Specification for Quality Control in Traditional Chinese Medicine Clinical Trials（GB/T 47336-2026） is the first national standard in the field of clinical research on traditional Chinese medicine （TCM）， aims to address the core issue that the quality shortcomings of current TCM clinical research restrict the transformation of achievements and international recognition. Through the interpretation of the core contents of this standard， including its scope of application， graded quality control system， TCM-specific quality control requirements， implementation and responsible entities， responsibilities of quality control personnel， formulation of quality control plans， critical nodes of quality control， and quality control archive management， it is believed that the promotion and implementation of this standard are of great significance for improving the standard system of TCM clinical research， enhancing research quality， optimizing the quality management model， and promoting the internationalization process of TCM. Meanwhile， the implementation paths for the standard are discussed， including carrying out pilot applications in institutions， establishing publicity， implementation， and training mechanisms， encouraging multi-party collaborative supervision， and setting up implementation feedback mechanisms. On this basis， the challenges that may be encountered during implementation， such as resource input pressure， difficulties in implementing TCM-specific quality control， and a relative shortage of interdisciplinary composite talents， are sorted out， and corresponding strategies are proposed， which can provide references for relevant researchers and practitioners.

Objective To explore the value of dual factor combined detection using tuberculosis(TB)specific cy-tokines interferon-γ(IFN-γ)and interleukin-2(IL-2)in TB diagnosis in patients with human immunodeficiency vi-rus(HIV)infection,and the influencing factors for underdiagnosis.Methods HIV-infected patients admitted to and underwent TB-related examination in the Department of Infectious Diseases in Hezhou People's Hospital from July 2022 to September 2024 were collected.According to the clinical diagnosis criteria,patients were divided into the HIV infection with TB group(HIV/TB group)and the HIV infection without TB group(control group).Diag-nostic efficacy of dual factor combined detection was evaluated.HIV/TB group was further divided into a true-posi-tive group and a false-negative group based on the detection results.The independent influencing factors for underdia-gnosis was analyzed using multivariate logistic regression.Results A total of 306 patients were included in the analysis,with an average age of(55.69±14.02)years.There were 105 patients in the HIV/TB group and 201 in the control group.The sensitivity and specificity of dual factor combined detection for TB in all HIV-infected pa-tients were 72.4％(76/105)and 87.1％(175/201),respectively.There was a statistically significant difference in sensitivity(x2=9.488,P=0.009)and no statistically significant difference in specificity(x2=5.846,P=0.054)among the three CD4+T lymphocyte count gradients in the dual factor detection.Among them,patients with CD4+T cell count＜100 cells/μL had lower sensitivity(58.8％)in dual factor detection than patients with CD4+T cell count ≥200 cells/μL(88.9％)and 100-199 cells/μL(81.5％),differences were both statistically significant(both P＜0.05).In HIV/TB co-infected patients with CD4+T lymphocyte count ≥100 cells/μL,the general sensi-tivity and the specificity of dual factor combined detection were 85.2％(46/54)and 82.0％(91/111),respectively.Multivariate analysis showed that CD4+T lymphocyte count was an independent influencing factor for the underdia-gnosis in HIV/TB patients conducting dual factor combined detection(P＜0.05),while age,gender,pathogen re-sults,and the presence or absence of TB had no statistically significant impact on the results of dual factor combined detection(all P＞0.05).Conclusion Dual factor combined detection using tuberculosis-specific cytokines IFN-γand IL-2 has a high diagnostic value in the diagnosis of TB in HIV-infected patients,especially in those with CD4+T lymphocyte count ≥100/μL,which can provide auxiliary diagnostic value for the clinical diagnosis of HIV infection combined with TB.

Purpose To investigate the expression of LAMB3 and ITGB4 in esophageal squamous cell carcinoma(ESCC)and analyze their associations with clinicopathological features.Methods Bioinformatics was used to assess the expression of LAMB3 and ITGB4 in pan-cancer and ESCC.Immunohistochemistry was performed to evaluate their expression and distribution in ESCC tissues,and correlations clinicopathological features were analyzed.Follow-up data were collected to construct Kaplan-Meier survival curves,and Cox regression analysis was proformed to determine their prognostic significance.Results Bioinformatics analysis showed that LAMB3 and ITGB4 were highly expressed in ES-CC tissues(P＜0.001).Immunohistochemistry confirmed that both proteins were localized in the cytoplasm and membrane of tumor cells.High LAMB3 expression was significantly associated with poor differentiation(P＜0.001),lymph node metastasis(P=0.015),and T staging(P＜0.001).High ITGB4 expression was significantly correlated with poor differentiation(P=0.004)and advanced T staging(P=0.004).Cox regression analysis identified high ex-pression of LAMB3 and ITGB4 as independent prognostic factors for overall survival[HR=4.97(95％CI:2.73-9.02);HR=2.33(95％CI:1.36-3.99)].Conclusion LAMB3 and ITGB4 are highly expressed in ESCC.High LAMB3 expression is associated with tumor differentiation,lymph node metastasis,and T staging,while high ITGB4 expression is correlated with tumor differentiation and T staging.Patients with high expression of LAMB3 or ITGB4 have poorer overall survival,suggesting that these proteins may serve as prognostic biomarkers for unfavorable outcome in ESCC.

