Objective To preliminarily investigate the safety and efficacy of donor pancreas needle biopsy in simultaneous pancreas-kidney transplantation. Methods Clinical data of 7 cases undergoing donor pancreas biopsy were collected retrospectively. All cases underwent donor pancreas biopsy before or during simultaneous pancreas-kidney transplantation. Frozen section or paraffin sectioning techniques were used for tissue preparation, and hematoxylin-eosin and Masson staining were performed to histologically evaluate the donor pancreas. The quality of donor pancreas was comprehensively assessed by combining histological findings with the donor's clinical data. Postoperative follow-up data of 5 simultaneous pancreas-kidney transplant recipients were collected to summarize the safety of donor pancreas biopsy and the prognosis of transplant recipients. Results The 7 pancreas donors were aged 28 to 62 years, with a body mass index ranging from 20.76 to 27.68 kg/m². Liver ultrasound indicated fatty liver in 3 cases, while pancreatic ultrasound did not reveal any significant abnormalities. Among them, biopsy was performed on 2 donors after completion of pancreatic procurement and processing, and the frozen section histology showed moderate acute pancreatitis changes (edema of acinar cells, necrosis and inflammatory cell infiltration). Combined with a serum amylase level elevated more than 3 times the upper limit of normal value, these two donor pancreases were finally discarded. The remaining 5 cases underwent biopsy immediately after pancreatic vascular anastomosis during simultaneous pancreas-kidney transplantation, and histological evaluation was performed on paraffin-embedded sections. No biopsy-related complications (such as bleeding, pancreatic fistula, etc.) occurred after transplantation. One recipient died of severe infection 2 months after transplantation, while the other 4 recipients were followed up for more than 5 years, with well-functioning transplant kidneys and pancreases. Conclusions Donor pancreas biopsy is relatively safe, and the risk of biopsy-related complications after transplantation is controllable. Comprehensive assessment of donor pancreas quality by combining histological evaluation with the donor's clinical indicators is conducive to improving the accuracy of donor pancreas selection and organ utilization.

Objective:To analyze the effect of high serum ferritin(SF)before transplantation on erythrocyte,granulocyte and platelet implantation in unrelated cord blood transplantation(UCBT)patients with myelodysplastic syndrome(MDS)and acute myeloid leukemia(AML).Methods:The medical records of 60 patients with MDS and AML who underwent UCBT in the First Affiliated Hospital of University of Science and Technology of China from January 2020 to December 2022 were retrospectively collected.According to the SF level before transplantation,they were divided into high SF group(SF ≥ 1 000 μg/L,n=20)and non-high SF group(SF＜1 000 μg/L,n=40).The red blood cell(RBC)infusion volume before transplantation,implantation time of RBC,granulocyte and platelet,implantation risk and prognosis were analyzed and compared between the two groups.Results:There was no correlation between the level of SF before transplantation and RBC infusion.After transplantation,the median implantation time of RBC in the high SF group was 28.5(14-149)d,which was longer than 21(10-83)d in the non-high SF group(P＜0.05).The median time of granulocyte engraftment in the high SF group was 16.5(12-63)d,while that in the non-high SF group was 16(12-49)d,with no statistical difference between the two groups(P＞0.05).The median platelet engraftment time in the high SF group was 45(12-206)d,while that in the non-high SF group was 35.5(14-149)d,with no statistical difference between the two groups(P＞0.05).Kaplan-Meier cumulative implantation probability analysis showed that the rate of erythroid implantation in the non-high SF group was higher than that in the high SF group(P＜0.05),while there was no significant difference in the rates of granulocyte and platelet implantation between the two groups(P＞0.05).The 1-year overall survival rates of the non-high SF group and high SF group were 95％and 90％,respectively,with no statistical difference between the two groups(P＞0.05).Conclusion:SF levels before cord blood transplantation in MDS and AML patients have an impact on post transplant erythroid implantation.Detecting and intervening of iron load in patients before transplant may be beneficial for improving implantation and prognosis.

