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.
2.Clinical Characteristics and Potential Risk Factors Analysis of Liver Injury Related to Epimedii Folium Preparation
Yongkang ZHAO ; Yuyang LIU ; Wei SHI ; Han GAO ; Zheng LI ; Zhaofang BAI ; Haibo SONG ; Yuan GAO ; Jiabo WANG ; Xiaohe XIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(6):205-210
ObjectiveThis paper aims to analyze the clinical characteristics and medication rationality of liver injury related to Epimedii Folium preparation (EP) and explore the possible risk factors of liver injury, so as to provide a reference for the safe clinical application of Epimedii Folium (EF). MethodA retrospective analysis was conducted on liver injury cases related to EP from 2012 to 2016. ResultThe number of reported liver injury cases and the proportion of severe cases related to the use of EP show an increasing trend, indicating the objective existence of liver injury caused by EP. There are more cases of liver injury related to EP in women than in men, with an onset age range of 15-91 years old and a median onset age of 60 years old (median onset ages for men and women are 59 and 60 years old, respectively). The time span from taking EP alone to the occurrence of liver injury is 1-386 days, with a median of 38 days. The time span from taking both EP and Western medicine to the occurrence of liver injury is 1-794 days, with a median of 34 days. EF-related liver injury preparations are mostly composed of traditional Chinese medicines that promote immunity and tonify the liver and kidney, indicating that immune stress in the body may be the mechanism of liver injury caused by the use of EP alone or in combination. There is no increasing trend of toxicity with time or dose in the liver injury caused by EP. By further exploring its risk factors, it is found that patients have unreasonable medication methods such as excessive dosage, repeated use, and multi-drug combination, which may also be one of the important risk factors for EF-related liver injury. ConclusionEP has a certain risk of liver injury and should be emphasized in clinical diagnosis and treatment. Immune stress may be the mechanism of liver injury caused by EP, and in clinical use, it is necessary to be vigilant about the risk of liver injury caused by unreasonable use and combined use with Western medicine.
3.Blood indexes of middle-aged and elderly persons with deep vein thrombosis of a lower extremity after a cerebral hemorrhage
Jingsong MU ; Chaomin NI ; Ming WU ; Wenxiang FAN ; Zheng LIU ; Lei LIU ; Xiaohe DONG
Chinese Journal of Physical Medicine and Rehabilitation 2022;44(9):784-787
Objective:To document the blood indexes of middle-aged and elderly intracerebral hemorrhage (ICH) patients complicated with deep vein thrombosis (DVT).Methods:A retrospective analysis was conducted of 77 hospitalized ICH patients using venous color Doppler ultrasonography within 3 days of admission. According to the results, they were divided into a DVT group (18 cases) and a non-DVT group (59 cases). The blood routine, biochemistry, coagulation, and D-dimer examinations were conducted on the 2nd day after admission. T-tests and rank sum tests tested the significance of any differences between the groups in average white blood cell counts, neutrophil percentages, platelets, albumin, globulin, fasting blood glucose, urea nitrogen, creatinine, uric acid, electrolytes, fibrinogen or D-dimer.Results:The average levels of albumin, uric acid and calcium in the DVT group were significantly lower than in the non-DVT group. The average levels of fasting blood glucose and D-dimer were significantly higher.Conclusions:Decreased serum uric acid, calcium and albumin levels, together with increased fasting blood glucose and D-dimer are related to the occurrence of DVT in ICH patients. To reduce the risk of DVT it is important to maintain normal levels of serum uric acid, calcium and albumin and to limit D-dimer and fasting blood glucose.
4.Emerging biotechnology applications in natural product and synthetic pharmaceutical analyses.
Shilin CHEN ; Zheng LI ; Sanyin ZHANG ; Yuxin ZHOU ; Xiaohe XIAO ; Pengdi CUI ; Binjie XU ; Qinghe ZHAO ; Shasha KONG ; Yuntao DAI
Acta Pharmaceutica Sinica B 2022;12(11):4075-4097
Pharmaceutical analysis is a discipline based on chemical, physical, biological, and information technologies. At present, biotechnological analysis is a short branch in pharmaceutical analysis; however, bioanalysis is the basis and an important part of medicine. Biotechnological approaches can provide information on biological activity and even clinical efficacy and safety, which are important characteristics of drug quality. Because of their advantages in reflecting the overall biological effects or functions of drugs and providing visual and intuitive results, some biotechnological analysis methods have been gradually applied to pharmaceutical analysis from raw material to manufacturing and final product analysis, including DNA super-barcoding, DNA-based rapid detection, multiplex ligation-dependent probe amplification, hyperspectral imaging combined with artificial intelligence, 3D biologically printed organoids, omics-based artificial intelligence, microfluidic chips, organ-on-a-chip, signal transduction pathway-related reporter gene assays, and the zebrafish thrombosis model. The applications of these emerging biotechniques in pharmaceutical analysis have been discussed in this review.
