1.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
2.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
3.Evaluation Value of Blood Biomarker Tests for Efficacy of EGFR-TKI in Advanced NSCLC Treatment
Rui FAN ; Yonghui WU ; Zhan GU ; Yanbin PENG ; Lixin WANG
Cancer Research on Prevention and Treatment 2025;52(5):382-387
Objective To analyze the levels of serum CTCs and ctDNA in NSCLC patients receiving first-line EGFR-TKI treatment, and to explore the clinical value of CTCs and ctDNA detection in assessing the efficacy of treatment for advanced lung cancer. Methods A total of 109 NSCLC patients receiving first-line EGFR-TKI treatment were enrolled. Serum tumor markers CEA, CTCs, and ctDNA were detected at baseline and after one month of treatment. Chest CT scans were performed, and treatment efficacy was evaluated based on RECIST1.1 criteria. CTCs were counted by enrichment-staining-computational algorithm to analyze malignant features, while ctDNA was assessed using digital PCR. Results Survival rate was low in patients with abnormal CEA and ctDNA tests at baseline and in patients with reduced serum CTCs after treatment. In the SD subgroup of patients with brain metastases and advanced stage, the PFS benefit was low. Conclusion Patients in the SD subgroup have significantly higher recurrence risks than those in the PR or CR subgroups. Therefore, CTC and ctDNA testing should be applied to patients in the SD subgroup to identify high-risk patients with poor response to EGFR-TKI treatment, intervene with additional treatment promptly, and obtain long progression-free survival.
4.Prevention and Treatment of Asthma by Traditional Chinese Medicine Regulating PI3K/Akt Signaling Pathway: A Review
Yasheng DENG ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinjiang XU ; Haobin CHEN ; Qiuye WU ; Jiang LIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):262-275
Asthma is a chronic inflammatory respiratory disease involving multiple cells and cellular components, characterized by recurrent episodes of wheezing, shortness of breath, chest tightness, and coughing, significantly impacting patients' quality of life. The phosphatidylinositol 3-kinase/protein kinase B(PI3K/Akt) signaling pathway, as a crucial hub in intracellular signaling, is widely involved in the regulation of cell growth, proliferation, survival, metabolism, and a series of pathophysiological processes. Its regulatory role in the pathological progression of asthma is particularly significant, specifically in promoting airway inflammation, mediating epithelial mesenchymal transition, accelerating airway remodeling, regulating cell autophagy, inducing mucus hypersecretion, and influencing immune response balance. This study analyzed potential molecular targets of the PI3K/Akt pathway, including activators such as cysteine proteinase inhibitor 1(CST1), found in inflammatory zone 1(FIZZ1) and free fatty acid receptor 1(FFAR1), and inhibitors such as human β-defensin-3(hBD-3), disintegrins, metalloproteinase 33(ADAM33) and interleukin-27(IL-27), and initially revealed the potential molecular mechanisms of traditional Chinese medicine(TCM) in asthma intervention. Based on this, the authors systematically summarized the efficacy and specific mechanisms of TCM monomers, compounds, and external treatments for asthma by regulating the PI3K/Akt signaling pathway through literature review and analysis, aiming at establishing a robust foundation for the wide application and advanced development of TCM in asthma treatment, offering innovative insights for clinical research and drug development of asthma.
5.Prevention and Treatment of Asthma by Traditional Chinese Medicine Regulating PI3K/Akt Signaling Pathway: A Review
Yasheng DENG ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinjiang XU ; Haobin CHEN ; Qiuye WU ; Jiang LIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):262-275
Asthma is a chronic inflammatory respiratory disease involving multiple cells and cellular components, characterized by recurrent episodes of wheezing, shortness of breath, chest tightness, and coughing, significantly impacting patients' quality of life. The phosphatidylinositol 3-kinase/protein kinase B(PI3K/Akt) signaling pathway, as a crucial hub in intracellular signaling, is widely involved in the regulation of cell growth, proliferation, survival, metabolism, and a series of pathophysiological processes. Its regulatory role in the pathological progression of asthma is particularly significant, specifically in promoting airway inflammation, mediating epithelial mesenchymal transition, accelerating airway remodeling, regulating cell autophagy, inducing mucus hypersecretion, and influencing immune response balance. This study analyzed potential molecular targets of the PI3K/Akt pathway, including activators such as cysteine proteinase inhibitor 1(CST1), found in inflammatory zone 1(FIZZ1) and free fatty acid receptor 1(FFAR1), and inhibitors such as human β-defensin-3(hBD-3), disintegrins, metalloproteinase 33(ADAM33) and interleukin-27(IL-27), and initially revealed the potential molecular mechanisms of traditional Chinese medicine(TCM) in asthma intervention. Based on this, the authors systematically summarized the efficacy and specific mechanisms of TCM monomers, compounds, and external treatments for asthma by regulating the PI3K/Akt signaling pathway through literature review and analysis, aiming at establishing a robust foundation for the wide application and advanced development of TCM in asthma treatment, offering innovative insights for clinical research and drug development of asthma.
