基于证据体的中医药临床证据分级标准建议

Recommendations for Clinical Evidence Grading on Traditional Chinese Medicine Based on Evidence Body

证据是循证医学的重要组成部分,而临床研究是证据的最重要来源。国际上证据分级体系不断发展并完善,其中认可度较高的是GRADE体系,但其在应用于中医学领域时仍存在一定局限性。本文在2007年的"基于证据体的中医药证据分级建议"的基础上进行了更新和完善,对中医药有效性和安全性的现代临床研究证据的质量分级标准提出了思路和构想,并借鉴国际公认的证据质量评价标准,综合考虑中医药临床研究的特点,详细描述了影响证据质量的因素,并按照不同的研究设计类型,分别提出了升降级的参考标准,以帮助研究者科学合理地整合评价中医临床证据,从而使指南更科学合理地用于指导临床实践,增加中医临床诊疗方案的科学性和实用性。

Clinical research is the most important source of evidence for evidence-based medicine. As the international evidence grading system continuously developed and improved, the GRADE system is highly recognized. However, there are still certain limitations when applied to the field of Traditional Chinese medicine(TCM). Based on the quality grading system proposed in 2007, this article proposes the recommendations for clinical evidence grading on TCM based on evidence body with the considerations on the characteristics of TCM, and gives specific upgrading and downgrading criteria for different types of research. Our aim is to help CM researchers to scientifically evaluate clinical evidence of TCM, so that the clinical practice guideline could be more scientifically and rationally.