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.Aortic-mitral annular enlargement technique in re-valve surgery: A retrospective study in a single center
Mingyuan YANG ; Wenhao LIU ; Laichun SONG ; Jingcheng WU ; Liang TAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(06):826-831
Objective To investigate and evaluate the safety and efficacy of the aortic-mitral annular enlargement technique (double annular enlargement) in patients with small-size valve prostheses after prior valve surgery. Methods The clinical data of patients who underwent double valve annular enlargement in Wuhan Asia Heart Hospital from April 2020 to April 2022 were retrospectively analyzed. Results A total of 30 patients were collected, including 2 males and 28 females aged 9-78 (52.71±3.53) years. All patients had previous heart valve surgery, including 1 patient receiving the third heart surgery. All patients were operated on successfully and there were no postoperative in-hospital deaths. There was no postoperative bleeding which needed a secondary open-chest hemostasis, and one patient underwent permanent pacemaker implantation due to postoperative sick sinus syndrome. The mean diameter of the implanted prosthetic aortic valve was 24.23±1.60 mm, which was significantly larger than that of the preoperative aortic valve (21.03±1.90 mm, P<0.001). The mean diameter of the implanted prosthetic mitral valve was 28.33±1.21 mm, which was significantly larger than that of the preoperative mitral valve (25.43±0.84 mm, P<0.001). The mean peak gradient difference across the prosthetic aortic valve on postoperative echocardiography was 18.17±6.44 mm Hg, which was significantly lower than that of the preoperative aortic valve (82.57±24.48 mm Hg, P<0.001). The mean peak gradient difference of the postoperative prosthetic mitral valve was 12.73±5.45 mm Hg, which was significantly lower than that of the preoperative mitral valve (19.43±8.97 mm Hg, P=0.003). Conclusion The double annular enlargement technique is safe and effective for reoperation in patients with a history of valve surgery with a small aortic root to obtain both a larger size prosthetic valve for a larger orifice area and stability of the mitral-aortic valve union, resulting in good postoperative hemodynamic characteristics and clinical outcomes.
4.Standardized specialist training for developmental and behavioral pediatrics in China and the United States: current status and thoughts
Xiaoyang CHEN ; Lingling WU ; Wenhao LI ; Wenyuan JIN ; Yanyan WANG ; Xiaolin LIU ; Zhiwei ZHU
Chinese Journal of Medical Education Research 2024;23(3):314-320
The United States has established a perfect specialist training system for developmental and behavioral pediatrics (DBP), while the DBP specialist training system in China is still in the early stage of development and has been constantly improved. This article analyzes and compares the current status of DBP specialist training system between the United States and China from the aspects of training pattern, eligibility criteria, training plans and contents, assessment and evaluation, and certification. With reference to the training system in the United States, we can further improve the DBP specialist training system in China by perfecting the training system and related documents, constructing reasonable eligibility criteria, establishing a training pattern guided by post competency, improving the DBP assessment and evaluation system based on competency, and enhancing the certification of DBP physicians.
5.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.
6.Application of Chimney technique in mitral valve reoperation: A retrospective study in a single center
Wenhao LIU ; Laichun SONG ; Mingyuan YANG ; Jingcheng WU ; Liang TAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(05):757-761
Objective To investigate and evaluate the safety and effectiveness of the Chimney technique in mitral valve reoperation. Methods The clinical data of mitral valve reoperation patients who underwent Chimney surgery in Wuhan Asia Heart Hospital from 2019 to 2021 were retrospectively analyzed. Results A total of 26 patients were collected, including 7 males and 19 females, aged 27-67 (53.46±11.18) years. All patients had previous mitral valve surgery, including 23 mitral valve replacements and 3 mitral valve repairs. All patients received Chimney technique using the ideal artificial sized mitral valve, and 1 patient died of neurological complications in hospital. The cardiopulmonary bypass time and the aortic cross-clamping time were 231.11±77.05 min and 148.50±52.70 min, respectively. The mean diameter of the implanted mitral valve prosthesis was 29.08±0.68 mm, which was statistically different from pre-replacement valve prosthesis size of 26.69±0.77 mm (P<0.001). The mean transvalvular pressure gradient of the prosthetic mitral valve measured on postoperative echocardiography was 14.77±5.34 mm Hg, which was statistically different from preoperative value of 20.92±9.83 mm Hg (P=0.005). Conclusion The Chimney technique is safe and effective for reoperation in patients with small mitral annuli, which can not only reduce the risk of reoperation, but also obtain larger prosthetic valve implants with good hemodynamic characteristics and clinical outcomes.
7.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).
8.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.
9.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.
10.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).

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