As the core vehicle for preserving and transmitting traditional Chinese medicine（TCM） academic thought and clinical experience， the establishment of a robust quality evaluation system for TCM clinical case reports is a crucial component in the current standardization and modernization of TCM. Based on the practical experience of constructing the China Clinical Cases Library of Traditional Chinese Medicine by the China Association of Chinese Medicine， this study conducted a comprehensive analysis of critical challenges， including insufficient authenticity and unfocused evaluation criteria. It proposed a three-dimensional evaluation framework grounded in the structure-process-outcome logic， encompassing three dimensions of authenticity and standardization， characteristics and advantages， application and translational impact. This framework integrated 12 key evaluation indicators in a systematic manner. The model preserved the academic characteristics of TCM syndrome differentiation and treatment， while aligning with modern scientific research standards， achieving a balance between individualized TCM experience and standardized evaluation. Concurrently， this study provided theoretical foundations and methodological guidance for evaluating the quality of TCM clinical cases， contributing significantly to the inheritance of TCM knowledge， evidence-based practice， and the reform of talent evaluation mechanisms.

This study aimed to establish an analytical method capable of simultaneously quantifying the prototype components of Si-Ni-San and screening their metabolites to elucidate its tissue distribution and metabolic characteristics in an ulcerative colitis (UC) mouse model. To this end, an integrated analysis strategy based on UPLC-QqQ-MS was developed and validated, combining the targeted quantification of 12 prototype components with a pseudo-targeted metabolite screening technique based on ion pair list-triggered data-dependent acquisition. Samples were extracted with 80% methanol (100 mg/mL) and processed with internal standards. Separation was achieved on a Waters Acquity UPLC HSS PFP column using a gradient elution with a mobile phase consisting of acetonitrile and 5 mmol/L ammonium acetate containing 0.1% formic acid. Analysis was performed using an electrospray ionization (ESI) source in multiple reaction monitoring mode. Methodological validation confirmed that all parameters met the requirements for bio-sample analysis. Application of this method revealed that the content of Si-Ni-San prototype components in the colon, liver, and kidneys of UC mice was significantly higher than that in healthy mice. Furthermore, the number of phase II metabolites was markedly greater than that of phase I metabolites in all tested samples. The results demonstrate the reliability of the established method and preliminarily reveal the tissue distribution characteristics of Si-Ni-San under UC conditions and its metabolism pattern dominated by phase II conjugation, which provides a methodological basis and experimental data for further in-depth research into its effective target tissues and pharmacodynamic material basis.

PURPOSE: To assess the relationship between dislocation and functional outcomes in supination-external rotation (SER) ankle fractures. METHODS: A retrospective case series study was performed on patients with ankle fractures treated surgically at a large trauma center from January 2015 to December 2021. The inclusion criteria were young and middle-aged patients of 18 - 65 years with SER ankle fractures that can be classified by Lauge-Hansen classification and underwent surgery at our trauma center. Exclusion criteria were serious life-threatening diseases, open fractures, fractures delayed for more than 3 weeks, fracture sites ≥ 2, etc. Then patients were divided into dislocation and no-dislocation groups. Patient demographics, injury characteristics, surgery-related outcomes, and postoperative functional outcomes were collected and analyzed. The functional outcomes of SER ankle fractures were assessed postoperatively at 1-year face-to-face follow-up using the foot and ankle outcome score (FAOS) and American Orthopedic Foot and Ankle Society ankle hindfoot score and by 2 experienced orthopedic physicians. Relevant data were analyzed using SPSS version 22.0 by Chi-square or t-test. RESULTS: During the study period, there were 371 ankle fractures. Among them, 190 (51.2%) were SER patterns with 69 (36.3%) combined with dislocations. Compared with the no-dislocation group, the dislocation group showed no statistically significant differences in gender, age composition, fracture type, diabetes, or smoking history, preoperative waiting time, operation time, and length of hospital stay (all p > 0.05), but a significantly higher Lauge-Hansen injury grade (p < 0.001) and syndesmotic screw fixation rate (p = 0.033). Moreover, the functional recovery was poorer, revealing a significantly lower FAOS in the sport/rec scale (p < 0.001). Subgroup analysis showed that among SER IV ankle fracture patients, FAOS was much lower in pain (p = 0.042) and sport/rec scales (p < 0.001) for those with dislocations. American Orthopedic Foot and Ankle Society ankle hindfoot score revealed no significant difference between dislocation and no-dislocation patients. CONCLUSION Dislocation in SER ankle fractures suggests more severe injury and negatively affects functional recovery, mainly manifested as more pain and poorer motor function, especially in SER IV ankle cases.
Humans ; Ankle Fractures/physiopathology* ; Male ; Female ; Retrospective Studies ; Adult ; Middle Aged ; Supination ; Aged ; Young Adult ; Rotation ; Joint Dislocations/surgery* ; Fracture Fixation, Internal/methods* ; Adolescent ; Recovery of Function ; Treatment Outcome

