叙事医学理念下中西医患共建临床试验方案设计探讨

Discussion on design of clinical trial scheme for doctor-patient co-construction of traditional Chinese medicine and Western medicine under concept of narrative medicine

随着现代医疗技术水平的不断提高,医疗实践活动变得越来越程序化,医疗过程往往以医生为主导,患者的价值取向常被忽视,医患之间缺乏有效交流,针对这一现象,丽塔·卡蓉(Charon R)提出了叙事医学的概念,并受到各界认可。近年来,医学人文主义价值受到重视,国内外有关叙事医学的研究逐渐增多,但目前有关叙事医学研究多在理论方面,缺乏叙事医学在临床方面的研究,如何使叙事医学的研究在真实世界中得以应用,是当前研究的一个重点。该文遵循叙事医学的理念,以医患共建平行病历评价中西医治疗消化疾病的临床真实疗效的研究为例,梳理叙事医学下中西医医患共建临床试验方案设计内容及要点,探讨叙事医学下医患共建的活动形式以及临床疗效评价方法。临床试验方案设计包括医学、伦理、统计、试验管理4个方面的内容,该研究从理论和实践两方面探讨叙事医学下医患共建临床试验方案设计,为未来医患共建的方案设计及研究提供借鉴,并期望建立更好的中西医医患共建临床疗效评价方法。

With the continuous improvement of modern medical technology,medical practice has become more and more procedural.The medical process is often dominated by doctors,while the value orientation of patients is often ignored,lacking effective communication between doctors and patients.In response to this phenomenon,Charon R proposed the concept of narrative medicine,which has been recognized by all walks of life.In recent years,the value of medical humanism has attracted more attention,and the research on narrative medicine at home and abroad is increasing gradually.But at present,most of the research on narrative medicine is in terms of theory,lacking clinical research.How to make narrative medicine applied in the real world is the focus of current research.Following the concept of narrative medicine,and taking the study on doctor-patient parallel medical record to evaluate the real clinical efficacy of traditional Chinese medicine(TCM)and Western medicine(WM)in the treatment of digestive diseases as an example,this study is to explore the design contents and key points of the clinical trial scheme of doctor-patient co-construction of TCM and WM under narrative medicine,and discuss the activity form and clinical efficacy evaluation method under narrative medicine.Clinical trial design includes four aspects:medicine,ethics,statistics and trial management.This study explored the design of the doctor-patient co-construction clinical trial scheme under narrative medicine from both theoretical and practical aspects,providing reference for the design and research of future doctor-patient co-construction scheme,and expecting to establish a better efficacy evaluation method of TCM and WM.