单病例随机对照试验在中医药临床疗效评价中的应用与思考

Application and reflection of single-case randomized controlled trial in efficacy evaluation of traditional Chinese medicine

目的对比单病例随机对照试验(N-of-1)、随机对照试验(RCT)、真实世界研究(RWS) 3种临床研究方法在中医药领域的优劣,并寻找出更适用于中医药临床疗效评价的研究方法。方法查阅国内外相关文献和最新版指南,对3种研究方法进行比较。结果中医学临床研究强调个体化,N-of-1能够科学合理地与中医自身规律有机结合,核心思想与中医临床诊疗模式相同。结论通过N-of-1是对中医诊疗个案研究的科学提炼与完善,通过对所得数据的系统评价,不仅能够获得对中医诊疗的疗效、治则等的科学评价,更能够为中医个体化诊疗提供有效的验证方式,在中医药临床研究中有极好的应用前景。

Objective To explore suitable clinical research methods for traditional Chinese medicine by comparing the advantages and disadvantages of the three clinical methods in traditional Chinese medicine,including single-case randomized controlled trial（ n-of-1）,randomized controlled trial（ RCT）,and real world study（ RWS）. Methods Relevant literature including latest guideline at home and abroad were searched to compare and contrast for analysis. Results Traditional Chinese medicine is featured by individualized treatment. N-of-1 trial seems to align with scientific and TCM rationale in clinical diagnosis and treatment. Conclusion N-of-1 trial is a scientifically refined case study in TCM. Systematic evaluation of data obtained could facilitate scientific evaluation of efficacy and validation of individualized treatment. Its application has great prospective in TCM clinical studies.