Hearing loss is the most prevalent disabling disease. Cochlear implantation（CI） serves as the primary intervention for severe to profound hearing loss. This consensus systematically explores the value of genetic diagnosis in the pre-operative assessment and efficacy prognosis for CI. Drawing upon domestic and international research and clinical experience, it proposes an evidence-based medicine three-tiered prognostic classification system（Favorable, Marginal, Poor）. The consensus focuses on common hereditary non-syndromic hearing loss（such as that caused by mutations in genes like GJB2, SLC26A4, OTOF, LOXHD1） and syndromic hereditary hearing loss（such as Jervell & Lange-Nielsen syndrome and Waardenburg syndrome）, which are closely associated with congenital hearing loss, analyzing the impact of their pathological mechanisms on CI outcomes. The consensus provides recommendations based on multiple round of expert discussion and voting. It emphasizes that genetic diagnosis can optimize patient selection, predict prognosis, guide post-operative rehabilitation, offer stratified management strategies for patients with different genotypes, and advance the application of precision medicine in the field of CI.
Humans ; Cochlear Implantation ; Prognosis ; Hearing Loss/surgery* ; Consensus ; Connexin 26 ; Mutation ; Sulfate Transporters ; Connexins/genetics*

Objective To explore the effect of exercise under cold exposure on hepatic protein ki-nase B(AKT)/forkhead box O1(FoxO1)expression in obese rats.Methods Among rats successfully induced nutritional obesity by high-fat diet,forty were selected and randomly divided into a normal-temperature control group(NC,n=10),a normal-temperature exercise group(NE,n=10),a sus-tained-cold control group(SC,n=10),and a sustained-cold exercise group(SE,n=10).The normal temperature was kept at 25°C±1°C,while the low temperature remained at 4°C±1°C,with 50%to 60%relative humidity.The exercise protocol was every other day at a speed of 25 m/min for 2 sets of 30 min each,with an interval of 10 minutes.After 5 weeks,glucose and insulin tolerance were tested by oral glucose tolerance test(OGTT)and insulin tolerance test insulin tolerance test(ITT).Then,all rats were weighed and sacrificed,then taken blood from the abdominal aorta to sepa-rate serum,followed by detection of serum alanine aminotransferase(ALT)and aspartate aminotransfer-ase(AST)levels using fully automatic biochemical analyzer.Moreover,livers were weighed to calcu-late the liver index.Meanwhile,the mRNA expressions of hepatic AKT,FoxO1 and PEPCK were de-tected using RT-qPCR,while the protein expressions of AKT,phosphorylated protein kinase B(p-AKT),and FoxO1 in the liver were measured using Western blotting.Results(1)The average body weights of the NE,SC and SE groups were significantly lower than the NC group(P<0.01),with that of the SC and SE groups significantly lower than the NE group(P<0.01).(2)Compared with the NC group,the area under the OGTT curve of the SC group decreased(P<0.01).Moreover,the area under the ITT curve of the SE group was significantly lower than the other 3 groups(P<0.01,P<0.01,P<0.05),with that of the NE and SC groups significantly lower than the NC group(P<0.05,P<0.01).(3)The liver indices of the NE,SC and SE groups were all significantly lower than the NC group(P<0.01),while the serum ALT level of the NE group was significantly lower than the NC and SE groups(P<0.05),with that of the SC group significantly lower than the NC group(P<0.01).(4)Compared with the NC group,hepatic AKT mRNA expression increased significantly in the SE group(P<0.05),while the hepatic FoxO1 and PEPCK mRNA expression decreased significantly in the other three groups(P<0.01).(5)Compared with the NC group,the liver AKT protein phosphorylation levels were significantly higher in the other three groups(P<0.05,P<0.05,P<0.01),while the FoxO1 protein expression decreased significantly(P<0.05,P<0.01,P<0.01).(6)Body mass,liver FoxO1,PEPCK mRNA expression,AKT protein phosphorylation level and FoxO1 protein expression level of obese rats were affected by cold exposure,exercise and cold exposure+exercise,and the liver index and serum ALT level were done by exercise and cold exposure+exercise.However,the area un-der the ITT curve and liver AKT mRNA content were impacted by cold exposure and exercise,while that under the OGTT curve was influenced by cold exposure and cold exposure+exercise.Conclu-sion Exercise under cold exposure can activate hepatic AKT/FoxO1 signaling pathway,protect liver function,increase insulin sensitivity,and effectively improve glucose metabolism in obese rats.