The objective of this study was to evaluate the toxicity and safety of novel Mycobacterium tuberculosis fusion strain protein derivatives,referred to as B/R strain active proteins.In cellular experiments,RAW264.7 cells were treated with each vaccine preparation,and apoptosis rates were measured.In subsequent animal experiments,C57BL/6 mice were immunized via subcutaneous injection,and their survival and body weight changes were monitored and recorded at 2,4,8,12,and 16 weeks.The lungs and spleens were harvested to calculate organ coefficients,and pathological examinations were conducted.At the eighth week of immunization,the mice were infected with high concentrations of BCG,and pathological changes in the lungs and spleens were observed 4 weeks post-infection.The apoptosis rate at 6 hours was significantly higher in the experimental group than the PBS group(P<0.05).At 12 and 24 hours,the apoptosis rate in the experimental group remained higher than that in the PBS group,although this difference was not statistically significant.After immunization,mice in all four groups exhibited normal growth patterns,as indicated by stable body weight changes.At 4 and 12 weeks post-immunization,the lung coefficients in the protein group were significantly higher than those in the PBS group at the same time points.Additionally,the lung coefficients in the BCG group were significantly elevated across all time periods(P<0.05).The spleen coefficients in the protein and BCG groups were significantly higher than those in the PBS group at 2,4,8,12,and 16 weeks,whereas the ICD B/R group showed higher spleen coefficients than the PBS group only at week 8(P<0.05).Pathological examination revealed normal lung and spleen tissues in the PBS group.However,during the 2-8 weeks immunization period,lung and spleen tissues in all experimental groups exhibited varying degrees of damage,which gradually diminished by 12-16 weeks.Notably,no tuberculosis nodules were observed in any experimental group.After infection with high concentrations of BCG,no overt pathological changes were observed on the surfaces of the lungs and spleens in any group.Microscopic examination revealed less severe pathological changes in the lungs and spleens of mice in the experimental groups than the PBS group.Furthermore,no statistically significant differences were observed between the protein group and the BCG group.Our findings suggested that the B/R strain active proteins'toxicity and safety profiles were comparable to those of BCG,and showed immunoprotective effects.This study provides an experimental foundation for the development of a novel tuberculosis vaccine.

Protein-protein interactions play an extremely important role in the biochemical functions of cells,and in-depth analysis of protein interactions is the key to understanding cellular life activities.In this study,we systematically mined the interacting proteins of Golgi protein 73(GP73)using classical immunoprecipitation combined with mass spectrometry,and sought to further analyze the molecular func-tion of GP73.Hepatocellular carcinoma cell line HepG2 was selected,and a stable cell line overexpress-ing GP73-3Flag was constructed using lentiviral infection technology.A total of 78 high-confidence GP73 interacting proteins were identified by immunoprecipitation coupled with mass spectrometry.Bioinformat-ics analyses suggested that GP73 interacted with nearly 40 cytosolic proteins and participated in the bio-logical processes of RNA transport,splicing,and translation.Further immunofluorescence and cytosolic protein isolation experiments confirmed the cytosolic localization of GP73 in a variety of tumor cells.Based on the 78 interacting proteins,we further screened protein interaction networks related to mRNA splicing and verified the existence of interactions between GP73 and seven proteins,including HNRN-PH3,SMN1,RBM14,andNCBP1,by co-immunoprecipitation experiments.In addition,minigene spli-cing assay results indicated that GP73 inhibited the splicing efficiency of pre-mRNA by cells.This study contributes to the expansion of knowledge regarding the function of GP73 and aids in elucidating its criti-cal role in cell biology and its potential association with diseases.

This article discusses the revision background and core content of 9621 General Requirements for Phar-maceutical Packaging Materials and Containers in the Chinese Pharmacopoeia 2025 Edition.In combination with the requirements of bundling review of pharmaceutical packaging and drug products,as well as harmonization of inter-national standards,it analyzed the revision philosophy of the new guideline and the impact to industry.The new edition of the guideline 9621 introduces the concept of "pharmaceutical packaging system" for the first time,constructing four suitability evaluation dimensions covering protection,compatibility,safety,and functionality,it also introduces the requirements for the self-stability evaluation of plastic and rubber pharmaceutical packaging materials,and strengthening the concept of full lifecycle management and risk management.Through the"1+4+58" standard system,the basis for determining the key quality attributes of packaging materials for phar-maceutical use and the optimization path of dynamic inspection rules have been clarified.This revision has resolved the contradiction between the old version of standards and current regulatory requirements through a systematic upgrade,promoting the transformation of pharmaceutical packaging materials and containers quality control towards a scientific,international,and full lifecycle management model,proving technical supports in ensuring the safety,effectiveness of drug products from standard perspective,including advancing the industry high-quality development.

