摘要
目的建设符合中国人自身凝血特点的心脏瓣膜置换术后抗凝治疗注册数据库,填补我国心脏瓣膜病临床研究在此领域的空白,并提供科学、客观的基础数据和信息交流平台。方法采用全国多中心、前瞻性、队列临床研究方法,建立以互联网为平台的中国人心脏瓣膜置换术后抗凝治疗数据库。由全国36家心脏中心参加的国家"十二五"科技支撑计划课题启动会制定符合我国心脏瓣膜术后抗凝患者实际情况的住院及随访病例登记表(casereport form,CRF)。前瞻性纳入2011年1月1日至2014年12月31日行心瓣膜置换术服用华法林抗凝,并接受正规抗凝监测的患者。数据库建设采用数据仓库技术,具有数据监测、查询和统计功能,并定期进行数据备份和系统更新。结果中国人心脏瓣膜置换术后抗凝治疗数据库链接于《中国胸心血管外科临床杂志》首页(http://www.zgxxwkzz.com),是全国范围内的互联网信息平台,2011年1月1日至2012年12月1日已完成全国34家三甲医院8 425例心脏瓣膜置换术后抗凝治疗患者的临床资料注册,各中心的随访工作正在进行中。结论我们建立了一个大型多中心、开放式的数据库及网络信息平台,数据库变量设置符合我国人群心脏瓣膜置换术后抗凝治疗自身临床特点,为今后临床研究系统性分析提供科学、客观的基础数据和保障。
Objective To construct an Anticoagulation Therapy Database of Chinese Patients after Heart Valve Replacement in aceordance with blood coagulation characteristics of Chinese patients, fill the gap of Chinese clinical research in valvular heart diseases, and provide a scientific and objective basic data and information exchange platform. Methods A national multicentre, prospective and cohort clinical research method was applied to establish an anticoagulation therapy database of Chinese patients after heart valve replacement, using the Internet as a platform. A case report form （CRF）, which was in line with the actual situation of Chinese antieoagulation patients after heart valve surgery, was formulated through the discussion of experts from 36 cardiovascular surgery centers in China in the starting meeting of National Science ＆ Technology Support Program during the Twelfth Five-year Plan Period. Patients after heart valve replalement conducted formal anticoagulation therapy and monitor were included from January 1, 2011 to December 31, 2014. Database was constructed using warehousing technology, which allowed not only data monitoring, query and statistics, but also regular data backup and system updates. Results A network database entitled Anticoagulant Therapy Database of Chinese Patients after Heart Valve Replacement was constructed and linked with the homepage of Chinese Journal of Clinical Thoracic and Cardiovascular Surgery （http：//www. zgxxwkzz, com）, which constituted a national Interact information platform. From 1 January 2011 to 1 December 2012, 8 452 anticoagulafion patients after heart valve replacement from 34 level-3A hospitals in China had been registered in the database. Further follow-up of these patients was being carried out in respective hospi- tals. Conclusion A large multi-center and open database and network information platform has been constructed. The database variables are in line with clinical characteristics of Chinese anticoagulation patients after heart valve replacement, which provide scientific and objective basic data and support for future clinical research and systemic analysis.
出处
《中国胸心血管外科临床杂志》
CAS
2013年第1期3-9,共7页
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
基金
"十二五"国家科技支撑计划项目(2011BAI11B18)~~
关键词
注册数据库
心脏瓣膜置换术
抗凝治疗
Registered database
Heart valve replacement
Anticoagulation therapy
