摘要
目的调查分析目前国内登记研究的现状,为下一步研究开展提供依据。方法检索世界卫生组织一级注册平台、美国临床试验注册平台和其他注册平台,搜集已注册的中国大陆境内实施的登记研究,检索时限为注册平台建立到2018年7月31日。由2名研究者收集、整理数据后,采用描述性统计方法进行分析,使用Python 3.5中的python-igraph程序包绘制网络关系图。结果共检索到247个登记研究,主要以疾病登记和医药产品登记研究为主。研究设计形式以队列研究和病例系列为主;研究方向集中于心脑血管等慢性疾病;研究地点主要集中于经济发达的北上广区域。研究设计和研究疾病系统网络关系图表明队列研究设计在神经系统和循环系统应用较多。研究发起地和研究疾病系统网络关系图显示北京以研究循环和神经系统疾病为主、上海以研究循环系统疾病为主、广东研究神经系统和泌尿系统疾病相对较多。结论我国登记研究日益增多,反映出我国对于疾病长期终点评价日益重视。
Objective To investigate the current situation of domestic registry studies, and to provide basis for future research. Methods World Health Organization(WHO) registration platform, ClinicalTrials.gov registration platform and other registration platforms were searched to collect the registered registration studies in China's Mainland from inception to July 31 st, 2018. Two researchers collected and collated data, analyzed by descriptive statistical methods,and then python-igraph package in Python 3.5 was used to draw the network diagram. Results A total of 247 studies were retrieved, mainly for disease registry and pharmaceutical product registry. Cohort and case-series were the principally study design. The research focused on chronic diseases such as cardiovascular and cerebrovascular diseases,and research sites were based on the economically developed area, for example, Beijing, Shanghai and Guangdong. The network diagram of study design and disease system shows that cohort research design is widely used in the nervous system and circulatory system;the network diagram of the research sites and disease system found that Beijing mainly studied circulatory and nervous system diseases, Shanghai mainly studied circulatory system diseases, and Guangdong relatively studied more on nervous system and urinary system diseases. Conclusion The increasing number of registry studies in China reflects the importance of long-term outcome assessment of diseases.
作者
周莉
欧阳文伟
李庚
刘澳林
温泽淮
ZHOU Li, OUYANG Wenwei, LI Geng, LIU Aolin, WENZehuai(Key Unit of Methodology in Clinical Research of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, 510120, P.R.China;DME Center of Guangzhou University of Chinese Medicine, Guangzhou, 510405, P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2019年第6期702-707,共6页
Chinese Journal of Evidence-based Medicine
基金
国家“十二五”科技支撑计划课题基金(编号:2013BAI02B10)
国家自然科学基金项目(编号:81703938)
关键词
登记研究
临床研究注册平台
研究设计
现状
Registry study
Clinical research registry platform
Study design
Current situation
