There is a substantial unmet need for treatments in the field of pediatric rare diseases, and investigator initiated trial(IIT) provide a critical pathway for testing and developing new drugs or treatment strategies. However, healthcare institutions, when conducting such research, must address compliance risks related to project approval, contract management, data protection, and conflict of interest management. This study aims to analyze the particularities and challenges of IIT in pediatric rare diseases, review relevant regulations and regulatory requirements, and provide healthcare institutions with a reference framework for compliance risk management to maximize the benefits of IIT. Based on literature review, analysis of laws and regulations, practical work experience, and frameworks from other institutions, we summarize the unique aspects of pediatric rare disease IIT in terms of participant characteristics, innovative technologies, and organizational structures.On this basis, targeted compliance management recommendations are proposed, which include establishing a risk rating and full-cycle risk monitoring mechanism, a consent and ethical review mechanism tailored to pediatric participants, a robust contract management mechanism, a comprehensive data security management mechanism, and a multidisciplinary team and multi-channel compensation mechanism. The study concludes that healthcare institutions, funders, and other collaborating entities should implement compliance management in line with the characteristics of IIT to ensure the safety and effectiveness of research and facilitate innovation and development in the treatment of pediatric rare diseases.

Objective To analyze the correlation between lipid metabolism indexes,serum gamma-glutamyl transpeptidyase(γ-GGT)and coronary heart disease(CHD)complicated with coronary artery calcification(CAC).Methods A total of 300 CHD patients admitted in this study were divided into the CAC group(n=193)and the non-CAC group(n=107).Clinical data of the two groups were compared,including high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C),total cholesterol(TC),triglyceride(TG),Apolipoprotein A1(Apo-A1),Apo-B(APO-B)and γ-GGT.The influencing factors of CAC were analyzed by multiple Logistic factors.And a nomogram prediction model was established.Results The basic data of the two groups were compared.Patients of the CAC group was older,had higher proportion of patients with hypertension and diabetes,had higher levels of LDL-C,TC,Apo-B and γ-GGT and lower level of Apo-A1 than those of the non-CAC group(P＜0.05).The results of Logistic multivariate regression analysis showed that advanced age,combined history of diabetes,elevated LDL-C,TC,Apo-B and γ-GGT were risk factors of CHD complicated with CAC,while elevated Apo-A1 was the protective factor of CHD complicated with CAC(P＜0.05).The AUC of the constructed nomogram model was 0.880(95%CI:0.840-0.919),which showed good distinguishing ability.Conclusion CHD complicated with CAC is related to lipid metabolism and γ-GGT level.The nomogram model constructed based on influencing factors can be used for clinical early warning of CAC risk.

Atherosclerosis(As)is a chronic inflammatory vascular disease and serves as the pathological basis for various cardiovascular diseases.Epigallocatechin-3-O-gallate(EGCG)is the most abundant and biologically active com-pound in green tea,possessing multiple pharmacological effects such as anti-inflammatory,antiviral,and antioxidative stress properties.In recent years,studies have found that EGCG can regulate lipid metabolism,improve vascular endo-thelial function,and enhance plaque stability,demonstrating its potential value in combating As.This article provides a systematic review of the mechanisms underlying EGCG's anti-As effects,aiming to offer multi-faceted theoretical support for its further research and clinical application in the prevention and treatment of As.

Objective To analyze the key driving factors for patent management and scientific and technological achieve-ment transformation in medical institutions in the Yangtze River Delta region,and to provide a scientific basis for improving the efficiency of regional medical scientific and technological achievement transformation.Methods A convenience sampling method was used to conduct a questionnaire survey among 480 medical staff from tertiary hospitals in three provinces and one city(An-hui,Jiangsu,Shanghai,Zhejiang)of the Yangtze River Delta region from November 2024 to January 2025.SPSS 23.0 software was used for univariate analysis,multiple linear regression analysis,and regional difference comparisons.Results Univariate a-nalysis showed that region,age,education level,and professional title had statistically significant effects on patent output(P＜0.05).Multiple linear regression analysis further indicated that cognitive factors(score:19.01±8.73,β=0.230,P＜0.001),support factors(score:25.84±11.33,β=0.211,P=0.004),and incentive factors(score:25.93±10.85,β=0.136,P=0.036)were key drivers of patent output.Significant regional differences were observed,with Anhui Province scoring lower across all dimensions compared to Jiangsu,Zhejiang,and Shanghai(total score:74.18 vs.101.16-107.40,P＜0.001).Conclusion Enhancing medical staff's awareness of patents,improving institutional support and incentive mechanisms,and nar-rowing regional development gaps are core optimization pathways for promoting the transformation of medical scientific and techno-logical achievements in the Yangtze River Delta region.

