Objective:To develop a bacterial endotoxin detection method suitable for mRNA vaccines based on lipid nanoparticle（LNP）delivery system.Methods:The gel clot limit test outlined in the third section of the Chinese Pharmacopoeia（2020 edition）was utilized. Taking the human herpesvirus type 2 mRNA vaccine as the detection object，the optimal conditions for bacterial endotoxin detection were established by evaluating sample dilution factors，diluents，and other interfering elements. The results were validated using the recombinant C factor method. Finally，the applicability of the established method was validated through testing the respiratory syncytial virus mRNA vaccine and the shingles mRNA vaccine.Results:Increasing the sample dilution factor to 480 times with a magnesium-containing buffer and using 0.06 EU/ml tachypleus amebocyte lysate effectively mitigated the interference caused by LNP on the test results of the human herpesvirus type 2 mRNA vaccine，the respiratory syncytial virus mRNA vaccine，and the shingles mRNA vaccine. The results from recombinant C factor method and the gel clot limit method were consistent.Conclusion:A bacterial endotoxin gel clot limit detection method tailored for human herpesvirus type 2 mRNA vaccine，respiratory syncytial virus mRNA vaccine，and shingles mRNA vaccine is successfully developed based on existing protocols in the Chinese Pharmacopoeia（2020 edition）. This study offers insights for the detection of bacterial endotoxin in LNP-based biological products.

Objective: To investigate the correlation of emotional and behavioral problems with sleep problems in children with cerebral palsy, so as to provide reference for intervention of emotional and behavioral problems in children. Methods: A cross sectional survey was conducted, and 402 children aged 6-18 with cerebral palsy who were adopted by social welfare institutions in Guangzhou City from January 2023 to January 2024 were selected to investigate their full time nurses. The Parents Strengths and Difficulties Questionnaire (SDQ) was used to assess the emotional and behavioral problems of children with cerebral palsy, and the Children s Sleep Habits Questionnaire (CSHQ) was used to assess sleep problems. Multiple linear regression analysis was used to analyze the correlation between the sleep problem of children with cerebral palsy and the emotional and behavioral problems. Results: The prevalence of emotional and behavioral difficulties among children with cerebral palsy was 15.7%. The median sleep problem score of children with emotional and behavioral problems [37.0(36.0, 41.0)] was significantly higher than that of children without emotional and behavioral [35.0(34.0, 36.0)] ( Z =-5.74, P <0.01). The results of multiple linear regression analysis showed that after adjusting covariables such as age, gender, cerebral palsy classification, language retardation, visual impairment and epilepsy, the total sleep problem score of children with cerebral palsy was positively correlated with the total difficulty score ( β= 0.28, 95%CI =0.17-0.34, P <0.05). Conclusions Sleep problems in children with cerebral palsy are associated with emotional and behavioral difficulties. Understanding of the management of sleep problems in children with cerebral palsy should be enhanced to reduce the incidence of emotional and behavioral problems in children with cerebral palsy.