BACKGROUND:The asymmetrical biomechanical environment of adolescent idiopathic scoliosis can lead to further wedge deformation of the vertebral body,which may affect cardiopulmonary function and compress nerves in severe cases.Adolescent idiopathic scoliosis with different degrees of scoliosis should be treated with exercise,bracing,and surgery.However,the mechanical mechanism of selecting an orthopedic approach remains unclear due to the individual variability of patients.OBJECTIVE:To investigate the biomechanical mechanism of different orthopedic modalities for the treatment of adolescent idiopathic scoliosis to provide a basis for clinical selection of treatment modalities based on the spine model of adolescent idiopathic scoliosis patients.METHODS:Based on the CT images of an adolescent idiopathic scoliosis patient,a scoliosis model(C7-L5)was reconstructed in Mimics software in three dimensions,and lateral thrust force was applied at the T8/T9 thorax and vertical distraction force was applied over the C7 vertebra with the magnitude of 20,40,60,80,100,and 120 N.The intervertebral disc stress and vertebral displacement in concave and convex sides,and Cobb angle of the spine were analyzed under two orthopedic modalities.RESULTS AND CONCLUSION:(1)With lateral thrust,there was no significant change in the C7T1-T7T8 intervertebral disc.The concave and convex stress of T7T8-L4L5 segment decreased first and then increased with the increase of lateral thrust force.The correction effect of lateral thrust on the segment near T8T9 was obvious and weakened with the extension of the segment to the cephalic and caudal ends.At 120 N of lateral thrust,the thoracic Cobb angle changed from 53.2° to 32.5° and the lumbar Cobb angle changed from 50.2° to 43.9°.(2)With the vertical distraction,the thoracic intervertebral disc stresses first decreased and then increased,and all the lumbar disc stresses decreased.The C7 displacement was the most obvious,and the correction effect gradually diminished with the segment extended to the caudal end.At a vertical distraction force of 120 N,the thoracic Cobb angle changed from 53.2° to 39.4° and the lumbar Cobb angle changed from 50.2° to 47.6°.(3)It is concluded that both orthopedic modalities provide improvement in the degree of scoliosis,with the thoracic correction being greater than the lumbar correction.Also,the asymmetric stress distribution on the concave and convex sides is improved,which contributes to normal bone growth.A vertical distraction approach is appropriate for larger Cobb angles,and a lateral thrust approach is appropriate for smaller Cobb angles.The results of this study help to understand the mechanism of spinal orthosis and provide a theoretical basis for the choice of orthopedic approach.

