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.Analysis of whole-genome sequences of coxsackievirus A4 strains isolated in Jiangsu Province from 2015 to 2022
Huan FAN ; Changjun BAO ; Liguo ZHU ; Jianli HU ; Hong JI
Chinese Journal of Microbiology and Immunology 2024;44(3):249-258
Objective:To retrospectively analyze the molecular epidemiological features and genetic recombination of coxsackievirus A4 (CVA4) strains isolated in Jiangsu from 2015 to 2022.Methods:Throat or anal swab samples were collected from patients with herpangina or hand, foot and mouth disease (HFMD). Real-time PCR was used to detect CVA4. A comprehensive and systematic phylogenetic analysis was conducted based on 72 whole genomes and 99 VP1 sequences of CVA4 strains. Several bioinformatics software including DNAStar, MEGA7.0 and Similarity plots3.5.1 was used for analysis of homology, genetic recombination and amino acid variation sites.Results:Four genotypes (A, B, C and D) and five sub-genotypes (C1-C5) of CVA4 were identified based on the VP1 nucleotide sequences. C2 was the predominant sub-genotype causing HFMD. The Jiangsu strains showed high homology with the CVA4 prototype in the P1 region, and higher identity with other strains of enterovirus group A (EV-A) in the P2 and P3 regions. Genetic recombination analysis revealed that the Jiangsu strains had three genetic recombination patterns with other EV-A epidemic strains in the P2, P3 and 3′-UTR regions. These recombination patterns took place during the sustained and widespread circulation of CVA4 in people and increased the transmissibility of CVA4.Conclusions:This study analyzes the phylogenetic and molecular features of 28 whole genomes of Jiangsu CVA4 strains, which helps to better understand the genomic diversity of CVA4. By analyzing the genetic recombination and amino acid mutations in the VP1 region, this study elucidates the evolution and transmission of CVA4, which is conducive to the control and prevention of CVA4 infection.
3.Application of IgG antibody combination of wild strain and epidemic strain of COVID-19 in identifying epidemic Omicron BA.5 strain infection
Jinjin CHU ; Hua TIAN ; Chuchu LI ; Zhifeng LI ; Chen DONG ; Xiaoxiao KONG ; Jiefu PENG ; Ke XU ; Jianli HU ; Changjun BAO ; Liguo ZHU
Chinese Journal of Preventive Medicine 2024;58(9):1354-1359
Objective:To explore the application of COVID-19-specific IgG antibody in identifying epidemic Omicron BA.5 strain infection.Method:Omicron BF.7/BA.5 naturally infected population, healthy population vaccinated with the COVID-19 vaccine, and Omicron BF.7/BA.5 breakthrough cases were enrolled into this study. The serum WT-S-IgG and BA.5-S-IgG were detected by indirect ELISA, and the serum-specific IgG antibody levels of different populations were compared. The application value of the two antibody titers and the ratio of the two antibodies in identifying Omicron BA.5 epidemic strain infection were explored by the ROC curve, aiming to provide technical support for pathogen diagnosis.Results:The antibody titers of WT-S-IgG and BA.5-S-IgG in the breakthrough cases were higher than those in the naturally infected population and the healthy population ( P<0.05). The area under the curve (AUC) of WT-S-IgG and BA.5-S-IgG in identifying epidemic Omicron BA.5 strain infection was 0.947 and 0.961, respectively. The AUC of BA.5-S-IgG and WT-S-IgG antibody titer ratio was 0.873. When the antibody titer ratio was 0.855, the sensitivity and specificity were 80.00% and 90.00%, respectively. According to the interval since the last infection, the AUC of the ratio of BA.5-S-IgG to WT-S-IgG antibody titer to identify the infection of epidemic strains less than 30 days and more than 30 days was 0.887 and 0.863, respectively, and the sensitivity and specificity were both above 80%. Conclusion:Both BA.5-S-IgG and WT-S-IgG, as well as the combination of these two antibodies, are of high value in the identification of epidemic strains.
