1.Compliance Risk Management of Investigator Initiated Trials on Children Rare Diseases: Medical Institution Perspective
Jingqi ZHANG ; Liandong ZUO ; Xueqi GAO ; Wenyue SI ; Rui LUO ; Qiang WU ; Wenhao ZHOU
JOURNAL OF RARE DISEASES 2025;4(1):132-138
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.
2.Cerium single-atom catalysts-armed Lactobacillus reuteri for multipronged anti-inflammatory/anti-fibrotic therapy of inflammatory bowel disease.
Yinying PU ; Shaorong HUANG ; Shuang GAO ; Yangying DUAN ; Wenhao LI ; Qiyue LI ; Han LIN ; Kun ZHANG ; Min ZHOU ; Wencheng WU
Acta Pharmaceutica Sinica B 2025;15(10):5400-5415
Simultaneous management of intestinal mucosal barrier dysfunction and gut microbiota dysregulation represents a significant challenge in the treatment of inflammatory bowel disease (IBD). Herein, we report a novel system that integrates multi-enzyme mimicking cerium single-atom nanocatalysts (CeSACs) with Lactobacillus reuteri probiotics (LR@CeSACs) for multipronged management of IBD. In this system, CeSACs demonstrate robust multi-enzyme activities across a broad pH range, effectively scavenging elevated reactive oxygen species, downregulating pro-inflammatory cytokines, and suppressing the expression of fibrosis-related genes. Moreover, probiotics promote the targeting and retention of the CeSACs for sustained catalytic antioxidant therapy. In turn, the inflammation relief enabled by CeSACs promotes bacterial viability, allowing for the rapid reshaping of intestinal barrier function and the restoration of gut microbiota. Therefore, LR@CeSACs exhibit excellent catalytic anti-inflammatory and anti-fibrotic therapeutic effects, as well as a certain prophylactic effect, as demonstrated in several murine models.
3.Expression of FAT1 in Lung Adenocarcinoma and Its Relationship with Immune Cell Infiltration
DING CHEN ; ZHAO WENHAO ; HUANG HUA ; LI YONGWEN ; ZHANG ZHANRUI ; ZHANG RUIHAO ; WANG YANAN ; WU DI ; CHEN CHEN ; LIU HONGYU ; CHEN JUN
Chinese Journal of Lung Cancer 2024;27(2):109-117
Background and objective Lung cancer is a leading cause of cancer-related deaths.Non-small cell lung cancer(NSCLC)is the most common pathological subtype,with adenocarcinoma being the predominant type.FAT atypical cadherin 1(FAT1)is a receptor-like protein with a high frequency of mutations in lung adenocarcinoma.The protein encoded by FAT1 plays a crucial role in processes such as cell adhesion,proliferation,and differentiation.This study aims to investigate the expression of FAT1 in lung adenocarcinoma and its relationship with immune infiltration.Methods Gene expression levels and relevant clinical information of 513 lung adenocarcinoma samples and 397 adjacent lung samples were obtained through The Cancer Genome Atlas(TCGA)and Genotype-Tissue Expression(GTEx)data.The mRNA expression levels of the FAT1 gene in lung adenocarcinoma tissues were analyzed,along with its association with the prognosis of lung adenocarcinoma patients.Pathway enrichment analysis was conducted to explore the signaling pathways regulated by the FAT1 gene.Immu-noblotting was used to detect the differential expression of FAT1 in lung epithelial cells and various lung cancer cell lines,while immunohistochemistry was employed to assess FAT1 expression in lung cancer and adjacent tissues.Results FAT1 gene muta-tions were identified in 14%of lung adenocarcinoma patients.TCGA database data revealed significantly higher FAT1 mRNA expression in lung adenocarcinoma tissues compared to adjacent lung tissues.Kaplan-Meier analysis indicated lower survival rates in lung adenocarcinoma patients with higher FAT gene expression.Pathway enrichment analysis suggested the involve-ment of FAT1 in tumor development pathways,and its expression was closely associated with immune cell infiltration.Immu-nohistochemical validation demonstrated significantly higher expression of FAT1 in cancer tissues compared to adjacent lung tissues.Conclusion FAT1 mRNA is highly expressed in lung adenocarcinoma tissues,and elevated FAT1 mRNA expression is associated with poor prognosis in lung adenocarcinoma patients.FAT1 may serve as a potential biomarker for lung cancer.
4.Advancements in the development and technological fabrication of wound healing biomaterials
Diandian LI ; Muran ZHOU ; Yang ZHAO ; Wenhao WU ; Keyi LIN ; Aimei ZHONG
Chinese Journal of Plastic Surgery 2024;40(3):355-361
Promoting wound healing is a common clinical challenge faced by surgeons, with a variety of repair method and materials currently available for clinical use. In recent years, with the continuous development of disciplines such as tissue engineering, regenerative medicine, and materials science, research on wound repair materials has progressed rapidly. This article will organize the classification, advantages and disadvantages, and the latest advancements in the preparation processes of wound repair materials. It will also discuss the current challenges faced by wound repair materials and future research directions, with the aim of providing a reference for related studies in wound repair.
