BACKGROUND: Treatment with chimeric antigen receptor-T (CAR-T) cells has shown promising effectiveness in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), although the process of preparing for this therapy usually takes a long time. We have recently created CD19 Fast-CAR-T (F-CAR-T) cells, which can be produced within a single day. The objective of this study was to evaluate and contrast the effectiveness and safety of CD19 F-CAR-T cells with those of CD19 conventional CAR-T cells in the management of R/R B-ALL. METHODS: A multicenter, retrospective analysis of the clinical data of 44 patients with R/R B-ALL was conducted. Overall, 23 patients were administered with innovative CD19 F-CAR-T cells (F-CAR-T group), whereas 21 patients were given CD19 conventional CAR-T cells (C-CAR-T group). We compared the rates of complete remission (CR), minimal residual disease (MRD)-negative CR, leukemia-free survival (LFS), overall survival (OS), and the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups. RESULTS: Compared with the C-CAR-T group, the F-CAR-T group had significantly higher CR and MRD-negative rates (95.7% and 91.3%, respectively; 71.4% and 66.7%, respectively; P = 0.036 and P = 0.044). No significant differences were observed in the 1-year or 2-year LFS or OS rates between the two groups: the 1-year and 2-year LFS for the F-CAR-T group vs.C-CAR-T group were 47.8% and 43.5% vs. 38.1% and 23.8% (P = 0.384 and P = 0.216), while the 1-year and 2-year OS rates were 65.2% and 56.5% vs. 52.4% and 47.6% (P = 0.395 and P = 0.540). Additionally, among CR patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) following CAR-T-cell therapy, there were no significant differences in the 1-year or 2-year LFS or OS rates: 57.1% and 50.0% vs. 47.8% and 34.8% (P = 0.506 and P = 0.356), 64.3% and 57.1% vs. 65.2% and 56.5% (P = 0.985 and P = 0.883), respectively. The incidence of CRS was greater in the F-CAR-T group (91.3%) than in the C-CAR-T group (66.7%) (P = 0.044). The incidence of ICANS was also greater in the F-CAR-T group (30.4%) than in the C-CAR-T group (9.5%) (P = 0.085), but no treatment-related deaths occurred in the two groups. CONCLUSION Compared with C-CAR-T-cell therapy, F-CAR-T-cell therapy has a superior remission rate but also leads to a tolerably increased incidence of CRS/ICANS. Further research is needed to explore the function of allo-HSCT as an intermediary therapy after CAR-T-cell therapy.

Purpose To investigate the value of intratumoral and different ranges of peritumoral radiomics features of the primary lesion of breast cancer based on ultrasound images in predicting axillary lymph node metastasis(ALNM),and to explore the best peritumoral range.Materials and Methods A total of 312 cases confirmed by pathology in breast cancer patients with preoperative ultrasound images from June 2022 to February 2024 in Binzhou Medical University Hospital were retrospectively enrolled,and were randomly divided into training set and testing set according to the 7∶3 proportion.The tumor border of the ultrasound images was manually delineated as the intratumoral region of interest,and the peritumoral region of interest was obtained by conformal automatically extended different range(1,2,3,4 and 5 mm).The radiomics features were screened.Based on the selected optimal radiomics features,random forest classifier was used to construct three types of radiomics models(intratumoral model,5 peritumoral models,and 5 intratumoral+peritumoral models).The performance and clinical practicability of the models was assessed the area under the curve(AUC)and decision curve analysis.Results The AUCs of the intratumoral+peritumoral radiomics models for predicting ALNM in the training set and test set were 0.807-0.873,0.728-0.780,respectively,which were superior to those of the single intratumoral radiomics models(0.822,0.758)and peritumoral radiomics models(0.722-0.768,0.650-0.710).The intratumoral+peritumoral 3 mm radiomics model showed the best predictive performance,with AUC of 0.873 in the training set and 0.780 in the test set,respectively,and the decision curve showed that the model had a good clinical net benefit.Conclusion The combined intratumoral and peritumoral radiomics features of the primary lesion of breast cancer based on ultrasound images can effectively predict ALNM,and 3 mm peritumoral may be the best peritumoral range for predicting ALNM.

