Animal model research on spleen and stomach diseases in traditional Chinese medicine （TCM） is of great significance for elucidating the nature of diseases and syndromes and for revealing the mechanisms of action of Chinese herbal medicinals. At present， studies on classical TCM syndrome models of spleen and stomach diseases mainly focus on spleen deficiency syndrome， liver constraint syndrome， and damp-heat syndrome. Model construction is mostly based on the etiological and pathophysiological characteristics of syndrome， and model evaluation primarily involves macroscopic manifestations and physicochemical indicators. This paper summarizes the current research status of animal models integrating disease and syndrome for seven common spleen and stomach diseases， including chronic gastritis and gastric precancerous lesions， gastroesophageal reflux disease， functional dyspepsia， inflammatory bowel disease， irritable bowel syndrome， functional constipation， and functional diarrhea. The modeling methods and characteristics of disease-syndrome combined animal models for each disease are analyzed. It is proposed that future research on disease-syndrome integration in spleen and stomach diseases should move toward syste-matic， precise， and integrative development， and that interdisciplinary and cross-disciplinary research approaches should be adopted to enhance the predictive value and application efficiency of disease-syndrome combined animal models.

Objective To study the MRI features of diabetic foot osteomyelitis(DFO)and its correlation with the atherogenic index of plasma(AIP).Methods The clinical data of 96 DF patients who were treated in the our hospital from January 2016 to December 2022 were collected.According to whether DFO occurs,the patients were divided into two groups:DF group(n=52)and DFO group(n=44).The differences of age,sex,course of diabetes,AIP and other clinical indicators between the two groups were compared.Logistic regression was used to analyze the influencing factors of DFO,and receiver operating characteristic(ROC)curve was used to analyze the efficacy of AIP and common clinical indicators in predicting DFO.Results The main manifestations of DFO on MRI were soft tissue cellulitis,abscess(50/96),osteomyelitis(48/96),sinus(45/96),and Charcot's joint(12/96).Among 48 cases of osteomyelitis,4 cases were confirmed as false positive by bone puncture biopsy,13(13/44)cases had exposed bone tissue,14(14/44)cases were confirmed by bone puncture biopsyand17(17/44)cases were positive for bone pathogen culturewhichincluding 9 cases of Gram-positive bacteria(5 cases of Staphylococcus aureus,3 cases of Staphylococcus epidermidis,and 1 case of Staphylococcus hemolysis);5 cases of Gram-negative bacteria(3 cases of Pseudomonas aeruginosa,1 case of Proteus mirabilis,and 1 case of Klebsiella pneumoniae)and 3 cases were mixed bacterial infections.Compared with the DF group,the BMI,AIP,High sensitivity C reactive protein,and smoking rate of patients in the DFO group increased(P<0.05).Binary logistic regression analysis showed that AIP and smoking were the influencing factors of DFO.The ROC curve analysis showed that the area under the ROC curve of AIP predicting DFO in DM patients was 0.738,with a sensitivity of 72.7%,a specificity of 73.1%,and an optimal cutoff value of 0.19.The Delong test showed that AIP has an advantage in predicting DFO(P<0.05).Conclusions MRI can better display the involvement of soft tissue and bone joints in DFO feet.AIP and smoking are influencing factors of DFO.AIP is a monitoring indicator for the prevention and treatment of DFO.

Monoclonal antibodies(mAbs)represent the most extensively utilized class of therapeutic proteins in clinical practice.While the majority of currently marketed mAbs are primarily employed for the treatment of non-infectious diseases,such as tumors and autoimmune disorders,the number of monoclonal antibody drugs approved globally for the prevention or treatment of infectious diseases has been progressively increasing since the onset of the COVID-19 pandemic.On March 25,2023,the World Health Organization(WHO)published the"Guidelines on the Non-Clinical and Clinical Evaluation of Monoclonal Antibodies and Related Products Intended for the Prevention or Treatment of Infectious Diseases".However,China has yet to release analogous guidelines.This article aims to elucidate the non-clinical evaluation aspects of monoclonal antibody drugs for infectious disease prevention and treatment as outlined in the WHO guidelines,with a focus on regulatory considerations,overarching principles of non-clinical evaluation,as well as pharmacodynamics,pharmacokinetics,and toxicology studies.It is intended to serve as a reference for the non-clinical research and evaluation of such novel drugs in China.

Objective To study the MRI features of diabetic foot osteomyelitis(DFO)and its correlation with the atherogenic index of plasma(AIP).Methods The clinical data of 96 DF patients who were treated in the our hospital from January 2016 to December 2022 were collected.According to whether DFO occurs,the patients were divided into two groups:DF group(n=52)and DFO group(n=44).The differences of age,sex,course of diabetes,AIP and other clinical indicators between the two groups were compared.Logistic regression was used to analyze the influencing factors of DFO,and receiver operating characteristic(ROC)curve was used to analyze the efficacy of AIP and common clinical indicators in predicting DFO.Results The main manifestations of DFO on MRI were soft tissue cellulitis,abscess(50/96),osteomyelitis(48/96),sinus(45/96),and Charcot's joint(12/96).Among 48 cases of osteomyelitis,4 cases were confirmed as false positive by bone puncture biopsy,13(13/44)cases had exposed bone tissue,14(14/44)cases were confirmed by bone puncture biopsyand17(17/44)cases were positive for bone pathogen culturewhichincluding 9 cases of Gram-positive bacteria(5 cases of Staphylococcus aureus,3 cases of Staphylococcus epidermidis,and 1 case of Staphylococcus hemolysis);5 cases of Gram-negative bacteria(3 cases of Pseudomonas aeruginosa,1 case of Proteus mirabilis,and 1 case of Klebsiella pneumoniae)and 3 cases were mixed bacterial infections.Compared with the DF group,the BMI,AIP,High sensitivity C reactive protein,and smoking rate of patients in the DFO group increased(P<0.05).Binary logistic regression analysis showed that AIP and smoking were the influencing factors of DFO.The ROC curve analysis showed that the area under the ROC curve of AIP predicting DFO in DM patients was 0.738,with a sensitivity of 72.7%,a specificity of 73.1%,and an optimal cutoff value of 0.19.The Delong test showed that AIP has an advantage in predicting DFO(P<0.05).Conclusions MRI can better display the involvement of soft tissue and bone joints in DFO feet.AIP and smoking are influencing factors of DFO.AIP is a monitoring indicator for the prevention and treatment of DFO.

