基于项目反应理论和混合值差度量的中医个体化诊疗疗效评价方法研究

Treatment based on syndrome differentiation and the overall concept are the features of individualized diagnosis and treatment of traditional Chinese medicine, this study found early that it cannot reflect the overall concept of traditional Chinese medicine by single or several indexes to efficacy evaluation.This research aims to conduct comprehensive calculation on the curative effect of every diagnosis and treatment and to take the clinical case of gastro-esophageal refluxas the example, that is, to adopt the multidimensional scaling to compare the data (symptoms, signs, detection indexes, and drugs) of the completely recorded case histories before and after the treatment, among which the process of qualitative data has adopted the method of hybrid value difference metric; to adopt the Item Response Theory to analyze the case history records after the treatment so as to analyze the potential therapeutic effect and security information, and to adopt the commonly used clinical comment methods on the curative effect for comparison, which is to extract and normalize the diagnosis information and screen out the curative effect evaluation indexes of greater significance. ROC curve is to be taken to test the curative effect comment efficiencies of the two methods. .This study is a cross junction research of information science and clinical curative effect evaluation. Using mathematical method makes the overall efficacy of individualized diagnosis and treatment of traditional Chinese medicine can be calculated, which is the basis of medical record recommend sorting and has a broad application prospect in the future for the medical record number and contains information keep increasing.

辨证论治和整体观念是中医个体化诊疗的特色，本研究前期发现采用单项或几项指标进行疗效评价难以体现中医整体观念。拟对包括全部指标以及更多因素的中医个体化诊疗全记录数据（症状、体征、检测指标、年龄、性别、药物等）进行模糊综合，实现对每一次诊疗的疗效进行整体的定量计算。拟以胃食管反流病为例，收集前瞻性临床试验病案200例，采集至少3次诊疗的全记录信息；采用混合值差度量的方法对治疗前后的病案全记录数据进行比较，定性数据进行值差度量，计量数据直接计算欧氏距离；采用项目反应理论分析治疗后的病案记录，分析潜在的疗效和安全性信息；设计数据实验，采用ROC曲线和敏感度、特异度指标验证疗效评价效能。.本研究为中医临床疗效评价与信息科学交叉处的研究，采用数学方法使中医的整体疗效变得可计算，能让医生病人更清楚地掌握临床整体疗效，也是病案推荐及有效方药筛选的基础，在病案数量及可用指标不断增加的未来有广阔的应用前景。

辨证论治和整体观念是中医个体化诊疗的特色，本研究对包括全部指标以及更多因素的中医个体化诊疗全记录数据（症状、体征、检测指标、年龄、性别、药物等）进行模糊综合，实现对每一次诊疗的疗效进行整体的定量计算。以胃食管反流病为例，收集前瞻性临床试验病案、临床电子病历以及期刊文献医案；采用混合值差度量的方法对治疗前后的病案全记录数据进行比较，定性数据进行值差度量，计量数据直接计算欧氏距离；采用项目反应理论分析治疗后的病案记录，分析潜在的疗效和安全性信息；设计数据实验，采用ROC曲线和敏感度、特异度指标验证疗效评价效能。.本研究为中医临床疗效评价与信息科学交叉处的研究，采用数学方法使中医的整体疗效变得可计算，能让医生病人清楚地掌握临床整体疗效，是进行病案推荐及有效方药筛选的基础，目前本研究病案信息处理、规范、分析等成果已在“古今医案云平台”“中医药健康管理云平台”等网络平台得到转化和应用。研究发表核心期刊论文2篇，获得专利1项，获得科技奖励1项，在国内学术会议中做分组报告1次。课题组2名研究生均已毕业。项目投入直接经费18万元，已支出10.15万元，结余7.85万元。结余经费拟用于本项目后期论文发表及拓展研究等。