6.Application Analysis of Animal Models for Pelvic Inflammatory Disease Based on Data Mining
Yiqing ZHENG ; Yasheng DENG ; Yanping FAN ; Tianwei LIANG ; Hui HUANG ; Yonghui LIU ; Zhaobing NI ; Jiang LIN
Laboratory Animal and Comparative Medicine 2024;44(4):405-418
Objective To investigate the key elements for model establishment and determine the evaluation indicators of animal models for pelvic inflammatory disease(PID),providing a reference for improving modelling methods and optimizing the application of PID animal models.Methods The search query"Pelvic Inflammatory Disease"AND"Animal Model"OR"Rat"OR"Mouse"OR"Guinea Pig"OR"Rabbit"OR"Dog"OR"Pig"was used to retrieve relevant literature on PID animal models published from 2013 to 2023 in China Knowledge Network Infrastructure(CNKI),Wanfang,and PubMed databases.The studies were analyzed and categorized based on experimental animal types,modelling methods,modelling cycles,detection indicators,positive control drugs,and administration duration.A database was established for statistical analysis.Results A total of 214 research articles on PID animal models meeting the inclusion criteria were identified.The most commonly used model animals are Sprague Dawley(SD)rats,followed by Wistar rats.The most frequently employed modelling method is a combination of mechanical injury and bacterial infection,followed by the phenol mucilage method.The most common modelling cycles for acute pelvic inflammatory disease(APID)and chronic pelvic inflammatory disease(CPID)/sequelae of pelvic inflammatory disease(SPID)are 8 to 14 days,while for PID models without specific staging,the cycles are 7 days.High-frequency detection methods and indicators include histopathological observation using hematoxylin-eosin staining,enzyme-linked immunosorbent assay(ELISA)for serum-related indicators,morphological changes of tissues observed with the naked eye,and immunohistochemical detection of related protein expression in uterine tissues,and pathological scoring.The most frequently used positive control drugs are Fuke Qianjin Tablets,followed by Jingangteng Capsules.The most common administration duration for APID is 7 days,and for CPID/SPID models,it ranges from 15 to 21 days.Conclusion Currently,SD rats and Wistar rats are commonly used as experimental animals for PID models.The dual modelling method of mechanical injury combined with mixed bacterial infection aligns closely with clinical pathogenesis and can be used to establish a PID model that simulates postoperative uterine cavity infection.Depending on the research objectives,different positive drugs and detection indicators should be selected for comprehensive evaluation.Most existing PID animal model studies are based on western medical diagnosis,with fewer studies focusing on Traditional Chinese Medicine(TCM)syndromes.There is a need to integrate TCM theories of etiology and pathogenesis to construct PID animal models that are more in line with TCM clinical symptoms.
7.Effects of moderate-altitude exposure on intestinal flora of Chinese healthy population
Yaoliang ZHOU ; Jingyan ZHOU ; Jiahui MA ; Xin QI ; Yonghui MA ; Xiaoyan GAO ; Yanqun FAN ; Zhipeng LIU ; Xin LI
Chinese Journal of Pathophysiology 2024;40(11):2124-2134
AIM:To explore the effects of moderate-altitude exposure on intestinal flora in healthy individuals.METHODS:The aid-Tibet cadres,who were sent to work from Guangdong(average altitude<50 m)to Nyingchi(average altitude of 2 900 m),were recruited.A total of 76 samples were collected,including 42 samples from healthy adults with plateau living for 0 day and 34 samples from healthy adults with plateau living for 6 months.Fecal samples DNA were ex-tracted,sequenced by the 16S rDNA high-throughput sequencing technology and analyzed bioinformatically.RESULTS:Compared with the base group,α diversity was increased(P=4.00×10-4)and β diversity was decreased(P=1.00×10-3).After moderate altitude exposure,the relative abundance of phylum Proteobacteria(|LDA|>4,P<0.05),genus Escherich-ia-Shigella,species Enterococcus_faecalis,Haemophilus_influenzae and Helicobacter_sp._UNSW1.7sp decreased(adjust-ed P<0.05),wheras the relative abundance of phylum Bacteroidetes(|LDA|>4,P<0.05),genus Butyricimona,species Lactobacillus_sp._RA2113(s)and Butyricimonas_sp._Marseille-P2440(s)increased(adjusted P<0.05).The function-al prediction by PICRUSt showed a decrease in the relative abundance of pathway related to xenobiotics biodegradation and metabolism,membrane transport and amino acid metabolism(adjusted P<0.05).Conversely,the relative abundance of pathway related to biosynthesis of other secondary metabolites and nucleotide metabolism was increased(adjusted P<0.05).Finally,the results of microbiome phenotype prediction by BugBase showed that moderate altitude exposure im-proves the gut microbiota functions involving anaerobic oxygen tolerance and gram positive(adjusted P<0.05).And bacte-ria containing facultatively anaerobic oxygen tolerance,oxidative stress tolerance,gram negative and biofilm formation in the six-group decreased significantly compared with those in base group(adjusted P<0.05).CONCLUSION:Moderate altitude exposure impacts the diversity,abundance and function of intestinal flora in healthy population,suggesting that al-titude factors may have some influence on gut microbiota.
