The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

ObjectiveTo express and purify the endolysin PlyL from the Bacillus anthracis prophage LambdaBa02 in prokaryotic cells, and to explore its role in the detection of Bacillus anthracis, so as to provide a novel strategy for the specific and rapid detection of Bacillus anthracis.MethodsAccording to the sequence of Bacillus anthracis vaccine strain CVCC40205 registered in GenBank, the plyL gene was amplified by PCR with plyL gene-specific primers and inserted into the prokaryotic expression vector pET28a(+) to construct the recombinant expression plasmid pET28a(+)-His-plyL, which was then transformed into E.coli BL21(DE3) and induced by IPTG. The induced expression conditions were optimized to enhance soluble expression, and the recombinant PlyL protein was purified via nickel-affinity chromatography. The lytic activity of recombinant PlyL protein was assessed by measuring absorbance values, and an ELISA method was established to evaluate the sensitivity and specificity of Bacillus anthracis detection.ResultsThe recombinant expression plasmid pET28a(+)-His-plyL was confirmed to be correctly constructed by NdeⅠ and XhoⅠ double digestion and sequencing. The optimal induction conditions were 0. 5 mmol/L IPTG at 16 ℃ for 16 h. The relative molecular mass of the expressed recombinant PlyL protein was about 28 600. After purification and concentration, the final concentration of the protein was2. 55 mg/mL, and the purity reached 80. 6%. The purified recombinant PlyL protein could reduce the A_(600)value of Bacillus anthracis culture solution. The sensitivity of the preliminarily established ELISA method for detecting Bacillus anthracis was1 × 10~3 CFU/mL, and there was no cross-reactivity against closely related strains such as Bacillus cereus and Bacillus thuringiensis(P < 0. 000 1).ConclusionThe recombinant PlyL protein was successfully expressed and purified in prokaryotic cells, which exhibits both efficient lytic activity and species specificity, making it a promising novel tool for the rapid detection of Bacillus anthracis.

To explore the advantages of traditional Chinese medicine （TCM） and integrative TCM-Western medicine approaches in the treatment of diabetic microvascular complications （DMC）， refine key pathophysiological insights and treatment principles， and promote academic innovation and strategic research planning in the prevention and treatment of DMC. The 38th session of the Expert Salon on Diseases Responding Specifically to Traditional Chinese Medicine， hosted by the China Association of Chinese Medicine， was held in Beijing， 2024. Experts in TCM， Western medicine， and interdisciplinary fields convened to conduct a systematic discussion on the pathogenesis， diagnostic and treatment challenges， and mechanism research related to DMC， ultimately forming a consensus on key directions. Four major research recommendations were proposed. The first is addressing clinical bottlenecks in the prevention and control of DMC by optimizing TCM-based evidence evaluation systems. The second is refining TCM core pathogenesis across DMC stages and establishing corresponding "disease-pattern-time" framework. The third is innovating mechanism research strategies to facilitate a shift from holistic regulation to targeted intervention in TCM. The fourth is advancing interdisciplinary collaboration to enhance the role of TCM in new drug development， research prioritization， and guideline formulation. TCM and integrative approaches offer distinct advantages in managing DMC. With a focus on the diseases responding specifically to TCM， strengthening evidence-based support and mechanism interpretation and promoting the integration of clinical care and research innovation will provide strong momentum for the modernization of TCM and the advancement of national health strategies.

