BACKGROUND: The primary limitation to kidney transplantation is organ shortage. Recent progress in gene editing and immunosuppressive regimens has made xenotransplantation with porcine organs a possibility. However, evidence in pig-to-human xenotransplantation remains scarce, and antibody-mediated rejection (AMR) is a major obstacle to clinical applications of xenotransplantation. METHODS: We conducted a kidney xenotransplantation in a brain-dead human recipient using a porcine kidney with five gene edits (5GE) on March 25, 2024 at Xijing Hospital, China. Clinical-grade immunosuppressive regimens were employed, and the observation period lasted 22 days. We collected and analyzed the xenograft function, ultrasound findings, sequential protocol biopsies, and immune surveillance of the recipient during the observation. RESULTS: The combination of 5GE in the porcine kidney and clinical-grade immunosuppressive regimens prevented hyperacute rejection. The xenograft kidney underwent delayed graft function in the first week, but urine output increased later and the single xenograft kidney maintained electrolyte and pH homeostasis from postoperative day (POD) 12 to 19. We observed AMR at 24 h post-transplantation, due to the presence of pre-existing anti-porcine antibodies and cytotoxicity before transplantation; this AMR persisted throughout the observation period. Plasma exchange and intravenous immunoglobulin treatment mitigated the AMR. We observed activation of latent porcine cytomegalovirus toward the end of the study, which might have contributed to coagulation disorder in the recipient. CONCLUSIONS 5GE and clinical-grade immunosuppressive regimens were sufficient to prevent hyperacute rejection during pig-to-human kidney xenotransplantation. Pre-existing anti-porcine antibodies predisposed the xenograft to AMR. Plasma exchange and intravenous immunoglobulin were safe and effective in the treatment of AMR after kidney xenotransplantation.
Transplantation, Heterologous/methods* ; Kidney Transplantation/methods* ; Heterografts/pathology* ; Immunoglobulins, Intravenous/administration & dosage* ; Graft Survival/immunology* ; Humans ; Animals ; Sus scrofa ; Graft Rejection/prevention & control* ; Kidney/pathology* ; Gene Editing ; Species Specificity ; Immunosuppression Therapy/methods* ; Plasma Exchange ; Brain Death ; Biopsy ; Male ; Aged

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

ObjectiveTo construct a quantitative prediction model of three indicators（moisture absorption rate， film thickness and coating weight gain） during the coating process of Vitamin C Yinqiao tablets（VCYT） by near-infrared spectroscopy（NIRS）， and to realize the endpoint judgment. MethodReal-time NIRS data of 4 batches of VCYT during the coating process were collected by diffuse reflection method. The coating method employed was the rolling coating method， and the samples were obtained at the spray stage from the coater's sampling port every 10 minutes， and 57 batches of samples（about 1 800 tablets） were collected at various coating times， the tablets were embedded in molten paraffin， cut longitudinally， and observed by stereomicroscope. The film thickness， with a target value of 38 μm， was then measured using Motic Images Advanced 3.2 software. Furthermore， the mositure absorption rate of samples， aiming for a target value of 3%， was determined in accordance with guiding principles for drug hygroscopicity testing in the 2020 edition of Chinese Pharmacopoeia， and 3 samples were randomly selected from each batch（10 tablets per batch）， and the coating weight gain was calculated（target value of 4%）. Partial least squares regression（PLSR） was used to construct a quantitative model of the 3 coating indicators， and the predicted values of the coating indicators were smoothed using the moving average method and used to determine the coating endpoints. ResultThe prediction determination coefficients（R_p²） for moisture absorption rate， film thickness and coating weight gain were 0.933 4， 0.932 6 and 0.965 9， the root mean square errors of prediction（RMSEP） were 0.163 5%， 1.870 9 μm and 0.240 3%， the relative percent deviations（RPD） were 3.711 0， 2.760 7 and 5.415 8， respectively. The results of the external validation set demonstrated that the real-time predicted values obtained by the models exhibited the same trend as the measured values， and the coating endpoint could be accurately predicted（with a prediction error of less than 7.32 min and a relative error of less than 5.63%）. ConclusionThe established NIRS model exhibits excellent predictive performance and can be used for quality control of VCYT during the coating process.

