OBJECTIVE To establish a core competency evaluation system for drug clinical trial quality management personnel in China and validate its application. METHODS Based on the scope of work， responsibilities， and role positioning of quality management personnel in drug clinical trials， a preliminary draft of the core competency evaluation system was constructed through literature analysis and expert consultation. The draft was refined through a Delphi method involving 17 experts who provided feedback and revisions， ultimately forming a complete evaluation system. The developed system was applied to conduct electronic surveys from March to May 2024 among 110 quality management personnel from 38 drug clinical trial institutions， comparing their scores on indicator importance and self-assessed capabilities. RESULTS The response rate of both rounds of questionnaire survey was 100%， with Kendall’s W coefficients of 0.256 and 0.277 （P＜0.001 for both）， and an expert authority coefficient of 0.946. The finalized evaluation system for core competencies of clinical trial quality management personnel comprised 9 primary indicators， covering individual professional competence， communication skills， implementation condition verification， informed consent process review， clinical trial execution monitoring， adverse event disposal， reporting and documentation， trial record examination， trial report auditing， and inspection of other tasks， and 107 secondary indicators. Empirical research revealed significant discrepancies between importance scores and self-assessed competency scores across 70 indicators among 110 respondents （P＜0.05）. Indicators with relatively notable gaps between importance scores and self-assessed competency scores included in-depth understanding of Good Clinical Practice （GCP） requirements （0.34-point gap）， familiarity with national and institutional clinical trial inspection priorities （0.24-point gap），etc. CONCLUSIONS The indicator system constructed in this study has good scientificity and reliability. Clinical trial quality management personnel demonstrate deficiencies in multiple critical competencies， highlighting the urgent need for targeted training programs to enhance their overall professional capabilities.

Objective To explore the materials and embolization technique employed in precision superselective transarterial embolization for the treatment of acute renal hemorrhage.Methods The data of 50 patients with acute renal hemorrhage who underwent precision superselective transarterial embolization were retrospectively analyzed.The angiographic findings,embolic materials and embolization methods were collected.The main outcome measures were technical success rate,clinical efficacy and renal function.Results In this study,44 patients had positive angiographic findings.The clinical success rate was 90.9%(40/44)after first precision superselective transarterial embolization.In patients of failure of first embolization,3 patients underwent successful repeated embolization and 1 patient refused repeat embolization.Empirical embolization was carried out among the 6 patients with negative angiographic findings.In 32 patients with complete data for estimated glomerular filtration rate(eGFR),there was no statistical difference before and those measured 7 d after precision superselective transarterial embolization.Conclusion Precision superselective transarterial embolization technique is an effective method for the treatment of acute renal hemorrhage,preserving renal function.

Objective:To investigate the preventive and therapeutic effects and mechanisms of Dachaihu decoction(DCD)on dextran sodium sulfate(DSS)-induced ulcerative colitis(UC)and liver injury in mice,as well as the association between DCD benefits and gut microbiota modulation.Methods:Mice were treated with DCD(20.10 and 10.05 g/kg)for 2 weeks,with free access to drinking water containing 3%DSS in the second week to induce UC.Histopathological examination,RT-qPCR and 16S rRNA sequencing were used to investigate the effect of DCD on UC mice.Results:DCD pretreatment significantly alleviated weight loss,bloody diarrhea with mucus,histopathological abnormalities of the colon,and colon shortening in mice with DSS-induced UC.In addition,DCD pretreat-ment significantly upregulated the levels of Occludin,ZO-1,and MUC-2 in the colon and protected the intestinal barrier of mice.DCD pretreatment also alleviated inflammatory cell infiltration in the colon and the liver and significantly reduced the expression levels of the proinflammatory factors such as IL-1β,IL-6,TNF-α,iNOS,COX-2,and NLRP3,thereby exerting a protective effect against UC and liver injury.It should be noted that DCD corrected gut micro-biota imbalance in UC mice by enriching probiotic bacteria such as Lactobacillus and Bifidobacterium and reducing harmful bacteria such as Norank_f_Desulfovibrionaceae and Escherichia-Shigella.Conclusion:DCD can alleviate DSS-induced UC and exert a liver-protecting effect by protecting intestinal barrier,inhibiting inflam-mation,and regulating gut microbiota.