Objective:To investigate the impact of high-density lipoprotein (HDL) subfraction cholesterol, measured by the vertical auto profile (VAP) technique based on vertical density gradient ultracentrifugation, on the occurrence and progression of coronary heart disease.Methods:This retrospective case-control study consecutively enrolled 94 inpatients diagnosed with coronary artery disease (CAD) by percutaneous coronary angiography at Ningbo University Affiliated First Hospital between June 2023 and June 2024 (CAD group), and 48 outpatients from the cardiology department without carotid or coronary atherosclerosis(non-CAD group). The VAP technique was employed to measure HDL subfraction cholesterol levels (HDL 3-C and HDL 2-C) and their subtypes (HDL 2a-C, HDL 2b-C, HDL 2c-C; HDL 3a-C, HDL 3b-C, HDL 3c-C, HDL 3d-C). Logistic regression analysis was performed to assess the association between HDL subfraction composition and CAD. CAD patients were further stratified by the number of affected coronary vessels (left anterior descending artery, left circumflex artery, and right coronary artery): 44 with single-vessel disease, 22 with double-vessel disease, and 28 with triple-vessel disease for correlation analysis. All CAD patients underwent 6-month clinical and telephone follow-up to record major adverse cardiovascular events (MACE), including acute myocardial infarction, stroke, and repeat revascularization. Using the median HDL 3d-C level (0.064 mmol/L) as cutoff, CAD patients were divided into high-level ( n=48) and low-level ( n=46) subgroups for Kaplan-Meier survival analysis with log-rank testing. Results:Compared with non-CAD controls, CAD patients showed significantly higher HDL 3d-C [0.064 (0.041, 0.095) mmol/L vs 0.055 (0.038, 0.067) mmol/L] and HDL 3b-C [0.031 (0.001, 0.054) mmol/L vs 0.007 (0.004, 0.029) mmol/L], lower HDL 3c-C (0.220±0.080 mmol/L vs 0.254±0.062 mmol/L) and HDL 3a-C [0.282 (0.224, 0.351) mmol/L vs 0.334 (0.269, 0.433) mmol/L] (all P<0.05). Logistic regression revealed that HDL2b-C was a protective factor against atherosclerosis severity ( OR=0.914, 95% CI 0.896-0.987, P<0.001); HDL 3d-C served as both a CAD risk factor ( OR=2.303,95% CI 1.740-3.047, P<0.001) and disease progression indicator ( OR=1.224, 95% CI 1.123-1.335, P=0.025). MACE patients ( n=6) had elevated HDL3d-C versus non-MACE cases ( n=88) [0.120 (0.083, 0.173) mmol/L vs 0.061 (0.037, 0.092) mmol/L, P<0.05]. The high HDL 3d-C subgroup demonstrated significantly lower 6-month survival (χ2=4.777, P=0.029). Conclusion:Contrary to conventional understanding, our study reveals that HDL2b serves as a protective factor against coronary artery disease progression, whereas HDL 3d-C acts not only as a pathogenic factor for CAD but also as a critical determinant of CAD-related adverse events.

Objective:To develop a bacterial endotoxin detection method suitable for mRNA vaccines based on lipid nanoparticle（LNP）delivery system.Methods:The gel clot limit test outlined in the third section of the Chinese Pharmacopoeia（2020 edition）was utilized. Taking the human herpesvirus type 2 mRNA vaccine as the detection object，the optimal conditions for bacterial endotoxin detection were established by evaluating sample dilution factors，diluents，and other interfering elements. The results were validated using the recombinant C factor method. Finally，the applicability of the established method was validated through testing the respiratory syncytial virus mRNA vaccine and the shingles mRNA vaccine.Results:Increasing the sample dilution factor to 480 times with a magnesium-containing buffer and using 0.06 EU/ml tachypleus amebocyte lysate effectively mitigated the interference caused by LNP on the test results of the human herpesvirus type 2 mRNA vaccine，the respiratory syncytial virus mRNA vaccine，and the shingles mRNA vaccine. The results from recombinant C factor method and the gel clot limit method were consistent.Conclusion:A bacterial endotoxin gel clot limit detection method tailored for human herpesvirus type 2 mRNA vaccine，respiratory syncytial virus mRNA vaccine，and shingles mRNA vaccine is successfully developed based on existing protocols in the Chinese Pharmacopoeia（2020 edition）. This study offers insights for the detection of bacterial endotoxin in LNP-based biological products.

