1.Key points of ethical governance in the clinical application of new biomedical technology
Ping YUAN ; Hongjuan LI ; Xiaojing LI ; Xiuying ZHANG ; Qiongge ZHANG ; Hongyu WANG
Chinese Medical Ethics 2025;38(1):89-94
Given the current ethical issues such as unknown high risks in the clinical application of new biomedical technology, thus, medical institutions need to establish new technology management systems, including clarifying the concept, the assessment and admission mechanism, and ethical management systems of new technology. According to the direction of the development of new technology in the medical institution, the ethics review committee should also perfect the management system of ethics committees and the professional composition of ethics review committee members, improve the ability of ethics committee members to evaluate new biomedical technology, increase the assessment of ethical risks of new technology in the preliminary review stage, strengthen the requirements for emergency plan formulation, as well as set the frequency of the follow-up review based on the risk level of new technology. The ethics review committee should work together with the medical management department to formulate an ethical standardization training system for the clinical application of medical technology in the institution, and regularly conduct training for all staff, to promote medical workers’ understanding of the management requirements of biomedical technologies. Different types of new biomedical technology have different ethical risks. Therefore, the medical management departments and ethics review committees of medical institutions should formulate specific management rules based on the characteristics of new technology types. However, it should be noted that when new biomedical technology generally is first introduced into clinical practice, there are often issues regarding fairness and justice in the use of the technology.
2.Transcutaneous bilirubin curves in healthy neonates based on multicenter remote monitoring data
Bi ZE ; Xiaoyue DONG ; Jin WANG ; Chuan NIE ; Jiajun ZHU ; Fang GUO ; Falin XU ; Chunhui YANG ; Bizhen SHI ; Zhankui LI ; Xinhua ZHANG ; Jing LI ; Bin YI ; Xiuying TIAN ; Lejia ZHANG ; Jun TANG ; Xinlin HOU ; Jiahua XU ; Guoying HUANG ; Shuping HAN ; Wenhao ZHOU
Chinese Journal of Pediatrics 2025;63(12):1318-1324
Objective:To establish 30-day of age transcutaneous bilirubin (TcB) reference curves for healthy neonates, and to investigate regional variations in bilirubin dynamics.Methods:A multicenter retrospective cohort study was conducted. A total of 220 950 healthy neonates born at a gestational age of 35-<42 weeks, with a birth weight ≥2 000 g, who did not receive phototherapy within 60 h after birth were recruited. All of them underwent remote TcB monitoring using the Bilibaby remote jaundice monitoring system between August 1 st, 2020 and December 31 st, 2024 in 426 hospitals. TcB data were collected within the period from birth to 30-day of age. The P40, P75, and P95 of TcB values were calculated, and dynamic TcB curves for 30-day of age were constructed. Patterns of bilirubin change, rates of change, and transition outcomes were described. Regional comparisons between South and North were conducted using linear mixed-effects models for TcB trajectories and Pearson′s chi-square test for outcome differences. Results:A total of 220 950 neonates were included, of whom 101 711 (46.03%) were female. Gestational age at birth was (38.75±1.12) weeks, and birth weight was (3 272±417) g. TcB levels increased rapidly within 3-day of age, peaked at 4-6-day of age, with peak values at P40, P75, and P95 of 200.6, 239.7 and 275.4 μmol/L (11.8, 14.1 and 16.2 mg/dl), respectively. TcB levels gradually declined thereafter and stabilized after 13-day of age, with values at P40, P75, and P95 fluctuating between 147.9-159.8, 190.4-200.6, and 231.2-239.7 μmol/L (8.7-9.4, 11.2-11.8, 13.6-14.1 mg/dl), respectively. Notably, among neonates categorized as low-or low-intermediate-risk within 3-day of age, 6 700 (12.76%) progressed to intermediate-high or high risk between 4 and 30 days of age. Before 13-day of age, TcB levels in the southern regions were consistently higher than those in the northern regions ( P=0.039); from 14 to 30 days of age, the overall TcB levels had no statistically difference, but the temporal changes in TcB still showed regional differences (degrees of freedom=3, all interaction P<0.05). Among neonates classified as low-or low-intermediate risk within 3-day of age, 25 326 were from southern regions, of whom 4 254 (16.80%) progressed to intermediate-high or high risk between 4 and 30 days of age. In northern regions, 27 193 neonates were classified as low-or low-intermediate risk within 3-day of age, among whom 2 446 (8.99%) progressed to intermediate-high or high risk. The risk progression between the 2 regions had statistically difference ( χ2=716.49, P<0.001). Conclusions:A TcB percentile curve for neonates within 30-day of age was established, revealing that both the overall TcB level and its temporal trend were higher in southern than in northern newborns. These findings provide baseline data to support continuous management of neonatal jaundice.
