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.Overview of animal models of idiopathic inflammatory myopathy-associated interstitial lung disease
Zhichao LIU ; Xiaohe LI ; Honggang ZHOU ; Na ZHANG
Tianjin Medical Journal 2024;52(7):709-713
Idiopathic inflammatory myopathy(IIM)is a heterogeneous autoimmune disease of unknown etiology characterized by proximal limb muscle involvement and chronic inflammation.Multiple systems may be involved,with interstitial lung disease(ILD)being the most common manifestation of respiratory system involvement in IIM.This article summarizes the current methods of myositis animal models and myositis-associated ILD model construction methods,so as to provide reference for the subsequent construction and research of IIM-ILD models.
3.Establishment and Preliminary Application Analysis of A Multiplex Detection Method for Influenza A and B Virus Antigen Based on Quantum Dot-encoded Microsphere Flow Cytometry Technology
Chengjing XIA ; Baohua LI ; Yanni GUO ; Xiaohe ZHOU ; Runling ZHANG ; Yingbo NIU
Journal of Modern Laboratory Medicine 2024;39(1):126-130
Objective To establish a multiplex assay method for the simultaneous detection of FluA and FluB virus(IBV)antigen based on the flow cytometry(FCM)quantum dot-encoded bead technologies,laying the foundation for the assay of multiple respiratory virus biomarkers.Methods Coupling was performed for FluA and FluB nucleoprotein(NP)monoclonal antibodies using self-made quantum dot-encoded beads,separately.FCM was used to detect known concentrations of FluA and FluB antigens separately and simultaneously,optimize the detection conditions,and establish a joint detection method for FluA and FluB antigens.Compared with the quantitative real-time PCR(qPCR)method,clinical samples were used to evaluate the clinical performance of this joint detection method.Results The joint detection method for FluA and FluB antigens was established,with detection limits of 26.1 pg/ml and 10.7 pg/ml,respectively,and measurement ranges of 15.3~250 000 pg/ml.The joint detection method for clinical sample evaluation was well correlated with the qPCR,with a positive coincidence rate of 57.4%,a negative coincidence rate of 100%,and a total coincidence rate of 71.6%.In addition,the joint detection method was superior to colloidal gold immunochromatographic strip assay commonly used in clinical practice(positive coincidence rate of 56.49%,negative coincidence rate of 99.75%).Conclusion The FCM quantum dot-encoded bead multiplex assay can be used for the joint detection of FluA and FluB antigens,which have a high sensitivity,good specificity and wide detection range.It may lay a good foundation for the multiplex detection of common respiratory viruses,and has clinical application prospects.
4.Effect of thalidomide combined with infliximab in treatment of refractory inflammatory bowel disease and its effects on insulin-like growth factor-1 and transforming growth factor-β1
Lijun MENG ; Xiaohe GUO ; Daiyuan DONG ; Yan YANG ; Yaofeng XUE ; Baolin ZHOU ; Yongmei QIN
Journal of Clinical Medicine in Practice 2024;28(1):68-72
Objective To investigate the effect of thalidomide combined with infliximab (IFX) in treatment of refractory inflammatory bowel disease (IBD) and its effects on insulin-like growth factor-1 (IGF-1) and transforming growth factor-β1 (TGF-β1). Methods A total of 120 patients with refractory IBD were randomly divided into experimental group and control group, with 60 cases in each group. The two groups were given conventional treatment (mesalazine), the control group was given IFX, and the experimental group was given IFX combined with thalidomide, continuous treatment for two months. The efficacy, intestinal flora disturbance rate, adverse reactions, Crohn's disease activity index (CDAI), Lewis score, serum IGF-1, TGF-β1 levels and nutritional status indexes[albumin (ALB), transferrin (Tf)]before and after treatment for 1 month and 2 months of the two groups were compared. Results The total effective rate of the experimental group was significantly higher than that of the control group (
5.Potential mechanism of Sophora flavescens against breast cancer via network pharmacology and molecular docking