Objective:To investigate the impact of high-density lipoprotein (HDL) subfraction cholesterol, measured by the vertical auto profile (VAP) technique based on vertical density gradient ultracentrifugation, on the occurrence and progression of coronary heart disease.Methods:This retrospective case-control study consecutively enrolled 94 inpatients diagnosed with coronary artery disease (CAD) by percutaneous coronary angiography at Ningbo University Affiliated First Hospital between June 2023 and June 2024 (CAD group), and 48 outpatients from the cardiology department without carotid or coronary atherosclerosis(non-CAD group). The VAP technique was employed to measure HDL subfraction cholesterol levels (HDL 3-C and HDL 2-C) and their subtypes (HDL 2a-C, HDL 2b-C, HDL 2c-C; HDL 3a-C, HDL 3b-C, HDL 3c-C, HDL 3d-C). Logistic regression analysis was performed to assess the association between HDL subfraction composition and CAD. CAD patients were further stratified by the number of affected coronary vessels (left anterior descending artery, left circumflex artery, and right coronary artery): 44 with single-vessel disease, 22 with double-vessel disease, and 28 with triple-vessel disease for correlation analysis. All CAD patients underwent 6-month clinical and telephone follow-up to record major adverse cardiovascular events (MACE), including acute myocardial infarction, stroke, and repeat revascularization. Using the median HDL 3d-C level (0.064 mmol/L) as cutoff, CAD patients were divided into high-level ( n=48) and low-level ( n=46) subgroups for Kaplan-Meier survival analysis with log-rank testing. Results:Compared with non-CAD controls, CAD patients showed significantly higher HDL 3d-C [0.064 (0.041, 0.095) mmol/L vs 0.055 (0.038, 0.067) mmol/L] and HDL 3b-C [0.031 (0.001, 0.054) mmol/L vs 0.007 (0.004, 0.029) mmol/L], lower HDL 3c-C (0.220±0.080 mmol/L vs 0.254±0.062 mmol/L) and HDL 3a-C [0.282 (0.224, 0.351) mmol/L vs 0.334 (0.269, 0.433) mmol/L] (all P<0.05). Logistic regression revealed that HDL2b-C was a protective factor against atherosclerosis severity ( OR=0.914, 95% CI 0.896-0.987, P<0.001); HDL 3d-C served as both a CAD risk factor ( OR=2.303,95% CI 1.740-3.047, P<0.001) and disease progression indicator ( OR=1.224, 95% CI 1.123-1.335, P=0.025). MACE patients ( n=6) had elevated HDL3d-C versus non-MACE cases ( n=88) [0.120 (0.083, 0.173) mmol/L vs 0.061 (0.037, 0.092) mmol/L, P<0.05]. The high HDL 3d-C subgroup demonstrated significantly lower 6-month survival (χ2=4.777, P=0.029). Conclusion:Contrary to conventional understanding, our study reveals that HDL2b serves as a protective factor against coronary artery disease progression, whereas HDL 3d-C acts not only as a pathogenic factor for CAD but also as a critical determinant of CAD-related adverse events.

Objective: To investigate the association between cysteine level and lumbar spine (LS) bone mineral density (BMD) among children with cerebral palsy, so as to provide a basis for bone health enhancement among children with cerebral palsy. Methods: A total of 149 children aged 10-18 with cerebral palsy who were admitted to the G city Social Welfare Institute (Luogang District) from January 2023 to January 2024. Basic demographic characteristics of children with cerebral palsy were extracted from medical records system. Cysteine levels were measured using the enzyme cycling method. LS BMD of the children was determined by specialized rehabilitation physicians using dual energy X ray absorptiometry, and the corrected BMD Z -scores for LS were calculated. Non restrictive cubic splines and segmented multiple linear regression were employed to analyze the correlation between cysteine levels and age specific height Z -scores (HAZ scores) for LS BMD in children with cerebral palsy. Results: The median cysteine concentration in children with cerebral palsy was 9.13(8.42, 10.30)μmol/L, with significantly higher levels in spastic type children [9.28(8.53，10.49)μmol/L] compared to non spastic types [8.64(7.89，9.66)μmol/L]( Z=-2.46，P <0.05). The median LS BMD HAZ score was -1.07( -2.10 , -0.16), and the detection rate of decreased bone mass was 29.5%. There was an "L" shaped association between serum homocysteine concentration and LS BMD HAZ score in children with cerebral palsy. When serum homocysteine concentration was below 8.7 μmol/L, a significant negative correlation was observed between LS BMD HAZ score and serum homocysteine concentration ( B=-0.32, 95%CI =-1.06 to -0.15, P <0.05). Conclusions The significant negative correlation between cysteine levels and LS BMD in children with cerebral palsy at lower cysteine concentrations, which suggests a potentially higher sensitivity to the influence of homocysteine than healthy children and adolescents, warranting attention even if not reaching the standard of hyperhomocysteinemia.

