Objective To analyze the problems in the operation and management of drug clinical trials and put forward targeted suggestion. Methods An electronic questionnaire survey was conducted among medical staff in about 80 hospitals in the yangtze river delta region. Results 606 valid questionnaires were received. 71% of the respondents expressed their willingness to study and participate in drug clinical trials. There were significant differences in the cognitive demands, willingness and motivation of the respondents with different occupations and educational backgrounds about the drug clinical trial work （P<0.05）. During the operation of drug clinical trials, respondents reported the main factors affecting the quality of clinical trials which including good clinical practice (GCP) awareness and subjective enthusiasm of investigators （response rate 27%）, job stability of supervisors and research coordinators （27%）, compliance of subjects （45%）, quality control of the whole process of the circulation of test drugs, medical devices and biological samples （52%）, and the informatization level of clinical trial institutions （30%）. Conclusion Hospitals, institutions and project teams could take measures to cultivate and stabilize the drug clinical trial talent team, improve the quality management system of drug clinical trials, improve work efficiency, and promote the high-quality development of drug clinical trials in medical institutions.

Objective To investigate the clinical efficacy of minimally invasive mitral valvuloplasty (MVP) in the treatment of infective endocarditis (IE) with mitral regurgitation (MR). Methods A retrospective analysis was conducted on the clinical data of patients who underwent MVP for IE with MR at the Department of Cardiovascular Surgery in Zhongshan Hospital, Fudan University from 2016 to 2020. Patients were divided into two groups based on the surgical incision: those with a right mini-thoracotomy were classified as a minimally invasive surgery (MIS) group, and those with a median sternotomy (MS) were classified as an MS group. All patients had isolated mitral valve involvement. Perioperative data were analyzed, and mid- to long-term outcomes were compared between the two groups. Results A total of 86 patients were included, with 40 in the MIS group [22 males and 18 females, with a mean age of (39.78±15.36) years ranging from 14 to 75 years] and 46 in the MS group [27 males and 19 females, with a mean age of (49.94±16.13) years ranging from 14 to 71 years]. The patients in the MIS group were relatively younger (P=0.004) with better preoperative cardiac function (P=0.004). There was no statistical difference in preoperative fever, gender, or comorbidities between the two groups (P>0.05). The MIS group had shorter postoperative ventilation times, less postoperative 24-hour drainage, less blood transfusion, and shorter total hospital stays compared to the MS group (P＜0.05). There was no statistical difference in cardiopulmonary bypass times or ICU stays between the two groups (P>0.05). The perioperative complication rates and mortality rates were not significantly different between the two groups (P>0.05). Follow-up was conducted for 11-92 months, with a mean duration of (49±19) months and an overall follow-up rate of 91.9%. During the follow-up, 3 patients in each group required reoperation for mitral valve issues, with no statistical difference in incidence (7.5% vs. 6.5%, P=0.691). There were no warfarin-related complications, recurrences, or deaths in either group during follow-up. Multivariate regression analysis identified age, preoperative cardiac function, and surgeon experience as influencing factors for the choice of surgical approach. Conclusion Minimally invasive MVP for IE with MR is relatively safe in the perioperative period and shows significant efficacy, with clear mid- to long-term outcomes. It is recommended for younger patients with better preoperative cardiac function and when performed by surgeons with extensive experience in mitral valvuloplasty.