Purpose To investigate the value of intratumoral and different ranges of peritumoral radiomics features of the primary lesion of breast cancer based on ultrasound images in predicting axillary lymph node metastasis(ALNM),and to explore the best peritumoral range.Materials and Methods A total of 312 cases confirmed by pathology in breast cancer patients with preoperative ultrasound images from June 2022 to February 2024 in Binzhou Medical University Hospital were retrospectively enrolled,and were randomly divided into training set and testing set according to the 7∶3 proportion.The tumor border of the ultrasound images was manually delineated as the intratumoral region of interest,and the peritumoral region of interest was obtained by conformal automatically extended different range(1,2,3,4 and 5 mm).The radiomics features were screened.Based on the selected optimal radiomics features,random forest classifier was used to construct three types of radiomics models(intratumoral model,5 peritumoral models,and 5 intratumoral+peritumoral models).The performance and clinical practicability of the models was assessed the area under the curve(AUC)and decision curve analysis.Results The AUCs of the intratumoral+peritumoral radiomics models for predicting ALNM in the training set and test set were 0.807-0.873,0.728-0.780,respectively,which were superior to those of the single intratumoral radiomics models(0.822,0.758)and peritumoral radiomics models(0.722-0.768,0.650-0.710).The intratumoral+peritumoral 3 mm radiomics model showed the best predictive performance,with AUC of 0.873 in the training set and 0.780 in the test set,respectively,and the decision curve showed that the model had a good clinical net benefit.Conclusion The combined intratumoral and peritumoral radiomics features of the primary lesion of breast cancer based on ultrasound images can effectively predict ALNM,and 3 mm peritumoral may be the best peritumoral range for predicting ALNM.

Objective The management of high-value medical consumables is a key challenge for healthcare institutions,yet medical record quality control(MRQC)is rarely applied in this area.This study aims to explore the role of MRQC in the management of high-value medical consumables.Methods A joint inspection team for MRQC was formed.Using the"High-Value Consumable Use Informed Consent Checklist,""High-Value Consumable Medical Record Sampling Statistics Table,""Surgical Operation Record Inspection Detail Table,"and"High-Value Medical Consumable Usage List Barcode Inspection Table,"we conducted random checks on the medical records of the top ten departments with high usage of these consumables.The main focus was on the informed consent forms,surgical operation records,barcode labeling of usage lists,and expense lists related to high-value medical consumables.We analyzed the consistency and compliance of registration information,informed consent forms,surgical records,and barcode labels,calculated defect rates for each indicator,identified causes of defects,and implemented quality improvements,including refining regulations and enhancing training;conducting reviews of high-value con-sumable medical records;initiating secondary management of high-value consumables;strengthening supervision;and establis-hing a long-term mechanism.Results Before improvements,the defect rates for informed consent forms,surgical records,and barcode labels were 13.3％,27.9％,and 42.7％,respectively.After improvements,these rates dropped to 1.4％,2.2％,and 1.6％.Comparisons of the three indicators before and after showed significant differences(P＜0.01).Conclusion The appli-cation of MRQC in managing high-value medical consumables is essential.Through medical record checks,we can achieve the"five checks and five correspondences"regarding the registration information of high-value medical consumables,informed con-sent forms,written records in surgical operation records,barcode labeling of usage lists,and expense lists.The key to successful implementation is thorough preparation before inspections,interdepartmental collaboration,problem-oriented self-assessment,strict discipline,and continuous improvement.

