Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

AIM:This study aims to investigate the changes in the lactylation levels of mitsugumin 53(MG53)protein during myocardial ischemia/reperfusion(I/R)and to further explore the potential molecular mechanisms by which MG53 lactylation impacts myocardial cell injury resulting from I/R.METHODS:A myocardial I/R model was established in mice through ligation of the left anterior descending coronary artery followed by reperfusion.Simultaneous-ly,a hypoxia/reoxygenation(H/R)model of rat myocardial H9C2 cells was created in vitro.In the mouse model,TTC and HE staining were employed to assess myocardial ischemia and injury.The levels of creatine kinase and cardiac troponin I were quantified using ELISA,while MG53 expression was evaluated through immunofluorescence.In the in vitro cell model,CCK-8 assay and flow cytometry were utilized to measure cell viability and apoptosis level,respectively.The levels of MG53 protein,its lactylation,and ferroptosis-related proteins in both mouse myocardial tissue and in vitro rat cardiomyo-cytes were analyzed using immunoprecipitation and Western blot.Additionally,the levels of reactive oxygen species,fer-rous ion,lactate dehydrogenase and malondialdehyde in tissues and cells were measured using appropriate assay kits.RE-SULTS:In the I/R group,mouse myocardial tissue exhibited significant injury following cardiac I/R.The expression of MG53 protein was reduced,while the lactylation level of MG53 protein and the ferroptosis of myocardial cells were in-creased.In the in vitro cardiomyocyte experiments,H/R exposure resulted in decreased cell viability,increased apoptosis and ferroptosis levels,reduced MG53 protein expression,and increased MG53 lactylation level.Treatment with 2-deoxy-D-glucose(2-DG)improved cardiomyocyte viability,decreased apoptosis and ferroptosis levels,increased MG53 expres-sion,and lowered MG53 lactylation level.Furthermore,the addition of exogenous lactate significantly countered the ef-fects of 2-DG on cell viability and MG53 expression,and increased the cell apoptosis,ferroptosis and MG53 lactylation levels.CONCLUSION:During myocardial I/R,there is a down-regulation of MG53 protein expression accompanied by an increase in the lactylation level of MG53 protein.The elevation of MG53 lactylation may exacerbate myocardial I/R inju-ry by facilitating the ferroptosis of cardiomyocytes.

Objective To analyze the status and its influencing factors of high-frequency hearing loss (HFHL) among occupational noise-exposed workers. Methods A total of 6 764 noise-exposed workers who participated in occupational medical examinations during their employment were selected as the study subjects using the judgmental sampling method. Their pure-tone audiometry results were analyzed. Results The detection rate of HFHL among the study subjects was 10.3%. Binary logistic regression analysis result revealed that males had a higher risk of HFHL than females (P<0.05). The HFHL risk of workers increased with age (all P<0.01). Workers with longer noise exposure durations had a higher risk of HFHL (all P<0.01). Smokers had a higher detection rate of HFHL than non-smokers (P<0.01). Workers in the mining industry, electricity/heat/gas and water production and supply industry, and other industries had a higher HFHL detection rate compared with manufacturing workers (all P<0.05). Medium-sized enterprise workers had a lower HFHL detection rate compared with micro-sized enterprise workers (P<0.05), while workers in private enterprises had a higher HFHL detection rate compared with those in state-owned enterprises (P<0.05). Workers who exposed to noise combined with dust, lead, high temperature, or multiple factors had a higher HFHL risk than those only exposed to noise (all P<0.05). Conclusion Gender, age, noise exposure duration, smoking, industry, and exposure to noise combined with other occupational hazard factors are all influencing factors for HFHL among noise-exposed workers. Targeted occupational health education on noise hazard prevention and occupational medical surveillance should be strengthened for key populations in priority industries, including male workers, older employees, individuals with prolonged noise exposure, smokers, and those concurrently exposed to noise and one of the following: dust, lead, high temperatures, or multiple occupational factors.

