The official implementation of the Regulations on Clinical Research and Translation of New Biomedical Technologies (State Council Decree No.818, hereinafter referred to as the "Regulations") marks a new stage of legal governance, standardization, and whole-chain regulation for emerging biomedical fields such as cell and gene therapy (CGT) in China, exerting a profound impact on the development of transfusion medicine as a discipline. Within the framework of the core regulatory systems established by the Regulations, and drawing upon the extensive experience of transfusion medicine in comprehensive quality control, cell processing and handling, ethical compliance, and clinical translation, this study systematically elucidates the intrinsic alignment between transfusion medicine and CGT with respect to technical workflows, quality control rationale, and management systems. It further clarifies the discipline-specific advantages of the department of transfusion medicine to proactively undertake CGT engagement, while analyzing current shortcomings and transformational bottlenecks. By leveraging the existing institutional framework, the department of transfusion medicine is well positioned to evolve into a core platform for whole-process quality control and a pivotal hub for in-hospital clinical translation of CGT. However, this transformation must concurrently address multiple challenges, including heightened compliance responsibilities, lagging technical infrastructure, a shortage of interdisciplinary talent, and increasingly stringent standards for clinical research and translation. The Regulations provide a legal basis and policy support for the department of transfusion medicine to transcend its traditional, singular function of blood safety assurance and establish a synergistic development model integrating blood safety and cell therapy. Therefore, the department of transfusion medicine should proactively align with regulatory requirements, refine whole-process compliance systems, upgrade technical platforms, and cultivate interdisciplinary professionals to achieve high-quality transformative development as a core supporting discipline for biotherapy.

Platelet-derived exosomes (PLT-Exos) are a subgroup of nanoscale extracellular vesicles released by platelets upon activatin. As key intercellular signaling mediators, they precisely regulate target cells through the delivery of functional molecules, exerting multiple biological effects that promote tissue repair. Accumulating evidence has demonstrated that PLT-Exos significantly facilitate the repair of various tissue injuries by modulating inflammatory responses, stimulating angiogenesis, activating key repair signaling pathways, and mediating stem cell homing. Furthermore, owing to their inherent targeting capacity and low immunogenicity, PLT-Exos have emerged as a promising platform for novel drug delivery carriers in tissue repair. This article systematically reviews the biological characteristics of PLT-Exos, their isolation and identification techniques, the underlying mechanisms of action, and recent advances in clinical application. It also addresses the current challenges in clinical translation, including standardized preparation, subpopulation heterogeneity, scalable production, and clinical implementation, aiming to provide a theoretical reference for both basic research and clinical translation of PLT-Exos in tissue repair.

ObjectiveTo clarify the independent and synergistic effects of dyslipidemia in the progression of hepatic steatosis in metabolic dysfunction-associated fatty liver disease （MAFLD）. MethodsA total of 7 697 participants who underwent physical examination in Beijing Friendship Hospital， Capital Medical University， from January 2022 to December 2024 were enrolled， and finally 2 177 patients with MAFLD were enrolled as subjects. Transient elastography was used to quantify the severity of hepatic steatosis （grades S1-S3）. The multivariable ordinal Logistic regression analysis was used to investigate the independent and synergistic associations of serum triglyceride （TG）， high-density lipoprotein cholesterol （HDL-C）， and low-density lipoprotein cholesterol （LDL-C） with the severity of hepatic steatosis， and their interactions and potential nonlinear relationships with metabolic factors were also examined. One-way analysis of variance or Kruskal-Wallis H test was used for comparison of continuous data between groups， and chi-square test was used for comparison of categorical data between groups. ResultsAn increase in TG （odds ratio ［OR］=1.77， 95% confidence interval ［CI］： 1.48 — 2.10， P<0.001） and a reduction in HDL-C （OR=1.35， 95%CI： 1.11 — 1.65， P=0.003） were independently associated with a greater severity of hepatic steatosis， with the strongest association when both abnormalities coexisted （OR=2.40， 95%CI： 1.87 — 3.07， P<0.001）. The dose-response relationship analysis further revealed a nonlinear threshold effect of TG on hepatic steatosis at the threshold of 1.51 mmol/L （P_nonlinearity=0.001）， below which the severity of steatosis increased more rapidly with the increase in TG concentration （P=0.001）. The subgroup analysis showed that the association between the reduction in HDL-C and the severity of steatosis was observed only in males， young adults （aged <45 years）， and metabolically healthier subgroups （without diabetes， obesity， hyperuricemia or hypertension）. Significant interactions were observed between the presence or absence of obesity and the abnormal levels of TG and HDL‑C （both P_interaction<0.05）. The association of the increase in LDL-C with steatosis was confined to specific subgroups （without obesity or hyperuricemia）. ConclusionThe increase in TG and the reduction in HDL-C are independently associated with the severity of hepatic steatosis in MAFLD. The synergistic effect of blood lipids and their interactions with metabolic factors may further refine risk stratification， so as to provide a basis for precise management of MAFLD.