This article discusses the revision background and core content of 9621 General Requirements for Phar-maceutical Packaging Materials and Containers in the Chinese Pharmacopoeia 2025 Edition.In combination with the requirements of bundling review of pharmaceutical packaging and drug products,as well as harmonization of inter-national standards,it analyzed the revision philosophy of the new guideline and the impact to industry.The new edition of the guideline 9621 introduces the concept of "pharmaceutical packaging system" for the first time,constructing four suitability evaluation dimensions covering protection,compatibility,safety,and functionality,it also introduces the requirements for the self-stability evaluation of plastic and rubber pharmaceutical packaging materials,and strengthening the concept of full lifecycle management and risk management.Through the"1+4+58" standard system,the basis for determining the key quality attributes of packaging materials for phar-maceutical use and the optimization path of dynamic inspection rules have been clarified.This revision has resolved the contradiction between the old version of standards and current regulatory requirements through a systematic upgrade,promoting the transformation of pharmaceutical packaging materials and containers quality control towards a scientific,international,and full lifecycle management model,proving technical supports in ensuring the safety,effectiveness of drug products from standard perspective,including advancing the industry high-quality development.

Objective To evaluate the safety and feasibility of percutaneous mitral balloon valvuloplasty with the assistance of arterio-venous circuit.Methods From January 2015 to October 2022,a total 25 patients[19 females,6 males;age(61.60±9.00)years]were included,who were diagnosed with rheumatic heart disease and severe mitral stenosis.A transseptal puncture was performed to establish a femoral arterio-venous circuit,followed by graded dilation with Inoue balloon(diameters:22.00 mm to 28.00 mm).The target was a mitral valve area≥1.50 cm2 with mild or less regurgitation.Results The arterio-venous circuit was established,and mitral balloon valvuloplasty was successfully completed in all 25 patients.Among them,20 patients experienced difficulty with transvalvular crossing using the balloon catheter with conventional methods,16 patients had valvular severe calcification,and 3 patients presented with a left atrial appendage thrombus despite of more than 6-month anticoagulation therapy with warfarin.The mean balloon diameter was(25.00±1.40)mm.The mitral valve area increased from(0.91±0.15)cm2 preoperatively to(1.70±0.14)cm2 postoperatively(P＜0.001).Mean left atrial pressure decreased from(27.00±7.50)mmHg to(16.36±4.07)mmHg(P＜0.001),and mean pulmonary artery pressure decreased from(40.84±13.81)mmHg to(25.00±7.12)mmHg(P＜0.001).All patients showed significant symptom improvement with no complications.Conclusions Arterio-venous circuit for percutaneous mitral balloon valvuloplasty is safe and feasible.This technique can serve as an alternative to standard technique for patients with complex mitral stenosis.

Objective:To analyze the effect of high serum ferritin(SF)before transplantation on erythrocyte,granulocyte and platelet implantation in unrelated cord blood transplantation(UCBT)patients with myelodysplastic syndrome(MDS)and acute myeloid leukemia(AML).Methods:The medical records of 60 patients with MDS and AML who underwent UCBT in the First Affiliated Hospital of University of Science and Technology of China from January 2020 to December 2022 were retrospectively collected.According to the SF level before transplantation,they were divided into high SF group(SF ≥ 1 000 μg/L,n=20)and non-high SF group(SF＜1 000 μg/L,n=40).The red blood cell(RBC)infusion volume before transplantation,implantation time of RBC,granulocyte and platelet,implantation risk and prognosis were analyzed and compared between the two groups.Results:There was no correlation between the level of SF before transplantation and RBC infusion.After transplantation,the median implantation time of RBC in the high SF group was 28.5(14-149)d,which was longer than 21(10-83)d in the non-high SF group(P＜0.05).The median time of granulocyte engraftment in the high SF group was 16.5(12-63)d,while that in the non-high SF group was 16(12-49)d,with no statistical difference between the two groups(P＞0.05).The median platelet engraftment time in the high SF group was 45(12-206)d,while that in the non-high SF group was 35.5(14-149)d,with no statistical difference between the two groups(P＞0.05).Kaplan-Meier cumulative implantation probability analysis showed that the rate of erythroid implantation in the non-high SF group was higher than that in the high SF group(P＜0.05),while there was no significant difference in the rates of granulocyte and platelet implantation between the two groups(P＞0.05).The 1-year overall survival rates of the non-high SF group and high SF group were 95％and 90％,respectively,with no statistical difference between the two groups(P＞0.05).Conclusion:SF levels before cord blood transplantation in MDS and AML patients have an impact on post transplant erythroid implantation.Detecting and intervening of iron load in patients before transplant may be beneficial for improving implantation and prognosis.