5.Advancements in the development and technological fabrication of wound healing biomaterials
Diandian LI ; Muran ZHOU ; Yang ZHAO ; Wenhao WU ; Keyi LIN ; Aimei ZHONG
Chinese Journal of Plastic Surgery 2024;40(3):355-361
Promoting wound healing is a common clinical challenge faced by surgeons, with a variety of repair method and materials currently available for clinical use. In recent years, with the continuous development of disciplines such as tissue engineering, regenerative medicine, and materials science, research on wound repair materials has progressed rapidly. This article will organize the classification, advantages and disadvantages, and the latest advancements in the preparation processes of wound repair materials. It will also discuss the current challenges faced by wound repair materials and future research directions, with the aim of providing a reference for related studies in wound repair.
6.Survey on the current situation of human resources of professional public health institutions in Weihai City from 2021 to 2023
Kun WU ; Wenhao WANG ; Xueqin YU ; Zhenghui YANG
Chinese Journal of Preventive Medicine 2024;58(8):1247-1251
This study aims to promote the system construction of public health talent through understanding the status and identifying problems of public health human resources in Weihai City. A survey on professional public health institutions was conducted through questionnaires and interviews in Weihai City, and statistical analysis on the personnel structure, introduction, and turnover of professional public health institutions was conducted. There were 24 professional public health institutions in Weihai City, with a vacancy rate of 44.27% (1 367/3 088). Health professionals accounted for 68.09% (1 669/2 451) of the on-duty personnel. The number of health technicians in professional public health institutions in the city was 0.57 per thousand people. Among the 1 669 health professionals, the age groups≤35, 36-45, 46-54, and ≥55 accounted for 47.63% (795/1 669), 30.26% (505/1 669), 18.10% (302/1 669), and 4.01% (67/1 669), respectively. The personnel with bachelor′s degrees and master′s degrees accounted for 74.60% (1 245/1 669) and 8.09% (135/1 669). The personnel holding clinical medical, nursing, laboratory, and public health qualifications accounted for 61.34% (995/1 622), 28.30% (459/1 622) and 10.36% (168/1 622), respectively. Only 17.73% (296/1 669) of personnel held deputy senior or above technical titles, while 45.96% (767/1 669) held junior or below technical titles. About 70.10% (1 170/1 669) personnel held permanent positions, and 29.90% (499/1 669) held non-permanent positions. From 2021 to 2023, the employment rate of public health institutions was 65.51% (207/316), and the ratio of introduced and lost personnel was approximately 3∶2 (207/132).
7.Advances in application of EEG-fNIRS technology in researches on neuropsychiatric disorders
Chenyang GAO ; Kai WU ; Wenhao LI ; Yi LI ; Zhile JIANG ; Yuxin WANG ; Wenrui CHEN ; Jing ZHOU
Chinese Journal of Medical Physics 2024;41(3):348-355
Currently,electroencephalogram(EEG),functional near-infrared spectroscopy(fNIRS),and functional magnetic resonance imaging have been widely studied and applied to neuropsychiatric disorders.In recent years,the devices which can realize the simultaneous acquisition of EEG and fNIRS has been developed and gradually applied in the studies on neuropsychiatric disorders.The review provides an introduction of the techniques of synchronized detection and data analysis for EEG-fNIRS,summarizes the analysis methods and new findings of the recent studies of stroke,epilepsy,and other neuropsychiatric disorders using EEG-fNIRS,and also discusses the future research directions.
8.Survey on the current situation of human resources of professional public health institutions in Weihai City from 2021 to 2023
Kun WU ; Wenhao WANG ; Xueqin YU ; Zhenghui YANG
Chinese Journal of Preventive Medicine 2024;58(8):1247-1251
This study aims to promote the system construction of public health talent through understanding the status and identifying problems of public health human resources in Weihai City. A survey on professional public health institutions was conducted through questionnaires and interviews in Weihai City, and statistical analysis on the personnel structure, introduction, and turnover of professional public health institutions was conducted. There were 24 professional public health institutions in Weihai City, with a vacancy rate of 44.27% (1 367/3 088). Health professionals accounted for 68.09% (1 669/2 451) of the on-duty personnel. The number of health technicians in professional public health institutions in the city was 0.57 per thousand people. Among the 1 669 health professionals, the age groups≤35, 36-45, 46-54, and ≥55 accounted for 47.63% (795/1 669), 30.26% (505/1 669), 18.10% (302/1 669), and 4.01% (67/1 669), respectively. The personnel with bachelor′s degrees and master′s degrees accounted for 74.60% (1 245/1 669) and 8.09% (135/1 669). The personnel holding clinical medical, nursing, laboratory, and public health qualifications accounted for 61.34% (995/1 622), 28.30% (459/1 622) and 10.36% (168/1 622), respectively. Only 17.73% (296/1 669) of personnel held deputy senior or above technical titles, while 45.96% (767/1 669) held junior or below technical titles. About 70.10% (1 170/1 669) personnel held permanent positions, and 29.90% (499/1 669) held non-permanent positions. From 2021 to 2023, the employment rate of public health institutions was 65.51% (207/316), and the ratio of introduced and lost personnel was approximately 3∶2 (207/132).