Despite primary glomerulonephritis (PGN) being a leading cause of chronic kidney disease and end-stage renal disease, specific and sensitive biomarkers for the early detection and monitoring of this condition are lacking. We evaluated the value of the combined detection of serum cystatin C (CYSC), β2-microglobulin (β2-MG), and urine transferrin (TRF) for diagnosing early-stage PGN. From May 2021 to May 2023, we enrolled 105 patients in our hospital as the observation group and 50 healthy volunteers as the control group. Their serum expression levels of CYSC, β2-MG, and TRF were evaluated. We plotted separate ROC curves and calculated the area under the curve (AUC) values of CYSC, β2-MG, and TRF to assess their diagnostic performance in PGN. The levels of CYSC, β2-MG, and TRF were significantly higher (P < 0.05) in the observation group than in the healthy control group. CYSC, β2-MG, and TRF were expressed at significantly higher levels in G2, G3a, and G3b of PGN than in G1. The combined use of CYSC, β2-MG, and TRF as biomarkers could significantly improve the early diagnosis and monitoring of PGN and may lead to better patient outcomes by facilitating earlier intervention and treatment strategies.

Objective To analyze the current research status,hotspots,and trends in the field of mechanical ventilation weaning.Methods Literatures in the field of mechanical ventilation wea-ning were retrieved from the Web of Science Core Collection,PubMed,China National Knowledge In-frastructure(CNKI),and Wanfang Data Knowledge Platform from January 1,2010 to November 27,2024.CiteSpace software was used to analyze the research status and future trends.Results A total of 705 English and 494 Chinese eligible articles were included in this study.The author with the most publications was Laurent Brochard(14 articles).Research hotspots focused on mechanical ventila-tion,weaning,non-invasive ventilation,respiratory failure,etc.New research hotspots have shifted towards mechanical ventilation weaning failure,weaning complications,and prolonged weaning.Con-clusion Further research is needed on weaning failure,complications,and prolonged weaning,par-ticularly in the direction of invasive-high-flow oxygen therapy sequential therapy,which will help opti-mize clinical treatment plans and reduce patients' suffering and economic burdens.

Atherosclerosis(As)is a chronic inflammatory vascular disease and serves as the pathological basis for various cardiovascular diseases.Epigallocatechin-3-O-gallate(EGCG)is the most abundant and biologically active com-pound in green tea,possessing multiple pharmacological effects such as anti-inflammatory,antiviral,and antioxidative stress properties.In recent years,studies have found that EGCG can regulate lipid metabolism,improve vascular endo-thelial function,and enhance plaque stability,demonstrating its potential value in combating As.This article provides a systematic review of the mechanisms underlying EGCG's anti-As effects,aiming to offer multi-faceted theoretical support for its further research and clinical application in the prevention and treatment of As.

Objective To analyze the key driving factors for patent management and scientific and technological achieve-ment transformation in medical institutions in the Yangtze River Delta region,and to provide a scientific basis for improving the efficiency of regional medical scientific and technological achievement transformation.Methods A convenience sampling method was used to conduct a questionnaire survey among 480 medical staff from tertiary hospitals in three provinces and one city(An-hui,Jiangsu,Shanghai,Zhejiang)of the Yangtze River Delta region from November 2024 to January 2025.SPSS 23.0 software was used for univariate analysis,multiple linear regression analysis,and regional difference comparisons.Results Univariate a-nalysis showed that region,age,education level,and professional title had statistically significant effects on patent output(P＜0.05).Multiple linear regression analysis further indicated that cognitive factors(score:19.01±8.73,β=0.230,P＜0.001),support factors(score:25.84±11.33,β=0.211,P=0.004),and incentive factors(score:25.93±10.85,β=0.136,P=0.036)were key drivers of patent output.Significant regional differences were observed,with Anhui Province scoring lower across all dimensions compared to Jiangsu,Zhejiang,and Shanghai(total score:74.18 vs.101.16-107.40,P＜0.001).Conclusion Enhancing medical staff's awareness of patents,improving institutional support and incentive mechanisms,and nar-rowing regional development gaps are core optimization pathways for promoting the transformation of medical scientific and techno-logical achievements in the Yangtze River Delta region.

Objective To analyze the correlation between lipid metabolism indexes,serum gamma-glutamyl transpeptidyase(γ-GGT)and coronary heart disease(CHD)complicated with coronary artery calcification(CAC).Methods A total of 300 CHD patients admitted in this study were divided into the CAC group(n=193)and the non-CAC group(n=107).Clinical data of the two groups were compared,including high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C),total cholesterol(TC),triglyceride(TG),Apolipoprotein A1(Apo-A1),Apo-B(APO-B)and γ-GGT.The influencing factors of CAC were analyzed by multiple Logistic factors.And a nomogram prediction model was established.Results The basic data of the two groups were compared.Patients of the CAC group was older,had higher proportion of patients with hypertension and diabetes,had higher levels of LDL-C,TC,Apo-B and γ-GGT and lower level of Apo-A1 than those of the non-CAC group(P＜0.05).The results of Logistic multivariate regression analysis showed that advanced age,combined history of diabetes,elevated LDL-C,TC,Apo-B and γ-GGT were risk factors of CHD complicated with CAC,while elevated Apo-A1 was the protective factor of CHD complicated with CAC(P＜0.05).The AUC of the constructed nomogram model was 0.880(95%CI:0.840-0.919),which showed good distinguishing ability.Conclusion CHD complicated with CAC is related to lipid metabolism and γ-GGT level.The nomogram model constructed based on influencing factors can be used for clinical early warning of CAC risk.