3.Current status and prospects of public health nursing development at home and abroad
Chunxia HE ; Jiali ZHANG ; Jimei ZHANG ; Lingli YAN ; Jia YIN ; Qian YAO ; Xiuying HU
Chinese Journal of Modern Nursing 2025;31(31):4321-4328
This paper conducts a systematic literature review to analyze and summarize the current status, admission standards, practical scope, competency requirements, and talent cultivation of public health nursing teams both domestically and internationally, in order to provide reference for the development of public health nursing in China and assist in the improvement of the public health talent team.
4.Relationship between CT quantitative left heart structure parameters and recurrence of hypertrophic cardiomyopathy complicated with atrial fibrillation after radiofrequency ablation
Lusheng SUN ; Lifang ZHANG ; Junjie GAO ; Xiuying TANG
Tianjin Medical Journal 2025;53(5):533-537
Objective To explore the relationship between CT quantitative left heart structure parameters and recurrence after hypertrophic cardiomyopathy(HCM)and atrial fibrillation(AF)radiofrequency ablation(RFCA).Methods A total of 120 patients with HCM and AF admitted to our hospital from April 2021 to June 2023 were selected.Patients were divided into the relapse group and the non-recurrence group according to whether RFCA recurred 6 months after operation.All patients underwent CT examination,and left ventricular ejection fraction(LVEF),left atrial ejection fraction(LAEF),left atrial volume index(LAVI)and left atrial auricular volume of the two groups were analyzed.The clinical data of patients were collected.Logistic regression model was used to analyze the influencing factors of postoperative recurrence of RFCA in HCM patients with AF.Receiver operating characteristic curve(ROC)curve was used to analyze the predictive efficacy of left heart structure parameters for postoperative recurrence of RFCA in HCM patients with AF.Results The volume levels of LAVI and left auricle were higher in the relapsed group than those in the non-relapsed group,and the level of LAEF was lower than those in the non-relapsed group(P<0.05).Logistic regression analysis showed that persistent atrial fibrillation,LAVI and high left atrial appendage volume were independent risk factors for postoperative recurrence in HCM patients with AF(P<0.05),and high LAEF was protective factor(P<0.05).The results of ROC curve analysis showed that the AUC value of LAVI,LAEF and left atrial appendage volume in predicting recurrence after RFCA in patients with HCM and AF was 0.902,which was higher than that of 0.789,0.755 and 0.675 of each individual test.The combined prediction efficiency of the three tests was higher than that of each single test(Z=2.177,2.555 and 3.628,P<0.05).Conclusion High level of LAVI and left atrial appendage volume and low level of LAEF are risk factors for postoperative recurrence of RFCA.The combined detection of the three methods has high predictive value for postoperative recurrence of RFCA in HCM patients with AF.
5.Correlation between Serum LncRNA RMST,miR-582-5p Expression Levels and Early Neurological Deterioration and Prognosis in Patients with Acute Ischemic Stroke
Jianhua REN ; Ran ZHANG ; Xiuying CUI ; Xin ZHAO
Journal of Modern Laboratory Medicine 2025;40(1):64-68
Objective To investigate the expression changes of serum long non-coding RNA rhabdomyosarcoma associated transcript-2 (LncRNA RMST) and miR-582-5p in patients with acute ischemic stroke (AIS),and their correlation with early neurological deterioration (END) and prognosis. Methods A total of 129 patients with ischemic stroke admitted to Chengde Central Hospital from January 2021 to December 2022 were gathered,according to diagnostic criteria and patients were divided into END group (n=42) and non END group (n=87) besed on whether END occurred within one week. In addition,59 healthy individuals who underwent physical examination in the hospital were regarded as the health group. The real-time fluorescence quantitative polymerase chain reaction method was applied to detect serum LncRNA RMST and miR-582-5p levels in each group. The Pearson method was used to analyze the correlation between serum LncRNA RMST and miR-582-5p levels in END patients. ROC curve was applied to evaluate further the levels of blood LncRNA RMST and miR-582-5p,and the efficacy analysis of their combination in predicting the prognosis of AIS patients. Results Serum LncRNA RMST(1.01±0.28,2.10±0.41,3.99±0.52) levels gradually increased in the healthy,non-END and END groups,and miR-582-5p(1.02±0.23,0.86±0.16,0.73±0.15) levels gradually decreased,and the differences were statistically significant (F=672.974,31.907,all P<0.05). There was a significant negative correlation between serum LncRNA RMST levels were significantly negatively correlated with miR-582-5p levels (r=-0.451,P<0.001). The AUC(95%CI) of the combined diagnosis of serum LncRNA RMST and miR-582-5p levels in AIS patients was 0.961(0.912~0.987),which was better than the independent prediction (Z=2.280,4.515,all P<0.05). Conclusion The levels of serum LncRNA RMST and miR-582-5p were closely related to END,and they are expected to become predictive factors for the prognosis of AIS patients.