Promoting whole life cycle management of large medical equipment is a crucial initiative to enhance hospital operational efficiency and service quality.It adopts the full life cycle theoretical,focusing on analyzing key operational issues in configuration planning,procurement,utilization,maintenance,and decommissioning during the planning,implementation,and decline phases of large medical equipment.Through in-depth analysis of these issues,the research proposes corresponding strategies:establishing multi-stakeholder participation mechanisms and equipment utilization protocols during the planning phase;improving allocation and performance evaluation mechanisms during the implementation phase;and scientifically standardizing maintenance and retirement procedures during the decline phase.These recommendations provide theoretical support and practical guidance for public hospitals to achieve lean operation of large medical equipment.

Objective:To analyze risk factors associated with false-positive results of quantitative fecal immunochemical testing (FIT), evaluate its performance for detecting advanced colorectal neoplasia across different subgroups, and explore the optimal positivity thresholds for each subgroup.Methods:Individuals who participated in the Zhejiang Colorectal Cancer Screening Program in 2020-2021, completed questionnaire-based risk assessment and quantitative FIT for initial screening, and undertook colonoscopy for confirmed diagnosis were included in this study. The information of individuals, including demographic characteristics, lifestyles, history of diseases, and family history of colorectal cancer (CRC), was collected by using questionnaires. The diagnostic outcomes of the individuals were obtained through colonoscopy and pathological examination. Multivariate logistic regression analyses were conducted to identify factors associated with false-positive FIT results. The optimal threshold of FIT was determined based on the receiver operating characteristic (ROC) curve and 10-fold cross-validation. The effectiveness of FIT screening in different subgroups was compared using the unified threshold of 100 ng/ml or optimal positivity thresholds.Results:There were 25 874 individuals included in the analysis, with 14 694 (56.79%) having fecal hemoglobin concentrations ≥100 ng/ml. A total of 3 830 advanced adenoma cases (14.80%) and 362 CRC cases (1.40%) were identified. Age below 60 years old, females, underweight, smoking, drinking, use of nonsteroidal anti-inflammatory drugs, no family history of CRC, no history of intestinal disease, no history of hypertension, and physical inactivity were associated with an elevated risk of false-positive results in FIT ( P<0.05). Compared to the predetermined threshold of 100 ng/ml, the false positive rate (FPR) of quantitative FIT decreased from 52.3% to 37.3% in all individuals, and decreased by more than 20% in females, individuals with normal weight, smokers, and those without a history of intestinal disease when adopting the optimal threshold (all P<0.001). Conclusion:The risk of false-positive results in quantitative FIT varies across different subgroups. Adopting the optimal thresholds could improve the specificity and reduce the FPR of quantitative FIT for CRC screening.

Objective:In order to reduce the trauma associated with fetal cardiopulmonary bypass(F-CPB), Our team plans to develop a minimally invasive F-CPB through a small incision in the right axilla. The efficacy of this technique will be verified by using a big experimental animal model, thereby laying the foundation for fetal cardiac surgery supported by F-CPB in the future.Methods:Ten pregnant sheep were divided into F-CPB group(n=5) and control group(n=5). After fasting for 24 h, fetal lambs in the F-CPB group underwent a right axillary incision to establish F-CPB running for 1 h; The control group of fetal lambs only expose heart 1 h without F-CPB. Collect blood sample for laboratory test at the CPB vehicle before(T0), 30 min(T1), and 1 h after F-CPB running(T2) for the F-CPB group and through Superior Vena Cava before(T0), 30 min(T1), and 1 h after F-CPB running(T2) for the control group.Results:The blood routine indicators such as RBC, HCT, and Hb in the F-CPB group of fetal lambs decreased significantly during F-CPB, and their distribution showed significant statistical differences compared with the control group( P<0.05). There were no significant statistical differences in blood gas indicators such as pH, PO 2, PCO 2, and lactate concentration between the F-CPB group and the control group( P>0.05). There was no statistically significant difference in the concentration of cTnI in fetal lamb serum at each time point( P>0.05). There were significant statistical differences( P<0.05) in the distribution of fetal lamb Alb, γ-GGT, CK concentration and cholesterol concentration at various time points in the F-CPB group compared with the control group in liver function examination. In addition, the distribution of BUN in fetal lambs showed a significant difference between the two groups( P=0.006). Conclusion:A minimally invasive F-CPB via small incision in the right axilla is safe and feasible. The experimental animal model has demonstrated that this technique has minimal impact on the vital organ functions and internal environment of fetal lambs, thereby laying the foundation for clinical fetal cardiac surgery in the future.