4.Application of IgG antibody combination of wild strain and epidemic strain of COVID-19 in identifying epidemic Omicron BA.5 strain infection
Jinjin CHU ; Hua TIAN ; Chuchu LI ; Zhifeng LI ; Chen DONG ; Xiaoxiao KONG ; Jiefu PENG ; Ke XU ; Jianli HU ; Changjun BAO ; Liguo ZHU
Chinese Journal of Preventive Medicine 2024;58(9):1354-1359
Objective:To explore the application of COVID-19-specific IgG antibody in identifying epidemic Omicron BA.5 strain infection.Method:Omicron BF.7/BA.5 naturally infected population, healthy population vaccinated with the COVID-19 vaccine, and Omicron BF.7/BA.5 breakthrough cases were enrolled into this study. The serum WT-S-IgG and BA.5-S-IgG were detected by indirect ELISA, and the serum-specific IgG antibody levels of different populations were compared. The application value of the two antibody titers and the ratio of the two antibodies in identifying Omicron BA.5 epidemic strain infection were explored by the ROC curve, aiming to provide technical support for pathogen diagnosis.Results:The antibody titers of WT-S-IgG and BA.5-S-IgG in the breakthrough cases were higher than those in the naturally infected population and the healthy population ( P<0.05). The area under the curve (AUC) of WT-S-IgG and BA.5-S-IgG in identifying epidemic Omicron BA.5 strain infection was 0.947 and 0.961, respectively. The AUC of BA.5-S-IgG and WT-S-IgG antibody titer ratio was 0.873. When the antibody titer ratio was 0.855, the sensitivity and specificity were 80.00% and 90.00%, respectively. According to the interval since the last infection, the AUC of the ratio of BA.5-S-IgG to WT-S-IgG antibody titer to identify the infection of epidemic strains less than 30 days and more than 30 days was 0.887 and 0.863, respectively, and the sensitivity and specificity were both above 80%. Conclusion:Both BA.5-S-IgG and WT-S-IgG, as well as the combination of these two antibodies, are of high value in the identification of epidemic strains.
5.Whole-genome sequence analysis of coxsackievirus A10 strains isolated in Jiangsu Province from 2015 to 2022
Huan FAN ; Changjun BAO ; Liguo ZHU ; Jianli HU ; Hong JI
Chinese Journal of Microbiology and Immunology 2023;43(12):945-954
Objective:To analyze the whole-genome sequences of coxsackievirus A10 (CVA10) strains isolated in Jiangsu Province from 2015 to 2022 and their molecular epidemiological characteristics.Methods:Forty-five CVA10 isolates circulating in Jiangsu Province during 2015 to 2022 were selected for whole-genome sequencing. Phylogenetic trees were constructed based on the whole genome, VP1, P1, P2 and P3 sequences of CVA10 strains. Bioinformatics software, including DNAStar, MEGA7.0 and Similarity plots3.5.1, was used for analysis of homology, genetic recombination and major amino acid variation sites.Results:The nucleotide and amino acid sequence homology of the whole-genome sequences of 45 CVA10 strains was 90.3%-99.1% and 97.9%-99.8%, respectively. The nucleotide sequence homology of P1 region was the highest (92.1%-100.0%), while the nucleotide sequence homology of P3 region ranged from 84.7% to 100.0%. In contrast to the diversity of nucleotide sequences, the amino acid sequences of each region were conserved. A phylogenetic analysis based on the complete VP1 sequences of CVA10 strains revealed eight genotypes: A-H. The CVA10 isolates in Jiangsu Province and other prevalent strains in China mainly belonged to genogroup C. Results of the phylogenetic analysis based on the whole-genome sequences and complete VP1 sequences were consistent. Phylogenetic analysis bases on different gene segments and Simplot recombination analysis revealed that Jiangsu isolates GD07/Lianyungang/2017 and N180/Suqian/2016 showed high homology with the CVA10 prototype in the P1 region, but had recombination sites with other strains of enterovirus group A in the P2, P3, 5′-UTR and 3′-UTR regions. Compared with the prototype strain AY421767/Kowalik/2004, the Jiangsu isolates showed frequent variations in the VP1 region and many other major amino acid sites, which might result in some imperceptible changes in capsid structure and potential receptor-binding sites.Conclusions:By analyzing the evolution and genetic recombination features of CVA10 strains at the genome level in Jiangsu Province, this study elucidated the influence of genetic recombination and amino acid site mutation on CVA10 infection, providing basic data for the prevention and control of hand-foot-mouth disease in Jiangsu Province.