Objective: To examine the association between parent-child communication frequency about school related matters and depressive symptom risk among children and adolescents and to characterize its dose response pattern, so as to provide a reference for family intervention and school mental health promotion. Methods: Data were obtained from the 2022 China Family Panel Studies(CFPS), conducted from May to December 2022. A total of 1 896 children and adolescents aged 10-15 years were included. The 8 item Center for Epidemiologic Studies Depression Scale (CES-D8) was adopted to assess depressive symptoms among children and adolescents. Data on the parent-child communication frequency about school related matters was obtained from CFPS Child Proxy Questionnaire. Multivariable Logistic regression, sensitivity analyses, and exploratory segmented regression were performed. Results: A total of 375 participants were screened positive for depressive symptoms, with a prevalence of 19.8%. The prevalence decreased from 23.3% in the "never" group to 10.6% in the "very often" group ( χ 2=19.30, P <0.05). In the fully adjusted model, the point estimate for the "very often" group suggested lower odds of a positive screen ( OR =0.52), and the test for trend was statistically significant ( P =0.03). The association was more pronounced among children aged 10-12 years ( OR=0.31, 95%CI=0.11-0.86, P <0.05). Sensitivity analyses yielded directionally consistent results, but the statistical evidence was weakened ( OR=0.83, P trend =0.08). Dose response analysis showed a statistically significant overall association between parent-child communication frequency about school related matters and depressive symptom risk ( P =0.04), with no significant departure from linearity ( P = 0.14 ). Among the prespecified cut points, exploratory segmented regression showed relatively better model fit at an ordinal frequency score of 4.5, between "often" and "very often" (likelihood ratio test P =0.03). However, the overall test for nonlinearity was not statistically significant ( P =0.14), and the finding should therefore be interpreted as exploratory. Conclusion More frequent parent-child communication about school related matters is associated with lower depressive symptom risk, suggesting that routine communication about such matters may help reduce the risk of depressive symptoms in children and adolescents.

Intraoperative cell salvage (IOCS) has been widely applied as an important blood conservation measure in surgical operations. However, there is currently a lack of clinical practice guidelines for the implementation of IOCS in patients with malignant tumors. This report aims to provide clinicians with recommendations on the use of IOCS in patients with malignant tumors based on the review and assessment of the existed evidence. Data were derived from databases such as PubMed, Embase, the Cochrane Library and Wanfang. The guideline development team formulated recommendations based on the quality of evidence, balance of benefits and harms, patient preferences, and health economic assessments. This study constructed seven major clinical questions. The main conclusions of this guideline are as follows: 1) Compared with no perioperative allogeneic blood transfusion (NPABT), perioperative allogeneic blood transfusion (PABT) leads to a more unfavorable prognosis in cancer patients (Recommended); 2) Compared with the transfusion of allogeneic blood or no transfusion, IOCS does not lead to a more unfavorable prognosis in cancer patients (Recommended); 3) The implementation of IOCS in cancer patients is economically feasible (Recommended); 4) Leukocyte depletion filters (LDF) should be used when implementing IOCS in cancer patients (Strongly Recommended); 5) Irradiation treatment of autologous blood to be reinfused can be used when implementing IOCS in cancer patients (Recommended); 6) A careful assessment of the condition of cancer patients (meeting indications and excluding contraindications) should be conducted before implementing IOCS (Strongly Recommended); 7) Informed consent from cancer patients should be obtained when implementing IOCS, with a thorough pre-assessment of the patient's condition and the likelihood of blood loss, adherence to standardized internally audited management procedures, meeting corresponding conditions, and obtaining corresponding qualifications (Recommended). In brief, current evidence indicates that IOCS can be implemented for some malignant tumor patients who need allogeneic blood transfusion after physician full evaluation, and LDF or irradiation should be used during the implementation process.