8.Construction and biological characterization of lmo2363 gene deletion strain of Listeria monocytogenes
Ji ZHI ; Qing CAO ; Xuehui ZHAO ; Haohao ZHANG ; Ziqiu FAN ; Yonghui MA ; Jing DENG ; Zengwen HE ; Jinrui MA ; Kunzhong ZHANG ; Qian CHONG ; Caixia WANG ; Huiwen XUE ; Huitian GOU
Chinese Journal of Veterinary Science 2024;44(9):1923-1929,1956
This study aims to investigate the function of lmo2363 gene in stress resistance of Liste-ria monocytogenes strain LM83-1.In this study,the lmo2363 gene deletion strain and complement-ation strain of Listeria monocytogenes were constructed using overlapping extended PCR and ho-mologous recombination techniques,and the growth ability,stress survival rate and biofilm forma-tion ability of wild,deletion strain and complementation strain were compared under different stress environments.lmo2363 gene deletion strain and complementation strain of Listeria monocy-togenes were successfully constructed in this experiment.The growth curves showed that the growth capacity of the deletion strain was weaker than the wild strain LM83-1 under 4 ℃,7%NaCl,10%NaCl,3.5%ethanol,4.0%ethanol and pH5 stress(P<0.001).The results of stress survival test showed that the survival rate of the deletion strain was significantly lower than the wild strain after 1 h treatment with pH3 and 10 mmol/L H2 O2 stress(P<0.010).The biofilm forming ability of the deletion strain was decreased compared with that of the wild strain(P<0.050).This study confirmed that lmo2363 gene mediated the adaptation of LM to low temperature,high osmotic pressure,ethanol and acid stress environment and affected the formation of LM bio-film.This study laid a foundation for further exploring the function of lmo2363 gene in the stress resistance process of Listeria monocytogenes.
9.Hot spots and prospects of medical quality and safety management in China since the new medical reform
Yonghui DU ; Siping DONG ; Zixuan FAN ; Tingfang LIU
Chinese Journal of Hospital Administration 2023;39(4):243-248
Objective:To analyze the hot spots and frontiers of medical quality and safety management since the new medical reform, and to provide reference for the continuous improvement of medical quality and safety management.Methods:Chinese literatures related to medical quality and medical safety management in CNKI database from April 2009 to December 2022 were retrieved, and the included literatures were processed and analyzed by CiteSpace software and Excel software.Results:1 921 literatures related to medical quality management and 2 497 literatures related to medical safety management were included. The publication trend showed a " double peak", showing a downward trend. The research hotspots in literature related to medical quality and safety management in China since the new medical reform have focused on practice exploration and influencing factors. The trend of future research is to closely follow the background of the times in medical quality and safety management research and intelligent medical quality and safety management evaluation system research.Conclusions:In the future, research on medical quality and safety management should be more in line with the changes of medical reform policies, focus on high-quality development to deepen the research on micro issues, promote information construction to continuously improve the indicator evaluation system, so as to promote the sustainable and high-quality development of medical quality and safety management in China.
10.Constructing theory model for medical quality and safety management based on grounded theory
Siping DONG ; Tingfang LIU ; Zhao SHANG ; Lijun ZHUO ; Zixuan FAN ; Yonghui DU
Chinese Journal of Hospital Administration 2023;39(4):263-268
Objective:To construct future-oriented theoretical management model for medical quality and patient safety.Methods:Procedure grounded theory was applied to code data including 30 expert interview records from July 2021 to June 2022 and the qualitative analysis results of 71 core literatures in Chinese and English, and then the theoretical model was constructed.Results:After three-level coding, 555 reference points, 249 initial concepts, 41 categories, 27 main categories and 7 core categories related to medical quality and safety management were sorted out, and the theoretical model of SQ (I-SPORT) matrix for medical quality and safety management was constructed. This model extended the traditional dimension in quality and safety management.Conclusions:Regarding medical quality and safety management, on one hand, should focus on the systematic improvement of structure, process, results, reengineering, education and training in terms of management functions; on the other hand, it is necessary to improve the organization, employees, resources, technology and tools, and patient experience in terms of management elements.

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