Investigator initiated trial （IIT） represents a primary format for clinical research in traditional Chinese medicine （TCM）. As key implementation sites for TCM-based IIT targeting malignant tumors， western medicine institutions often face unique challenges in conducting such studies， which limit their feasibility and standardization. This paper reviews the registration status of TCM-based IIT for malignancies conducted in western medical institutions and analyzes key difficulties， including complex project initiation and management processes， limited TCM knowledge and skills among western medicine physicians， and relatively low patient acceptance of TCM. From a practical perspective， the study proposes several optimization strategies. These include improving the review and management mechanisms of TCM-related IIT within western medical institutions， establishing multidisciplinary clinical research teams that integrate TCM and western medicine， and enhancing investigators' training in TCM theory and clinical skills. Additionally， the study suggests standardizing IIT operational procedures， objectifying the collection of TCM diagnostic information， refining subject recruitment methods， and increasing TCM involvement in patient follow-up and management. These investigator-oriented， TCM-featured， and operable strategies aim to promote the high-quality development of TCM-based IIT in western medicine institutions and enhance the clinical application of TCM.

Objective To quantitatively assess the association of short-term exposure to polycyclic aromatic hydrocarbons (PAHs) in ambient fine particulate matter (PM2.5) with residents mortality. Methods A time-stratified case-crossover study was conducted from 2020 to 2022 among 10606 non-accidental residents by using the Guangzhou Cause of Death Surveillance System in Conghua District, Guangzhou. Exposure levels of PAHs in PM_2.5 and meteorological data during the study period were obtained from the Center for Disease Control and Prevention in Conghua District and the China Meteorological Administration Land Data Assimilation System (CLDAS-V2.0), respectively. Conditional Poisson regression model was used to estimate the exposure-response association between PAHs and the mortality risk. Results Fluoranthene, chrysene, benzo[k]fluoranthene, benzo[a]pyrene, and indeno[1,2,3-cd]pyrene were significantly associated with an increased risk of mortality. For every one interquartile range increase in exposure levels, the non-accidental mortality risks increased by 8.33% (95% CI: 1.80%, 15.27%), 4.67% (95% CI: 1.86%, 7.57%), 6.07% (95% CI: 2.08%, 10.21%), 4.62% (95% CI: 1.85%, 7.47%), and 4.70% (95% CI: 0.53%, 9.03%), respectively. The estimated non accidental deaths attributable to exposure to fluoranthene, chrysene, benzo[k]fluorine, benzo[a]pyrene and indine[1,2,3-cd]pyrene were 5.91%, 6.08%, 6.51%, 6.46%, and 4.21%, respectively. Conclusions Short-term exposure to PAHs in PM_2.5, including fluoranthene, chrysene, benzo[k]fluoranthene, benzo[a]pyrene and indine[1,2,3-cd]pyrene, was significantly associated with an increased risk of mortality among residents.

Objective:To analyze the association of CD19+CD24hiCD27+regulatory B cells(Bregs)with ankylosing spondylitis(AS).Methods:Eighty patients with AS in Ganzhou People's Hospital from January 2019 to December 2021 were enrolled as observa-tion group,meantime,another 60 healthy individuals were set as control group.Observation group was further divided into subgroups according to clinical stages and disease activity,advanced stage,ankylosis stage,active stage and non-active stage.Percentage of CD19+CD24hiCD27+Bregs in CD19+cells in peripheral blood of observation group and control group,and observation group patients with different stages were detected and compared,thereafter,relationship between percentage of CD19+CD24hiCD27+Bregs and clini-cal characteristics of AS patients were discussed,such as course of disease,duration of morning stiffness,the Bath Ankylosing Spon-dylitis Disease Activity Index(BASDAI),IL-10,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP)and X-ray classifi-cation of sacroiliitis.Results:Percentage of CD19+CD24hiCD27+Bregs in peripheral blood in observation group was higher than that in control group.Percentage of CD19+CD24hiCD27+Bregs in CD19+cells in AS patients at ankylosis stage was higher than that in patients at advanced stage,and percentage of CD19+CD24hiCD27+Bregs in peripheral blood of patients with bony ankylosis stage was higher than that in patients with fibrous ankylosis stage.Percentage of CD19+CD24hiCD27+Breg in CD19+B cells in active AS patients was sig-nificantly higher than that of patients with stable AS(P<0.05).Serum IL-10 level in observation group was lower than that in control group,while ESR and CRP levels were higher than those in control group,with statistical significance(P<0.05).Percentage of CD19+CD24hiCD27+Breg in CD19+B cells in peripheral blood of AS patients was positively correlated with BASDAI score and serum IL-10 level,while negatively correlated with ESR and CRP levels,and had no correlation with morning stiffness time and X-ray classi-fication of sacroiliitis.Conclusion:Percentage of CD19+CD24hiCD27+Bregs in peripheral blood is reduced in AS patients,moreover,percentage is closely related to disease stage,activity and laboratory indicators IL-10,ESR and CRP,which may be involved in the occurrence and development of AS.

