1.Resesrch on Technical Pathways for Trusted Data Space in Clinical Research of Large-Scale Hospitals
Runkang SUN ; Jin LI ; Yufei REN ; Yanyan CHEN ; Huoming WANG
Chinese Hospital Management 2025;45(4):70-72
To enhance the trustworthiness,security,and convenience of research data management and pro-mote the deep utilization of clinical research data,it introduces core technologies such as data sandboxing,ze-ro-trust architecture,elastic resource scheduling in cloud computing,and data lakes to construct a clinical research trusted data space with trusted management,resource interaction,and value co-creation capabilities.This trusted data space provides a secure and efficient platform for data processing and analysis through strict network access control,dynamic authentication,data anonymization,and digital watermarking technologies.It ensures the secure flow and precise traceability of research data throughout its lifecycle,effectively facilitating resource interaction and value co-creation.The implementation offers a valuable technical reference and practical guidance for other hospitals aiming to build trusted research data platforms.
2.Development and tissue distribution assessment of a qPCR-based detection method for VGM-R02b in cynomolgus monkeys
Caihong GAO ; Xinyi REN ; Wenjing LUO ; Yufei ZHANG ; Yuanguo CHENG
Chinese Journal of Pharmacology and Toxicology 2025;39(2):100-108
OBJECTIVE To develop a highly sensitive and specific quantitative real-time poly-merase chain reaction(qPCR)method for detecting the VGM-R02b(a gene therapy drug for glutaric acidemia type Ⅰ)gene in cynomolgus monkeys and analyze the biological distribution of VGM-R02b.METHODS A standard curve was constructed using the VGM-R02b standard plasmid[an adeno-associ-ated virus serotype 9(AAV9)capsid]on a qPCR platform.The detection method was optimized and validated for key parameters,including the quantitative range,accuracy,precision,dilution linearity,selectivity,specificity,stability,and parallelism.The established method was used to determine the target gene of VGM-R02b in the blood,brain,stomach,heart,liver,spleen,lung,kidney,thymus,and duodenum of cynomolgus monkeys on day 29(D29)and D92 after a single,unilateral intraventricular injection of VGM-R02b.The biodistribution of VGM-R02b in cynomolgus monkeys was analyzed.RESULTS A qPCR method for quantifying the VGM-R02b target gene in cynomolgus monkeys was established and validated.The standard curve demonstrated a quantitative range of 5.00×109 to 5.00×10^1 copies·μg-1 DNA,with excellent precision,accuracy,dilution linearity,selectivity,and specificity.The target gene in tissues remained stable after being stored at room temperature for 4 h,-15 to-25℃ for 9 d,-60 to-80℃ for 90 d and after five freeze-thaw cycles.Similarly,the target gene in whole blood remained stable after being stored at room temperature for 4 h,-15 to-25℃ for 93 d,-60 to-80℃ for 93 d and after five freeze-thaw cycles.Extracted nucleic acid samples also showed stability after being stored at room temperature for 4.25 h,2-8℃ for 24.16 h,-60 to-80℃ for 109 d and after five freeze-thaw cycles.The method was also applied to evaluate the biological distribution of the target gene in cynomolgus monkeys.In the control group,the target gene was undetectable on D29 and D92 post-administration,but in the drug administration group,the target gene was distributed across the tissues,with higher concen-trations observed in the brain,liver,spleen,and spinal cord,and there were no significant differences in the target gene content across the tissues between D29 and D92.CONCLUSION The established qPCR method is robust,reliable and suitable for determination of VGM-R02b target gene in cynomolgus monkeys.