Monoclonal antibodies(mAbs)represent the most extensively utilized class of therapeutic proteins in clinical practice.While the majority of currently marketed mAbs are primarily employed for the treatment of non-infectious diseases,such as tumors and autoimmune disorders,the number of monoclonal antibody drugs approved globally for the prevention or treatment of infectious diseases has been progressively increasing since the onset of the COVID-19 pandemic.On March 25,2023,the World Health Organization(WHO)published the"Guidelines on the Non-Clinical and Clinical Evaluation of Monoclonal Antibodies and Related Products Intended for the Prevention or Treatment of Infectious Diseases".However,China has yet to release analogous guidelines.This article aims to elucidate the non-clinical evaluation aspects of monoclonal antibody drugs for infectious disease prevention and treatment as outlined in the WHO guidelines,with a focus on regulatory considerations,overarching principles of non-clinical evaluation,as well as pharmacodynamics,pharmacokinetics,and toxicology studies.It is intended to serve as a reference for the non-clinical research and evaluation of such novel drugs in China.

Objective This study aimed to explore the heterogeneity and gene ontology of Wnt1-Cre-marked and Pax2-Cre-marked first branchial arch cranial neural crest cells(CNCs)in mice.Methods The embryos of Wnt1-Cre;R26RmTmG and Pax2-Cre;R26RmTmG at embryonic day(E)8.0-E9.25 were collected for histological observation.We per-formed immunostaining to compare green fluorescent pro-tein(GFP)-positive CNCs in Pax2-Cre;R26RAi9 and Wnt1-Cre;R26RAi9 mice at E15.5.Single-cell RNA sequencing(scRNA-seq)was used to analyze the first branchial arch GFP-positive CNCs from Wnt1-Cre;R26RmTmG and Pax2-cre;R26RmTmGmice at E10.5.Real time fluorescence quantitative polymerase chain reaction(q-PCR)was performed to val-idate the differential genes.Results Wnt1-Cre-marked and Pax2-Cre-marked CNCs migrated from the neural plateto first and second branchial arches and to the first branchial arch,respectively,at E8.0.Although Wnt1-Cre-marked and Pax2-Cre-marked CNCs were found mostly in cranial-facial tissues,the former had higher expression in palate and tongue.The results of scRNA-seq showed that Pax2-Cre-marked CNCs specifically contributed to osteoblast differentia-tion and ossification,while Wnt1-Cre-marked CNCs participated in limb development,cell migration,and ossification.The q-PCR data also confirmed the results of gene ontology analysis.Conclusion Pax2-Cre mice are perfect experimen-tal animal models for research on first branchial arch CNCs and derivatives in osteoblast differentiation and ossification.

As a normal physiological substance,D-galactose can induce a process similar to natural brain aging in vivo and in vitro when administered excessively,and thus it is widely used to induce brain aging models in China and abroad.The model of brain failure induced by D-galactose has the advantages of a short modeling time,low cost,and significant effect.However,the induction mechanisms are complex and diverse,and the relationships between the mechanisms are unclear,which limit the practical applications of the model.This article reviews the in vivo metabolism of D-galactose and the various mechanisms involved in the induction of brain aging,as well as the links between the mechanisms,to provide a reference for the application and development of this model and the in-depth study of brain aging.

Objective:To construct a preoperative rehabilitation program for gastric cancer patients, aiming to provide scientific and reasonable preoperative guidance for gastric cancer patients.Methods:On the basis of literature research and expert group meeting, the first draft of the preoperative rehabilitation program for gastric cancer patients was constructed. From October 2021 to January 2022, the Delphi method was used to conduct 2 rounds of expert letter inquiries to 16 experts in related fields from 11 hospitals in Jiangsu Province, and the entries were revised according to the experts′ inquiries.Results:In the two rounds of expert correspondence, the positive coefficients of experts were 88.89% and 100.00%, and the authority coefficients of experts were both 0.88. The coordination coefficients of the items in the two rounds of inquiry were 0.279 and 0.290, respectively. The final program consisted of 3 first-level entries, 11 second-level entries and 32 third-level entries.Conclusions:The scheme constructed in this study is scientific, reliable and applicable, and is worth being promoted further in clinical practice.

Humans ; Asthma/drug therapy* ; Biological Therapy

Patient safety is the cornerstone of medical quality and an important foundation for a healthy China.In May 2023,the National Health Commission and the National Administration of Traditional Chinese Medicine jointly is-suedthe Action Plan for Comprehensively Improving Medical Quality(2023-2025),which identified patient safety as an important task and special action.It introduces the concept of patient safety,the status quo of patient safety ac-tions at home and abroad,and the research trend of patient safety,and compares the work requirements of patient safety management and special actions in the Action Plan for Comprehensively Improving Medical Quality(2023-2025),and finally puts forward a series of suggestions for formulating the Implementation Plan of Special Ac-tions for Patient Safetywith Chinese characteristics.