧密;国内外研究的热点方向和核心方向也有很大的不同。该研究以期通过对目前国内外关于真实世界研究主题与研究能力的现况描述,为我国进一步研究提供借鉴与参考。
As a new concept in clinical research,the real world research(RWR) has attracted the attention of researchers in the world with its unique advantages. This research mainly analyzed it through visual methods,the specific steps were as follows. Firstly,the Chinese Biomedical Literature Database,China National Knowledge Infrastructure,Wan Fang Database,Medline and EMbase were searched and RWS were included,414 articles in Chinese and 2 158 articles in English were included in this research after layer-bylayer screening; secondly,the main information was extracted and sorted by BICOMS 2 software and generated its co-occurrence matrix; the network relationship diagram was drawn by Net Draw software; the cluster analysis was carried out by using g CLUTO software;finally,this research results show that the numbers of domestic and foreign literatures have shown an overall growth trend,but compared with foreign countries,China's research on the real world started late,the overall strength of research was not as good as abroad;and the domestic and foreign research on the real world was uneven in the region,the research in China was mainly distributed in developed provinces and cities,such as Beijing,Guangdong,Shanghai,etc,and there was a lack of close cooperation between provinces and cities; the foreign research are mainly distributed in developed countries such as the United States,the United Kingdom,Germany,et al; the cooperation between countries was relatively close. And the hotspots and core directions of domestic and foreign research were also different. This research was intended to provide reference for the further research of Chinese researchers through the current description of the themes and capability of the real world research in the world.
As a new concept in clinical research,the real world research(RWR) has attracted the attention of researchers in the world with its unique advantages. This research mainly analyzed it through visual methods,the specific steps were as follows. Firstly,the Chinese Biomedical Literature Database,China National Knowledge Infrastructure,Wan Fang Database,Medline and EMbase were searched and RWS were included,414 articles in Chinese and 2 158 articles in English were included in this research after layer-bylayer screening; secondly,the main information was extracted and sorted by BICOMS 2 software and generated its co-occurrence matrix; the network relationship diagram was drawn by Net Draw software; the cluster analysis was carried out by using g CLUTO software;finally,this research results show that the numbers of domestic and foreign literatures have shown an overall growth trend,but compared with foreign countries,China's research on the real world started late,the overall strength of research was not as good as abroad;and the domestic and foreign research on the real world was uneven in the region,the research in China was mainly distributed in developed provinces and cities,such as Beijing,Guangdong,Shanghai,etc,and there was a lack of close cooperation between provinces and cities; the foreign research are mainly distributed in developed countries such as the United States,the United Kingdom,Germany,et al; the cooperation between countries was relatively close. And the hotspots and core directions of domestic and foreign research were also different. This research was intended to provide reference for the further research of Chinese researchers through the current description of the themes and capability of the real world research in the world.
引文
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[2]中国临床医学真实世界研究施行规范专家委员会.中国临床医学真实世界研究施行规范[J].中华实验和临床感染病杂志,2017,11(6):521.
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[6]孙月,陈吉,布优祥,等.NGC收录护理临床实践指南方法学分析[J].护理学杂志,2018,33(14):99.
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[9]赵晔,张俊华,李伦,等.全球网状Meta分析研究主题的可视化分析[J].中国药物评价,2017,34(1):18.
[10]潘蓓,兰思琴,王盼杰,等.医学专业任务驱动教学方法研究的可视化分析[J].中国医药导刊,2018,20(4):252.
[11]田金徽,施树珍,赵晔,等.中药干预放射性肺损伤规律的复杂网络分析[J].中国中药杂志,2018,43(14):3018.
[12]康继红,陈葛,舒逸,等.国家基本药物制度研究主题的可视化分析[J].中国全科医学,2017,20(28):3471.
[13]霍勇.伴随循证医学走入真实世界———GRACE研究给我们的提示[J].中华医学信息导报,2002(11):12.
[14] Kaplan N M,Sproul L E,Mulcahy W S. Large prospective study of ramipril inpatients with hypertension CARE investigators[J].Chin Ther,1993,15(5):810.
[15]于子凯,张昱.浅谈真实世界研究及其在中医药临床科研中的应用[J].中医药导报,2016,22(17):11.
[16]朱丽君.学科发展对发文量的影响[J].武汉工程学院学报,2011(12):99.
[17]蔡荣林,胡玲,吴子建.循证医学、真实世界研究在针灸临床研究中的应用与思考[J].中国针灸,2015,35(9):949.
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[19]许鸣,陆嘉惠.基于真实世界研究的中医药临床数据挖掘方法浅探[J].中华中医药杂志,2017,32(4):1640.
[20]田峰,谢雁鸣.真实世界研究:中医干预措施效果评价的新理念[J].中西医结合学报,2010,8(4):301.
[21]付玲,周学平,李国春.“真实世界研究”———中医药科研新思路[J].浙江中医药大学学报,2013,37(9):1127.
[22]廖星,于丹丹,谢雁鸣,等.碟脉灵苦碟子注射液上市后安全性监测:一项30 233例真实世界注册登记研究[J].中国中药杂志,2017,42(15):2857.