The incidence of osteoporotic thoracolumbar vertebral fracture (OTLVF) in the elderly is gradually increasing. The kyphotic deformity caused by various factors has become an important characteristic of OTLVF and has received increasing attention. Its clinical manifestations include pain, delayed nerve damage, sagittal imbalance, etc. Currently, the definition and diagnosis of OTLVF with kyphotic deformity in the elderly are still unclear. Although there are many treatment options, they are controversial. Existing guidelines or consensuses pay little attention to this type of fracture with kyphotic deformity. To this end, the Lumbar Education Working Group of the Spine Branch of the Chinese Medicine Education Association and Editorial Committee of Chinese Journal of Trauma organized the experts in the relevant fields to jointly develop Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fractures with kyphotic deformity in the elderly ( version 2024), based on evidence-based medical advancements and the principles of scientificity, practicality, and advanced nature, which provided 18 recommendations to standardize the clinical diagnosis and treatment.

Implanted brain-computer interface (iBCI) is a system that establishes a direct communication channel between human brain and computer or an external devices by implanted neural electrode. Because of the good functional extensibility, iBCI devices as a platform technology have the potential to bring benefit to people with nervous system disease and progress rapidly from fundamental neuroscience discoveries to translational applications and market access. In this report, the industrialization process of implanted neural regulation medical devices is reviewed, and the translational pathway of iBCI in clinical application is proposed. However, the Food and Drug Administration (FDA) regulations and guidances for iBCI were expounded as a breakthrough medical device. Furthermore, several iBCI products in the process of applying for medical device registration certificate were briefly introduced and compared recently. Due to the complexity of iBCI in clinical application, the translational applications and industrialization of iBCI as a medical device need the closely cooperation between regulatory departments, companies, universities, institutes and hospitals in the future.
Humans ; Brain-Computer Interfaces ; Brain/physiology* ; Electrodes, Implanted

Objective:To evaluate the efficacy and safety of sodium hyaluronate gel in preventing adhesion after prophylactic enterostomy.Methods:One hundred and twenty four patients from 6 hospitals were enrolled in this prospective multi-center randomized controlled trial. Patients were randomized into the study group ( n=59) or the control group ( n=65).All patients underwent prophylactic enterostomy. Patients of study group received odium hyaluronate gel for adhesion-prevention,while those in control group did not receive any adhesion-prevention treatment. The incidence of moderate to severe adhesion around the incision in the stoma area were evalutated during stoma reduction surgery. Results:The incidence of moderate to severe adhesion around the incision in the stoma area was 6.3% in the study group, the difference was statistically significant ( P<0.05) compared to that of the control group (32.6%). Conclusion:Sodium hyaluronate gel can safely and effectively reduce the incidence of moderate and severe adhesions after abdominal surgery.

With the progress of science and technology and the increase of clinical demand, medical robots have developed rapidly and played a important role in promoting the medical cause. Service robot is a branch of medical robot, which is mainly oriented to medical service and assistance needs, and has been applied in many medical scenarios and achieved demonstration effects. This research first describes the development of medical service robots, and then summarizes the key technologies and clinical applications of robots. Finally, it points out the challenges and directions that medical service robots face at present, and puts forward prospects for their further development in the medical field.
Robotics ; Technology