ObjectiveTo investigate the association of physical activity and balance ability with disability, and to further examine the mediating role of balance ability in the relationship between physical activity and disability. MethodsBased on data from 2021 to 2023 National Health and Nutrition Examination Survey (NHANES) cycle, a multivariable Logistic regression model was constructed to evaluate the independent association of physical activity and balance ability with disability, with covariates adjusted in four steps. An interaction model was further developed to assess the multiplicative interaction between physical activity and balance ability. Mediation analysis was performed using the Baron and Kenny three-step approach to examine the mediating role of balance ability, and the proportion of the mediation effect was calculated. The significance of the mediation effect was assessed using the Delta method, and robustness was verified through the Bootstrap method with a fixed random seed. Multiple sensitivity analyses were conducted to ensure the stability of the results. ResultsA total of 3 902 participants were included, with a prevalence of disability of 17.7%. Multivariable regression analysis showed that, after adjusting for all covariates, both light-intensity physical activity (LIPA) (OR = 0.489, 95%CI 0.380 to 0.629, P < 0.001) and high-intensity physical activity (HIPA) (OR = 0.493, 95%CI 0.371 to 0.656, P < 0.001) were significantly associated with a reduced risk of disability, whereas impaired balance ability was significantly associated with an increased risk (OR = 1.579, 95%CI 1.266 to 1.970, P < 0.001). The interaction effect analysis showed that the interaction between physical activity and balance ability were not significant (P > 0.05), however, the main effect of LIPA remained robust (β = -0.597, SE = 0.221, OR = 0.550, P = 0.007), while impaired balance ability was significantly associated with an increased risk of disability (β = 0.577, SE = 0.231, OR = 1.780, P = 0.012). The mediation analysis further indicated that balance ability played a robust mediating role in the association between LIPA and disability, with a mediation proportion of 21.1%. The indirect effect (a × b) was statistically significant (P < 0.001), and the 95% confidence intervals derived from the bootstrap method did not include zero. ConclusionPhysical activity and balance ability are significantly associated with disability, and balance ability may mediate the relationship between physical activity and disability, highlighting its potential value in disability risk assessment and intervention strategies.

Idiopathic pulmonary fibrosis （IPF） is a chronic and fibrotic lethal interstitial lung disease with poor prognosis. It is mainly treated by organ transplantation and administration of chemical drugs， which have poor efficacy and induce side effects， failing to meet the clinical needs. Therefore， it is urgent to develop more safe and effective drugs to treat IPF. Traditional Chinese medicine （TCM） has garnered increasing attention in recent years in the treatment of IPF due to its unique advantages. Increasing studies have shown that TCM has remarkable therapeutic effects on IPF and thus demonstrate broad application prospects. Modern medical research shows that the pathogenesis of IPF can be discussed from inflammation （macrophage polarization）， oxidative stress， epithelial-mesenchymal transition （EMT）， autophagy inhibition and other related signaling pathways， while few studies systematically explain the relationship between the signaling pathways and TCM theory. According to the theory of TCM， lung collateral obstruction is the basic pathogenesis of IPF. Therefore， according to the principle of dredging and replenishing lung collaterals， IPF can be treated with the methods of reinforcing healthy qi and eliminating pathogen， replenishing qi and activating blood， and detoxifying and dredging collaterals， which demonstrate definite curative effect and can effectively relieve clinical symptoms， restore the lung function and blood oxygen partial pressure， improve the quality of life of patients， and reduce adverse reactions. Experimental studies have found that dredging and replenishing lung collaterals have significant effects on IPF inflammation （macrophage polarization）， oxidative stress， EMT， autophagy inhibition and other signaling pathways. Therefore， from the perspective of impediment， this article reviews pathogenesis of IPF， the research progress in TCM treatment of IPF， and the treatment of IPF from active components， single herbs， and compound prescriptions of TCM， with the aim of revealing the scientific connotation of the treatment of IPF from impediment and providing a new theoretical basis for enriching the TCM methods of treating IPF.

Acute-on-chronic liver failure （ACLF） is a syndrome of multiple organ failure on the basis of underlying chronic liver disease and has an extremely high short-term mortality rate， while there is still a lack of unified diagnostic criteria around the world. Radiology plays an important role in the evaluation and prognostic prediction of ACLF， constituting a multi-dimensional assessment system covering morphology， function， and hemodynamics. Computed tomography can be used for the measurement of liver volume and the diagnosis of sarcopenia by providing key morphological and nutritional parameters. Magnetic resonance imaging （MRI）， especially gadobenate dimeglumine-enhanced MRI， enables quantitative assessment of liver function and has critical significance for predicting short-term survival rate. Ultrasonography and elastography techniques facilitate the early warning of ACLF onset and the dynamic monitoring of its progression through noninvasive measurement of liver stiffness and hemodynamic parameters. This article systematically reviews the pivotal role of these three imaging modalities in the diagnosis and monitoring of ACLF， and integrating the strengths of multiple imaging techniques with clinical indicators to construct diagnostic and prognostic models may become a key future direction for achieving early intervention and improving clinical outcomes in ACLF.