Min ZHANG ; Xiaohe WANG ; Yangyun ZHOU ; Meizhi SHI ; Xinyun HAN ; Xianghui HAN ; Junjun CHEN
Journal of Pharmaceutical Practice 2023;41(12):722-732
Objective To analyze the main active components and potential molecular mechanism of Sophora flavescens against breast cancer based on network pharmacology and molecular docking. Methods The chemical constituents were collected and screened by TCMSP, ETCM database and literature review. The targets of active ingredients were predicted by Swiss Target Prediction database. Breast cancer-related targets were collected by GeneCards, TTD, Drugbank and OMIM. The anti-breast cancer targets of Sophora flavescens were screened by Venny 2.1.0 software. Cytoscape software was used to construct the network diagram of Sophora flavescens-key active ingredients-targets. STRING database was used to analyze the common targets, and PPI network diagram was constructed. GO function enrichment analysis and KEGG pathway enrichment analysis of key target proteins were performed by DAVID database and Hiplot online platform. Schrodinger software was used to calculate the molecular docking between the active ingredients and targets. Molecular biological methods were used to verify the key targets. Results A total of 36 active components with clear structures were screened from Sophora flavescens. 70 anti-breast cancer targets of Sophora flavescens were screened out. 12 core targets including EGFR, AKT1, ESR1, SRC, CYP19A1, AR and ABCB1 participate in endocrine resistance, EGFR tyrosine kinase inhibitors and estrogen signaling pathways in breast cancer. Moreover, the docking score between the core component and the key target AR is the highest. In vitro experiments showed that the extract of Sophora flavescens can inhibit the proliferation of breast cancer cells, induce cell apoptosis and up-regulate AR protein expression. Conclusion It was revealed that Sophora flavescens plays an anti-breast cancer role by regulating complex biological processes through multiple components acting on multiple targets and signaling pathways. The upregulation of AR protein by Sophora flavescens may become a new therapeutic strategy for the treatment of breast cancer.
6.Effect of rTMS combined with CBT on alcohol craving and cognitive function in patients with alcohol dependence
Chang CHENG ; Hongxuan WANG ; Weibian YANG ; Xiaohong WANG ; Chuanyi KANG ; Xiaorui HU ; Jia LU ; Huaizhi WANG ; Na ZHAO ; Xiaohe FAN ; Mei YANG ; Jianzhong YANG ; Yanjie JIA ; Yingjie ZHANG ; Xuhui ZHOU ; Lei LIU ; Yong CHI ; Ying PENG ; Jian HU
Chinese Journal of Behavioral Medicine and Brain Science 2022;31(8):685-691
Objective:To explore the effect of repetitive transcranial magnetic stimulation (rTMS) combined with cognitive behavioral therapies (CBT) on the cognitive function and alcohol craving in patients with alcohol dependence.Methods:From March 2019 to September 2021, a total of 150 patients with alcohol dependence were enrolled and randomly divided into rTMS treatment group (rTMS+ sham CBT, n=41), CBT treatment group (CBT+ sham rTMS, n=34), rTMS+ CBT treatment group( n=36) and control group (sham rTMS+ sham CBT, n=39). At baseline (before treatment), 2nd week, 8th week, 12th week and 24th week, alcohol dependence scale (ADS) was used to evaluate the degree of alcohol dependence, the obsessive compulsive drinking scale (OCDS) was used to assess patients' drinking craving, and Montreal cognitive assessment scale (MoCA) was used to assess the overall cognitive level of patients.SPSS 23.0 statistical software was used to compare the differences of ADS, OCDS and MoCA scale scores of the four groups by repeated measure ANOVA and simple effect analysis. Results:(1)The patients in the four groups were evaluated with ADS scale at baseline, 12th week and 24th week respectively.The interaction of group×time( F=1.279, P=0.279) and the main effect of group were not significant ( F=0.882, P=0.454), and the main effect of time was significant ( F=12.925, P<0.001) .Further simple effect analysis showed that the ADS score of rTMS+ CBT group was lower than that of baseline(14.48±5.70, 10.00±6.51) ( P=0.01) at 24th week.