Objective To establish an effective model for distinguishing glandular prodromal lesions(PGL)mixed with ground-glass nodules(mGGN)from minimally invasive adenocarcinoma(MIA)on CT based on artificial intelligence.Methods A retrospective analysis was conducted on the clinical and CT image data of 180 patients with lung adenocarcinoma confirmed by surgical pathology and with CT manifestations of mGGN in the First Affiliated Hospital of Wenzhou Medical University from January 2017 to June 2023,inclu-ding 66 patients with PGL and 114 patients with MIA.Patients were divided into the training set(n=144)and the test set(n=36)in an 8∶2 ratio using a completely random method.The quantitative parameters and radiomics features of the lesions in CT images were automatically extracted using artificial intelligence soft-ware(United Imaging Research Platform uRP).By incorporating the most obvious correlation features of omics through dimensionality reduction,five machine learning classifiers were established,including logistic regression(LR),support vector machine(SVM),Random forest(RF),Gaussian process(GP),and Decision Tree(DT).The classifier with the training set highest area under the curve(AUC)was selected as the best radiomics model,and output the result as radiomics score(Rad-score).The clinical information,CT morpho-logical characteristics and quantitative data of the two groups were included in the multivariate logistic regres-sion analysis to screen the independent influencing factors for effectively differentiating PGL and MIA,and a clinical model was established.Finally,a comprehensive prediction model was constructed based on Rad-score and clinical risk factors.The diagnostic performance of the three models was evaluated by using the AUC,sen-sitivity,specificity and accuracy of receiver operating characteristic(ROC)curve.Results Eleven radiomics features for distinguishing PGL from MIA were obtained through LASSO dimensionality reduction.Among the five machine learning classifiers,GP has the best diagnostic performance,with AUC of 0.865 in the train-ing set and 0.762 in the test set,respectively.Univariate and multivariate logistic regression analyses were used for clinical feature screening.The clinical model was constructed by using the average CT value,average long and short diameter,and solid partial long diameter of mGGN,and the AUCs of the training set and the test set were 0.870 and 0.794,respectively.The comprehensive prediction model demonstrated superior diag-nostic performance,with AUC,sensitivity,specificity,and accuracy in the training set being 0.948,81.1%,91.2%and 87.5%respectively,while 0.883,76.9%,91.3%and 86.1%respectively in the test set.Conclu-sion The comprehensive prediction model established based on the quantitative and omics feature analysis of pulmonary nodules by artificial intelligence can well distinguish mGGN mixed with PGL from MIA on CT,and can be used to guide clinical treatment decisions.

[Objective] To explore the strategy of blood management in patients with massive transfusion in the frigid plateau region. [Methods] The treatment process of a patient with liver rupture in the frigid plateau region was analyzed, and the blood management strategy of the frigid plateau region was discussed in combination with the difficulties of blood transfusion and literature review. [Results] The preoperative complete blood count (CBC) test results of the patient were as follows: RBC 3.14×10¹²/L, Hb 10⁶ g/L, HCT 30.40%, PLT 115.00×10⁹/L; coagulation function: PT 18.9 s, FiB 1.31 g/L, DD > 6 μg/mL, FDP 25.86 μg/mL; ultrasound examination and imaging manifestations suggested liver contusion and laceration / intraparenchymal hematoma, splenic contusion and laceration, and massive blood accumulation in the abdominal cavity; it was estimated that the patient's blood loss was ≥ 2 000 mL, and massive blood transfusion was required during the operation; red blood cell components were timely transfused during the operation, and the blood component transfusion was guided according to the patient's CBC and coagulation function test results, providing strong support and guarantee for the successful treatment of the patient. The patient recovered well after the operation, and the CBC test results were as follows: RBC 4.32×10¹²/L, Hb 144 g/L, HCT 39.50%, PLT 329.00×10⁹/L; coagulation function: APTT 29.3 s, PT 12.1 s, FiB 2.728 g/L, DD>6 μg/mL, FDP 25.86 μg/mL. The patient was discharged after 20 days, and regular follow-up reexamination showed no abnormal results. [Conclusion] Individualized blood management strategy should comprehensively consider the patient’s clinical symptoms, the degree of hemoglobin decline, dynamic coagulation test results and existing treatment conditions. Efficient and reasonable patient blood management strategies can effectively improve the clinical outcomes of massive transfusion patients in the frigid plateau region.