3.Development and tissue distribution assessment of a qPCR-based detection method for VGM-R02b in cynomolgus monkeys
Caihong GAO ; Xinyi REN ; Wenjing LUO ; Yufei ZHANG ; Yuanguo CHENG
Chinese Journal of Pharmacology and Toxicology 2025;39(2):100-108
OBJECTIVE To develop a highly sensitive and specific quantitative real-time poly-merase chain reaction(qPCR)method for detecting the VGM-R02b(a gene therapy drug for glutaric acidemia type Ⅰ)gene in cynomolgus monkeys and analyze the biological distribution of VGM-R02b.METHODS A standard curve was constructed using the VGM-R02b standard plasmid[an adeno-associ-ated virus serotype 9(AAV9)capsid]on a qPCR platform.The detection method was optimized and validated for key parameters,including the quantitative range,accuracy,precision,dilution linearity,selectivity,specificity,stability,and parallelism.The established method was used to determine the target gene of VGM-R02b in the blood,brain,stomach,heart,liver,spleen,lung,kidney,thymus,and duodenum of cynomolgus monkeys on day 29(D29)and D92 after a single,unilateral intraventricular injection of VGM-R02b.The biodistribution of VGM-R02b in cynomolgus monkeys was analyzed.RESULTS A qPCR method for quantifying the VGM-R02b target gene in cynomolgus monkeys was established and validated.The standard curve demonstrated a quantitative range of 5.00×109 to 5.00×10^1 copies·μg-1 DNA,with excellent precision,accuracy,dilution linearity,selectivity,and specificity.The target gene in tissues remained stable after being stored at room temperature for 4 h,-15 to-25℃ for 9 d,-60 to-80℃ for 90 d and after five freeze-thaw cycles.Similarly,the target gene in whole blood remained stable after being stored at room temperature for 4 h,-15 to-25℃ for 93 d,-60 to-80℃ for 93 d and after five freeze-thaw cycles.Extracted nucleic acid samples also showed stability after being stored at room temperature for 4.25 h,2-8℃ for 24.16 h,-60 to-80℃ for 109 d and after five freeze-thaw cycles.The method was also applied to evaluate the biological distribution of the target gene in cynomolgus monkeys.In the control group,the target gene was undetectable on D29 and D92 post-administration,but in the drug administration group,the target gene was distributed across the tissues,with higher concen-trations observed in the brain,liver,spleen,and spinal cord,and there were no significant differences in the target gene content across the tissues between D29 and D92.CONCLUSION The established qPCR method is robust,reliable and suitable for determination of VGM-R02b target gene in cynomolgus monkeys.
4.Resesrch on Technical Pathways for Trusted Data Space in Clinical Research of Large-Scale Hospitals
Runkang SUN ; Jin LI ; Yufei REN ; Yanyan CHEN ; Huoming WANG
Chinese Hospital Management 2025;45(4):70-72
To enhance the trustworthiness,security,and convenience of research data management and pro-mote the deep utilization of clinical research data,it introduces core technologies such as data sandboxing,ze-ro-trust architecture,elastic resource scheduling in cloud computing,and data lakes to construct a clinical research trusted data space with trusted management,resource interaction,and value co-creation capabilities.This trusted data space provides a secure and efficient platform for data processing and analysis through strict network access control,dynamic authentication,data anonymization,and digital watermarking technologies.It ensures the secure flow and precise traceability of research data throughout its lifecycle,effectively facilitating resource interaction and value co-creation.The implementation offers a valuable technical reference and practical guidance for other hospitals aiming to build trusted research data platforms.