6.Clinical characteristics of 272 437 patients with different histopathological subtypes of primary esophageal malignant tumors
Lidong WANG ; Liuyu LI ; Xin SONG ; Xueke ZHAO ; Fuyou ZHOU ; Ruihua XU ; Zhicai LIU ; Aili LI ; Jilin LI ; Xianzeng WANG ; Liguo ZHANG ; Fangheng ZHU ; Xuemin LI ; Weixing ZHAO ; Guizhou GUO ; Wenjun GAO ; Xiumin LI ; Lixin WAN ; Jianwei KU ; Quanxiao XU ; Fuguo ZHU ; Aifang JI ; Huixiang LI ; Jingli REN ; Shengli ZHOU ; Peinan CHEN ; Qide BAO ; Shegan GAO ; Haijun YANG ; Jinchang WEI ; Weimin MAO ; Zhanqiang HAN ; Zhiwei CHANG ; Yingfa ZHOU ; Xuena HAN ; Wenli HAN ; Lingling LEI ; Zongmin FAN ; Ran WANG ; Yuanze YANG ; Jiajia JI ; Yao CHEN ; Zhiqiang LI ; Jingfeng HU ; Lin SUN ; Yajie CHEN ; Helin BAI ; Duo YOU
Chinese Journal of Internal Medicine 2022;61(9):1023-1030
Objective:To characterize the histopathological subtypes and their clinicopathological parameters of gender and onset age by common, rare and sparse primary esophageal malignant tumors (PEMT).Methods:A total of 272 437 patients with PEMT were enrolled in this study, and all of the patients were received radical surgery. The clinicopathological information of the patients was obtained from the database established by the State Key Laboratory of Esophageal Cancer Prevention & Treatment from September 1973 to December 2020, which included the clinical treatment, pathological diagnosis and follow-up information of esophagus and gastric cardia cancers. All patients were diagnosed and classified by the criteria of esophageal tumor histopathological diagnosis and classification (2019) of the World Health Organization (WHO). The esophageal tumors, which were not included in the WHO classification, were analyzed separately according to the postoperative pathological diagnosis. The χ 2 test was performed by the SPSS 25.0 software on count data, and the test standard α=0.05. Results:A total of 32 histopathological types were identified in the enrolled PEMT patients, of which 10 subtypes were not included in the WHO classification. According to the frequency, PEMT were divided into common (esophageal squamous cell carcinoma, ESCC, accounting for 97.1%), rare (esophageal adenocarcinoma, EAC, accounting for 2.3%) and sparse (mainly esophageal small cell carcinoma, malignant melanoma, etc., accounting for 0.6%). All the common, rare, and sparse types occurred predominantly in male patients, and the gender difference of rare type was most significant (EAC, male∶ female, 2.67∶1), followed with common type (ESCC, male∶ female, 1.78∶1) and sparse type (male∶ female, 1.71∶1). The common type (ESCC) mainly occurred in the middle thoracic segment (65.2%), while the rare type (EAC) mainly occurred in the lower thoracic segment (56.8%). Among the sparse type, malignant melanoma and malignant fibrous histiocytoma were both predominantly located in the lower thoracic segment (51.7%, 66.7%), and the others were mainly in the middle thoracic segment.Conclusion:ESCC is the most common type among the 32 histopathological types of PEMT, followed by EAC as the rare type, and esophageal small cell carcinoma and malignant melanoma as the major sparse type, and all of which are mainly occur in male patients. The common type of ESCC mainly occur in the middle thoracic segment, while the rare type of EAC mainly in the lower thoracic segment. The mainly sparse type of malignant melanoma and malignant fibrous histiocytoma predominately occur in the lower thoracic segment, and the remaining sparse types mainly occur in the middle thoracic segment.