Objective:To report the nationwide surveillance results of pathogenic profiles and antimicrobial resistance patterns of Gram-positive bloodstream infections in China in 2023.Methods:The clinical isolates of Gram-posttive bacteria from blood cultures were collected in member hospitals of National Bloodstream Infection Bacterial Resistant Investigation Collaborative System（BRICS）during January to December 2023. Antimicrobial susceptibility testing was performed using the dilution method recommended by the Clinical and Laboratory Standards Institute（CLSI）. Statistical analyses were conducted using WHONET 5.6 and SPSS 25.0 software.Results:A total of 4 385 Gram-positive bacterial isolates were obtained from 60 participating center. The top five pathogens were Staphylococcus aureus（ n=1 544，35.2%），coagulase-negative Staphylococci（ n=1 441，32.9%）， Enterococcus faecium（ n=574，13.1%）， Enterococcus faecalis（ n=385，8.8%），and α-hemolytic Streptococci（ n=187，4.3%）. The prevalence of methicillin-resistant Staphylococcus aureus（MRSA）and methicillin-resistant coagulase-negative Staphylococci（MRCNS）was 26.2%（405/1 544）and 69.8%（1 006/1 441），respectively. Notably，all Staphylococci remained susceptible to glycopeptide or daptomycin. Staphylococcus aureus demonstrated excellent susceptibility（>97.0%）to cephalobiol，rifampicin，trimethoprim-sulfamethoxazole，linezolid，minocycline，tigecycline，and eravacycline. No Enterococcus exhibiting resistance to linezolid were detected. Glycopeptide resistance was uncommon but more frequent in Enterococcus faecium（resistance to vancomycin and teicoplanin：both 1.7%）compared to Enterococcus faecalis（both 0.3%）. The detection rates of MRSA and MRCNS exhibited significant regional variations across the country（ χ2=17.674 and 148.650，respectively，both P<0.001）. No vancomycin-resistant Enterococci were detected in central China. Institutional comparison demonstrated higher prevalence of MRSA（ χ2=14.111， P<0.001）and MRCNS（ χ2=4.828， P=0.028）in provincial hospitals than that in municipal hospitals. Socioeconomic analysis identified elevated detection rates of both MRSA（ χ2=18.986， P<0.001）and MRCNS（ χ2=4.477， P=0.034）in less developed regions（per capita GDP

Objective:To report the results of bacterial resistant investigation collaborative system（BRICS）on the distribution and antimicrobial resistance profile of clinical Gram-negative bacteria isolates from bloodstream infections in China in 2023，and provide reference for clinical tretment of bloodstream infections and prevention and control of bacterial resistance.Methods:The clinical isolates of Gram-negative bacteria from blood cultures in member hospitals of BRICS were collected during January 2023 to December 2023. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical and Laboratory Standards Institute（CLSI）. WHONET 5.6 and SPSS 25.0 were used to analyze the data.Results:During the study period，11 492 strains of Gram-negative bacteria were collected from 60 hospitals，of which 10 098（87.9%）were Enterobacterales and 1 394（12.1%）were non-fermentative bacteria. The top 5 bacterial species were Escherichia coli（50.0%）， Klebsiella pneumoniae（26.1%）， Pseudomonas aeruginosa（5.1%）， Acinetobacter baumannii complex（5.0%）and Enterobacter cloacae complex（4.1%）. The ESBL-producing rates in Escherichia coli， Klebsiella pneumoniae and Proteus mirablilis were 46.8%（2 685/5 741），18.3%（549/2 999）and 44.0%（77/175），respectively. The prevalence of carbapenem-resistant Escherichia coli（CREC）and carbapenem-resistant Klebsiella pneumoniae（CRKP）were 1.3%（76/5 741）and 15.0%（450/2 999）；32.9%（25/76）and 78.0%（351/450）of CREC and CRKP were sensitive to ceftazidime/avibactam combination，respectively. 94.7%（72/76）and 90.2%（406/450）of CREC and CRKP were sensitive to aztreonam/avibactam combination. Furthermore，57.9%（44/76）and 79.1%（356/450）were sensitive to imipenem/relebactam combination. The prevalence of carbapenem-resistant Acinetobacter baumannii（CRAB）complex was 64.6%（370/573），while more than 80.0% of CRAB complex was sensitive to tigecycline，eravacycline and polymyxin B. The prevalence of carbapenem-resistant Pseudomonas aeruginosa（CRPA）was 17.0%（99/581）. There were differences in the composition ratio of Gram-negative bacteria in bloodstream infections and the prevalence of important Gram-negative bacteria resistance among different regions in China，with statistically significant differences in the prevalence of CREC，CRKP，CRPA and CRAB complex（ χ2=10.6，28.6，10.8 and 19.3， P<0.05）. The prevalence of ESBL-producing Escherichia coli， CREC，CRAB complex and CRKP were higher in provincial hospitals than those in municipal hospitals（ χ2=12.5，9.8，12.7 and 57.8，all P<0.01）. Conclusions:Gram-negative bacteria are the main pathogens causing bloodstream infections in China，and Escherichia coli is ranked in the top，while the trend of Klebsiella pneumoniae increases continuously with time. CRKP infection shows a slow upward trend，CREC infecton maintains a low prevalence level，and CRAB complex infection continues to exhibit a high prevalence rate. The composition and resistance patterns of pathogens causing bloodstream infections vary to some extent across different regions and levels of hospitals in China.

Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.