Objective:To study the changes of early (i.e., within post injury day (PID) 14) coagulation function in patients with severe burns.Methods:A retrospective case series study was conducted. From December 2018 to December 2019, 50 severe burn patients who met the inclusion criteria were admitted to Guangzhou Red Cross Hospital of Jinan University. According to the severity of burns, the patients were divided into severe burn group (17 cases, including 12 males and 5 females) and extremely severe burn group (33 cases, including 26 males and 7 females). The platelet count (PLT), and conventional coagulation indexe and thromboelastogram index levels of patients were collected at admission, post injury hour (PIH) 48 and 72, and on PID 7 and 14. The conventional coagulation indexes included prothrombin time (PT), thrombin time (TT), activated partial prothrombin time (APTT), and fibrinogen (FIB) and D-dimer levels. The thromboelastogram indexes included coagulation angle (i.e., α angle), coagulation composite index (CI), MA value, R value, and K value (reflecting maximum amplitude, coagulation reaction time, and blood agglutination time, respectively). Data were statistically analyzed with independent sample t-test, Wilcoxon rank sum test, and chi-square test. Verification of the mixed effect model was performed on each index data of patients in the two groups, while the repeated measures analysis of variance was performed on PLT. Pearson correlation analysis or Spearman correlation analysis were performed to analyze the correlation between the thromboelastogram index data (except CI) and the PLT and conventional coagulation index data, respectively. Results:At admission, PIH 48 and 72, and on PID 7 and 14, PLT of patients in severe burn group were (203±91), (148±70), (123±63), (203±62), (402±140)×10 9/L, respectively, PLT of patients in extremely severe burn group were (235±116), (145±71), (109±52), (235±106), (455±138)×10 9/L, respectively. In overall comparison, only the difference of the main effect of time factor was statistically significant ( F=92.55, P<0.05). In severe burn group, statistically significant differences were only identified in comparison of patients' PLT between PID 7 and the adjacent two time points (at PIH 72 and on PID 14, with both P values <0.05). The differences in PLT of patients between all the adjacent time points in extremely severe burn group were statistically significant ( P<0.05). In the overall comparison of PT, TT, and FIB level of patients in the two groups at each time point, only the difference of main effect of time factor was statistically significant (with F values of 6.04, 8.45, and 32.90, respectively, all P values <0.05), and APTT and FIB level of patients in extremely severe burn group within PID 14 were higher than those in severe burn group. There were statistically significant differences in MA value, α angle, K value, and CI of patients in the two groups at each time point (with F values of 18.82, 11.38, 9.11, and 9.42, respectively, all P values <0.05). MA value was moderately correlated with PLT ( r=0.69, P<0.05), weakly correlated with TT and FIB level (with r values of -0.29 and 0.30 respectively, P<0.05), and very weakly correlated with D-dimer level ( r=-0.15, P<0.05); α angle was moderately correlated with PLT ( r=0.58, P<0.05), and weakly correlated with FIB level and TT (with r values of 0.26 and -0.29, respectively, P<0.05); R value was weakly correlated with APTT and FIB level (with r values of 0.24 and 0.31, respectively, P<0.05), and very weakly correlated with PT and TT (with r values of 0.16 and 0.14, respectively, P<0.05); K value was moderately correlated with PLT ( r=-0.59, P<0.05), and weakly correlated with FIB and TT (with r values of -0.29 and 0.32, respectively, P<0.05), and very weakly correlated with D-dimer level ( r=-0.15, P<0.05). Conclusions:Severe burn patients are already characterized with coagulation function changes in early stage, including insufficiency of coagulation function, enhanced platelet aggregation ability and enhanced FIB function. There is a certain correlation between conventional coagulation indexes and thromboelastogram indexes, but they cannot replace each other.

Osteoporotic thoracolumbar fracture in the elderly will seriously reduce their quality of life and life expectancy. For osteoporotic thoracolumbar fracture in the elderly, spinal reconstruction is necessary, which should comprehensively consider factors such as the physical condition, fracture type, clinical characteristics and osteoporosis degree. While there lacks relevant clinical norms or guidelines on selection of spinal reconstruction strategies. In order to standardize the concept of spinal reconstruction for osteoporotic thoracolumbar fracture in the elderly, based on the principles of scientificity, practicality and progressiveness, the authors formulated the Clinical guideline for spinal reconstruction of osteoporotic thoracolumbar fracture in elderly patients ( version 2022), in which suggestions based on evidence of evidence-based medicine were put forward upon 10 important issues related to the fracture classification, non-operative treatment strategies and surgical treatment strategies in spinal reconstruction after osteoporosis thoracolumbar fracture in the elderly, hoping to provide a reference for clinical treatment.

Xi'an Jiaotong University Health Science Center introduces the concept of CDIO (conceive, design, implement and operate) into the training practice of medicine-engineering interdisciplinary talents. By optimizing the curriculum and graduate training mechanism, building academic exchanges and innovative experimental platforms, and guiding students to carry out scientific research oriented to clinical problems, Xi'an Jiaotong University Health Science Center uses medical and industrial methods to solve clinical problems and produce medical achievements. The application of the CDIO model is conducive to deepening students' understanding of interdisciplinary knowledge, forming a fused innovative thinking, and improving the ability to solve problems and cooperate with others. The CDIO model is also conducive to the growth of high-level composite innovative talents, clinical technology innovation, team construction and discipline development, which provides new ideas for exploring the training of medical and engineering interdisciplinary talents.