6.Optimization of Electrotransfection Conditions of EGFP Reporter Gene PiggyBac Vector in Triple Negative Breast Cancer MDA-MB-231 Cell Line
Peipei WANG ; Xiaotian ZHANG ; Zhiming LING ; Wenjuan WANG ; Xiuying LIU ; Jianxun WANG
Journal of Modern Laboratory Medicine 2025;40(3):189-194
Objective To explore the optimal conditions for stable transfer of reporter gene containing enhanced green fluorescent protein(EGFP)into human breast cancer cells MDA-MB-231 cells under different electrotransfection conditions.Methods A PiggyBac(PB)transposon system containing EGFP reporter gene was constructed,and transfection conditions such as waveform,voltage,shock time,shock times,plasmid concentration,cell density,transposon to transposase ratio were controlled during electrotransfection of MDA-MB-231 cells.The transfection efficiency was detected by flow cytometry fluorescein isothiocyanate(FITC)channel.The expression of fluorescent protein was observed under laser scanning confocal microscope,the electrotransfection efficiency and expression of EGFP reporter gene were verified,and the electrotransfer efficiency of MDA-MB-231 cells was analyzed under different electrotransfection conditions.Results The optimal transfection conditions of MDA-MB-231 cells were as follows:voltage 280V,exponential wave,electric shock once,concentration of transposon plasmid about 1 000 ng/μl,mass ratio of transposon to transpotase 1:1,number of cells 2×106,electrotransfection rate up to 60.23%±5.63%.The state of MDA-MB-231 cells was good.Conclusion The electrotransfection conditions of MDA-MB-231 cells were successfully optimized to achieve stable and efficient transfection,which provided efficient electrotransfer experimental parameters for the relevant basic research of MDA-MB-231 cell line.
7.Meta-analysis of Reduning in the treatment of respiratory syncytial virus pneumonia in children
Hui WANG ; Xuefeng WANG ; Ruixue LI ; Jingwen MU ; Xiuying ZHANG
China Modern Doctor 2025;63(17):47-51
Objective To evaluate the clinical efficacy,safety and economy of Reduning injection in the treatment of respiratory syncytial virus pneumonia in children.Methods Randomized controlled trials that met the inclusion and exclusion criteria in database were searched.The data extraction and quality evaluation of the literature were performed independently by two people.Meta-analysis was performed.A total of 6 studies involving 514 children were included.Results The total effective rate of Reduning injection combined with western medicine in the treatment of children with respiratory syncytial virus pneumonia was higher than that in western medicine group.The cough,dyspnea,wheezing disappearance time,hospitalization time were shorter than those in western medicine group,and the levels of inflammatory factors and immune cells were better than those in western medicine group.The incidence of adverse events in Reduning injection combined with western medicine group was lower than that in western medicine group,and the hospitalization cost was lower than that in western medicine group.The above results were statistically significant(P<0.05).Conclusion Reduning injection combined with western medicine in the treatment of children with respiratory syncytial virus pneumonia can improve the clinical efficacy,with good safety and less hospitalization costs.