[23]刘亚欣,谢雁鸣,张寅,等.复方苦参注射液治疗食管恶性肿瘤临床应用特征:一项基于医院信息系统电子医疗数据的真实世界研究[J].中国中药杂志,2017,42(15):2877.
[24]庄海舟,王志飞,谢雁鸣,等.基于医院信息系统数据库的急性胰腺炎患者临床特征分析[J].中医杂志,2014,55(19):1688.
[25] Kreutz R P,Stanek E J,Aubert R,et al. Impact of proton pump inhibitors on the effectiveness of clopidogrel after coronary stent placement:the clopidogrel Medco outcomes study[J]. Pharmacotherapy,2010,30(8):787.
[26]刘连新,李轲宇.2015年肝脏肿瘤NCCN临床实践指南更新与解读[J].中国实用外科杂志,2015,35(3):283.
[27] Guyatt G H,Oxman A D,Vist G E,et al. GRADE:an emerging consensus on rating quality of evidence and strength of recommendations[J].BMJ,2008,336(7650):924.
[2]中国临床医学真实世界研究施行规范专家委员会.中国临床医学真实世界研究施行规范[J].中华实验和临床感染病杂志,2017,11(6):521.
[3]康德英.浅议真实世界研究[J].中国癌症防治杂志,2017,9(2):100.
[4] Robson C. Real world research(3rd Edn)[M]. United Kingdom:John Wiley&Sons Ltd,2011.
[5]荀杨芹,张元元,王建成,等.透明质酸治疗膝骨关节炎的临床实践指南质量评价[J].中国医药导刊,2018,20(10):584.
[6]孙月,陈吉,布优祥,等.NGC收录护理临床实践指南方法学分析[J].护理学杂志,2018,33(14):99.
[7]杜丽东,田金徽,吴国泰,等.基于文献的中药治疗便秘的社会网络分析[J].中国中药杂志,2017,42(2):370.
[8]崔雷,刘伟,闫雷,等.文献数据库中书目信息共现挖掘系统的开发[J].情报分析与研究,2008(8):70.
[9]赵晔,张俊华,李伦,等.全球网状Meta分析研究主题的可视化分析[J].中国药物评价,2017,34(1):18.
[10]潘蓓,兰思琴,王盼杰,等.医学专业任务驱动教学方法研究的可视化分析[J].中国医药导刊,2018,20(4):252.
[11]田金徽,施树珍,赵晔,等.中药干预放射性肺损伤规律的复杂网络分析[J].中国中药杂志,2018,43(14):3018.
[12]康继红,陈葛,舒逸,等.国家基本药物制度研究主题的可视化分析[J].中国全科医学,2017,20(28):3471.
[13]霍勇.伴随循证医学走入真实世界———GRACE研究给我们的提示[J].中华医学信息导报,2002(11):12.
[14] Kaplan N M,Sproul L E,Mulcahy W S. Large prospective study of ramipril inpatients with hypertension CARE investigators[J].Chin Ther,1993,15(5):810.
[15]于子凯,张昱.浅谈真实世界研究及其在中医药临床科研中的应用[J].中医药导报,2016,22(17):11.
[16]朱丽君.学科发展对发文量的影响[J].武汉工程学院学报,2011(12):99.
[17]蔡荣林,胡玲,吴子建.循证医学、真实世界研究在针灸临床研究中的应用与思考[J].中国针灸,2015,35(9):949.
[18] Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices:draft guidance for industry and Food and Drug Administration staff[EB/OL].[2018-11-05]. http://www. fda. gov/downloads/Medical Devices/Device Regulation and Guidance/Guidance Documents/UCM513027.pdf.2016.
[19]许鸣,陆嘉惠.基于真实世界研究的中医药临床数据挖掘方法浅探[J].中华中医药杂志,2017,32(4):1640.
[20]田峰,谢雁鸣.真实世界研究:中医干预措施效果评价的新理念[J].中西医结合学报,2010,8(4):301.
[21]付玲,周学平,李国春.“真实世界研究”———中医药科研新思路[J].浙江中医药大学学报,2013,37(9):1127.
[22]廖星,于丹丹,谢雁鸣,等.碟脉灵苦碟子注射液上市后安全性监测:一项30 233例真实世界注册登记研究[J].中国中药杂志,2017,42(15):2857.
[23]刘亚欣,谢雁鸣,张寅,等.复方苦参注射液治疗食管恶性肿瘤临床应用特征:一项基于医院信息系统电子医疗数据的真实世界研究[J].中国中药杂志,2017,42(15):2877.
[24]庄海舟,王志飞,谢雁鸣,等.基于医院信息系统数据库的急性胰腺炎患者临床特征分析[J].中医杂志,2014,55(19):1688.
[25] Kreutz R P,Stanek E J,Aubert R,et al. Impact of proton pump inhibitors on the effectiveness of clopidogrel after coronary stent placement:the clopidogrel Medco outcomes study[J]. Pharmacotherapy,2010,30(8):787.
[26]刘连新,李轲宇.2015年肝脏肿瘤NCCN临床实践指南更新与解读[J].中国实用外科杂志,2015,35(3):283.
[27] Guyatt G H,Oxman A D,Vist G E,et al. GRADE:an emerging consensus on rating quality of evidence and strength of recommendations[J].BMJ,2008,336(7650):924.