Objective To addresses the challenges arising from the rapid expansion of pharmaceutical clinical trials and the growing demands for quality management,this paper investigates the application of low-code technology in project management.Its goals are to enhance the operational efficiency and execution capabilities of clinical trial institutions,ensure trial quality and safety,and accelerate the translation of pharmaceutical scientific achievements.Methods A brainstorming session was conducted to analyze the technical and functional requirements for managing pharmaceutical clinical trial projects.Utilizing the ＂template design＂ and ＂decision analysis＂ functionalities of low-code technology,the study adopted a modular and visually driven data management approach to develop a system compliant with Good Clinical Practice(GCP)standards.This system integrates key functionalities,including project progress management,funding management,drug inventory management,and quality control.Its effectiveness was evaluated through real-world operation and performance validation.Results The system had demonstrated stable operation with substantial improvements in practical application.Compared with conventional management approaches,it significantly enhanced project management efficiency:the time required for project schedule management was reduced by 80%,the efficiency of financial processing increased by 95%,drug inventory management efficiency improved by 75%,and the time spent on quality control was shortened by 60%.Conclusion The pharmaceutical clinical trial project management system developed using low-code technology offers substantial advantages and promising application potential.It represents a critical practice in applying digital and intelligent tools to advance pharmaceutical productivity in the medical and healthcare sectors.

Objective To addresses the challenges arising from the rapid expansion of pharmaceutical clinical trials and the growing demands for quality management,this paper investigates the application of low-code technology in project management.Its goals are to enhance the operational efficiency and execution capabilities of clinical trial institutions,ensure trial quality and safety,and accelerate the translation of pharmaceutical scientific achievements.Methods A brainstorming session was conducted to analyze the technical and functional requirements for managing pharmaceutical clinical trial projects.Utilizing the ＂template design＂ and ＂decision analysis＂ functionalities of low-code technology,the study adopted a modular and visually driven data management approach to develop a system compliant with Good Clinical Practice(GCP)standards.This system integrates key functionalities,including project progress management,funding management,drug inventory management,and quality control.Its effectiveness was evaluated through real-world operation and performance validation.Results The system had demonstrated stable operation with substantial improvements in practical application.Compared with conventional management approaches,it significantly enhanced project management efficiency:the time required for project schedule management was reduced by 80%,the efficiency of financial processing increased by 95%,drug inventory management efficiency improved by 75%,and the time spent on quality control was shortened by 60%.Conclusion The pharmaceutical clinical trial project management system developed using low-code technology offers substantial advantages and promising application potential.It represents a critical practice in applying digital and intelligent tools to advance pharmaceutical productivity in the medical and healthcare sectors.

