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.

Type 2 diabetes mellitus(T2DM)is a chronic metabolic disease that can lead to the damage of multiple tissues and organs throughout the body.Stimulator of interferon genes(STING)is an endoplasmic reticulum membrane protein that acts as an indirect cytoplasmic DNA sensor.The activation of the STING signaling pathway may be involved in T2DM and its microvascular complications through various mechanisms.This article reviews the research progress in the mechanism of STING in T2DM and its microvascular complications.

Objective To investigate the method of esophageal protection and nursing of pa-tients during peri-ablation of atrial fibrillation. Methods 31 patients hospitalized from June to July,2007 underwent radiofrequeney ablation under the mapping of Carto system, who were treated with liq-uid diet, anti-acid drugs and lowering energy ablation in posterior wall of left atrium for the aim of esophageal protection. Results The success rate of ablation was 100% with no occurrence of atrial-esophgeal fistula and uneomfort of digestive tract. Conclusions Careful esophageal protection and nursing plays an important role in prevention of atrial-esophgeal fistula.

OBJECTIVETo study the influence of cytokine gene polymorphism on the incidence of acute rejection in renal transplantation.

METHODSThe cytokine genotypes of TNF-alpha, TGF-beta(1), IL-10 and IL-6 in 24 normal people and 115 consecutive renal transplant recipients were determined by PCR-SSP using sequence-specific oligonucleotide primer. The cytokine genotypes were then correlated with the incidence of acute rejection in renal transplantation.

RESULTSThe frequency of TNF-alpha and IL-10 low producer genotype in the 115 kidney recipients and control group was 88.7%, 80% and 87.5%, 75% respectively, and the frequency of TGF-beta(1) and IL-6 high producer genotype was 79.1%, 100% and 66.7%, 100% respectively. The incidence of acute rejection was higher in the recipients with TNF-(high producer or IL-10 intermediate high producer genotype than in the recipients with low producer genotype [53.8%, 43.5% vs 18.6% (chi(2) = 8.17), 17.4% (chi(2) = 7.16), P < 0.01, respectively].

CONCLUSIONThis study demonstrated that TNF-alpha and IL-10 gene polymorphism has significant influence on the incidence of acute rejection in renal transplantation.

Adolescent ; Adult ; Aged ; Cytokines ; genetics ; Female ; Gene Expression ; Gene Frequency ; Graft Rejection ; epidemiology ; genetics ; Humans ; Interleukin-10 ; genetics ; Kidney Transplantation ; physiology ; Male ; Middle Aged ; Polymorphism, Genetic ; Tumor Necrosis Factor-alpha ; genetics