混合方法研究制定中医药临床实践指南及实例解读

中医药临床实践指南的制定是实现中医药标准化的重要工作内容。中医药指南对临床的指导意义极大，但目前仍存在临床实际使用情况不佳的现状，这可能与指南的内容有关。由于高质量的中医药临床研究数量较少，以循证医学证据，即定量研究结果为主导的指南，在指南推荐干预措施的确定上存在一定的局限性。而混合方法研究重视实用主义，其将定量研究与定性研究的结果相结合，在中医药指南的制定中存在一定优势。本文初步探讨混合方法研究在指南制定过程中的思路及作用，并以《中医药治疗流感临床实践指南》为例，探讨以定量研究为主导制定指南时遇到的问题及混合方法研究在指南制定中的具体应用。结果发现，混合方法研究可以弥补单纯依赖定量研究或定性研究结果的不足，有可能成为未来指南制定的主要方法之一，但仍存在一定的局限性，需进一步研究。

Development of Traditional Chinese Medicine Clinical Practice Guidelines Using Mixed Methods and Example Interpretation

The development of Traditional Chinese Medicine（TCM）clinical practice guidelines is a key measure to achieve the standardization of TCM. The TCM guidelines greatly contribute to the guidance of clinical practice，but the phenomenon of inadequate use of them exists，which may be related to the contents of the guidelines. As there is a small number of high-quality TCM clinical studies，guidelines developed based on evidence-based medical data derived from them，namely，guidelines mainly based on quantitative research results，have showed limitations in their recommendations. In contrast，the evidence（quantitative and qualitative research results）from mixed methods studies may be more practical，which may better benefit the development of TCM guidelines. This paper preliminarily discussed the idea and function of mixed method research in the process of guidelines formulation，and took the Clinical practice guide in the treatment of influenza by TCM as an example. This paper discussed the problems encountered in the guideline formulation led by quantitative research and the specific application of mixed method research in the guideline formulation. It was found that mixed method research can make up for the lack of relying solely on quantitative or qualitative research results，and may become one of the main methods for future guideline formulation，but there are still certain limitations and further research is needed.