Objective: To evaluate the practical effectiveness of confidential unit exclusion (CUE) in ensuring blood safety in Zhengzhou, analyze its application characteristics and existing problems, and provide a basis for optimizing blood safety management strategies. Methods: A retrospective analysis was conducted on CUE data handled by Henan Red Cross Blood Center from January 2019 to December 2024. Parameters such as the number of cases, demographic characteristics, reasons for exclusion, and time of report were statistically analyzed and compared with those of non-CUE. Results: From 2019 to 2024, the CUE reporting rate in Zhengzhou was 0.002 6% (40/1 547 666). CUE donors were predominantly male (65.00%, 26/40), aged 18-34 years (47.50%, 19/40), had college degree orabove (50.00%, 20/40), and were employees of enterprises or public institutions (32.50%, 13/40). Among the 40 CUE blood units, only one was reactive for anti-TP, while all others were qualified. The main reasons for CUE were recent vaccination (32.50%, 13/40), medical conditions unsuitable for donation (27.50%, 11/40), and high-risk sexual behavior (17.50%, 7/40). A total of 70.00% of reports occurred within 24 hours after donation, during which none of the corresponding blood units had been released; all units reported after more than 7 days had already been issued for clinical use, with no adverse transfusion reactions reported upon follow-up. Conclusion: The confidential unit exclusion program has played an active role in establishing a supplementary information feedback channel for blood donors. The procedure can be optimized by strengthening interactive communication and confirmation before donation, improving the accuracy of donors' self-assessment, and expanding convenient and rapid information-based reporting channels.

OBJECTIVE: To explore the prenatal and postnatal phenotypes of 22q11.2 microdeletion syndrome (22q11.2DS) and enhance clinical understanding of this condition. METHODS: Data were collected from 86 fetuses diagnosed with 22q11.2DS at four prenatal diagnostic centers across China between January 2014 and August 2025. Prenatal imaging findings, pregnancy outcomes, and postnatal conditions were analyzed. RESULTS: Among the 86 fetuses, complete ultrasound data were available for 65 cases. Cardiovascular abnormalities were observed in 42 cases, thymic hypoplasia or aplasia in 7 cases, urinary system anomalies in 6 cases, nuchal translucency (NT) thickening in 7 cases, butterfly vertebrae, clubfoot, omphalocele and diaphragmatic hernia in 1 case each, cleft lip and palate in 2 cases, and ultrasound soft markers in 13 cases. The parents of 9 fetuses opted to continue with the pregnancy. Among these, 6 showed no significant ultrasound abnormalities and no related phenotypes postnatally, while the remaining 3 exhibited ultrasound anomalies with postnatal manifestations including developmental delay, immunodeficiency, and cardiac defects. CONCLUSION Fetuses with 22q11.2DS may exhibit various ultrasound abnormalities in multiple systems before and after birth. In addition to cardiovascular anomalies, they may also present with thymic hypoplasia or aplasia, thickened NT, and urinary abnormalities. Fetuses with thickened NT or thymic anomalies should be closely monitored, and thymic assessment should be included in routine prenatal imaging evaluations. For fetuses with 22q11.2DS who show no ultrasound abnormalities, the risk of developing severe phenotypes after birth is relatively low, but occult palate clefts and psychiatric disorders cannot be ruled out. Due to limitations in sample size and follow-up duration, above conclusions require further validation through large-scale prospective studies.
Humans ; Female ; Pregnancy ; Ultrasonography, Prenatal ; DiGeorge Syndrome/genetics* ; Adult ; Male ; Follow-Up Studies ; Fetus/diagnostic imaging* ; Phenotype ; Infant, Newborn