Objective:To study the distribution of CT doses to paediatric patients in Shanghai by investigating the CT dose parameters availiable in Shanghai′s children′s hospticals, and to provide the basis for establishing the diagnostic reference level for the paediatic patients subjected to CT scanning in Shanghai.Methods:In 2021, a general survey was carried out of the CT doses to the head, chest and abdomen of the scanned paediatric patients in four children′s hospitals in the municipality. The scanned paediatic patients were divided into four age groups of 0-, 1-, 5- and 10-15 years old, each with 30 subjects. The basic information were collected on the subjects, CT scanning parameters, volume CT dose index (CTDI vol) and dose length product (DLP). SPSS 16.0 was used to carry out statistical analysis of the differences in CTDI vol and DLP between different age groups at the same site and between different hospitals for the same age group at the same site. Results:The 75 th percentile values of CTDI vol and DLP for 0-, 1-, 5- and 10-15 age groups were 25, 25, 28, 43 mGy and 402, 477, 504, 752 mGy·cm, respectively, for head scanning; 2.7, 2.2, 2.8, 5.4 mGy and 40, 48, 75 and 176 mGy·cm for chest; and 4.9, 4.4, 8.2, 12 mGy and 106, 131, 273, 471 mGy·cm for abdomen. There were significant differences in CTDI vol and DLP between different age groups at the same site and between different hospitals for the same age group at the same site (head, chest and abdomen CTDI vol:χ2=221.68, 167.27, 127.07, DLP: χ2=220.63, 261.46, 216.61; for four age groups, CTDI vol: head χ2=30.46, 38.39, 25.21, 73.04, chest χ2=30.46, 35.69, 58.92, and 48.03, abdomen χ2=66.58, 41.62, 48.93, and 67.38; DLP: head χ2=28.82, 72.49, 47.72, 52.34, chest χ2=28.82, 35.95, 50.66, 41.64, abdomen χ2=45.53, 26.02 39.34, 44.24, P <0.05 ). Conclusions:The 75 th percentile values of CTDI vol and DLP for head, chest and abdomen in 4 children′s hospitals in Shanghai are lower or close to the values given in the relevant national standards and the diagnostic reference levels in some European countries, with higher DLP values on some scanning sites. The CT scanning procedures for paediatric patients needs to be further optimized.

Objective:The paper seeks to explore the characteristics of myeloid tumors with genetic DDX41 gene mutations,especially focusing on the understanding and treatment of acute myeloid leukemia with germline/somatic DDX41 mutation. Methods:One AML patient with germline/somatic DDX41 mutation who was diagnosed by using morphology,immunology,cytogenetics and molecular biology in Shanghai Shidong Hospital was retrospectively analyzed,and the patient was treated with lenalidomide combined with decitabine,and the literatures were reviewed. Results:The patient obtained complete remission after the therapy and there were no relevant adverse reactions to the treatment. Conclusion:The DDX41 gene mutations have effects on the prognosis and treatment of myeloid malignancies,and lenalidomide combined with decitabine is effective in acute myeloid leukemia with germline/somatic DDX41 mutation.The germline mutation status should be identified and confirmed early.

Objective:To analyze the effectiveness and safety of reoperation for obstructive azoospermia (OA) with initial microsurgical anastomosis failure.Methods:A retrospective case series was performed for OA patients who underwent reoperation after initial microsurgical anastomosis failure, in Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Institute of Urology, Urologic Medical Center from March 2015 to June 2020. Totally, 21 patients were enrolled in the study, and the clinical data, patency and pregnancy outcomes were reviewed.Results:During the initial surgery, 8 cases underwent vasovasostomy and 8 cases underwent vasoepididymostomy, while the other 5 cases underwent crossover anastomosis; 19 cases underwent reoperation because of reproductive needs, and 2 for post-vasectomy chronic testicular pain. During the reoperation, anastomotic stricture was found in 14 cases, and sperm granuloma was found in 6 cases, while spermatogenic dysfunction was confirmed in 1 case. Unilateral or bilateral anastomosis was performed successfully in 19 cases. Testicular sperm extraction was performed for 1 case with non-obstructive azoospermia (NOA) and 1 case with severe adhesion respectively. Totally 19 cases was followed for 3 to 58 months [(30.21±18.43) months], and 2 cases were lost to follow-up. Chronic testicular pain was relieved completely in 1 of the 2 cases suffering from the post-vasectomy testicular pain. Overall, 11 cases achieved patency, and 4 cases concieved naturally. Furthermore, 3 cases underwent in vitro fertilization cycle (1 case with semen sperm, and the other 2 cases with frozen testicular sperm). There were no severe post-operational complications in all cases. Conclusion:Microsurgical reoperation, which allows a favorable patency rate and natural pregnancy rate, is a valid option for the treatment of OA with initial microsurgical anastomosis failure.