Background and Aims:Minimally invasive surgery,represented by laparoscopic techniques,plays a vital role in the treatment of gastric cancer.However,postoperative infectious complications remain a key factor affecting patient recovery and prognosis.This study was performed to identify the risk factors associated with early(≤1 month)infectious complications after laparoscopic surgery for gastric cancer,providing a reference for clinical prevention strategies.Methods:A retrospective analysis was conducted on 1 572 patients who underwent laparoscopic surgery for gastric cancer at the First Affiliated Hospital of Xi'an Jiaotong University from March 2020 to February 2024.Patients were divided into infection and non-infection groups based on the occurrence of postoperative infectious complications.Univariate and multivariate Logistic regression analyses were performed to identify related risk factors.Results:Among the 1 572 patients,194 cases(12.3％)developed early postoperative infectious complications,including intra-abdominal infections(4.1％),surgical site infections(3.7％),and pulmonary infections(5.6％).Univariate analysis revealed that a history of diabetes,pulmonary disease,smoking,and preoperative anemia and hypoalbuminemia were significantly associated with postoperative infections(all P＜0.05).Multivariate analysis indicated that a history of diabetes(OR=6.927,95％CI=4.194-12.935),smoking(OR=3.079,95％CI=2.261-4.913),and preoperative albumin＜35 g/L(OR=0.572,95％CI=0.302-1.578)were independent risk factors for early postoperative infectious complications.Conclusion:A history of diabetes,smoking,and preoperative hypoalbuminemia are closely associated with the occurrence of early postoperative infectious complications after laparoscopic gastric cancer surgery.Clinical attention should be paid to perioperative metabolic,nutritional,and lifestyle management,and early intervention for high-risk patients may help reduce the incidence of complications,improve recovery,and enhance treatment outcomes.

Background and Aims:Minimally invasive surgery,represented by laparoscopic techniques,plays a vital role in the treatment of gastric cancer.However,postoperative infectious complications remain a key factor affecting patient recovery and prognosis.This study was performed to identify the risk factors associated with early(≤1 month)infectious complications after laparoscopic surgery for gastric cancer,providing a reference for clinical prevention strategies.Methods:A retrospective analysis was conducted on 1 572 patients who underwent laparoscopic surgery for gastric cancer at the First Affiliated Hospital of Xi'an Jiaotong University from March 2020 to February 2024.Patients were divided into infection and non-infection groups based on the occurrence of postoperative infectious complications.Univariate and multivariate Logistic regression analyses were performed to identify related risk factors.Results:Among the 1 572 patients,194 cases(12.3％)developed early postoperative infectious complications,including intra-abdominal infections(4.1％),surgical site infections(3.7％),and pulmonary infections(5.6％).Univariate analysis revealed that a history of diabetes,pulmonary disease,smoking,and preoperative anemia and hypoalbuminemia were significantly associated with postoperative infections(all P＜0.05).Multivariate analysis indicated that a history of diabetes(OR=6.927,95％CI=4.194-12.935),smoking(OR=3.079,95％CI=2.261-4.913),and preoperative albumin＜35 g/L(OR=0.572,95％CI=0.302-1.578)were independent risk factors for early postoperative infectious complications.Conclusion:A history of diabetes,smoking,and preoperative hypoalbuminemia are closely associated with the occurrence of early postoperative infectious complications after laparoscopic gastric cancer surgery.Clinical attention should be paid to perioperative metabolic,nutritional,and lifestyle management,and early intervention for high-risk patients may help reduce the incidence of complications,improve recovery,and enhance treatment outcomes.

AIM:This study aims to investigate the changes in the lactylation levels of mitsugumin 53(MG53)protein during myocardial ischemia/reperfusion(I/R)and to further explore the potential molecular mechanisms by which MG53 lactylation impacts myocardial cell injury resulting from I/R.METHODS:A myocardial I/R model was established in mice through ligation of the left anterior descending coronary artery followed by reperfusion.Simultaneous-ly,a hypoxia/reoxygenation(H/R)model of rat myocardial H9C2 cells was created in vitro.In the mouse model,TTC and HE staining were employed to assess myocardial ischemia and injury.The levels of creatine kinase and cardiac troponin I were quantified using ELISA,while MG53 expression was evaluated through immunofluorescence.In the in vitro cell model,CCK-8 assay and flow cytometry were utilized to measure cell viability and apoptosis level,respectively.The levels of MG53 protein,its lactylation,and ferroptosis-related proteins in both mouse myocardial tissue and in vitro rat cardiomyo-cytes were analyzed using immunoprecipitation and Western blot.Additionally,the levels of reactive oxygen species,fer-rous ion,lactate dehydrogenase and malondialdehyde in tissues and cells were measured using appropriate assay kits.RE-SULTS:In the I/R group,mouse myocardial tissue exhibited significant injury following cardiac I/R.The expression of MG53 protein was reduced,while the lactylation level of MG53 protein and the ferroptosis of myocardial cells were in-creased.In the in vitro cardiomyocyte experiments,H/R exposure resulted in decreased cell viability,increased apoptosis and ferroptosis levels,reduced MG53 protein expression,and increased MG53 lactylation level.Treatment with 2-deoxy-D-glucose(2-DG)improved cardiomyocyte viability,decreased apoptosis and ferroptosis levels,increased MG53 expres-sion,and lowered MG53 lactylation level.Furthermore,the addition of exogenous lactate significantly countered the ef-fects of 2-DG on cell viability and MG53 expression,and increased the cell apoptosis,ferroptosis and MG53 lactylation levels.CONCLUSION:During myocardial I/R,there is a down-regulation of MG53 protein expression accompanied by an increase in the lactylation level of MG53 protein.The elevation of MG53 lactylation may exacerbate myocardial I/R inju-ry by facilitating the ferroptosis of cardiomyocytes.

Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.