Objective: To validate the analytical performance, operational performance, and process control measures of a domestic fully automatic nucleic acid testing (NAT) system, thereby ensuring an efficient and orderly blood screening workflow. Methods: The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1, HCV and HBV, while precision was assessed using weak positive samples of HIV-1, HCV and HBV. As for its operational performance evaluation, cross-contamination resistance was assessed using strong positive samples, and throughput and stress testing were conducted using negative samples. Reagent stability was verified using weak positive samples, and inter-system performance consistency was assessed using verification panels. In addition, the process control measures were verified using the laboratory quality control demand scale. Results: 1) Verification of concordance rate: The detection results of negative and positive samples of HIV-1, HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations, and the concordance rate was 100%. 2) Precision verification: the repeatability and intermediate precision were extremely high, and the coefficient of variation was less than 5%. 3) Verification of analytical sensitivity: The detection limit of 95% for standard strains of HIV-1, HCV and HBV by WanTag-Vortex Plus system in our laboratory was consistent with the analytical sensitivity provided by reagent manufacturers. 4) Verification of cross-contamination resistance: Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design, and the test results were consistent with expectations, with no cross-contamination in the testing system. 5) Throughput and stress testing: Each system completed the individual donor-nucleic acid amplification testing (ID-NAT) of 276 samples in three batches within 12 hours, and successfully completed the ID-NAT test of 828 samples in three consecutive days. 6) Verification of reagent stability: After extreme storage (unsealed storage for 1 week with 4 freeze-thaw cycles), the reagents maintained 100% detection rate in the weak positive samples of HIV-1, HCV, and HBV, showing no significant differences from the control group (Kappa=1). 7) Verification of inter-system performance consistency: The system has stable operation performance, and the performance comparison results across the four devices were consistent (Kappa=1). 8) Process control measures: WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures, and correctly interpreted and safely reported the test results. Conclusion: The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements. Integrated with laboratory information system (LIS), the system's control software meets standard process control requirements, yet requires further improvement.

OBJECTIVES: Global epidemiological data indicate that 20% to 30% of intensive care unit (ICU) sepsis patients progress to deep vein thrombosis (DVT) due to coagulopathy, with an associated mortality rate of 25% to 40%. Existing prognostic tools have limitations. This study aims to develop and validate nomogram and machine learning models to predict in-hospital mortality in sepsis patients with DVT and assess their clinical applicability. METHODS: This multicenter retrospective study drew on data from the Medical Information Mart for Intensive Care IV (MIMIC-IV; n=2 235), the eICU Collaborative Research Database (eICU-CRD; n=1 274), and the Patient Admission Dataset from the ICU of Third Xiangya Hospital, Central South University (CSU-XYS-ICU; n=107). MIMIC-IV was split into a training set (n=1 584) and internal validation set (n=651), with the remaining datasets used for external validation. Predictors were selected via least absolute shrinkage and selection operator (LASSO) regression and Bayesian Information Criterion (BIC), and a nomogram model was constructed. An extreme gradient boosting (XGBoost) algorithm was used to build the machine learning model. Model performance was assessed by the concordance index (C-index), calibration curves, Brier score, decision curve analysis (DCA), and net reclassification improvement index (NRI). RESULTS: Five key predictors, age [odds ratio (OR)=1.02, 95% CI 1.01 to 1.03, P<0.001], minimum activated partial thromboplastin (APTT; OR=1.09, 95% CI 1.08 to 1.11, P<0.001), maximum APTT (OR=1.01, 95% CI 1.00 to 1.01, P<0.001), maximum lactate (OR=1.56, 95% CI 1.39 to 1.75, P<0.001), and maximum serum creatinine (OR=2.03, 95% CI 1.79 to 2.30, P<0.001), were included in the nomogram. The model showed robust performance in internal validation (C-index=0.845, 95% CI 0.811 to 0.879) and external validation (eICU-CRD: C-index=0.827, 95% CI 0.800 to 0.854; CSU-XYS-ICU: C-index=0.779, 95% CI 0.687 to 0.871). Calibration curves indicated good agreement between predicted and observed outcomes (Brier score<0.25), and DCA confirmed clinical benefit. The XGBoost model achieved an area under the receiver operating characteristic curve (AUC) of 0.982 (95% CI 0.969 to 0.985) in the training set, but performance declined in external validation (eICU-CRD, AUC=0.825, 95% CI 0.817 to 0.861; CSU-XYS-ICU, AUC=0.766, 95% CI 0.700 to 0.873), though it remained above clinical thresholds. Net reclassification improvement was slightly lower for XGBoost compared with the nomogram (NRI=0.58). CONCLUSIONS Both the nomogram and XGBoost models effectively predict in-hospital mortality in sepsis patients with DVT. However, the nomogram offers superior generalizability and clinical usability. Its visual scoring system provides a quantitative tool for identifying high-risk patients and implementing individualized interventions.
Humans ; Sepsis/complications* ; Machine Learning ; Nomograms ; Venous Thrombosis/complications* ; Retrospective Studies ; Hospital Mortality ; Male ; Female ; Middle Aged ; Aged ; Intensive Care Units ; Prognosis ; Bayes Theorem