Objective: To investigate the ferroptosis induced by sesamin in triple-negative breast cancer ( TNBC) 4T1 cells and its underlying mechanism . Methods: The binding energy of sesamin with glutathione peroxidase 4 (GPX4) , solute carrier family 7 member 11 ( SLC7A11) , and P53 was analyzed by molecular docking. Mouse TNBC cell line 4T1 was used as a model . Different concentrations of sesamin were administered to 4T1 cells . The effect of sesamin on cell viability was assessed using the cell counting kit 8 (CCK-8) . Transwell assay was used to evaluate the effect of sesamin on cell migration and invasion . The contents of Fe2 + , malondialdehyde (MDA) , and reduced glutathione (GSH) in the cells were measured using kits . 2 ′,7 ′-dichlorofluorescein diacetate (DCFH-DA) probe was employed to detect the content of reactive oxygen species (ROS) in cells . Real-time quantitative reverse transcription polymerase chain reaction (RT-qPCR) and Western blot were performed to evaluate the expression of GPX4 , SLC7A11 , and P53 at mRNA and protein levels . Results: The binding energies of sesamin with GPX4 , SLC7A11 and P53 were - 21 . 46 , - 21 . 67 , and - 27 . 03 kJ/mol , respectively . Compared with the control group , the viability of 4T1 cells in different concentrations of sesamin groups decreased gradually ( P < 0. 001) , and the migration and invasion ability of 4T1 cells in 20 , 40 , and 80 μmol/L sesamin groups decreased gradually (all P < 0. 001) . Compared with the control group , the contents of Fe2 + , MDA , and ROS in 4T1 cells of 20 , 40 , and 80 μmol/L sesamin groups increased , and the content of GSH decreased . Compared with the control group , the mRNA and protein expression of GPX4 and SLC7A11 in 4T1 cells in the sesamin treatment group decreased , and the mRNA and protein expression of P53 increased ( all P < 0. 001) . Conclusion Sesamin may induce the ferroptosis in 4T1 cells through P53/SLC7A11 /GPX4 pathway .

Apical microsurgery is accurate and minimally invasive, produces few complications, and has a success rate of more than 90%. However, due to the lack of awareness and understanding of apical microsurgery by dental general practitioners and even endodontists, many clinical problems remain to be overcome. The consensus has gathered well-known domestic experts to hold a series of special discussions and reached the consensus. This document specifies the indications, contraindications, preoperative preparations, operational procedures, complication prevention measures, and efficacy evaluation of apical microsurgery and is applicable to dentists who perform apical microsurgery after systematic training.
Microsurgery/standards* ; Humans ; Apicoectomy ; Contraindications, Procedure ; Tooth Apex/diagnostic imaging* ; Postoperative Complications/prevention & control* ; Consensus ; Treatment Outcome

Enamel demineralization, the formation of white spot lesions, is a common issue in clinical orthodontic treatment. The appearance of white spot lesions not only affects the texture and health of dental hard tissues but also impacts the health and aesthetics of teeth after orthodontic treatment. The prevention, diagnosis, and treatment of white spot lesions that occur throughout the orthodontic treatment process involve multiple dental specialties. This expert consensus will focus on providing guiding opinions on the management and prevention of white spot lesions during orthodontic treatment, advocating for proactive prevention, early detection, timely treatment, scientific follow-up, and multidisciplinary management of white spot lesions throughout the orthodontic process, thereby maintaining the dental health of patients during orthodontic treatment.
Humans ; Consensus ; Dental Caries/etiology* ; Dental Enamel/pathology* ; Tooth Demineralization/etiology* ; Tooth Remineralization