Objective To explore the effect of exercise under cold exposure on hepatic protein ki-nase B(AKT)/forkhead box O1(FoxO1)expression in obese rats.Methods Among rats successfully induced nutritional obesity by high-fat diet,forty were selected and randomly divided into a normal-temperature control group(NC,n=10),a normal-temperature exercise group(NE,n=10),a sus-tained-cold control group(SC,n=10),and a sustained-cold exercise group(SE,n=10).The normal temperature was kept at 25°C±1°C,while the low temperature remained at 4°C±1°C,with 50%to 60%relative humidity.The exercise protocol was every other day at a speed of 25 m/min for 2 sets of 30 min each,with an interval of 10 minutes.After 5 weeks,glucose and insulin tolerance were tested by oral glucose tolerance test(OGTT)and insulin tolerance test insulin tolerance test(ITT).Then,all rats were weighed and sacrificed,then taken blood from the abdominal aorta to sepa-rate serum,followed by detection of serum alanine aminotransferase(ALT)and aspartate aminotransfer-ase(AST)levels using fully automatic biochemical analyzer.Moreover,livers were weighed to calcu-late the liver index.Meanwhile,the mRNA expressions of hepatic AKT,FoxO1 and PEPCK were de-tected using RT-qPCR,while the protein expressions of AKT,phosphorylated protein kinase B(p-AKT),and FoxO1 in the liver were measured using Western blotting.Results(1)The average body weights of the NE,SC and SE groups were significantly lower than the NC group(P<0.01),with that of the SC and SE groups significantly lower than the NE group(P<0.01).(2)Compared with the NC group,the area under the OGTT curve of the SC group decreased(P<0.01).Moreover,the area under the ITT curve of the SE group was significantly lower than the other 3 groups(P<0.01,P<0.01,P<0.05),with that of the NE and SC groups significantly lower than the NC group(P<0.05,P<0.01).(3)The liver indices of the NE,SC and SE groups were all significantly lower than the NC group(P<0.01),while the serum ALT level of the NE group was significantly lower than the NC and SE groups(P<0.05),with that of the SC group significantly lower than the NC group(P<0.01).(4)Compared with the NC group,hepatic AKT mRNA expression increased significantly in the SE group(P<0.05),while the hepatic FoxO1 and PEPCK mRNA expression decreased significantly in the other three groups(P<0.01).(5)Compared with the NC group,the liver AKT protein phosphorylation levels were significantly higher in the other three groups(P<0.05,P<0.05,P<0.01),while the FoxO1 protein expression decreased significantly(P<0.05,P<0.01,P<0.01).(6)Body mass,liver FoxO1,PEPCK mRNA expression,AKT protein phosphorylation level and FoxO1 protein expression level of obese rats were affected by cold exposure,exercise and cold exposure+exercise,and the liver index and serum ALT level were done by exercise and cold exposure+exercise.However,the area un-der the ITT curve and liver AKT mRNA content were impacted by cold exposure and exercise,while that under the OGTT curve was influenced by cold exposure and cold exposure+exercise.Conclu-sion Exercise under cold exposure can activate hepatic AKT/FoxO1 signaling pathway,protect liver function,increase insulin sensitivity,and effectively improve glucose metabolism in obese rats.

Objective:This multicenter retrospective study aimed to analyze the clinicopathological features of duodenal adenocarcinoma (DA) and identify prognostic factors for postoperative survival.Methods:Demographic characteristics, clinicopathological features, treatment outcomes and survival of DA patients undergoing surgical treatment at 18 Chinese medical centers from January 2012 to December 2023 were retrospectively analyzed.Results:Among the 2 056 DA patients included, 46.8% (963) had extra-ampullary DA (EA-DA), and 53.2% (1 093) had peri-ampullary DA (PA-DA). The 1-, 3-, and 5-year overall survival (OS) rates for patients who underwent radical surgery were 93.2%, 71.0%, and 57.2%, respectively. The median overall survival was 76 months, and the median progression-free survival (PFS) was 65 months. No differences in survival were observed between the laparotomy group and minimally invasive surgery (MIS) group either before or after propensity score matching (OS: 76 vs. 75 months before PSM, P=0.986; OS: 75 vs. 75 months after PSM, P=0.602). Furthermore, there were no significant differences between-group in operation time and postoperative complications ( P＞0.05). The MIS group experienced less intraoperative blood loss and shorter hospital stays. The multivariate Cox regression analysis revealed that advanced age ( HR=1.43,95% CI:1.18-1.73), elevated carbohydrate antigen 19-9 levels ( HR=1.24,95% CI:1.02-1.51), perineural invasion ( HR=1.44,95% CI:1.14-1.81), vascular invasion ( HR=1.35,95% CI:1.07-1.71), advanced T stage (T3-4 vs. T1-2: HR=1.86,95% CI:1.49-2.31), regional lymph node metastasis ( HR=1.93,95% CI:1.58-2.36), preoperative biliary drainage ( HR=1.26,95% CI:1.04-1.53), intraoperative blood loss ( HR=1.34,95% CI:1.11-1.62), clinically significant postoperative pancreatic fistulas ( HR=1.53,95% CI:1.12-2.09), and postoperative hemorrhage ( HR=1.62,95% CI:1.14-2.29) were independent risk factors for poor prognosis after surgery (all P＜0.05). Conclusions:Radical surgery is associated with favorable overall survival among DA patients, and no difference in survival is observed between EA-DA and PA-DA patients. MIS is a reliable alternative for DA treatment.