Transarterial radioembolization (TARE) is a widely utilized therapeutic approach for hepatocellular carcinoma (HCC), however, the clinical implementation is constrained by the stringent preparation conditions of radioembolization agents. Herein, we incorporated the superstable homogeneous iodinated formulation technology (SHIFT), simultaneously utilizing an enhanced solvent form in a carbon dioxide supercritical fluid environment, to encapsulate radionuclides (such as ¹³¹I,¹⁷⁷Lu, or ¹⁸F) with lipiodol for the preparation of radiolipiodol. The resulting radiolipiodol exhibited exceptional stability and ultra-high labeling efficiency (≥99%) and displayed notable intratumoral radionuclide retention and in vivo stability more than 2 weeks following locoregional injection in subcutaneous tumors in mice and orthotopic liver tumors in rats and rabbits. Given these encouraging findings, ¹⁸F was authorized as a radiotracer in radiolipiodol for clinical trials in HCC patients, and showed a favorable tumor accumulation, with a tumor-to-liver uptake ratio of ≥50 and minimal radionuclide leakage, confirming the feasibility of SHIFT for TARE applications. In the context of transforming from preclinical to clinical screening, the preparation of radiolipiodol by SHIFT represents an innovative physical strategy for radionuclide encapsulation. Hence, this work offers a reliable and efficient approach for TARE in HCC, showing considerable promise for clinical application (ChiCTR2400087731).

Osteosarcoma (OS), chondrosarcoma (CS), and Ewing sarcoma (ES) represent primary malignant bone tumors and pose significant challenges in oncology research and clinical management. Conventional research methods, such as two-dimensional (2D) cultured tumor cells and animal models, have limitations in recapitulating the complex tumor microenvironment (TME) and often fail to translate into effective clinical treatments. The advancement of three-dimensional (3D) culture technology has revolutionized the field by enabling the development of in vitro constructed bone tumor models that closely mimic the in vivo TME. These models provide powerful tools for investigating tumor biology, assessing therapeutic responses, and advancing personalized medicine. This comprehensive review summarizes the recent advancements in research on 3D tumor models constructed in vitro for OS, CS, and ES. We discuss the various techniques employed in model construction, their applications, and the challenges and future directions in this field. The integration of advanced technologies and the incorporation of additional cell types hold promise for the development of more sophisticated and physiologically relevant models. As research in this field continues to evolve, we anticipate that these models will play an increasingly crucial role in unraveling the complexities of malignant bone tumors and accelerating the development of novel therapeutic strategies.
Bone Neoplasms/pathology* ; Humans ; Osteosarcoma/pathology* ; Tumor Microenvironment ; Sarcoma, Ewing/pathology* ; Chondrosarcoma/pathology* ; Animals ; Cell Culture Techniques/methods* ; Cell Culture Techniques, Three Dimensional/methods* ; Cell Line, Tumor

OBJECTIVES: To explore the potential of pyrroline-5-carboxylate reductase 1 (PYCR1) as a pan-cancer biomarker and investigate its expression, function, and clinical significance in bladder cancer (BLCA). METHODS: Bioinformatics analysis was conducted to evaluate the associations of PYCR1 with prognosis, immune microenvironment remodeling, tumor mutation burden (TMB), and microsatellite instability (MSI) in cancer patients. Using the TCGA-BLCA dataset, univariate and multivariate regression analyses were performed to assess the potential of PYCR1 as an independent prognostic risk factor for BLCA, and a clinical decision model was constructed. The IMvigor210 cohort was utilized to evaluate the potential of PYCR1 for independently predicting the efficacy of immunotherapy. The pRRophetic was employed to screen candidate chemotherapeutic agents for treating BLCA with high PYCR1 expression. The CMap-XSum algorithm and molecular docking techniques were used to explore and validate small molecule inhibitors of PYCR1. RESULTS: A high expression of PYCR1 was significantly associated with poor prognosis, immune cell infiltration, TMB and MSI in various tumors (r>0.3). PYCR1 was overexpressed in BLCA, and high PYCR1 expression was closely related to poor prognosis in BLCA patients (HR: 1.14, 95% CI: 1.02-1.68, P=0.006). The IC₅₀ of the anti-cancer drugs cetuximab, 5-fluorouracil, and doxorubicin increased significantly in BLCA cell lines with high PYCR1 expressions (P<0.0001). CONCLUSIONS High PYCR1 expression is an independent risk factor for poor prognosis in BLCA patients and can serve as a significant indicator for clinical decision-making as well as a marker for predicting sensitivity to chemotherapeutic agents and the efficacy of immunotherapy.
Humans ; Urinary Bladder Neoplasms/genetics* ; Immunotherapy ; Prognosis ; Pyrroline Carboxylate Reductases/metabolism* ; Biomarkers, Tumor/genetics* ; delta-1-Pyrroline-5-Carboxylate Reductase ; Microsatellite Instability ; Tumor Microenvironment ; Mutation ; Computational Biology ; Molecular Docking Simulation

