中医干预类临床证据分级系统构建思路探讨

Exploration on the Development of Evidence-based Grading System for Chinese Medicine Interventional Clinical Evidence

证据分级水平是进行临床决策的重要考虑因素。中医药领域完全照搬国际常用证据评价体系存在一定局限性,故提出中医临床证据分级思路,即在遵循国际证据分级标准基础上,充分考虑中医药临床实践特点,以GRADE(Grades of Recommendation,Assessment,Development,and Evaluation)证据评价系统为基础,结合中医古籍证据及现代名医经验证据分级标准,进而整合形成中医干预类临床证据分级系统,其中古籍证据从医案来源、诊疗内容的全面性和传承性三方面进行评价,现代名医经验证据根据名医的资质、经验内容完整性、经验传承性进行评价。针对中医古籍、现代名医经验及现代研究多来源证据的整合,以定性综合为主,多来源证据的分级水平与现代研究GRADE证据评价保持一致,而中医古籍及现代名医经验作为辅助证据呈现,以期更加客观、全面地评价中医临床证据,进而指导临床实践。

The grading of evidence is an important factor in clinical decision-making. The current evidence grading system based on western medicine is limited in the clinical practice of traditional Chinese medicine(TCM), therefore we propose the solutions to the development of grading system for TCM interventional evidence, following the international evidence grading standards, taking into considerations of the unique characteristics of TCM practice, based on the Grades of recommendation, assessment, development and evaluation(GARDE) evaluation system, and integrating with grading system regarding TCM classical literature and empirical evidence from modern famous doctors. The evidence from classical literature is suggested to be evaluated from three aspects including source of ancient medical records, comprehensive of treatment details, and the inheritance. The qualification of famous doctors, content integrity, and inheritance of experiences will be used to evaluate the evidence from famous doctors' experience. The multi-sourced evidence such as TCM classical literature, experience of modern famous doctors, and modern researches is mainly integrated in a qualitative way, and the overall level of evidence of TCM interventions will be graded consistently with the GRADE system based on modern research. The evidence from classical literature and modern famous doctors' experience will be assessed and considered as supplementary evidence, which will make the evaluation of clinical evidence more objectively and comprehensively, thereby guiding clinical practice further.