Objective:To discuss the effect of sericin on the phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt)/nuclear factor-κB(NF-κB)signaling pathway and apoptosis in the streptozotocin(STZ)-damaged INS-1 cells,and to clarify its mechanism.Methods:The INS-1 cells were cultured with complete medium containing 0,0.1,0.3,1.0,3.0,and 10.0 μmol·L-1 Akt1 inhibitor A-674563,10 mmol·L-1 STZ,and 600 mg·L-1 sericin,and divided into 0,0.1,0.3,1.0,3.0,and 10.0 μmol·L-1 A-674563 groups,and the control group(complete medium without drugs)was set up.Cell counting kit-8(CCK-8)method was used to detect the survival rates of the INS-1 cells,and the half-maximal inhibitory concentration(IC50)value was calculated to determine the optimal inhibitory concentration of A-674563,which was further verified by Western blotting method.The INS-1 cells were divided into normal control group(complete medium),model group(10 mmol·L-1 STZ+complete medium),and low,medium,and high doses of sericin groups(10 mmol·L-1 STZ+150 mg·L-1 sericin+complete medium,10 mmol·L-1 STZ+300 mg·L-1 sericin+complete medium,and 10 mmol·L-1 STZ+600 mg·L-1 sericin+complete medium).CCK-8 method was used to detect the survival rates of the INS-1 cells in various groups to determine the optimal concentration of sericin.Additionally,the INS-1 cells were divided into normal control group(complete medium),model group(10 mmol·L-1 STZ+complete medium),sericin group(10 mmol·L-1 STZ+600 mg·L-1 sericin+complete medium),and A-674563 group(10 mmol·L-1 STZ+600 mg·L-1 sericin+0.3 μmol·L-1 A-674563+complete medium).Flow cytometry was used to detect the apoptotic rates of the INS-1 cells in various groups;real-time fluorescence quantitative PCR(RT-qPCR)method was used to detect the expression levels of Akt1,NF-κB,tumor necrosis factor-α(TNF-α),and interleukin-6(IL-6)mRNA in the INS-1 cells in various groups;Western blotting method was used to detect the expression levels of phosphorylated Akt1(p-Akt1)and NF-κB proteins in the INS-1 cells in various groups;enzyme linked immunosorbent assay(ELISA)method was used to detect the levels of TNF-α and IL-6 in the INS-1 cells in various groups.Results:The survival rates of the INS-1 cells in control group was 100.00%±0.00%;in 0,0.1,0.3,1.0,3.0,and 10.0 μmol·L-1 A-674563+10 mmol·L-1 STZ+600 mg·L-1 sericin+complete medium groups,which were 82.50%±2.28%,69.47%±1.94%,51.51%±1.74%,38.94%±1.57%,24.79%±1.14%,and 19.85%±1.03%,respectively.The IC?? value of A-674563 for INS-1 cells was 0.3 μmol·L-1,and 0.3 μmol·L-1 A-674563 was selected for subsequent experiments.Compared with 0 μmol·L-1 A-674563,the expression level of p-Akt1 protein in the INS-1 cells after treated with 0.3 μmol·L-1 A-674563+10 mmol·L-1 STZ+600 mg·L-1 sericin+complete medium was significantly decreased(P<0.05).The CCK-8 results showed that compared with normal control group,the survival rate of the INS-1 cells in model group was significantly decreased(P<0.05);compared with model group,the survival rates of the INS-1 cells in low,medium,and high doses of sericin groups were significantly increased(P<0.05);compared with low and medium doses of sericin groups,the survival rate of the INS-1 cells in high dose of sericin group was significantly increased(P<0.05).Thus,600 mg·L-1 sericin was selected for subsequent experiments.The CCK-8 results showed that compared with normal control group,the survival rate of the INS-1 cells in model group was significantly decreased(P<0.05);compared with model group,the survival rate of the INS-1 cells in sericin group was significantly increased(P<0.05);compared with sericin group,the survival rate of the INS-1 cells in A-674563 group was significantly decreased(P<0.05).The flow cytometry results showed that compared with normal control group,the apoptotic rate of the INS-1 cells in model group was significantly increased(P<0.05);compared with model group,the apoptotic rate of the INS-1 cells in sericin group was significantly decreased(P<0.05);compared with sericin group,the apoptotic rate of the INS-1 cells in A-674563 group was significantly increased(P<0.05).The RT-qPCR results showed that compared with normal control group,the expression level of Akt1 mRNA in the INS-1 cells in model group was significantly decreased(P<0.05);compared with model group,the expression levels of Akt1 mRNA in the INS-1 cells in low,medium,and high doses of sericin groups were significantly increased(P<0.05);compared with low and medium doses of sericin groups,the expression level of Akt1 mRNA in the INS-1 cells in high dose of sericin group was significantly increased(P<0.05).Compared with normal control group,the expression levels of NF-κB,TNF-α,and IL-6 mRNA in the INS-1 cells in model group were significantly increased(P<0.05);compared with model group,the expression levels of NF-κB,TNF-α,and IL-6 mRNA in the INS-1 cells in sericin group were significantly decreased(P<0.05);compared with sericin group,the expression level of NF-κB mRNA in the INS-1 cells in A-674563 group was significantly increased(P<0.05).The Western blotting results showed that compared with normal control group,the expression level of p-Akt1 protein in the INS-1 cells in model group was significantly decreased(P<0.05);compared with model group,the expression levels of p-Akt1 protein in the INS-1 cells in low,medium,and high doses of sericin groups were significantly increased(P<0.05);compared with low and medium doses of sericin groups,the expression level of p-Akt1 protein in the INS-1 cells in high dose of sericin group was significantly increased(P<0.05).Compared with normal control group,the expression level of NF-κB protein in the INS-1 cells in model group was significantly increased(P<0.05);compared with model group,the expression level of NF-κB protein in the INS-1 cells in sericin group was significantly decreased(P<0.05);compared with sericin group,the expression level of NF-κB protein in the INS-1 cells in A-674563 group was significantly increased(P<0.05).The ELISA results showed that compared with normal control group,the levels of TNF-α and IL-6 in the INS-1 cells in model group were significantly increased(P<0.05);compared with model group,the levels of TNF-α and IL-6 in the INS-1 cells in sericin group were significantly decreased(P<0.05);compared with sericin group,the levels of TNF-α and IL-6 in the INS-1 cells in A-674563 group were significantly increased(P<0.05).Conclusion:Sericin alleviates the PI3K/Akt/NF-κB signaling pathway-mediated inflammatory response and apoptosis by targeting Akt1,exerting a protective effect against STZ-induced damage in INS-1 cells.

