基于真实世界中医电子病历数据的原发性肝癌疗效评价难点及解决策略

Difficulties and Solutions for Evaluating the Efficacy of Primary Liver Cancer Based on Real-World Traditional Chinese Medicine Electronic Medical Record Data

中医临床治疗原发性肝癌具有独特优势,但目前在临床疗效研究中未得到充分体现,故亟需更适用于中医药临床疗效评价的方法。近年来,基于临床数据的真实世界研究受到了业内人士的广泛重视。通过借助中医临床电子病历数据开展的原发性肝癌的真实世界研究,针对中医临床疗效评价中遇到的核心问题,如研究设计中样本量估算、原发性肝癌中医治疗如何界定中药复杂干预的标准、原发性肝癌结局指标的选取及生存时间起点时间的界定、提高研究实践过程中数据采集与录入质量、后期随访阶段数据的丢失以及数据统计分析对混杂因素的控制方法的选取等问题进行了分析,并提出相应的解决方法,可为开展真实世界的中医临床疗效评价研究提供借鉴。

Traditional Chinese medicine( TCM) has its unique advantages in the treatment of primary liver cancer.However,its clinical treatment effect on primary liver cancer has not been fully reflected,and method more suitable for evaluating Chinese medicine therapeutic effect is needed. In recent years,real-world study based on clinical data has received extensive attention. Based on the clinical electronic medical record of TCM,our research team carried out real-world research on primary liver cancer,and the key problems encountered in the evaluation of clinical efficacy of TCM,such as sample size estimation in research design,how to define the standard of complex intervention of TCM treatment,the selection of the outcome of primary liver cancer and the definition of the starting time of survival time,how to improve the data collection and data input quality during the research,the loss of data in the later follow-up period and the selection of the statistical analysis of the confounding factors. This paper analyzed the above issues and proposed corresponding solutions,to provide reference for the development of TCM clinical efficacy evaluation research based on real-world study.