探讨中药人用经验的临床数据类型和统计分析方法

Types of clinical data and statistical methodology of human use experience in traditional Chinese medicine

人用经验是中医药临床实践的总结,也是中药新药研发中评价中药安全性、有效性和临床价值的重要数据来源。收集和总结中药人用经验数据,应用相关统计分析,形成可用于评价的证据是中药人用经验研究关键一环。该文尝试归纳并探讨目前中药人用经验的临床数据特点和统计分析方法,对数据类型、结局评价、偏倚评估、混杂因素及缺失值的处理逐一进行总结。该文强调中药人用经验的数据分析对于中医药证据形成的重要性,同时提出了目前的难点,如数据质量不高,内部差异性大;缺少个体化数据处理方法;缺少“病证结合”中医特色数据的方法等。相信随着相关方法的规范化和科学化,中药人用经验数据能为中药新药的研发提供有力的证据。

Application experience in humans,a summary of the clinical practice of traditional Chinese medicine(TCM),serves as an important data source for evaluating the safety,effectiveness,and clinical value of drugs in the development of new Chinese medicine.The collected data serving as the evaluation evidence through statistical analysis are critical to the research on the application experience in humans.This article summarized and analyzed the data characteristics and statistical methodology of application experience of Chinese medicine in humans,and concluded the data types,outcome evaluation,bias evaluation,confounding factors,and missing values.Furthermore,the article emphasized the importance of data analysis of application experience of Chinese medicine in humans for TCM evidence and put forward the current difficulties,such as low data quality and large internal bias,lack of individualized data processing methods,and lack of methods for"disease-syndrome combination"data.We believe that with the development of methodology,the application experience of Chinese medicine in humans can strongly support the development of new drugs in TCM.