9.Clinical study on Da Vinci Robot-assisted prostate cancer radical operation with maximal preservation of periprostatic structures
Wenhao XU ; Liang LIU ; Min DENG ; Jingzhen ZHU ; Siyue LI ; Yu CHEN ; Qingjian WU ; Ji ZHENG
Chongqing Medicine 2024;53(18):2776-2780
Objective To observe the functional recovery situation after prostate cancer radical opera-tion with maximal preservation of the periprostatic structures (MS-RARP).Methods Sixty-seven patients with localized prostatic cancer undergoing MS-RARP in the Second Affiliated Hospital of Army Military Med-ical University from June 2019 to June 2022 were selected as the study subjects.The changes of urinary con-trol function,erection function,quality of life and total prostate specific antigen (t-PSA) were compared at the time between before operation and postoperative 6 weeks,3 months,6 months,12 months.The expanded pros-tate cancer index composite index (EPIC-50) was used to evaluate the urinary control function,the interna-tional index of erectile function (IIEF-5) questionnaire was used to evaluate the erection function of the pa-tients,and EPIC-50 and the american urological associated symptom score rating scale (AUA-SS) were used to evaluate the life satisfaction of the patients.Results The urinary control function recovery rate,erection function recovery rate and life quality satisfaction rate in postoperative 6 weeks,3 months,6 months,12 months were 71.8%,95.5%,97.3% and 98.1%;31.7%,38.1%,41.3% and 44.4%;38.9%,83.6%,88.1% and 97.0%,respectively.The median t-PSA was gradually decreased,which were 0.026(0.010,0.410),0.009 (0.003,0.060),0.006(0.001,0.050)and 0.004(0.001,0.006)ng/mL,respectively.The life quality satisfac-tion rates at various postoperative time points were significantly increased when compared with before opera-tion (P<0.05).t-PSA was significantly decreased compared with before operation (P<0.05).Conclusion RARP could protect the postoperative urinary function and sexual function,and increase the postoperative life quality of the patients.
10.Nomogram for predicting the risk of post hepatectomy liver failure was established based on preoperative routine test indexes
Guoping DONG ; Chen CHEN ; Xudong LU ; Jiali WU ; Wenhao ZHENG ; Lin TONG
Chinese Journal of Laboratory Medicine 2024;47(8):895-901
Objective:To establish a risk prediction model of liver failure after liver resection for hepatocellular carcinoma.Method:A retrospective case-control study was designed. Clinical data and laboratory results, including gender, age, and preoperative 18 laboratory indicators, were collected from 320 patients with hepatocellular carcinoma undergoing liver resection in Eastern Hepatobiliary Surgery Hospital Affiliated to Naval Medical University from January 1, 2013 to December 31, 2023. According to the surgical time, 252 cases in the training cohort were divided into 62 and 190 cases with and without postoperative liver failure, respectively. Of the 68 cases in validation cohort, 34 developed postoperative liver failure and 34 did not. Binary Logistic regression analysis was used to conduct univariate analysis of gender, age, and 18 preoperative laboratory indicators, and multivariate analysis was carried out for significant results to determine the influencing factors of liver failure after liver resection for hepatocellular carcinoma, and Logistic regression model was established.Result:In the training cohort, indicators significantly associated with liver failure after liver resection for hepatocellular carcinoma included age ( P=0.016), platelets ( P=0.005), prealbumin ( P<0.001), and alkaline phosphatase ( P<0.001). Logistic regression was used to construct a nomogram model and draw a calibration curve by combining these four indicators. In the training cohort, the nomogram model showed good discriminability in predicting the risk of liver failure after hepatectomy for hepatocellular carcinoma. The area under the curve of was 0.82 (95% CI 0.76-0.88), and the sensitivity was 73% and specificity was 80% when the optimal cut-off value was 0.2646. In the validation cohort, the predictive performance of the nomogram model was comparable to that of the training cohort, with an area under the curve of 0.81 (95% CI 0.71-0.92), sensitivity of 82%, and specificity of 77%. Conclusion:Preoperative platelet and prealbumin decreases, alkaline phosphatase increases, and elderly patients are prone to liver failure after liver resection. The nomogram model constructed with preoperative test data has shows good discriminatory ability and accuracy in predicting liver failure after liver resection for hepatocellular carcinoma.

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