7.Pallidus Stimulation for Chorea-Acanthocytosis: A Systematic Review and Meta-Analysis of Individual Data
Weibin HE ; Chenhui LI ; Hongjuan DONG ; Lingmin SHAO ; Bo YIN ; Dianyou LI ; Liguo YE ; Ping HU ; Chencheng ZHANG ; Wei YI
Journal of Movement Disorders 2022;15(3):197-205
A significant proportion of patients with chorea-acanthocytosis (ChAc) fail to respond to standard therapies. Recent evidence suggests that globus pallidus internus (GPi) deep brain stimulation (DBS) is a promising treatment option; however, reports are few and limited by sample sizes. We conducted a systematic literature review to evaluate the clinical outcome of GPi-DBS for ChAc. PubMed, Embase, and Cochrane Library databases were searched for relevant articles published before August 2021. The improvement of multiple motor and nonmotor symptoms was qualitatively presented. Improvements in the Unified Huntington’s Disease Rating Scale motor score (UHDRS-MS) were also analyzed during different follow-up periods. A multivariate linear regression analysis was conducted to identify potential predictors of clinical outcomes. Twenty articles, including 27 patients, were eligible. Ninety-six percent of patients with oromandibular dystonia reported significant improvement. GPi-DBS significantly improved the UHDRS-motor score at < 6 months (p < 0.001) and ≥ 6 months (p < 0.001). The UHDRS-motor score improvement rate was over 25% in 75% (15/20 cases) of patients at long-term follow-up (≥ 6 months). The multiple linear regression analysis showed that sex, age at onset, course of disease, and preoperative movement score had no linear relationship with motor improvement at long-term follow-up (p > 0.05). GPi-DBS is an effective and safe treatment in most patients with ChAc, but no reliable predictor of efficacy has been found. Oromandibular dystonia-dominant patients might be the best candidates for GPi-DBS.
8.Incidence and mortality of acute kidney injury in coronary care unit: a retrospective study from a single center
Yugang HU ; Xiaoning LI ; Jing WAN ; Hongtao HU ; Liguo DU ; Huilan LIU
Chinese Journal of Nephrology 2017;33(2):92-99
Objective To evaluate the incidence and mortality of acute kidney injury (AKI) in coronary care unit (CCU),and to identify the risk factors of the incidence of AKI and the mortality of CCU patients.Methods A total of 414 patients in CCU from January 1,2014 to June 1,2015 at Zhongnan Hospital of Wuhan University were enrolled.Based on the KDIGO-AKI criteria,these patients were classified into two groups:NAKI group (patients without AKI) and AKI group.Clinical characteristics and laboratory data of two groups were compared.The risk factors of the incidence of AKI and the mortality of CCU patients was analyzed by logistic regression,and then the receiver operating characteristic (ROC) curve was drawn to evaluate the predictive value of these risk factors.Results (1) Among 414 patients,136(32.9%) patients fulfilled the criteria for AKI,and 14.0% patients in AKI stage 1,10.9% in AKI stage 2 and 8.0% in AKI stage 3.(2) The total CCU mortality was 15.0%.Mortality of AKI patients in the CCU was 33.3%,higher than 6.1% in patients without AKI (OR=7.735,95%CI 4.215-14.196,P < 0.001).The mortality worsened with increasing severity of AKI (22.4% for AKI stage 1 group,37.8% for AKI stage 2 group,45.4% for AKI stage 3 group).(3) Anemia (OR=8.274,95% CI 4.363-15.689),history of chronic illness (OR=2.582,95% CI 1.400-4.760),APACHE]Ⅱ seores (OR=1.813,95%CI 1.739-1.895),male (OR=3.666,95%CI 1.860-7.226) were the independent risk factors for AKI,while the normal mean arterial pressure (MAP) (OR=0.292,95%CI 0.153-0.556) and normal estimated glonerular filtration rate (eGFR) (OR=0.166,95%CI 0.090-0.306) are the protective factors for AKI (all P < 0.05).(4) AKI was the most powerful independent factor associated with the mortality of CCU patients (OR=7.050,95% CI 2.970-16.735,P < 0.001).Other independent risk factors for CCU mortality included history of chronic illness,ejection fraction and APACHE Ⅱ ≥ 15 scores (all P < 0.05),while the normal MAP and normal eGFR were the protective factors (all P < 0.05).(5) For predicting AKI,eGFR displayed an excellent areas under the ROC curve (AUC=0.815,P < 0.001),and for CCU mortality,APACHE Ⅱ scores had the highest overall correctness of prediction (AUC=0.757 P < 0.001).Conclusions CCU patients have high morbidity of AKI,which is the most powerful independent factor associated with the increased CCU mortality.The eGFR is the best predictor for AKI,and then through the evaluation of eGFR for CCU patients,we can evaluate high-risk groups,make early interventions and then improve the prognosis of CCU patients.
