摘要
临床试验方案是证实科学研究内容真实有效的载体。科学的研究方法、合理的试验设计以及正确的疗效评价是合格的临床试验方案的基础和前提。然而,纵观国内中医药相关临床试验方案设计,在试验设计方法、循证医学及临床流行病学应用、医学伦理设计等诸多条目上存在问题。该文从上述问题出发,以中药治疗膝骨关节炎临床研究方案为例,阐述相关内容并进行深入思考。同时,该文以大数据时代为背景,结合目前中医药发展遇见的瓶颈和未来发展趋势,就如何有效地利用信息化、科学化和多样化的数据库展开讨论,为有志于发展中医药事业的临床和科研工作者提供启迪。
Clinical trial design is the supporter to certify the truth and effectiveness of scientific research. Scientific research method,reasonable experiment design and correct therapeutic evaluation are the foundation and prerequisite of qualified design. However,we can find many issues in the designs inland,just about the method of the experiment design,the use of evidence-based medicine and clinical epidemiology and the design of medical ethics. The article will take a design about traditional Chinese medicine curing knee osteoarthritis for example to illustrate and think deeply from the issues above. It will also combine the problems we meet today and the trend in the future to discuss how to use the informationalized,scientific and diversified data base on the age of big data. It aims at providing enlightenments for those who aspire to develop traditional Chinese medicine cause.
作者
张师侥
杨永菊
关雪峰
ZHANG Shiyao;YANG Yongju;GUAN Xuefeng(Liaoning University of Traditional Chinese Medicine, Shenyang 110847, Liaoning, China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, Liaoning, China)
出处
《辽宁中医药大学学报》
CAS
2018年第4期157-160,共4页
Journal of Liaoning University of Traditional Chinese Medicine
基金
辽宁省中医药临床学(专)科能力建设项目(辽卫办发(2015)140号)
关键词
中医药
临床试验
方案设计
大数据
膝骨关节炎
traditional Chinese medicine
clinical trial
project design
big data
knee osteoarthritis