5.Network meta-analysis of first-line treatments for metastatic urothelial carcinoma
Xuejia QIU ; Bingnan REN ; Lingzhi FANG ; Yufei LIAN ; Yupei WU ; Zhanjun DONG
China Pharmacy 2024;35(22):2815-2821
OBJECTIVE To systematically evaluate the effectiveness of different treatment regimens as first-line treatment for metastatic urothelial carcinoma (UC) using a network meta-analysis (NMA) approach. METHODS Electronic databases including PubMed, the Cochrane Library, Embase, Wanfang Data, CNKI, and VIP were searched for randomized controlled clinical trials (RCTs) on first-line treatment for metastatic UC from January 1, 2010 to January 31, 2024. After literature screening and data extraction, a risk of bias assessment of included studies was conducted. R software (version 4.3.2) was used to perform the NMA. RESULTS A total of 11 RCTs involving 14 treatment interventions were included. No significant differences were noted in objective response rate among groups, with the combination of pembrolizumab, gemcitabine and cisplatin having the highest probability of ranking first. Regarding progression-free survival (PFS) and overall survival (OS), no significant differences were observed among groups, while enfortumab vedotin combined with pembrolizumab showed a trend towards better PFS extension compared to gemcitabine combined with cisplatin [HR=0.45, 95%CI(0.20,1.06), P=0.049], and it had the highest probability of ranking first in both PFS and OS. CONCLUSIONS The combination of enfortumab vedotin and pembrolizumab may have an advantage in prolonging survival in the first-line treatments for metastatic UC.
6.Effect of pre-infusion of hypertonic saline on postoperative cognitive function in elderly patients
Fang XU ; Xupeng WANG ; Yanan LI ; Yahui ZHANG ; Qi ZHOU ; Mingyang GAO ; Yufei HU ; Xiaoqin REN ; Qiujun WANG
Chinese Journal of Anesthesiology 2024;44(10):1186-1189
Objective:To evaluate the effect of pre-infusion of hypertonic saline on the postoperative cognitive function in elderly patients.Methods:This was a prospective study. Seventy-six patients of both sexes, aged≥60 yr, of American Society of Anesthesiologists Physical Status classification Ⅱ or Ⅲ, who underwent elective shoulder arthroscopic surgery under brachial plexus block combined with general anesthesia from June 2022 to January 2023 in our hospital, were selected and divided into 2 groups ( n=38 each) by the random number table method: hypertonic saline group and normal saline group. At 30 min before anesthesia induction, 3% hypertonic saline of 4 ml/kg was intravenously infused in hypertonic saline group, and normal saline 4 ml/kg was intravenously infused in normal saline group. The occurrence of intraoperative cerebral desaturation events was recorded. Venous blood samples were collected at 24 h postoperatively, and the plasma concentrations of interleukin-1beta (IL-1β), IL-6, tumor necrosis factor-alpha and S-100β were measured by enzyme-linked immunosorbent assay, and the expression of neutrophil CD11b was detected by flow cytometry. Rey auditory verbal learning test, trail making test, digit symbol substitution test, and stroop color-word test were performed at 1 day before surgery and 5 days after surgery, and the postoperative cognitive dysfunction was assessed using the Z-score method. Results:Compared with normal saline group, the concentrations of plasma IL-6, tumor necrosis factor-alpha and S-100β and expression of neutrophil CD11b were significantly decreased in hypertonic saline group, and the incidence of cognitive dysfunction and cerebral desaturation events was decreased in hypertonic saline group ( P<0.05). Conclusions:Pre-infusion of hypertonic saline can reduce inflammatory responses and improve postoperative cognitive function in elderly patients.
7.Construction of an intelligent scheduling management information system for " one-stop" transportation service in a hospital
Lan DENG ; Bingbing TUO ; Yufei REN ; Lei ZHANG ; Demin XU
Chinese Journal of Hospital Administration 2024;40(6):458-463
To solve the problems such as decentralized management of transportation needs and personnel, a tertiary hospital launched an intelligent scheduling management information system for " one-stop" transportation service in March 2022, which included the business layer, data layer, and control layer. The system used graph neural network algorithm to train multi feature transportation service data and established an artificial intelligence model for transportation service scheduling, which was used to assist the hospital transportation command center in intelligent scheduling, achieving unified application, task scheduling, process control, and personnel assessment of hospital transportation services.The coverage of transportation services had increased from 188 departments before the system online (March 2021 to February 2022) to 268 departments after the system online (March 2022 to February 2023), as well as the service types and the per capita efficiency coefficient of transportation personnel had increased from 36 categories and 4 086.53 orders/person to 52 categories and 5 839.83 orders/person, respectively. This system met the growing demand for hospital transportation services, improved the level of transportation scheduling management and user satisfaction, which could provide references for other hospitals to promote intelligent management of transportation services.