9.Analysis of the factors of brucellosis infection in professional population in Jingyuan County, Gansu Province
Wu LIU ; Tongxia ZENG ; Xiaobin HU ; Jiusheng WEI ; Jingyu LI ; Liguo YANG ; Hongrui LIU ; Huijuan KONG
Chinese Journal of Endemiology 2017;36(10):724-730
Objective To investigate influencing factors of brucellosis infection in occupational population in Gansu Province.Methods In Jingyuan County of Gansu Province,using the case-control method,the cases were collected through "National Disease Surveillance Information Reporting Management System",the case group was confirmed as brucellosis professionals after laboratory tests were positive in 2013-2015 (203 cases),and the control group was confmmed as occupations without brucellosis (809 cases) in the same periods.Information on general sociological characteristics and occupational exposure characteristic was collected,non-conditional Logistic regression analysis was used for analyzing influence factors of brucellosis.Results A total of 1 012 questionnaires were collected,among them,203 were case group and 809 were control group.Logistic regression analysis showed that,captive (OR =1.971,95%CI:1.193-3.256),type of water source (lage,OR =1.610,95%CI:1.392-1.950),often stripping the dead lamb (OR =2.027,95 % CI:1.272-3.231),processing abortion material (throwing away,feeding the dog,stripping;OR =2.120,1.176,2.160;95%CI:1.274-3.731,1.148-2.134,1.548-4.671),often eating dead meat (OR =2.497,95%CI:1.438-4.339),Hui nationality (OR =1.202,95%CI:1.061-1.995),household income less than 10 000 yuan (OR =3.857,95%CI:1.593-9.336),work experience 1-4 years (OR =2.892,95%CI:1.838-4.552) were major risk factors for occupational persons suffering from brucellosis.Livestock was sheep or sheep and goats (OR =0.412,0.277,95%CI:0.217-0.782,0.107-0.720),married(OR =0.124,95%CI:0.016-0.979),wearing gloves and mask when exposed to livestock or livestock lambing (OR =0.455,95%CI:0.230-0.899),and livestock vaccination (OR =0.283,95%CI:0.107-0.747) were protective factors for occupational infection of brucellosis.Conclusions The poor living habits and behaviors of professional people in Jingyuan County of Gansu Province are the main causes of the disease.Among them,captive,often stripping the dead lamb,processing abortion material,eating dead meat are the risk factors for brucella infection.Wearing masks and gloves when livestock lambing,and livestock vaccination are important means in avoiding brucellosis infection.
10.Knowledge and perceptions of brucellosis and human behavior of occupational exposure person and patients with brucellosis in Jingyuan County, Gansu Province
Wu LIU ; Liansheng LI ; Tongxia ZENG ; Xiaobin HU ; Liguo YANG ; Genxia GAO ; Wenli MIAO ; Shubo YANG ; Hongrui LIU
Chinese Journal of Endemiology 2017;36(7):528-532
Objective To analyze the knowledge and perceptions of brucellosis and human behavior in different populations in Jingyuan County Gansu Province,and to provide a scientific basis for carrying out health education and prevention accurately on brucellosis.Methods In 2015,using two-stage cluster sampling method,nine towns with more accumulative incidence of brucellosis in the past 3 years in Jingyuan Country were selected,5 villages were selected from each town,occupational exposure and patients with brucellosis were selected in each village as respondents.A questionnaire survey was carried out to collect basic information,brucellosis related knowledge,population's behavio.Results The overall awareness rate of prevention and control knowledge on brucellosis was 44.10% (12 943/29 348),included 809 people with the occupation exposure population and 203 patients with brucellosis,among them,the rate of patients with brucellosis knowledge was 50.40% (2 967/5 887),occupational exposure population was 42.52% (9 976/23 461);There were significant differences in the awareness rate of knowledge on prevention and control of brucellosis in population of different gender,age,education and years of work experience (x2 =84.413,166.100,207.200,16.822,P < 0.01);of the following parameters:shared water,peel dead lamb,How to deal with flow products,treatment of abortion without gloves,masks,not wearing gloves,masks when lambing ,to give livestock vaccines and drugs,eat dead cow,lamb,and sale of diseased,dead livestock,slaughter livestock,there were statistical significant differences between patients with brucellosis and exposure people (x2 =13.940,27.965,30.031,19.575,22.597,21.139,14.524,436.450,8.482,P < 0.05).Conclusions The occupational exposure population has a low knowledge awareness rate;high risk behaviors have higher risk of brucellosis infection in Jingyuan County.We should carry out health education and high-risk behavior intervention in targeted population.


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