The associated specialists of The Society of Maternal and Child Health Management, China Healthy Birth Science Association and Shanghai Society for Immunology, Pediatric Branch updated the guidelines for human papilloma virus(HPV)vaccine against HPV infections in the Chinese children and adolescence based on guideline on human papilloma virus vaccine immunization schedule(shanghai) for adolescence.The guideline covers 11 recommendations on 8 aspects, including the purpose of recommending HPV vaccines for children and adolescents, the importance of early vaccination, the safety and efficacy of the vaccines, vaccination for immunocompromised children, vaccine processing technique, adverse reactions of vaccines, and combined vaccination with multiple vaccines.Although some of the guideline provisioners have controversies regarding aspects such as HPV infection leading to certain tumors and the therapeutic effects of vaccine fields, but this interpretation still provide these background literatures for reference.Now, this guideline will be interpreted from the perspective of the recommended content and the research progress of related HPV vaccines, with the aim of providing reference for pediatric clinical work.

Objective To explore the variation characteristics of ganglion cell complex(GCC)parameters in patients with diabetic retinopathy(DR)at different stages and their relationship with hemoglobin(HB)level.Methods A total of 97 DR patients who were treated in our hospital from January 2021 to January 2023 were selected and divided into the moderate non-proliferative DR(mNPDR)group(n=35),the severe non-proliferative DR(sNPDR)group(n=32),and the proliferative DR(PDR)group(n=30).The general data,biochemical indicators,and GCC parameters of the three groups were compared.Logistic regression was used to analyze the influence of ganglion cell layer(GCL)parameters on the staging of DR.In addition,according to the terartiles of HB levels,they were divided into the low-level(LHB)group of(10.31±1.13)g/dl(n=32),the medium-level(MHB)group of(12.52±0.32)g/dl(n=31),and the high-level(HHB)group of(14.73±0.31)g/dl(n=34).The general data,biochemical indicators and GCC parameters of the three groups were compared,and the influence of HB on the stage of DR were analyzed by Logistic regression.Logistic regression was used to analyze the influence of HB level on GCC parameters.Results The age,hemoglobin A1c(HbA1c),fasting plasma glucose(FPG),total cholesterol,local lost volume of GCC(FLV),and overall lost volume of GCC(GLV)in the mNPDR,sNPDR,and PDR groups increased successively(P<0.05).Rate of anemia,low-density lipoprotein cholesterol in PDR group was higher than mNPDR and sNPDR groups(P<0.05).The HB,albumin,total bilirubin(TBIL),direct bilirubin(DBIL),thicknesses of GCC,retinal nerve fiber layer(RNFL),and ganglion cell layer(GCL)decreased successively(P<0.05).The TBIL,DBIL,GCC thickness,RNFL thickness and GCL thickness in the LHB,MHB and HHB groups increased successively(P<0.05),while the age,serum creatinine,FLV and GLV decreased successively(P<0.05).HbA1c,FPG,rate of anemia in the HHB group were lower than those in the LHB and MHB groups(P<0.05),and triglyceride in the MHB and HHB groups were higher than that in the LHB group(P<0.05).Logistic regression analysis showed that after adjusting for confounding factors,all GCL thicknesses and HB levels were influencing factors for DR staging.After adjusting for GCC and RNFL thicknesses,HB levels were influencing factors for the average thickness,minimum thickness,upper thickness,and lower thickness of GCL.Conclusions Both the thickness of GCL and the level of HB are factors affecting the DR staging.The level of HB has an impact on the thickness of GCL and deserves clinical attention.