现代中医临床2024,Vol.31Issue(2) :1-5.DOI:10.3969/j.issn.2095-6606.2024.02.001

循证中医临床试验的机遇、挑战与对策

Opportunities,challenges and strategies of evidence-based traditional Chinese medicine clinical trials

刘建平
现代中医临床2024,Vol.31Issue(2) :1-5.DOI:10.3969/j.issn.2095-6606.2024.02.001

循证中医临床试验的机遇、挑战与对策

Opportunities,challenges and strategies of evidence-based traditional Chinese medicine clinical trials

刘建平1
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作者信息

  • 1. 北京中医药大学循证医学中心 北京 100029
  • 折叠

摘要

循证医学自20世纪90年代引入我国,现已成为临床疾病诊断、药物治疗的重要思想指南和实践工具.应用循证概念指导中医临床试验,需学透方法、读懂循证.临床试验的始动因素必须基于系统评价证据.做好中医临床试验的6要素包括:构思严谨的设计、严格正确实施方法学、开展前期探索性研究、针对重点难点专项攻关、实施合理严格的监管制度和符合国际规则.中医药走向现代化与国际化,需坚守自身特色、注重交叉融通,在遵守国际通行规则的前提下展示中医临床试验成果.

Abstract

Since its inception in the 1990s in China,evidence-based medicine(EBM)has emerged as a significant guiding principle and practical tool in the realm of clinical disease diagnosis and pharmacotherapy.To effectively employ EBM within traditional Chinese medicine(TCM)clinical trials,a comprehensive understanding of the methodology and principles of EBM is imperative.Additionally,the initiation of these clinical trials should be predicated on thorough evidence from systematic review.A well-executed TCM clinical trial should involve several essential components,namely:the implementation of meticulous study design,adherence to the accurate and stringent methodological approach,preliminary exploratory investigation,focused breakthrough of critical and intricate aspects,establishment of a pragmatic regulatory framework,and conformity to international standards.As TCM progresses towards modernization and globalization,it is crucial to maintain its distinct characteristics,while simultaneously embracing interdisciplinary integration and showcasing the achievements of TCM clinical trials,all within the confines of international regulations.

关键词

中医临床试验/循证医学/方法学质量/问题挑战/对策

Key words

traditional Chinese medicine clinical trial/evidence-based medicine/methodological quality/questions and challenges/strategies

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基金项目

国家自然科学基金重点项目(81830115)

出版年

2024
现代中医临床
北京中医药大学

现代中医临床

CSTPCD
影响因子:0.816
ISSN:2095-6606
参考文献量15
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