5.Isolation, structural identification of secondary metabolites from Pseudomonas aeruginosa HBD-12 with antibacterial and antitumor activities.
Xiaohe LI ; Jian LI ; Wen HOU ; Shen ZHENG ; Xiangdong ZHU
Chinese Journal of Biotechnology 2020;36(11):2451-2458
To screen strains with antibacterial and antitumor activity, pregnenolone was used as the sole carbon source for screening bacteria from soil. Based on bacteriostatic activity assay, Pseudomonas aeruginosa HBD-12 was found to be effectively inhibiting the growth of Escherichia coli, Bacillus thuringiensis, Penicillium digitatum and Penicillium italicum, and its fermentation broth was separated and purified using column chromatography. Then, structure of the obtained monomeric compounds was analyzed by spectrum analysis, and their antitumor activity was measured using HTRF kinase detection kit. The isolated monomeric compounds 1-hydroxy-9,10-phenanthroline and 3-hydroxy-9,10-dihydrophenanthroline had significant antitumor activity. At 20 μg/mL, 1-hydroxy-9,10-phenanthroline and 3-hydroxy-9,10-dihydrophenanthroline inhibited 78.39±2.29% and 60.34±8.35% Aurora kinase A, respectively. Therefore, the secondary metabolites of Pseudomonas aeruginosa HBD-12 have the potential to develop antibacterial and antitumor drugs.
Anti-Bacterial Agents/pharmacology*
;
Microbial Sensitivity Tests
;
Penicillium
;
Pseudomonas aeruginosa
6.Study on the participating farmers'interest demands for the payment system reform in China's new rural cooperative medical care scheme
Xingguang ZHONG ; Xiaohe WANG ; Kang ZHENG ; Wei YANG ; Yu LI ; Xianhong HUANG ; Meng ZHANG
Chinese Journal of Hospital Administration 2018;34(5):353-358
Objective To study the participating farmers'interest demands for NRCMs in order to provide basis for the payment system reform based on the demand side perspective. Methods A cross-sectional study was conducted from September 2016 to February 2017. Multi-stage stratified random sampling was conducted in six counties of three provinces in the eastern, middle and western regions of China. Mathematical statistics analysis was conducted to clarify the interest demands and influencing factors of the participating farmers. Results The interests claims of the 1 452 participating farmers were to improve service quality, to reduce the economic burden of disease, and to standardize the management. The medians found were 4.00, 4.00 and 3.63 respectively. Relative to the flat rate, the DRGs raised higher requirements for standardized medical behaviors offered by the medical workers. Furthermore, it called for effective medical quality supervision, rigorous control of medical costs and highly scientific and standardized management. The differences were statistically significant ( P <0.05 ). Conclusions The diversity of participating farmers'interest demands deserves due attention, the payment methods combination should fit local needs, the interests demands expression channel of the participants should be expanded, and the demand side deserves a due role in supervision of the funds.
7.Comprehensive evaluation of patient satisfaction based on bounded rationality theory
Jie CHEN ; Yu QIAN ; Xiaohe WANG ; Xiaofei DONG ; Xianhong HUANG ; Hui WANG ; Guoguan ZHENG ; Lina ZHU
Chinese Journal of Hospital Administration 2018;34(9):743-748
Objective To further improve the comprehensive evaluation program of patient satisfaction in view of the defective item screening and weight design short of considerations for patients'psychological expectation and rational judgment, based on the theory of bounded rationality. Methods A satisfaction measurement scale was compiled and used to survey 847 inpatients in July-August 2017. The internal consistency test, correlation and factor analysis were used to evaluate the reliability and validity of the scale. The combination weight PWi was calculated based on patients' importance of the five satisfaction dimensions and the scoring of certainty degree of their responses. The combination weight EWi was calculated based on the five-dimension importance and operability scoring of expert consultation. The indicator combination weight OWi was determined using the integrated factors scoring, TOPSIS, weight rank-sun ratio, gray correlation method, and synthetic index method were used in a general assessment of patient satisfaction of a hospital in question. Results The Cronbach α coefficient of the patient satisfaction rating scale was 0.939, and the half-reliability coefficient was 0.951. The cumulative contribution rate of the five common factors variance extracted from the factor analysis was 71. 4%. The rational weights of five dimensions of service environment, service efficiency, service attitude, service technology, and service costs were 0.220, 0.214, 0.217, 0.179, and 0.171 respectively, while the comprehensive weights of the five dimensions were 0.115, 0.233, 0.196, 0.264, and 0.192 respectively. The comprehensive evaluation results of the two correlation coefficients were greater than 0.95. Conclusions The patient satisfaction measurement scale developed based on the theory of bounded rationality can expand the index connotation and items of core elements such as service technology and cost. The design of index weights fits with the concern of medical service factors and the degree of rational judgment in the patient's medical treatment process. The evaluation results are basically consistent with the actual situation and can be used as a reference tool for the scientific rational evaluation of patient satisfaction.