[Objective] To assess the data characteristics of quality monitoring indicators for red blood cell (RBC) preparations, so as to provide reference for continuous improvement of blood quality. [Methods] The quality inspection data of 6 types of RBC preparations from Chongqing blood center from 2019 to 2023 were summarized. For the same indicators, the numerical range of quality indicators was monitored by comparing different types of preparations with the national standard GB18469. The loss and/or damage to RBCs caused by different preparation process were compared, and the impact of different preparation processes on the quality of RBCs was discussed. [Results] The appearance and sterility test compliance rates of the six types of RBC preparations were both 100%, while the compliance rates of other items were all ≥75%. The compliance rate of hematocrit for suspended RBCs was the lowest at 75%, with a median of 0.52, which was close to the lower limit of GB18469, while the medians of hematocrit for the other types were all at the midline level of GB18469. The Hb content for different types of RBCs was significantly higher than the corresponding requirements of GB18469 (P<0.05). The hemolysis rate at the end of storage for different types of RBCs was significantly lower than the requirements of GB18469 (P<0.05). The 1 U leukoreduction process resulted in a hemoglobin content loss of about 5% and had a significant impact on the hemolysis rate at the end of storage (P<0.05). The washing process resulted in a hemoglobin content loss of <3% and had no significant impact on the hemolysis rate at the end of storage (P>0.05). The concentration process resulted in a hemoglobin content loss of <3% and had a significant impact on the hemolysis rate at the end of storage (P<0.05). [Conclusion] The impact of different processes on RBC preparations is within a controllable range and meets the requirements of GB18469. The quality monitoring data can provide a reference for clinical blood selection, effectiveness evaluation and revision of related standards.

Aim To explore the impact and mechanism of proprotein convertase subtilisin kexin 9(PCSK9)on the progression of abdominal aortic aneurysm(AAA).Methods 6～8 week old ApoE-/-mice were selected to estab-lish the AAA model.Angiotensin Ⅱ(Ang Ⅱ)was continuously infused through subcutaneous implantation of a micro-os-motic pump.The mice were fed with high-fat diet and killed after 28 days.The expression of PCSK9 in abdominal aor-tic smooth muscle cells was detected by immunohistochemistry and immunofluorescence in normal abdominal aortic blood vessels and AAA samples in human and mice.Primary cultured murine vascular smooth muscle cells(mVSMC)of C57BL/6 mice were treated with different concentrations of AngⅡ for 24 h,and the expression of PCSK9 mRNA and pro-tein was detected.PCSK9 overexpression and knockdown cell models were established,and mitochondrial reactive oxygen species(mtROS),mitochondrial membrane potential(MMP),mitochondrial permeability transition pore(MPTP)open-ing,and Z-DNA binding protein 1(ZBP1)protein expression were detected.Bioinformatics was used to analyze the dif-ferential expression of multiple single-cell sequencing datasets to obtain the key differentially expressed genes,and to study their expression and role in AAA.Results Immunohistochemistry and immunofluorescence results showed that PCSK9 expression in human and mouse AAA increased(P＜0.01),and co-localized with smooth muscle.Ang Ⅱ promoted PCSK9 expression in mVSMC in a concentration-dependent manner,the 2.0 μmol/L Ang Ⅱ group showed a 2.9-fold and 1.1-fold increase in the expression of PCSK9 mRNA and protein,respectively(P＜0.01),with the most significant effect observed.After successfully constructing PCSK9 overexpression and PCSK9 interference mVSMC models,PCSK9 overex-pression led to an increase in intracellular mtROS,a decrease in MMP,an increase in MPTP opening,and a decrease in cellular activity(P＜0.01);PCSK9 knockdown could reduce Ang Ⅱ induced increase in mtROS,decrease in MMP and MPTP opening;compared with the siNC+Ang Ⅱ group,the siPCSK9+Ang Ⅱ group showed a decrease in mtROS and an in-crease in the fluorescence brightness of MMP and MPTP(P＜0.05).Bioinformatics analysis revealed that ZBP1 was a core differentially expressed gene in AAA.Immunohistochemistry and immunofluorescence results showed that ZBP1 ex-pression in human and mouse AAA tissues increased,and co-localized with smooth muscle.Western blot results showed that PCSK9 overexpression or treatment with 2.0 μmol/L Ang Ⅱ could increase ZBP1 protein expression(P＜0.01),while PCSK9 knockdown could alleviate the increased ZBP1 expression caused by AngⅡ(P＜0.05).Conclusion PCSK9 may induce mitochondrial damage in smooth muscle cells,activate downstream molecule ZBP1 to cause cell damage,and promote the development of AAA.

