中医临床实践指南联合真实世界研究模式的方法学思考

Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study

摘要:

中医临床实践指南存在临床实际应用较少，实施效果不明确等问题，可能与缺少符合临床实践需要的证据有关。为给临床实践提供可靠、精准的证据，该文提出中医指南联合真实世界研究的模式，具体包括4个研究步骤：第一，在指南实施阶段，需同步建立一个高质量的研究型数据库；第二，基于该库，对指南推荐意见进行多维度评价，包括对指南的应用性、有效性、安全性、经济性等方面进行全面评估，以确定其在实际应用中的效果；第三，基于数据库明确核心处方，并精准定位获益人群及用药方案，即通过对大量临床数据的分析，探索不同用药频率、不同剂量、不同用药时间对疗效的影响，以得到最佳的治疗方案；第四，使用真实世界证据指导指南的更新。基于这一研究模式，可以为古方、验方提供真实世界证据，提高其在临床实践中的应用。同时，这一模式也可以降低研究成本，提高研究效率。在应用这一模式时，需要重视真实世界研究证据的质量，确保其能够真实反映临床实践中的情况。此外，还需要重视指南推荐措施的临床应用，确保医生能够根据指南进行规范化的诊疗。最后，需要重视多学科专家的全流程参与，以确保研究的全面性和科学性。综上，该模式的应用将有助于形成更加符合临床实践需要的中医指南，达到促进中医临床诊疗均质化发展的最终目的。

Abstract:

The clinical practice guidelines of traditional Chinese medicine （TCM） have problems such as limited clinical application and unclear implementation effects， which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice， this article proposes a model of combining TCM guidelines with real-world study， which includes 4 steps. Firstly， during the implementation process of the guidelines， a high-quality research database is established. Secondly， the recommendations in the guidelines are evaluated based on the established database in multiple dimensions， including applicability， effectiveness， safety， and cost-effectiveness， and thus their effectiveness in practical applications can be determined. Thirdly， based on the established database， core prescriptions are identified， and the targeted populations and medication plans are determined. That is， the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies， dosages， and duration on efficacy. Fourthly， the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions， improving their application in clinical practice. Moreover， this model can reduce research costs and improve research efficiency. When applying this model， researchers need to pay attention to the quality of real-world evidence， ensuring that it can truly reflect the situation in clinical practice. In addition， importance should be attached to the clinical application of guideline recommendations， ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally， full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion， the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.