目标值法在名老中医经验传承临床研究中的方法学价值和设计要点

Methodological Value and Design Key Points of Target Value Method in Clinical Research of Experience Inheritance of Famous and Experienced Traditional Chinese Medicine Doctors

名老中医经验是传统医学的重要载体,由于患者寻求名老中医诊治的主观意愿较为强烈,故而研究结果多以病例系列或病例报告的形式报道和推广。目标值法可作为随机对照试验或非随机的同期对照设计无法使用时的替代方法之一,但目标值的选择及与名老中医经验传承相结合的方法学设计还存在一定困难。基于名老中医经验传承临床研究现有研究方法及其面临的挑战,结合名老中医经验传承的实际情况,详细分析目标值法中病种、结局指标、目标值的选择、样本量计算及统计方法的使用等多个环节在名老中医经验传承研究中的应用,以期为解决名老中医经验传承研究中存在的严格的方法学设计要求与真实世界中诸多实际困难二者之间的矛盾提供新的思路,同时合理节约研究投入,减少伦理问题。

The experience of famous experienced traditional Chinese medicine(TCM)doctors is an important carrier of traditional medicine.Because patients7 subjective willingness to seek treatment of famous experienced TCM doctors is relatively strong,the research results are mostly reported and promoted in the form of case series or case reports.The target value method can be used as one of the alternatives when randomized controlled trials or nonrandomized concurrent control designs are not available.However,there are still some difficulties in the selection of target values and the methodologies design that combine with the experience inheritance of famous and experienced TCM doctors.Based on the existing research methods and challenges of clinical research on experience inheritance of famous and experienced TCM doctors,combined with the actual situation of experience inheritance of famous and experienced TCM doctors,the application of disease type,outcome index,target value selection,sample size calculation and statistics in the target value method and other links in the study of experience inheritance of famous and expe・rienced TCM doctors were analyzed in detail,in order to provide new ideas to solve the contradiction between the strict methodological design requirements and many practical difficulties in the real world,and rationally save research investment and reduce ethical issues.