8.Armored IL15 or IL15 receptor adaptors enhance proliferation and anti-tumor activity of CD19-targeted CAR-NK cells
Mengyuan YU ; Xiuying LIU ; Xiaotian ZHANG ; Jiaying WANG ; Zhiming LING ; Jianxun WANG
Journal of Army Medical University 2025;47(23):2903-2912
Objective To construct CD19-targeted chimeric antigen receptor natural killer(CAR-NK)cells armored with interleukin15(IL15)or IL15 receptor-linker(RLI)and preliminarily validate their proliferative capacity and anti-tumor activity in vitro.Methods Natural killer cells(NK92 and NK92MI)from patients with human malignant non-Hodgkin lymphoma were cultured,and CD19-targeted CAR-NK cells armored with IL15 or RLI were prepared using retroviral vector particles.IL15 secretion was measured by ELISA,and proliferative capacity was assessed via CFSE dilution assays.Human B-lymphocytic leukemia cells(Nalm6-GFP-Luc)and human colon cancer cells overexpressing CD19(hCD19-SW620-GFP-Luc)were cultured,with surface CD19 expression confirmed(>99%positivity for both).Anti-tumor activity was evaluated by measuring cytotoxicity at effector-to-target(E:T)ratios using luciferase-based assays(4/12 h),detecting surface CD107a expression via flow cytometry,and quantifying cytokine release using CBA assays.Results NK92/NK92MI-CD19 CAR cells armored with IL15 or RLI were successfully generated.IL15 secretion was significantly higher in armored groups versus non-armored controls(P<0.01).Without IL-2 stimulation,IL15/RLI enhanced CAR-NK proliferation(P<0.05).Both armored designs significantly increased tumor-killing efficiency(P<0.05)and CD107a degranulation.IL15/RLI-armored NK92-CD19 CAR cells exhibited elevated release of IL2,IL10,IL6,TNF-α,sFas,IFN-γ,and Granulysin(P<0.05),while armored NK92MI-CD19 CAR cells showed additional increases in Granzyme A,Granzyme B,and Perforin(P<0.05).Conclusion IL15/RLI-armored NK92/NK92MI-CD19 CAR cells demonstrate potent anti-tumor activity,supporting their combined clinical therapeutic potential for tumors.
9.Exon Sequencing of HNF1β in Chinese Patients with Early-Onset Diabetes
Siqian GONG ; Hong LIAN ; Yating LI ; Xiaoling CAI ; Wei LIU ; Yingying LUO ; Meng LI ; Si-min ZHANG ; Rui ZHANG ; Lingli ZHOU ; Yu ZHU ; Qian REN ; Xiuying ZHANG ; Jing CHEN ; Jing WU ; Xianghai ZHOU ; Xirui WANG ; Xueyao HAN ; Linong JI
Diabetes & Metabolism Journal 2025;49(2):321-330
Background:
Maturity-onset diabetes of the young (MODY) due to variants of hepatocyte nuclear factor 1-beta (HNF1β) (MODY5) has not been well studied in the Chinese population. This study aimed to estimate its prevalence and evaluate the application of a clinical screening method (Faguer score) in Chinese early-onset diabetes (EOD) patients.
Methods:
Among 679 EOD patients clinically diagnosed with type 2 diabetes mellitus (age at diagnosis ≤40 years), the exons of HNF1β were sequenced. Functional impact of rare variants was evaluated using a dual-luciferase reporter system. Faguer scores ≥8 prompted multiplex ligation-dependent probe amplification (MLPA) for large deletions. Pathogenicity of HNF1β variants was assessed following the American College of Medical Genetics and Genomics (ACMG) guidelines.
Results:
Two rare HNF1β missense mutations (E105K and G454R) were identified by sequencing in five patients, showing functional impact in vitro. Another patient was found to have a whole-gene deletion by MLPA in 22 patients with the Faguer score above 8. Following ACMG guidelines, six patients carrying pathogenic or likely pathogenic variant were diagnosed with MODY5. The estimated prevalence of MODY5 in Chinese EOD patients was approximately 0.9% or higher.
Conclusion
MODY5 is not uncommon in China. The Faguer score is helpful in deciding whether to perform MLPA analysis on patients with negative sequencing results.
10.Erratum: Author correction to "The upregulated intestinal folate transporters direct the uptake of ligand-modified nanoparticles for enhanced oral insulin delivery" Acta Pharm Sin B 12 (2022) 1460-1472.
Jingyi LI ; Yaqi ZHANG ; Miaorong YU ; Aohua WANG ; Yu QIU ; Weiwei FAN ; Lars HOVGAARD ; Mingshi YANG ; Yiming LI ; Rui WANG ; Xiuying LI ; Yong GAN
Acta Pharmaceutica Sinica B 2025;15(6):3353-3353
[This corrects the article DOI: 10.1016/j.apsb.2021.07.024.].

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