Objective To analyze the clinical features of premature rupture of membrane(PROM)complicated with histologic chorioamnionitis(HCA),and to provide insights for clinical management of such pregnant women and their newborns.Methods A total of 202 cases of PROM pregnant women who gave birth and performed placental pathological examination in the Affiliated Hospital of Southwest Medical University from January to December 2021 were retrospectively analyzed.According to the histopathological results,the pregnant women were divided into HCA group(n=151)and control group(n=51),and the prenatal factors and short-term maternal-fetal pregnancy outcomes of two groups were compared and analyzed.Results The amniotic fluid contamination rate,white blood cell count,neutrophil count and serum amyloid A levels in HCA group were significantly higher than those in control group(P＜0.05).There was a higher incidence of early neonatal septicemia in HCA group than in control group(P＜0.05).Conclusion The risk of early-onset sepsis in neonates with PROM complicated with HCA significantly increases.It is necessary to strengthen the screening and early intervention in such cases.Amniotic fluid contamination and increased maternal infection indicators are associated with the occurrence of HCA,which may has potential value in predicting HCA occurrence.

Objective To explore the materials and embolization technique employed in precision superselective transarterial embolization for the treatment of acute renal hemorrhage.Methods The data of 50 patients with acute renal hemorrhage who underwent precision superselective transarterial embolization were retrospectively analyzed.The angiographic findings,embolic materials and embolization methods were collected.The main outcome measures were technical success rate,clinical efficacy and renal function.Results In this study,44 patients had positive angiographic findings.The clinical success rate was 90.9%(40/44)after first precision superselective transarterial embolization.In patients of failure of first embolization,3 patients underwent successful repeated embolization and 1 patient refused repeat embolization.Empirical embolization was carried out among the 6 patients with negative angiographic findings.In 32 patients with complete data for estimated glomerular filtration rate(eGFR),there was no statistical difference before and those measured 7 d after precision superselective transarterial embolization.Conclusion Precision superselective transarterial embolization technique is an effective method for the treatment of acute renal hemorrhage,preserving renal function.

OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution,providing a basis for optimizing the training system for committee members,improving the quality of ethical review,and fully safeguarding the safety and rights of subjects.METHODS Using methods such as literature research and expert consultation,a preliminary core competency evaluation index system was constructed.The Delphi method was employed to revise and validate it,ultimately forming an evaluation index system for the core competencies of ethics committee members.Based on this system,a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide,comparing their importance rating and self-assessment scores of the core competency indexes.RESULTS The evaluation system constructed included 4 primary indicators(ethics and professional knowledge,ethics review ability,communication and expression ability,moral integrity and work style)and 39 secondary indicators(familiarity with the content of clinical trial-related laws and regulations,ability to complete project ethics review and identify ethical defects in research protocols within a short period of time,ability to judge the scientific value of clinical research,etc.).The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge,ethical norms,review efficiency,risk judgment,and problem analysis.The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38.CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members.It can provide a scientific framework for committee member training,qualification certification,and standardized management of ethics committees.

Objective To analyze the clinical features of premature rupture of membrane(PROM)complicated with histologic chorioamnionitis(HCA),and to provide insights for clinical management of such pregnant women and their newborns.Methods A total of 202 cases of PROM pregnant women who gave birth and performed placental pathological examination in the Affiliated Hospital of Southwest Medical University from January to December 2021 were retrospectively analyzed.According to the histopathological results,the pregnant women were divided into HCA group(n=151)and control group(n=51),and the prenatal factors and short-term maternal-fetal pregnancy outcomes of two groups were compared and analyzed.Results The amniotic fluid contamination rate,white blood cell count,neutrophil count and serum amyloid A levels in HCA group were significantly higher than those in control group(P＜0.05).There was a higher incidence of early neonatal septicemia in HCA group than in control group(P＜0.05).Conclusion The risk of early-onset sepsis in neonates with PROM complicated with HCA significantly increases.It is necessary to strengthen the screening and early intervention in such cases.Amniotic fluid contamination and increased maternal infection indicators are associated with the occurrence of HCA,which may has potential value in predicting HCA occurrence.

