新时代中医药临床疗效评价的问题与策略  

Problems and strategies of clinical efficacy evaluation of Traditional Chinese Medicine in the new era

作　　者：张晶晶 刘岩 商洪才[1,3] Jingjing Zhang;Yan Liu;Hongcai Shang(Ministry of Education and Beijing Key Laboratory of Internal Medicine of Chinese Medicine,Dongzhimen Hospital,Beijing University of Chinese Medicine;The First Clinical Medical College of Beijing University of Chinese Medicine;College of Integrated Chinese and Western Medicine,Hunan University of Chinese Medicine)

机构地区：[1]北京中医药大学东直门医院中医内科学教育部重点实验室中医内科学北京市重点实验室,北京100700 [2]北京中医药大学第一临床医学院,北京100029 [3]湖南中医药大学中西医结合学院,长沙410208

出　　处：《科学通报》2022年第9期814-821,共8页Chinese Science Bulletin

基　　金：国家杰出青年科学基金(81725024)资助。

摘　　要：中医药在新型冠状病毒肺炎的防治中发挥了巨大作用,但缺少高质量研究证据,极大限制了中医药的推广及国际化.本文从循证医学理念出发,梳理疫情期间中医药临床研究的不足,探讨新时代应对新发突发疾病中医药临床研究的策略,为中医药临床疗效评价提供新思路.Traditional Chinese medicine(TCM)has been widely used to prevent and treat Coronavirus Disease 2019(COVID-19).In the absence of any miracle drug or vaccine,TCM was applied to all stages of the COVID-19 prevention and treatment for the first time and played a significant role.In addition to the first-line clinical treatment for the COVID-19,TCM scholars have also carried out various types of clinical research to evaluate the efficacy and safety of TCM.However,the lack of high-quality research evidence has led to TCM not being included in the list of treatment options recommended by the World Health Organization(WHO),which makes it difficult to provide references for TCM treatment protocols for the prevention and treatment of the COVID-19 for other countries,which significantly limits its promotion and internationalization.Evidence-based medicine has been operative in the TCM research field for more than 20 years.How best to combine the methods of evidence-based medicine with the characteristics and advantages of TCM so that the effect of TCM can be“clarified and understood”has always been a big challenge.The emergence of COVID-19 has highlighted the importance of this issue.Based on the concept of evidence-based medicine,this paper has elicited the shortcomings of TCM clinical research and efficacy evaluation during the COVID-19,such as design flaws,replicated research,insufficient professional involvement and lack of information sharing.It discusses the strategies of TCM clinical research on new emergent diseases in the new era from the aspects of research design and implementation.It is worth emphasizing that in future research,we should pay attention to the individualized efficacy evaluation of TCM,introduce the design concept of the master protocol platform,strengthen the overall planning of clinical research resources,retain the involvement of professionals,and establish a data-sharing mechanism.It is necessary to promote the integration of evidence-based norms and TCM differentiation and treatment,provid

关 键 词：突发疾病 中医药临床研究 中医药临床疗效评价 循证医学理念 新型冠状病毒 问题与策略 研究证据 国际化 

分 类 号：R288[医药卫生—中药学]