8.Phenotypic and genotypic analysis of a fetus carrying an intermediate 22q11.2 deletion encompassing the CRKL gene.
Shaobin LIN ; Xiaohe ZHENG ; Heng GU ; Mingzhen LI
Chinese Journal of Medical Genetics 2017;34(3):393-397
OBJECTIVETo delineate the phenotypic characteristics of 22q11.2 deletion syndrome and the role of CRKL gene in the pathogenesis of cardiac abnormalities.
METHODSG-banded karyotyping, single nucleotide polymorphism (SNP) array and fluorescence in situ hybridization (FISH) were performed on a fetus with tetralogy of Fallot detected by ultrasound. Correlation between the genotype and phenotype was explored after precise mapping of the breakpoints on chromosome 22q11.2. SNP array was also performed on peripheral blood samples from both parents to clarify its origin.
RESULTSThe fetus showed a normal karyotype of 46,XY. SNP array performed on fetal blood sample revealed a 749 kb deletion (chr22: 20 716 876-21 465 659) at 22q11.21, which encompassed the CRKL gene but not TBX1, HIRA, COMT and MAPK1. Precise mapping of the breakpoints suggested that the deleted region has overlapped with that of central 22q11.2 deletion syndrome. SNP array analysis of the parental blood samples suggested that the 22q11.21 deletion has a de novo origin. The presence of 22q11.21 deletion in the fetus was also confirmed by FISH analysis.
CONCLUSIONCentral 22q11.21 deletion probably accounts for the cardiac abnormalities in the fetus, for which the CRKL gene should be considered as an important candidate.
Adaptor Proteins, Signal Transducing ; genetics ; Adult ; Chromosome Deletion ; Chromosomes, Human, Pair 22 ; genetics ; DiGeorge Syndrome ; diagnosis ; embryology ; genetics ; Female ; Fetal Diseases ; diagnosis ; genetics ; Genotype ; Humans ; In Situ Hybridization, Fluorescence ; Male ; Nuclear Proteins ; genetics ; Phenotype ; Pregnancy ; Prenatal Diagnosis
9.Study of the formation mechanism and governance logic of the service motivation for community doctors' first contact
Xiaohe WANG ; Wan FENG ; Yu QIAN ; Wenfeng FANG ; Guoguan ZHENG ; Hui WANG ; Peng LI
Chinese Journal of Health Policy 2017;10(4):57-64
The service capabilities and sustainable development of community doctors' first contact are undoubtedly the critical factors to promote the construction of grassroots clinics and tiered health care system.Based on the review of motivation-related concepts and its development, as well as the analysis of the current conditions of community first contact and characteristics of community doctors in China, this paper puts forward and defines the concept and connotation of service motivation for community doctors' first contact by logically summarizing the concept of force in physical sciences ,motivation in service science, Based on analyzing the extrinsic motivations to form community doctors' first contact such as attraction, support, constraint, and stress the intrinsic motivations produced by professional identity, self-efficacy and achievement,as well as the interactions and relationships between them, this paper contructs a formation mechanism of the service motivation for community doctors' first contact, which is visual and intuitive.This paper provides a logical path and basis for scientific governance and upgrade of the service motivation for community doctors's first contact to effectively promote community first contact system in China.
10.Reference value range of pulse oximetry plethysmographic waveform parameters in the normal adults
Chen LI ; Jun XU ; Fei HAN ; Xiaocui ZHANG ; Yangyang FU ; Liangliang ZHENG ; Daoyuan JING ; Ruifeng ZENG ; Xiaohe LIU ; Banghan DING ; Yingping TIAN ; Yanfen CHAI ; Zhongqiu LU ; Huadong ZHU ; Xuezhong YU
Chinese Journal of Emergency Medicine 2016;25(12):1294-1300
Objective To Pulse oximetry saturation has been wildly used clinically.It has been reported that pulse oximetry plethysmographic waveform (POP) reflected the peripheral tissue perfusion.In this study,we parameterized POP,observed the value of POP parameters in normal adults,and established the normal reference value range.Methods A multi-center prospective descriptive study.Total of 1 019 adult volunteers with normovolemia from 7 cities were enrolled in this study.Sex,age,height,weight and pulse oximetry data in awake and spontaneous breathing under in quiet conditions in the room temperature were collected.POP parameters and perfusion index were analyzed using MATLAB 2012a software.The normal reference value ranges of POP parameters,including the amplitude of POP (Amp) and the area under the curve of POP (AUC),were formulated.Results Statistical differences of POP parameters were detected between men and women in the normal adult.The 95% confidence reference value of POP parameters in normal population was as follows:Amp (104.8-2298.7) PVA and AUC (3265.8-6028.5) PVPGin total,Amp (129.4-2433.6) PVA and AUC (3319.0-5862.2) PVPG in male;Amp (89.5-2138.2) PVA and AUC (3163.9-5929.9) PVPG in female.Conclusions POP,including the amplitude of POP (Amp) and the area under the curve of POP (AUC),had normal reference value ranges in normal adults.


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