Objective:To summarize the current research status, assessment tools, and influencing factors of fatigue in patients receiving maintenance hemodialysis (MHD) and provide a reference for the management of fatigue in this patient population.Methods:A literature search was conducted in databases including PubMed, Web of Science, ProQuest, Cochrane Library, Science Direct, Embase, CINAHL, China National Knowledge Infrastructure, WanFang Data, VIP, and China Biology Medicine disc for studies related to fatigue in patients receiving MHD. The search timeframe was from establishing the databases to January 23, 2024.Results:A total of 46 studies were included. Various assessment tools for fatigue in patients receiving MHD were identified, though specific tools were limited. The Short Form 36 Vitality Subscale (SF-36 VS) was the most commonly used assessment tool. The main factors influencing fatigue in these patients included sociodemographic, dialysis-related, disease-related, physical, nutritional, and psychological factors.Conclusions:Fatigue is a significant symptom in patients receiving MHD. Healthcare professionals must develop specific tools for accurately assessing fatigue in this population and explore standardized management plans.

Objective To observe splenic T cell apoptosis and XIAP-associated factor 1(XAF1),FAS,and tumor necrosis factor(TNF)-α protein expression levels in rats with acute lung injury(ALI),and to determine their roles in the protective effect of Yifei Jianpi formula.Methods Sixty male specific pathogen-free SD rats were divided randomly into blank,model,positive control,and high-,medium-,and low-dose Yifei Jianpi formula groups.Rats in the positive control group were given 0.5 g/kg dexamethasone by gavage,and rats in the high-,medium-,and low-dose Yifei Jianpi formula groups were given 12,6,and 3 g/kg Yifei Jianpi formula by gavage,respectively.Rats in the model and blank groups were given equal amounts of saline by gavage.All medications were administered once a day for 14 days.Lung function testing was carried out in all rats.We observed the imaging characteristics of the lungs and changes in the organ index and lung tissue wet/dry weight(W/D)in each group,and detected the pathological changes in lung tissues by hematoxylin-eosin staining.Splenic T-cell subpopulations(CD4+/CD8+)and apoptosis of splenic T-cells were detected by flow cytometry and XAF1,FAS,and TNF-α protein expression levels in the spleen were detected by Western Blot.Results Rats in the model group showed reduced lung function,decreased spleen and thymus organ indexes,and significantly higher W/D of lung tissue(P＜0.01).In addition,they had inflammatory exudation and alveolar rupture in the lung tissue,accompanied by thickening of the lung texture and large areas of ground-glass shadows,with a significant decrease in T-cell subsets(CD4+/CD8+)and significant increases in XAF1,FAS,and TNF-α proteins,and in the rate of T-cell apoptosis(P＜0.01).Yifei Jianpi formula significantly reduced the W/D spleen of rat lung tissues,significantly increased the thymus organ index(P＜0.05,P＜0.01)and the T-cell subpopulation(CD4+/CD8+),and significantly decreased the protein expression levels of XAF1,FAS,and TNF-α,and the T-cell apoptosis rate(P＜0.05,P＜0.01).Conclusions ALI induced up-regulation of XAF1,FAS,and TNF-α protein expression and T-cell apoptosis in the spleen of rats,and Yifei Jianpi formula may protect against ALI by down-regulating these factors.

Objective By investigating the effects of miR-379-5p on the proliferation,invasion and metastasis of mouse breast cancer 4T1 cells,we aimed to provide new therapeutic targets for the clinical inhibition of breast cancer proliferation,invasion,and metastasis.Methods After plasmid transfection,4T1 cells were utilized to detect the expression of miR-379-5p using fluorescence quantitative PCR.While 5-ethynyl-2'doxyuridine(EdU)cell proliferation and Transwell assays were employed to detect changes in the proliferation and invasion ability of 4T1 cells in each group.The migration ability of 4T1 cells after overexpression and knockdown of miR-379-5p was examined by scratch healing assay.A transplanted tumor model of breast cancer was established in BABL/c mice,and the effects of overexpressing miR-379-5p on tumor growth and the number and size of lung metastases were observed.Results EdU result showed that knocking down miR-379-5p enhanced the proliferation ability of the cells compared with the control group cells,and miR-379-5p overexpression reduced the capacity of breast cancer cells to proliferate(P＜0.05).Transwell and wound healing assays showed that miR-379-5p knockdown enhanced,while miR-379-5p overexpression significantly inhibited,the invasion and migratory ability of breast cancer cells(P＜0.01).An in vivo tumorigenesis experiment with BABL/c mice showed that miR-379-5p overexpression significantly slowed the tumor growth rate(P＜0.05)and inhibited lung metastasis(P＜0.01).Conclusions MiR-379-5p plays a role in tumor gene suppression in breast cancer and inhibits the proliferation,invasion,and migration of mouse breast cancer 4T1 cells.