Replacement of the temporomandibular joint (RTJ) has undergone decades of technological improvements and is now an important treatment for end-stage temporomandibular joint (TMJ) disease. The main complications of RTJ include aseptic loosening, heterotopic ossification, postsurgical infection, hypersensitivity reaction, prosthesis loosening or malposition, nerve injury and severe bleeding. Improvement in clinical technique is now the key to resolving complications. In the future, improvements in prosthetic materials may be an important development for newer iterations. With the development and popularity of TMJ surgical techniques, prosthesis-related complications will increasingly come into clinical view. This article provides a systematic review of the complications of RTJ prosthesis replacement and the measures to deal with them, and looks forward to the direction of the development of this field from the perspective of reducing complications, so as to provide a reference for clinical work.

Objective To evaluate the efficacy of XELOX regimen as neoadjuvant chemotherapy in the treatment of stage Ⅱ and Ⅲ colon cancer.Methods The clinical data of 50 patients with clinical stage Ⅱ(T4)Ⅲ colon cancer who underwent laparoscopic radical resection at general surgery department of our hospital from January 1,2012 to January 1,2021 were retrospectively analyzed.Patients were divided into neoadjuvant chemotherapy group(NACT)and adjuvant chemotherapy group(ACT)according to whether they received neoadjuvant chemotherapy with XELOX regimen.The general clinical data,adverse reactions of chemotherapy,surgical complications,operation time,intraoperative blood loss,hospitalization time,hospitalization cost,negative conversion rate of tumor markers,tumor remission rate,tumor downstaging rate,tumor response grade after chemotherapy,postoperative disease-free survival curve,and overall survival curve were retrospectively analyzed and compared among the groups.Results There were no significant differences in operative complications,postoperative exhaust time and hospital stay between NACT group and ACT group(P＞0.05).The adverse reactions of chemotherapy,the negative conversion rate of postoperative CEA and CA19-9,the duration of operation,the amount of bleeding,and the hospitalization cost in NACT group were significantly better than those in ACT group(P＜0.05).In terms of DFS and OS survival curves,with the extension of time,the decline of the NACT survival curve was smaller than that of the ACT group,and there was a significant difference in DFS survival curve(P＜0.05),but no significant difference in OS survival curve(P＞0.05).Conclusion XELOX neoadjuvant chemotherapy is safe and effective in the treatment of stage Ⅱ(T4)and stage Ⅲcolon cancer.

Objective:To understand the commercial homosexual behavior characteristics of men who have sex with men (MSM) and the factors associated with unprotected anal intercourse (UAI) in this population, and provide reference for the development of intervention strategy in MSM.Methods:Men who were aged ≥16 years and had anal sex with men in the past 6 months were recruited through internet in Fuzhou from January to December 2023 for a cross-sectional study with a sample size of 283. Multivariate logistic regression model was used to analyze the factors associated with the incidence of UAI in the past 6 months in MSM. The SPSS 25.0 software was used for statistical analysis.Results:In 4 484 MSM, the proportion of those with commercial homosexual behaviors was 9.59% (430/4 484), the average age was (27.00±9.07) years. In the MSM with commercial homosexual behaviors, 70.00% (301/430) had anal sex in the past one week, and 43.02% (185/430) had anal sex with more than 10 partners in the past 6 months. The proportion of MSM with UAI was 75.58% (325/430) in the past 6 months. The results of multivariate analysis showed showed that in MSM with commercial homosexual behaviors in the past 6 months, compared with those who were students, age >18 years at the first sexual intercourse, had not anal sex in the past one week, and anal sex with less than 10 partners in the past 6 months, the risk for UAI was higher in those who were not students (a OR=1.99,95% CI:1.18-3.36), those who were aged ≤18 years at first sexual intercourse sex (a OR=2.04,95% CI:1.26-3.29), those who had anal sex in the past one week (a OR=2.04,95% CI:1.25-3.33), and those who had anal sex with more than 10 partners in the past 6 months (a OR=1.97,95% CI:1.16-3.35). Conclusions:The risk for UAI was high in MSM with commercial homosexual behaviors in Fuzhou, so it is necessary to improve the awareness of safe sex and promote sex with regular partners and condom use, and preventing drug abuse in MSM.

