病证结合体系下中医临床循证评价的思考与实践

Thinking and Practice of Clinical Evidence-based Evaluation in TCM with Disease-syndrome Diagnostic System

摘要:

近年来，用循证医学的思维和方法来评价中医药临床疗效有成就也有质疑。其主要原因是中医药与现代医学在学科特点和临床思维上存在一定差异。为了更好地开展适应于中医药临床研究的循证评价，该文首先对于中医临床循证评价所面临的中医诊断、临床干预、疗效评价方法等方面困境进行分析。结合中医临床评价现状与团队长期临床科研实践积累，该研究认为从根源上确立和梳理中医病证结合体系，是实现中医临床循证的首要因素。该文进一步对于病证结合体系的具体内涵、发展演变及当下所面临问题进行探讨，特别是对于病证结合体系选择中医病名还是现代医学病名诊断的问题进行探讨。进而从“中医病名+证型诊断”和“西医病名+证型诊断”两方面分别阐述临床适用场景，并就临床评价中疾病、证候诊断规范化，临床评价与循证方法选择等实际问题提出相应解决方案。文章指出病证结合诊断标准的确立有助于后续临床干预的确定、临床研究方法的选择及评价指标的确立，对高质量临床证据的产生具有重要意义。综上所述，该文通过梳理病证结合体系发展与现状，探索性提出中医病证结合体系规范化建设及临床循证评价应用路径，以期更好地融合中医传统与现代临床，实现中医药循证的标准化和客观真实评价，以促进中医药与循证医学更好地融合。

Abstract:

In recent years， there have been both achievements and criticisms in using the methods of evidence-based medicine to evaluate the efficacy of traditional Chinese medicine （TCM）， which is mainly due to the differences between TCM and Western medicine. To facilitate the clinical evidence-based evaluation in TCM， this paper analyzes the challenges faced in TCM clinical evaluation， particularly in the diagnosis， clinical intervention， and efficacy assessment methods. Considering the current state of TCM clinical evaluation and our clinical research experience， we believe that establishing and refining the TCM disease-syndrome diagnostic system is a prerequisite for the practice of clinical evidence-based evaluation in TCM. Furthermore， this paper discusses the specific connotation， development， and challenges of the disease-syndrome diagnostic system， especially the choice of TCM disease name or modern medical disease name in this system. Then， the clinical application scenarios are expounded from ''TCM disease name + syndrome differentiation'' and ''Western medicine disease name + syndrome differentiation''. Moreover， this paper proposed solutions for practical issues such as the standardization of disease and syndrome diagnosis， selection of clinical evaluation methods， and application of evidence-based approaches in clinical evaluation. Establishing the criteria for the disease-syndrome diagnostic system is crucial for the determination of clinical intervention regimen， the selection of clinical research methods， and the establishment of evaluation indicators， which are essential for generating high-quality clinical evidence. To sum up， this paper reviews the development and current situation of the disease-syndrome diagnostic system and proposes an exploratory approach for the standardization and application of this system in clinical evidence-based evaluation. This approach aims to facilitate the integration of TCM with modern clinical practice， thereby achieving standardized evaluation of TCM efficacy and deepening the integration of TCM with evidence-based medicine.