Objective:To analyze the effectiveness and safety of reoperation for obstructive azoospermia (OA) with initial microsurgical anastomosis failure.Methods:A retrospective case series was performed for OA patients who underwent reoperation after initial microsurgical anastomosis failure, in Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Institute of Urology, Urologic Medical Center from March 2015 to June 2020. Totally, 21 patients were enrolled in the study, and the clinical data, patency and pregnancy outcomes were reviewed.Results:During the initial surgery, 8 cases underwent vasovasostomy and 8 cases underwent vasoepididymostomy, while the other 5 cases underwent crossover anastomosis; 19 cases underwent reoperation because of reproductive needs, and 2 for post-vasectomy chronic testicular pain. During the reoperation, anastomotic stricture was found in 14 cases, and sperm granuloma was found in 6 cases, while spermatogenic dysfunction was confirmed in 1 case. Unilateral or bilateral anastomosis was performed successfully in 19 cases. Testicular sperm extraction was performed for 1 case with non-obstructive azoospermia (NOA) and 1 case with severe adhesion respectively. Totally 19 cases was followed for 3 to 58 months [(30.21±18.43) months], and 2 cases were lost to follow-up. Chronic testicular pain was relieved completely in 1 of the 2 cases suffering from the post-vasectomy testicular pain. Overall, 11 cases achieved patency, and 4 cases concieved naturally. Furthermore, 3 cases underwent in vitro fertilization cycle (1 case with semen sperm, and the other 2 cases with frozen testicular sperm). There were no severe post-operational complications in all cases. Conclusion:Microsurgical reoperation, which allows a favorable patency rate and natural pregnancy rate, is a valid option for the treatment of OA with initial microsurgical anastomosis failure.

Objective:To observe the changes of the structure and visual function of the retina in patients with or without the ectopic inner foveal layers (EIFL) and to explore the factors influencing the recovery of visual function in patients with idiopathic epimacular membrane (IMEM).Methods:A retrospective clinical study. From March 2015 to June 2019, 90 patients with MEM who were diagnosed by Ophthalmic Center of the Second Hospital of Hebei Medical University were enrolled in the study. All patients were examined by best corrected visual acuity (BCVA) and frequency domain optical coherence scan. BCVA was recorded by Snellen vision table, and it was converted into the minimum resolution angle logarithm (logMAR) vision. Among 90 eyes, IMEM grade 2-4 was 68 (75.6%, 68/90), 18 (20.0%, 18/90), 4 (4.4%, 4/90), respectively. According to this, the grade 2 was set as group A, and the grade 3 and grade 4 were combined to group B. There was no significant difference in age ( t=0.015), sex composition ratio of patients between two groups ( χ2=0.060) and the average of central macular thickness (CMT) ( F=2.277) ( P=0.904, 0.809, 0.141). The difference of average logMAR and BCVA was statistically significant ( F=35.913, P=0.000). All patients underwent 25G pars plana three channel vitrectomy with simultaneous removal of epiretinal membrane and internal limiting membrane. BCVA, CMT and improvement of IMEM grading were observed at 1, 3, 6 and 12 months after operation. BCVA, EIFL thickness and CMT were compared before and after operation by single factor repeated variance analysis; Fisher exact probability method was used to compare the changes of the anatomical structure of the eyes in the two groups at 12 months after operation. Results:1, 3, 6, 12 months after operation, the average eyes of logMAR BCVA in group A were 0.50±0.13, 0.38±0.12, 0.27±0.12, 0.19±0.10. The patients in group B were 0.66±0.14, 0.60±0.13, 0.54±0.14, 0.52±0.14. CMT in group A were 364.82±81.29, 281.65±72.45, 228.55±55.34, 182.84±56.13 μm. The patients in group B were 455.88±69.60, 440.18±68.65, 383.76±65.38, 371.39±66.60 μm. The difference was statistically significant in the two groups (BCVA: F=37.913, 11.479, 24.250, 39.013; P=0.000, 0.002, 0.000, 0.000. CMT: F=10.987, 39.610, 55.789, 79.987; P=0.002, 0.000, 0.000, 0.000). In group A, IMEM was improved to 57 eyes of grade 1 on 12 months after operation. Among the 18 eyes in group B, IMEM was improved to 1 and 3 eyes in level 1 and level 2, respectively, and no improvement was found in 4 eyes in grade 4. The difference was statistically significant ( P=0.000) in the improvement of the number of eyes in the two groups. Conclusions:The patients with IMEM without EIFL have better visual prognosis and reversible anatomical changes. EIFL is an important factor affecting the visual function and anatomical structure recovery after operation.