8.Application of artificial neural network algorithm in pathological diagnosis and prognosis prediction of digestive tract malignant tumors.
Ya XIAO ; Shuyang WANG ; Ren LING ; Yufei SONG
Journal of Zhejiang University. Medical sciences 2023;52(2):243-248
The application of artificial neural network algorithm in pathological diagnosis of gastrointestinal malignant tumors has become a research hotspot. In the previous studies, the algorithm research mainly focused on the model development based on convolutional neural networks, while only a few studies used the combination of convolutional neural networks and recurrent neural networks. The research contents included classical histopathological diagnosis and molecular typing of malignant tumors, and the prediction of patient prognosis by utilizing artificial neural networks. This article reviews the research progress on artificial neural network algorithm in the pathological diagnosis and prognosis prediction of digestive tract malignant tumors.
Humans
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Neural Networks, Computer
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Algorithms
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Prognosis
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Gastrointestinal Neoplasms/diagnosis*
9.Practice of comprehensive cloud-based services in large general hospitals
Runkang SUN ; Xiaoxiang ZHANG ; Jin LI ; Jin XU ; Yufei REN
Chinese Journal of Hospital Administration 2022;38(11):819-823
In order to carry out the " Healthy China 2030″ initiative, accelerate the cloud-based transformation of hospital information platforms, promote the construction of smart hospitals, and improve hospital informatization service capabilities, a tertiary hospital launched a comprehensive cloud-based practice for hospital operations in November 2020. A high-availability medical cloud platform designed for large general hospitals was built, by renting from carriers the Internet data center, installing highly scalable infrastructure, building multi-loop self-healing fiber-optic private network, applying the cloud-based software architecture using microservices and distributed storage, and implementing distributed systems′ full-link log and performance monitoring. In February 2021, the hospital migrated its medical care and operation management services on the cloud, achieving unified management of multiple hospital campuses, and reducing manpower and capital investment in computer room constructions. This practice ensured the continuity of hospital business, promoted the regional medical cooperation and the sinking of high-quality medical resources, and provided a reference for speeding up the promotion of nationwide hospital business to the cloud.
10.Report of national proficiency testing for urinary iodine among the laboratories of iodine deficiency disorders in Shaanxi Province in 2020
Chinese Journal of Endemiology 2021;40(10):857-860
Objective:To evaluate the operation of urinary iodine external quality control network in Shaanxi Province in 2020, to know the urinary iodine detection capabilities of iodine deficiency disorders (IDD) laboratories in Shaanxi Province, so as to ensure the technical support for epidemiological surveillance and control of IDD.Methods:In 2020, a total of 118 IDD laboratories in Shaanxi Province participated in the external quality control assessment, and the two concentrations of urinary iodine quality control samples were measured by As 3+-Ce 4+ catalytic spectrophotometry. The testing results of urinary iodine were statistically analyzed with standard value ± uncertainty and Z-ratio scoring methods. Results:All the 118 laboratories participating in the external quality control assessment of urinary iodine in the province had feedback the assessment results. The standard value ± uncertainty method was used for evaluation, the test results of 118 laboratories in the province were all within the uncertainty range, and all were qualified. The Z-ratio scoring method was used for evaluation, there were two county level laboratories with an inter-laboratory |Z| score≥3, and the evaluation results of other laboratories were all qualified, with a qualified rate of 98.31% (116/118). The results of the two evaluation methods were basically consistent.Conclusions:After years of external quality control network operation, the urinary iodine detection capability of laboratories at all levels in Shaanxi Province is stable and reliable, and most laboratories have passed the ability verification. It is suggested that individual laboratory should strengthen internal quality control and improve detection capabilities to lay a solid foundation for monitoring and prevention of IDD.

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