Aim To perform high-throughput screen-ing of immunomodulatory traditional Chinese medicine(TCMs)based on an in vitro B cell differentiation-antibody secretion model,identifying active herbal candidates with immune-enhancing properties to pro-vide novel therapeutic options and theoretical support for influenza virus treatment in immunocompromised in-dividuals.Methods B cells were stimulated with dif-ferent concentrations of cytosine-phosphate-guanine oli-godeoxynucleotide 2006(CpG)and nterleukin-2(IL-2)to promote proliferation,differentiation,and anti-body secretion,and the effects of varying concentra-tions of the solvent DMSO were also evaluated.The op-timal conditions for the B cell differentiation-anti-body secretion model were determined based on the se-cretion levels of three antibody isotypes.The feasibility of the model was further validated using rapamycin,a known B cell function inhibitor.On this basis,a high-throughput screening platform for immunomodulatory a-gents was optimized and established.Subsequently,the immune-enhancing activity of 465 polarity extract from TCMs was evaluated.Results The optimal con-ditions for the model were determined as 2 mg·L-1 CpG,1.67 × 106 nkat·L-1 IL-2,and DMSO with a volume fraction of 0.1％.Rapamycin effectively inhib-ited B cell differentiation into plasmablast and signifi-cantly reduced antibody production,indicating the reli-ability of the model.Multiple rounds of screening re-vealed that the dichloromethane extract of licorice,the dichloromethane extract of Vinegar-processed Curcumae Rhizoma,the cyclohexane extract of Honey-prepared Radix Asteris,and the aqueous extract of Siphonostegia chinensis Benth were identified to significantly promote both B cell proliferation and differentiation and anti-body secretion at a concentration of 600 μg·L-1.Conclusion This study successfully optimizes an in vitro B cell differentiation-antibody secretion model and identifies several TCM extracts,including licorice,with potential immune-enhancing activity.

Protein-protein interactions play an extremely important role in the biochemical functions of cells,and in-depth analysis of protein interactions is the key to understanding cellular life activities.In this study,we systematically mined the interacting proteins of Golgi protein 73(GP73)using classical immunoprecipitation combined with mass spectrometry,and sought to further analyze the molecular func-tion of GP73.Hepatocellular carcinoma cell line HepG2 was selected,and a stable cell line overexpress-ing GP73-3Flag was constructed using lentiviral infection technology.A total of 78 high-confidence GP73 interacting proteins were identified by immunoprecipitation coupled with mass spectrometry.Bioinformat-ics analyses suggested that GP73 interacted with nearly 40 cytosolic proteins and participated in the bio-logical processes of RNA transport,splicing,and translation.Further immunofluorescence and cytosolic protein isolation experiments confirmed the cytosolic localization of GP73 in a variety of tumor cells.Based on the 78 interacting proteins,we further screened protein interaction networks related to mRNA splicing and verified the existence of interactions between GP73 and seven proteins,including HNRN-PH3,SMN1,RBM14,andNCBP1,by co-immunoprecipitation experiments.In addition,minigene spli-cing assay results indicated that GP73 inhibited the splicing efficiency of pre-mRNA by cells.This study contributes to the expansion of knowledge regarding the function of GP73 and aids in elucidating its criti-cal role in cell biology and its potential association with diseases.