Objective To compare the effects of dulaglutide and liraglutide combined with metformin on serum C1q/TNF-related protein 3(CTRP3)and vascular cell adhesion molecule 1(VCAM-1)in obese patients with type 2 diabetes mellitus(T2DM).Methods A total of 89 obese T2DM patients who were admitted to Affiliated Nantong Hospital of 3 Nantong University from March 2019 to September 2022 were selected as research subjects.They were randomly divided into liraglutide group(n=45,liraglutide+metformin)and dulaglutide group(n=44,dulaglutide+metformin).Body mass index(BMI),obesity degree,waist circumference,hip circumference,glucolipid metabolism related indexes,insulin resistance related indexes,CTRP3,and VCAM-1 were compared between the two groups.Results Compared with those before treatment,BMI,obesity degree,hip circumference,waist circumference,glucolipid metabolism related indexes,insulin resistance related indexes,CTRP3,and VCAM-1 were significantly changed after treatment(all P<0.05).Mean amplitude of glucose fluctuation(MAGE)and VCAM-1 in the dulaglutide group were significantly lower than those in the liraglutide group after treatment,while time in target glucose range(TIR)and CTRP3 in the dulaglutide group were significantly higher than those in the liraglutide group after treatment(all P<0.05).There was no statistically significant difference in the other indexes between the two groups after treatment(all P>0.05).Conclusion Both dulaglutide and liraglutide combined with metformin can control blood glucose levels and improve glucolipid metabolism in obese T2DM patients.But dulaglutide is more effective in controlling MAGE and TIR than liraglutide,which may be related to the ability of dulaglutide to regulate the levels of CTRP3 and VCAM-1.

Objective To observe the feasibility and safety of CT-guided fine-needle assisted localization for puncturing difficult lung or liver lesions.Methods Data of 30 patients with single difficult lung or liver lesion,i.e.lesion located at difficult part for puncturing or deep lesion with diameter of 0.5-2.0 cm who underwent CT-guided 22G needle assisted localization before puncturing were retrospectively analyzed.The success rate of fine-needle assisted localization,the success rate of the first-time puncturing and the occurrence of complications were recorded.Results Among 30 difficult lesions,there were 27 lung lesions and 3 hepatic lesions,with a mean diameter of(1.0±0.4)cm.Assisted localization of difficult lesions were successfully performed with 22G needle under CT guidance at the edge of lesion,1 cm adjacent to lesion or at the puncture path,with success rate of fine-needle assisted localization of 100%,and no obvious complication happened.The followed operations included preoperative localization of 14 lung nodules,biopsy of 10 lung nodules and 3 liver nodules,as well as microwave ablation of 3 liver nodules,with the success rate of the first-time puncturing of 100%.Mild pneumothorax was observed in 3 cases(3/27,11.11%)of difficult lung lesions after biopy.No other obvious complication occurred.Conclusion CT-guided fine-needle assisted localization for percutaneous puncturing difficult lung or liver lesions was feasible and safe.

Objective:To develop the interpersonal emotion regulation questionnaire for healthcare workers and examine its reliability and validity.Methods:Based on the theory of social regulatory cycle (SRC), literatures review and semi-structured interview were used to form the item pool of the scale.Through expert consultation, project analysis and the exploratory factor analysis, the scale items were screened, and the interpersonal emotion regulation questionnaire for healthcare workers was initially formed.The convenient sampling method was adopted to select 619 healthcare workers from multiple hospitals in Anhui province to conduct the formal survey to test the reliability and validity of the questionnaire and confirmatory factor analysis (CFA) using the SPSS 24.0 and Mplus 8.0 software.Results:There were 18 items and four dimensions including emotion identification, motivation, regulation strategy and implementation strategy process in the interpersonal emotion regulation questionnaire for healthcare workers.The results of CFA showed that the questionnaire fitted the data with well construct validity.The correlation coefficients between each dimension and the scale were 0.830-0.932.The Cronbach’s α coefficient of the overall questionnaire was 0.962, the split-half reliability was 0.880 and the test-retest reliability was 0.786.The score of total questionnaire was significantly positively correlated with the score of emotional intelligence ( r=0.680, P<0.001) and empathic ability ( r=0.554, P<0.001), and was significantly negatively correlated with the doctor-patient relationship ( r=-0.353, P<0.001). Conclusion:The interpersonal emotion regulation questionnaire for healthcare workers has satisfactory reliability and validity, which can be used to measure the ability of interpersonal emotion regulation in healthcare workers.