Objective To extract and summarize the clinical registration information of periodontitis registered in the US ClinicalTrials.gov and Chinese Clinical Trial Registry(ChiCTR),and further analyze the registration characteristics of periodontitis clinical trials.Methods The ClinicalTrials.gov and ChiCTR data-bases were searched and compiled for periodontitis clinical registration information from 2000 to December 26,2024,including registration number,country/region of registration,annual number of registered projects,sample size,study type and design,study phase,and trial progress status.Results As of December 26,2024,a total of 520 242 registered clinical trials were retrieved from the ClinicalTrials.gov registry platform,of which 1 542(0.30%)were related to periodontitis.There were 189(12.26%)studies on periodontitis-related pro-jects in Turkey,while a total of 37(2.4%)projects were initiated by researchers in China,which ranked ninth.The Chinese Clinical Trial Register(ChiCTR)had 92 954 registered projects,of which 165 were on pe-riodontitis,and most of them were conducted by well-known affiliated hospitals and stomatology hospitals.The number of registrations in the ClinicalTrials.gov database increased year by year and reached a peak in 2022(146 registrations).Trial designs were focused on interventional and observational studies.ClinicalTri-als.gov study phases were focused on phases 2 and 4,while ChiCTR was clustered at phase 0(pre-registra-tion).Conclusion The number of clinical registrations for periodontitis in China's database is relatively low,and despite a steady upward trend,there is still a gap compared with other countries internationally.Future re-search should focus on how to encourage more oral health related research institutions to register on the plat-form and how to increase the sample size.

