Clinical research report on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions(2022)  

作　　者：Danlei Wang Menglong Shi Haiyin Hu Yucong Ma Dehui Peng Junhua Zhang Alice Josephine Fauci Zhaochen Ji 

机构地区：[1]Tianjin University of Traditional Chinese Medicine,Tianjin,China [2]Haihe Modern Traditional Chinese Medicine Laboratory,Tianjin,China [3]Joint Sino-Italian Laboratory of Traditional Chinese Medicine,Italian National Institute of Health,Rome,Italy

出　　处：《Acupuncture and Herbal Medicine》2024年第3期306-319,共14页针灸和草药（英文）

基　　金：funded by Tianjin Science and Technology Bureau-Outstanding youth program-Methodological research on Intelligent Transformation of evicence in Traditional Chinese medicine(20JCJQJC00120);Traditional Chinese Medicine Innovation Team and Talent Support Program National Traditional Chinese Medicine Multidisciplinary Interdisciplinary Innovation Team Project(ZYYCXTD-D-202204).

摘　　要：Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;“traditional Chinese patent medicines+Western medicine vs.Western medicine”was the most widely used intervention and control setting,involving 417 RCTs(28.48%).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions.“Decoction+conventional treatment vs.conventional treatment”was the most widely used intervention and control setting,with 87 RCTs(35.51%).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most“allocation concealment”and“blinding of patients and personnel”were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent

关 键 词：Chinese patent medicine Evidence-based medicine Randomized controlled trials Traditional Chinese classic famous prescriptions 

分 类 号：R285[医药卫生—中药学]