This review introduces the daily management practices related to laboratory animal licensing in Hubei Province and the supervision processes during and after licensing.We consider the current status of laboratory animal license management,achievements,problems,and countermeasures in Hubei Province,with a focus on analyzing the legislative situation for laboratory animals,the issuance and distribution of permits,the scale of facilities,and the composition of employees.The number of laboratory animal licenses issued in Hubei Province has recently been increasing year by year,and the numbers of animals produced and used by licensed units have also continued to rise.Although the related industries are flourishing however,there are some regulatory deficiencies.This paper considers the perspective of biosafety,combined with the problems encountered in license management,and proposes relevant safety supervision countermeasures and suggestions to promote the development of the laboratory animal industry in Hubei Province.

A virus was successfully isolated from a sick cat exhibiting clinical signs such as oral mu-cosal ulceration,nasal mucosal redness,and increased nasal secretions utilizing F81 cells.Through a comprehensive analysis as such PCR amplication,sequencing,morphology,serology,and animal re-gression tests,the virus was identified as a feline calicivirus and named FCV-BJ,an inactivated vac-cine was developed from this isolated strain its safety and efficacy were assessed.The results re-vealed that the isolated FCV-BJ strain exhibited characteristic serological and morphological fea-tures consistent with caliciviruses.Furthermore,inoculation of cats with the FCV-BJ demonstrated the strain is highly virulent and the cats manifested the clinical signs of feline calicivirus infection.For the vaccination trial,domestic cats were immunized with inactivated fifth-generation virus cell culture at varying dilutions,followed by a booster immunization after 21 days.Fourteen days after the challenge with the virus,cats immunized with 107.0 TCID50/mL or higher remained largely healthy,while all cats in the control group developed clinical signs of FCV.These findings suggest that the inactivated vaccine derived from the FCV-BJ isolate exhibits strong immunogenicity and protective efficacy at a minimum immunization dose of 107.0 TCID50/mL.This strain holds promise as a candidate for vaccine production,providing a valuable reference and foundation for future re-search and development of feline calicivirus vaccines.

Objective:To detect the pathogen and clinically diagnose for a suspected case of Neisseria meningitidis with positive blood culture result, and assess the risk of disease transmission among the community. Methods:Blood sample was collected for Neisseria meningitidis isolation and culture. Pathogen identification and serogroup typing were conducted by colony morphology, Gram staining, biochemical tests, latex agglutination test, slide agglutination test, and nucleic acid testing. The susceptibility to 12 antibiotics was also tested. Epidemiological investigation was conducted on the case, and epidemic control measures were also implemented. Results:Through various detection, the suspected case was diagnosed as Neisseria meningitidis invasive infection. The isolated strain belonged to group Y serotype, type 767 (multilocus sequence typing), and the ST167 clonal complex. The strain was sensitive to nine antibiotics, including penicillin, ampicillin, and meropenem. It exhibited intermediate sensitivity to ciprofloxacin and levofloxacin, and resistance to methicillin/sulfamethoxazole. Close contacts of the case and environmental testing results were negative. Conclusions:The case is confirmed to be an invasive infection caused by group Y Neisseria meningitidis, the ST167 clonal complex. Epidemiological investigation shows a relatively low risk of epidemic transmission. Continuous monitoring and surveillance are necessary for further assessment.

Objective To investigate the mechanism of mikanolide derivative LY19380b in inhibiting the growth of human leukemia cell HEL.Methods Methyl thiazolyl tetrazolium(MTT)assay was used to detect the effect of compound LY19380b on the proliferation of human tumor cells,flow cytometry was used to determine cell cycle,Annexin V-FITC/PI double staining and Hoechst 33258 staining were used to determine apoptosis.Western blot was used to analyze effects of LY19380b on cell cycle and apoptosis-related proteins.Results LY19380b had anti-proliferative activity on different human tumor cells,and significantly inhibited the growth of human leukemia cell HEL.It can also induce apoptosis and affect the cell cycle of HEL.In addition,LY19380b could significantly increase the expressions of P53,BIM,BID,BAD,BAX,FLIP,P21 and Cyclin B1 proteins,while decreased the expressions of Bcl-2,p-CDC25C,p-AKT,p-STAT3 and p-ERK proteins.Conclusion By increasing the expressions of pro-apoptotic proteins BIM,BID,BAD and BAX,decreasing the expression of anti-apoptotic protein Bcl-2,LY19380b induced the apoptosis of human leukemia cell HEL,and upregulated the expressions of P21 and Cyclin B1,thus leading to cell cycle arrest in HEL.