Objective To explore the value of dual factor combined detection using tuberculosis(TB)specific cy-tokines interferon-γ(IFN-γ)and interleukin-2(IL-2)in TB diagnosis in patients with human immunodeficiency vi-rus(HIV)infection,and the influencing factors for underdiagnosis.Methods HIV-infected patients admitted to and underwent TB-related examination in the Department of Infectious Diseases in Hezhou People's Hospital from July 2022 to September 2024 were collected.According to the clinical diagnosis criteria,patients were divided into the HIV infection with TB group(HIV/TB group)and the HIV infection without TB group(control group).Diag-nostic efficacy of dual factor combined detection was evaluated.HIV/TB group was further divided into a true-posi-tive group and a false-negative group based on the detection results.The independent influencing factors for underdia-gnosis was analyzed using multivariate logistic regression.Results A total of 306 patients were included in the analysis,with an average age of(55.69±14.02)years.There were 105 patients in the HIV/TB group and 201 in the control group.The sensitivity and specificity of dual factor combined detection for TB in all HIV-infected pa-tients were 72.4％(76/105)and 87.1％(175/201),respectively.There was a statistically significant difference in sensitivity(x2=9.488,P=0.009)and no statistically significant difference in specificity(x2=5.846,P=0.054)among the three CD4+T lymphocyte count gradients in the dual factor detection.Among them,patients with CD4+T cell count＜100 cells/μL had lower sensitivity(58.8％)in dual factor detection than patients with CD4+T cell count ≥200 cells/μL(88.9％)and 100-199 cells/μL(81.5％),differences were both statistically significant(both P＜0.05).In HIV/TB co-infected patients with CD4+T lymphocyte count ≥100 cells/μL,the general sensi-tivity and the specificity of dual factor combined detection were 85.2％(46/54)and 82.0％(91/111),respectively.Multivariate analysis showed that CD4+T lymphocyte count was an independent influencing factor for the underdia-gnosis in HIV/TB patients conducting dual factor combined detection(P＜0.05),while age,gender,pathogen re-sults,and the presence or absence of TB had no statistically significant impact on the results of dual factor combined detection(all P＞0.05).Conclusion Dual factor combined detection using tuberculosis-specific cytokines IFN-γand IL-2 has a high diagnostic value in the diagnosis of TB in HIV-infected patients,especially in those with CD4+T lymphocyte count ≥100/μL,which can provide auxiliary diagnostic value for the clinical diagnosis of HIV infection combined with TB.

Purpose To investigate the expression of LAMB3 and ITGB4 in esophageal squamous cell carcinoma(ESCC)and analyze their associations with clinicopathological features.Methods Bioinformatics was used to assess the expression of LAMB3 and ITGB4 in pan-cancer and ESCC.Immunohistochemistry was performed to evaluate their expression and distribution in ESCC tissues,and correlations clinicopathological features were analyzed.Follow-up data were collected to construct Kaplan-Meier survival curves,and Cox regression analysis was proformed to determine their prognostic significance.Results Bioinformatics analysis showed that LAMB3 and ITGB4 were highly expressed in ES-CC tissues(P＜0.001).Immunohistochemistry confirmed that both proteins were localized in the cytoplasm and membrane of tumor cells.High LAMB3 expression was significantly associated with poor differentiation(P＜0.001),lymph node metastasis(P=0.015),and T staging(P＜0.001).High ITGB4 expression was significantly correlated with poor differentiation(P=0.004)and advanced T staging(P=0.004).Cox regression analysis identified high ex-pression of LAMB3 and ITGB4 as independent prognostic factors for overall survival[HR=4.97(95％CI:2.73-9.02);HR=2.33(95％CI:1.36-3.99)].Conclusion LAMB3 and ITGB4 are highly expressed in ESCC.High LAMB3 expression is associated with tumor differentiation,lymph node metastasis,and T staging,while high ITGB4 expression is correlated with tumor differentiation and T staging.Patients with high expression of LAMB3 or ITGB4 have poorer overall survival,suggesting that these proteins may serve as prognostic biomarkers for unfavorable outcome in ESCC.

Osteosarcoma is the most common malignant bone tumor disease in young children and young people. It usually has strong invasiveness, and conventional treatment cannot achieve the expected results. Therefore, studying the mechanism of tumor cell death and exploring more effective treatment methods is of great significance. As a new form of cell death, ferroptosis has been found to have three main regulatory pathways closely related to tumor cell molecular mechanisms, genes, etc. This provides a theoretical basis for the application of ferroptosis in the treatment of osteosarcoma. This article reviews recent research on the interaction between ferroptosis and osteosarcoma in regulating molecules, genes, and other factors, as well as the application of ferroptosis in the treatment of osteosarcoma.

Exosomes are extracellular microbubbles related to intercellular communication, which have the ability to transport and transfer biological macromolecules. Pain will lead to a sharp decline in the quality of life of patients, and will give patients and society a heavy medical burden. More and more evidences show that the exosomes plays an important role in the pathological process of pain related diseases.Summarizing the exosomes and the biomolecules carried by them under different pain conditions, and identifying the specific exosomes related to the pain state will be helpful for early diagnosis and treatment of pain related diseases. In addition, the ability of exosomes to transmit information and its widespread characteristics in the body indicate that they have broad prospects as a new diagnosis and treatment tool in the field of pain. A better understanding of the relationship between the exosomes and pain will provide a novel and promising treatment for patients with pain.