Objective:To analyze the influence of work engagement and self-efficacy of nurses on clinical practice ability in burn intensive care unit (BICU), and to explore its potential pathways of action.Methods:A cross-sectional survey was conducted. From May to October 2020, a total of 30 hospitals with BICU in China were selected by stratified sampling method. Among BICU nurses who met the inclusion criteria, their clinical practice ability, work engagement, and self-efficacy were evaluated by self-evaluation scale of oriented problem-solving behavior in nursing practice (OPSN), Utrecht work engagement scale (UWES), and general self-efficacy scale (GSES), respectively. The total scale scores of each index and the average item scores were recorded. The self-designed general data questionnaire was used to investigate the nurses' gender, age, marital status, education background, working years, professional title, and the economic region of the hospital that they belonged to. The total scale scores of the above-mentioned three evaluation indexes were compared after the classification of nurses according to general data, and the data were statistically analyzed with independent sample t test or one-way analysis of variance. Pearson correlation analysis was used to analyze the correlation between the total scale scores of the three evaluation indexes. Based on the total scale scores of the above-mentioned three evaluation indexes, a structural equation model was established, the mediation analysis of the relationship among the three evaluation indexes and the pathway analysis of the structural model were conducted, and the Bootstrap method was used to verify the pathways of action. Results:A total of 401 questionnaires were distributed, and 337 valid questionnaires were returned, with a valid return rate of 84.04%. The total scale scores of clinical practice ability, work engagement, and self-efficacy of 337 nurses were 98.2±11.7, 67.7±18.6, and 26.6±5.6, respectively, and the average item scores were 3.9±0.5, 4.5±1.2, and 2.7±0.6, respectively. Among the 337 nurses, the majority were female, aged 40 or below, married, and had a bachelor's degree with work experience of ≤10 years; both nurses with professional nurse title and nurses from the Southeast region accounted for about 50%. There were statistically significant differences in the total scale score of clinical practice ability among nurses with different ages, education backgrounds, working years, and professional titles (with F values of 3.26, 4.36, 3.12, and 2.80, respectively, P<0.05). There was statistically significant difference in the total scale score of work engagement among nurses with different working years ( F=4.50, P<0.05). There were statistically significant differences in the total scale score of self-efficacy among nurses with different ages, working years, and professional titles (with F values of 4.91, 4.50, and 2.91, respectively, P<0.05). The total scale score of nurses' work engagement was significantly positively correlated with the total scale score of clinical practice ability and the total scale score of self-efficacy (with r values of 0.30 and 0.51, respectively, P<0.05). The total scale score of nurses' self-efficacy was significantly positively correlated with the total scale score of clinical practice ability ( r=0.37, P<0.05). The model had good adaptability, and the intermediary model was established. Nurses' work engagement had a significantly positive effect on both self-efficacy and clinical practice ability (with β values of 0.54 and 0.16, respectively, P<0.05), and nurses' self-efficacy had a significantly positive effect on clinical practice ability ( β=0.29, P<0.05). Work engagement had a direct effect on self-efficacy and clinical practice ability, and self-efficacy had a direct effect on clinical practice ability and played a mediating role between work engagement and clinical practice ability. Bootstrap validation showed that self-efficacy played a significantly mediating role in the influence of work engagement on clinical practice ability (with effect size of 0.16, with 95% confidence interval of 0.08-0.24, P<0.05), accounting for half of the total effect of work engagement on clinical practice ability (with effect size of 0.32). Conclusions:BICU nurses have an above-average level of clinical practice ability, a medium level of self-efficacy, and a high level of work engagement. Work engagement and self-efficacy are positively correlated with clinical practice ability. Work engagement can directly affect clinical practice ability or indirectly affect clinical practice ability through the mediating role of self-efficacy.