1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
3.Ultrasound and blood indicators in diagnosis of early cirrhosis for patients with chronic hepatitis B
Qing YANG ; Shibin DING ; Yingchun YAN ; Mingxiang ZHANG ; Danyang LIU
Chinese Journal of Clinical Infectious Diseases 2014;7(4):339-345
Objective To investigate the application of ultrasound and blood indicators in diagnosis of early liver cirrhosis (S4) for patients with chronic hepatitis B (CHB).Methods Data of blood and ultrasound examinations of 631 patients with CHB who received liver biopsy in the Sixth People' s Hospital of Shenyang during April 2002 and March 2011 were collected.Logistic regression analysis was performed to determine the factors independently correlated with early liver cirrhosis,and the diagnostic model was established using these indicators.The diagnostic value of the established model was assessed by using area under receiver operating characteristic curve (AUROC) and compared with FIB-4 index,aspartate aminotransferase (AST)/platelet (PLT) ratio index (APRI) and S index.Results Logistic regression analysis indicated that age,PLT,albumin globulin ratio (A/G) and splenic square area (SPS) in ultrasound findings were independently correlated to early liver cirrhosis (Wald =10056,46.236,3.751 and 10.669,P <0.01).AUROC of the model based on the above factors in diagnosing early liver cirrhosis was 0.908,which was higher than those of FIB-1 index,APRI index and S index (Z =8.322,4.334 and 4.087,P < 0.05).Taking 0.063 as cut-off value,the sensitivity,specificity,positive predict value and negative predict value of the established model in diagnosis of early liver cirrhosis were 90.1%,77.8%,50.0% and 97.1%,respectively.Taking <0.060 and ≥0.110 as the cut-off values to exclude,and diagnose early liver cirrhosis,69.7% (440/631) patients could avoid liver biopsy.Conclusion The model based on age,PLT,A/G and SPS can effectively predict early liver cirrhosis,and can reduce liver biopsy.


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