(2)Patients in the four groups were assessed with OCDs scale at baseline, 2nd week, 8th week, 12th week and 24th week, and the interaction of group×time was significant ( F=2.015, P=0.042). Further simple effect analysis showed that the OCDs scores of rTMS group and rTMS+ CBT group at each follow-up time node were lower than those at baseline period (all P<0.05). (3)Patients in the four groups were assessed with MoCA scale at baseline, 8th week, 12th week and 24th week, and the interaction of group×time was not significant ( F=1.660, P=0.106), and the main effect of group and the main effect of time were significant ( F=2.964, P=0.038; F=14.239, P<0.001). Further simple effect analysis showed that the score of MoCA scale in CBT group at the 24th week was higher than that at baseline (21.73±5.81, 24.60±3.98)( P=0.029), the score of MoCA scale in rTMS+ CBT group at the 24th week was higher than that at the 8th week (23.50±6.01, 25.95±2.87) ( P=0.006), and the score of MoCA scale in rTMS group at the 12th week was higher than that in control group (22.08±6.64, 26.64±2.46)( P=0.009). Conclusion:rTMS combined with CBT can be effective in improving alcohol craving and cognitive function in patients with alcohol dependence, and has a good long-term effect.
7.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.
8.Experience and enlightenment of countywide medical alliances construction in Hangzhou
Hao ZHANG ; Xiaohe WANG ; Meng ZHANG ; Shangren QIN ; Yanxiang ZHANG ; Jianrong TENG ; Beifang YUAN ; Hua ZHOU
Chinese Journal of Hospital Administration 2019;35(6):462-467
Based on a sufficient analysis of the theoretical framework of " transformation learning collaboration" ( TLC ) and " people-centered and integrated health care " ( PCIC ) mode, this article introduced the main practices and achievements of " Hangzhou characteristics" countywide medical alliances, centering on TLC mode.Hangzhou takes the countywide medical alliance construction as a pilot, refers to the TLC model, and takes growth-oriented collaboration as the guidance, to promote responsibility sharing, benefit sharing, service integration and management collaboration.Guided by the PCIC model proposed by the World Health Organization, the city has established an integrated service model of hierarchical medical system-prevention-rehabilitation-aging care.The countywide medical alliance system framework features " 5 fields, unified leadership, unified culture, 6 supports, 3 tasks and TLC teams " , which may provide references for the coordinated and integrated development of such alliances.
9. Association of human rhinovirus infection with asthma in children
Chinese Journal of Experimental and Clinical Virology 2018;32(3):333-337
Asthma is a serious global health problem affecting all age groups. It has been recognized as a complex disease resulting from interactions between multiple genetic and environmental factors. Human rhinovirus (HRV) infections in early life constitute a major environmental risk factor for the development of childhood asthma and the most common cause of asthma exacerbation. HRV-C, the novel HRV, using cadherin-related family member 3 (CDHR3) as receptors, plays a key role in the development of childhood asthma. This review discusses the role and the potential underlying mechanisms of HRV infections in the development and exacerbation of childhood asthma based on recent clinical and experimental evidence.
10.Research progress of helicobacter pylori in the development of hepatitis,cirrhosis and hepatic carcinoma
Meizhou SUN ; Xiaohe TANG ; Kun SUN ; Yufeng WANG ; Hui SUN ; Cunjin ZHOU ; Yikui XIE
Clinical Medicine of China 2016;32(7):665-667
Objective Helicobacter pylori ( Hp ) infection is an important risk factor of the gastrointestinal disease, including chronic gastritis, peptic ulcer and gastric cancer. However, many recent experimental and clinical studies have shown that its addition to causing gastrointestinal diseases, but also associated with many diseases, and closely related with the occurrence of liver diseases. Summarized recent advances in the study of the relevant studies,including the relationship between hepatitis and cirrhosis,and the occurrence and development of liver cancer.


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