Objective To investigate the detection rate and related influencing factors of gastrointestinal diseases in grass-roots personnel.Methods A total of 481 grass-roots personnel were enrolled and examined by magnetic-controlled capsule endoscopy(MCCE).Multivariate logistic regression were used to analyze the influencing factors of gastrointestinal diseases detected by MCCE.Results All personnel completed MCCE,and gastrointestinal diseases were detected in 154(32.0%)cases,including 106 cases of erosive gastritis,25 cases of chronic atrophic gastritis,17 cases of digestive tract polyp,16 cases of gastric ulcer,5 cases of reflux esophagitis,4 cases of cardia,1 case of duodenitis,and 1 case of enteritis.Gastrointestinal diseases was correlated with special operation posts,long-term tasks within recent 6 months,abdominal distension,belching,nausea and vomiting,diarrhea and other symptoms(all P＜0.05).Multivariate logistic regression analysis showed that the risk factors of gastrointestinal diseases were working in special operation posts,performing long tasks within 6 months,belching,nausea and vomiting symptoms(all P＜0.05).Conclusion The overall detection rate of gastrointestinal diseases(mainly acid related diseases)is relatively high,and its incidence is closely related to working in special operation posts and performing long-term tasks within recent 6 months.Personnel working in special operation posts should be more alert to gastrointestinal diseases.Gastrointestinal symptoms have reference value for the prediction of lesions,but more attention should be paid to the identification of functional gastrointestinal diseases with endoscopy.

Objective:To study the comprehensive surgical treatment of brucellosis with chest wall cysts as the main manifestation.Methods:Retrospective analysis was made on the general information epidemiological characteristics, clinical manifestations, laboratory examinations, imaging examinations, treatment and outcomes of five patients with brucellosis mainly manifested by chest wall cysts admitted to the 948 Hospital of the People's Liberation Army from July 2019 to June 2022.Results:Among the 5 patients, there were 4 males and 1 female, aged between 23 and 64 years old, with a clear history of contact with cattle and sheep. The main clinical manifestation was painless cystic masses on the chest wall. Both the serum tiger red plate agglutination test (RBPT) and the test tube agglutination test (SAT) were positive. Four cases were infected with Brucella and one case was infected with Actinobacillus pleuropneumoniae (considered as Brucella infection based on the overall condition). All patients exhibited abnormal chest wall signals (manifesting as hypointense on T1-weighted imaging and hyperintense on T2-weighted imaging) on magnetic resonance imaging(MRI), and were ultimately diagnosed with brucellosis presenting predominantly as chest wall cysts. After complete removal of the chest wall cyst through surgery, a combination treatment of rifampicin capsules and doxycycline hyclate tablets was given for 6 weeks. There were no significant adverse reactions and the wound healed in one stage. During the postoperative follow-up period of 11 - 40 months, MRI reexamination demonstrated no evidence of chest wall cyst recurrence, and all SAT results were negative. Conclusions:Patients with brucellosis presenting as chest wall cysts are clinically rare and lack specific symptoms. Surgical resection of the affected lesion combined with early, standardized, combined, and full course antimicrobial therapy results in a good prognosis for the patient.