Radiochemotherapy-induced oral mucositis (OM) is a common oral complication in patients with tumors following head and neck radiotherapy or chemotherapy. Erosion and ulcers are the main features of OM that seriously affect the quality of life of patients and even the progress of tumor treatment. To date, differences in clinical prevention and treatment plans for OM have been noted among doctors of various specialties, which has increased the uncertainty of treatment effects. On the basis of current research evidence, this expert consensus outlines risk factors, clinical manifestations, clinical grading, ancillary examinations, diagnostic basis, prevention and treatment strategies and efficacy indicators for OM. In addition to strategies such as basic oral care, anti-inflammatory and analgesic agents, anti-infective agents, pro-healing agents, and photobiotherapy recommended in previous guidelines, we also emphasize the role of traditional Chinese medicine in OM prevention and treatment. This expert consensus aims to provide references and guidance for dental physicians and oncologists in formulating strategies for OM prevention, diagnosis, and treatment, standardizing clinical practice, reducing OM occurrence, promoting healing, and improving the quality of life of patients.
Humans ; Chemoradiotherapy/adverse effects* ; Consensus ; Risk Factors ; Stomatitis/etiology*

AIM:To analyze the reasons for screening failure and explore the influencing fac-tors in clinical trial in healthy volunteers,guidance was provided to improve the success rate of screen-ing in the future.clarify the reasons for the failure in healthy subjects(HS)screening,and to provide guidance for screening in phase Ⅰ clinical trials.METHODS:We performed a retrospective study that described the process of HS screening in phase Ⅰ clinical trials carried out in department of clinical pharmacology lab,Nanjing First Hospital be-tween 2019 and 2022.We analyzed the reasons for screening failure and their impact on the failure rate.A retrospective analysis was conducted on the data of subjects who participated in drug clinical trial screening 2019 to 2022.The reasons for screening failure were analyzed,and statistical methods were used to explore the independent factors that led to screening failure.RESULTS:A to-tal of 11 clinical trials were included in this study,and 502 out of 1 582 participants(31.7％)passed the screening.The analysis of the remaining 1 080 subjects showed that the items that did not pass the screening were laboratory examinations(631 cases,58.4％),abnormal vital signs results(228 cas-es,21.1％),intolerance to blood drawn(86 cases,8.0％),sufficient subjects(62 cases,5.7％),with-drawal at the screening(54 cases,5.0％),demogra-phy(54 cases,5.0％),urinary cotinine examination(42 cases,3.9％),imaging examination(31 cases,2.9％),electrocardiogram(24 cases,2.2％),inquiry(medical inquiry 19 cases,1.8％,smoking inquiry 2 cases,0.2％,alcohol inquiry 2 cases,0.2％)and identity verification(17 cases,1.8％).In the popula-tion with a body mass index(BMI)of 19.0 to 26.0,an increase in BMI is an independent factor signifi-cantly associated with screening failure(P＜0.000 1,OR=0.890 4,95％CI 0.841 9-0.941 3).The impact of different examination items on the screening fail-ure rate varies.CONCLUSION:In clinical trials of healthy subjects,laboratory tests,vital signs and in-tolerance to blood drawn are the main reasons for screening failure.Lowering the upper limit of BMI when recruiting subjects may increase the success rate of screening.Laboratory examinations,vital signs,intolerance to blood drawn are the most im-portant three reasons for screening failure,and im-provements can be made to reduce the screening failure rate of phase Ⅰ clinical trials in response to the main screening failure reasons.