[发展和应用中国传统医学核心成果的总体战略]
Jun-Hua Zhang1, Bo Pang1, Yu-Yun Li1
1Tianjin University of Traditional Chinese Medicine Tianjin 301617, China Key Laboratory of Evidence Based Evaluation of Traditional Chinese Medicine, National Medical Products Administration Tianjin 301617, China.
概括
开发传统中医药的核心成果集对于高质量的研究至关重要. 本研究回顾了TCM核心结果集 (COS-TCM) 的发展,提出了标准化和更好的临床应用的途径.
科学领域:
- 整合和补充医学
- 临床试验方法
- 基于证据的实践
背景情况:
- 标准化对中国传统医学 (TCM) 临床疗效的评估对于其高质量发展至关重要.
- 对TCM进行认可的评估结果系统对于产生和转换临床证据至关重要.
- 诸如结果异质性和"西方法律在中间"问题等挑战推动了TCM核心结果集 (COS-TCM) 的研究.
研究的目的:
- 系统地审查COS-TCM研究的发展历史和现状.
- 澄清"国际标准+TCM特征"的原则以及COS-TCM发展的关键任务.
- 为推进COS-TCM标准化,系统化和科学应用提出发展路径和战略.
主要方法:
- 审查过去十年COS-TCM方法的探索和实践.
- 分析理论基础,技术方法,平台支持和人才团队发展.
- 确定COS-TCM发展当前阶段的机遇和挑战.
主要成果:
- 从最初的介绍到标准化系统构建,COS-TCM研究已经进步,进入了系统发展的新阶段.
- 通过理论,技术,平台和人才方面的协调发展,方法系统得到了深化.
- 目前的局限性包括研究规模,质量和COS-TCM结果的翻译/应用不足.
结论:
- 为COS-TCM提出了三步发展路径 ("探索和研究,标准开发和监管转型").
- 关键战略包括升级研究平台,加强支持系统和优化协作机制.
- 这些进展旨在更好地服务于TCM的临床研究,证据翻译和新药审查.
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