Objective:To study the effects of fluoride and aluminum exposure alone and in combination on pyroptosis and the NOD-like receptor protein 3 (NLRP3)/cysteinyl aspartate specific proteinase-1 (Caspase-1)/gasdermin D (GSDMD) signaling pathway in NG108-15 cells.Methods:Using a factorial design method, NG108-15 cells cultured in vitro were divided into control group [0 mg/L sodium fluoride (NaF) + 0 mg/L aluminium trichloride (AlCl 3)], fluoride group (40 mg/L NaF + 0 mg/L AlCl 3), aluminum group (0 mg/L NaF + 160 mg/L AlCl 3), and fluoride + aluminum group (40 mg/L NaF + 160 mg/L AlCl 3) according to the concentrations of NaF and AlCl 3. After 24 hours of cultivation, the cells were collected for subsequent experiments. The fluorescence intensity of pyroptosis index GSDMD in each group was detected by immunofluorescence method. The mRNA expression levels of NLRP3, apoptosis associated speck-like protein (ASC), Caspase-1, and GSDMD in each group were detected by real-time fluorescence quantitative PCR (qRT-PCR). The protein expression levels of NLRP3, ASC, Caspase-1, GSDMD, gasdermin D N-terminus (GSDMD-N) and interleukin-1β (IL-1β) in each group were detected by Western blotting. Results:The immunofluorescence results showed that compared with the control group (1.00 ± 0.02), the fluorescence intensity of GSDMD in the fluoride, aluminum, and fluoride + aluminum groups (1.49 ± 0.02, 1.22 ± 0.04, 1.25 ± 0.03) were higher ( P < 0.05). The results of qRT-PCR showed that compared with the control group (1.00 ± 0.02, 1.00 ± 0.01, 1.00 ± 0.08, 1.00 ± 0.06), the mRNA expression levels of NLRP3 (1.21 ± 0.06, 1.60 ± 0.07, 1.42 ± 0.02), ASC (2.61 ± 0.07, 1.53 ± 0.01, 2.12 ± 0.03), Caspase-1 (1.32 ± 0.05, 1.53 ± 0.04, 2.07 ± 0.05), and GSDMD (1.60 ± 0.03, 1.65 ± 0.04, 2.23 ± 0.05) were higher in the fluoride, aluminum, and fluoride + aluminum groups ( P < 0.05). Western blotting results showed that compared with the control group (1.00 ± 0.04, 1.00 ± 0.08, 1.00 ± 0.05, 1.00 ± 0.02, 1.00 ± 0.03, 1.00 ± 0.06), the protein expression levels of NLRP3 (1.55 ± 0.06, 1.40 ± 0.07, 1.24 ± 0.05), ASC (1.66 ± 0.05, 1.48 ± 0.06, 1.32 ± 0.06), Caspase-1 (1.51 ± 0.02, 1.40 ± 0.01, 1.28 ± 0.03), GSDMD (1.24 ± 0.03, 1.31 ± 0.06, 1.18 ± 0.03), GSDMD-N (1.18 ± 0.04, 1.27 ± 0.03, 1.27 ± 0.03), and IL-1β (1.81 ± 0.03, 1.70 ± 0.08, 1.52 ± 0.05) were higher in the fluoride, aluminum, and fluoride + aluminum groups ( P < 0.05). Conclusion:Exposure to fluoride and aluminum alone and in combination can induce pyroptosis in NG108-15 cells, and the mechanism may be related to up-regulation of molecules related to the NLRP3/Caspase-1/GSDMD signaling pathway.

Objective To explore the fear of ulcer recurrence in patients with diabetic foot and analyze its influencing factors,so as to provide strategies for medical staff to implement comprehensive and personalized nursing interventions.Methods From February 2024 to March 2025,convenience sampling was used to select inpatients and outpatients with diabetic foot ulcers from 6 tertiary hospitals in China as the survey subjects.The general information questionnaire,ADL,MNA,PSQI,Diabetic Foot Self-Management Behavior Scale and FOP-Q-SF were used to investigate and analyze the results.Results A total of 191 questionnaires were distributed and 186 valid questionnaires were returned,with an effective recovery rate of 97.38％.The total score of ulcer recurrence fear of diabetic foot patients was(31.78±7.41).Binary Logistic regression analysis showed that nutritional status,sleep quality,duration of diabetes,other chronic diseases,family per capita monthly income and medical insurance were the influencing factors of ulcer recurrence fear in patients with diabetic foot(P＜0.05).Conclusion Patients with diabetic foot have a high level of fear of ulcer recurrence.Nutritional status,sleep quality,duration of diabetes,combined with other chronic diseases,family per capita monthly income,and medical insurance are its influencing factors.Nursing staff should take targeted nursing measures according to its influencing factors to reduce the occurrence of patients' fear of ulcer recurrence.