Radiotherapy is a crucial treatment modality for head and neck tumors. However, while effectively killing tumor cells, it significantly disrupts the homeostasis of the oral microecology, which is closely associated with various complications such as radiation-induced oral mucositis. Literature review indicates that as radiotherapy doses accumulate and treatment durations extend, the richness and diversity of the oral microbiota show a declining trend, with the genus Streptococcus decreasing most markedly. In contrast, radiotherapy selectively promotes the proliferation of bacterial phyla such as Proteobacteria and Bacteroidetes, which are rich in opportunistic pathogens. Mechanistically, radiotherapy activates the nuclear factor-kappa B pathway, triggering chronic inflammation and oxidative stress, damaging the epithelial barrier, suppressing local immunity, and causing damage to organs such as the salivary glands. It can also induce systemic diseases via the oral-gut axis, forming a multi-level, interconnected pathogenic network. In terms of interventions, treatment strategies including probiotics and prebiotics have shown promising efficacy against side effects such as radiation-induced oral mucositis. Saliva-based oral microbiota transplantation is an emerging strategy that is expected to become widely utilized for restoring oral microecological balance. Existing interventions provide preliminary pathways for clinical practice, but this field still faces several key scientific questions. The association between oral microecology and systemic diseases remains largely correlative, lacking causal evidence. Furthermore, critical parameters for oral microbiota transplantation, such as donor screening criteria, transplantation protocols, and long-term safety, are not yet well-defined. Therefore, future research should focus on conducting large-scale clinical trials to establish standardized protocols and safety evaluation systems for oral microecological interventions, and explore combined treatment therapies such as probiotics, prebiotics, and microbiota transplantation to advance the development of personalized precision modulation. These will enable more effective management of radiotherapy-induced oral microecological dysbiosis and improve treatment outcomes and quality of life for patients with head and neck tumors.

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

In recent years, the incidence rate of tubal infertility has been rising. In China, most patients with tubal infertility prioritize conservative management or tubal reconstruction surgery in order to preserve fallopian tubes as far as possible. In order to meet the reproductive needs of tubal infertile patients, clinicians in the reproductive field need to evaluate various infertility risk factors comprehensively, weigh the pros and cons, and explore individualized reproductive programs which are more in line with the interests of patients. Correspondingly, higher requirements for the imaging evaluation efficiency of the fallopian tubes have been put forward. Hysterosalpingo-contrast sonography (HyCoSy), as a first-line imaging technique for evaluating tubal patency, still faces many controversies and dilemmas despite its value being widely recognized in clinical practice. This paper aims to provide viewpoints for the advancement of HyCoSy by reviewing literature and summarizing experiences.

In recent years, the incidence rate of tubal infertility has been rising. In China, most patients with tubal infertility prioritize conservative management or tubal reconstruction surgery in order to preserve fallopian tubes as far as possible. In order to meet the reproductive needs of tubal infertile patients, clinicians in the reproductive field need to evaluate various infertility risk factors comprehensively, weigh the pros and cons, and explore individualized reproductive programs which are more in line with the interests of patients. Correspondingly, higher requirements for the imaging evaluation efficiency of the fallopian tubes have been put forward. Hysterosalpingo-contrast sonography (HyCoSy), as a first-line imaging technique for evaluating tubal patency, still faces many controversies and dilemmas despite its value being widely recognized in clinical practice. This paper aims to provide viewpoints for the advancement of HyCoSy by reviewing literature and summarizing experiences.

Objective:To investigate the risk factors of central lymph node metastasis (CLNM) in cN0 paillary thyroicl microcarcinoma (PTMC) and to establish a nomogram model for predicting the probability of cN0 PTMC CLNM.Methods:The clinicopathological data of 192 patients with cN0 PTMC admitted to the Department of General Surgery of the Second Hospital of Lanzhou University from Aug. 2016 to Aug. 2020 were retrospectively analyzed. There were 41 males and 151 females, 50 with CLNM and 142 without CLNM. The patients were divided into 2 groups according to the presence or absence of pathologically confirmed CLNM. Patient’s age, gender, tumor diameter, multiple, with Hashimoto’s disease, with nodular goiter, with or without near the posterior dorsal membrane, aspect ratio >1, with or without extratumoral infiltration, with or without lymphadenopathy, TSH levels, and TG levels were statistically analyzed. Pearson chi-square test was used to analyze the count data of hypothesis test, and the R language software package was used for Logistic multivariate analysis. The entry conditions were screened by stepwise regression to establish a nomogram prediction model, and the Bootstrap method was used for model verification. P<0.05 was considered statistically significant. Results:Multivariate logistic analysis showed that extratumoral invasion ( P=0.032) , presence of lymphadenopathy ( P=0.010) , and TG>68 μg/L ( P=0.007) were risk factors for central lymph node metastasis. The optimal model was established by stepwise regression. The factors included tumor diameter ≥0.5 cm, nodular goiter, extratumoral invasion, lymphadenopathy and TG>68 μg/L (AIC: 212.27) . The nomogram model was established according to the above risk factors. The consistency index (c-index) was 0.711. The results of calibration graph drawing and internal and external validation demonstrated its good consistency and applicability. Conclusion:Extratumoral invasion, lymphadenopathy, and TG>68 μg/L are risk factors for cN0 PTMC CLNM, and the nomogram established in the study can effectively predict the CLNM rate in patients with cN0PTMC and contribute to clinicians’ diagnosis and treatment decisions.

Objective To analyze the characteristics of left ventricular systolic function in Kawasaki disease (KD) patients with intravenous immunoglobulin (IVIG) resistant during acute phase by two-dimensional speckle tracking imaging (2D STI).Methods IVIG resistant patients (n=40) as well as age and gender matched IVIG responder patients (n=40) were selected from KD patients in acute phase.Patients in IVIG resistant group were further divided into coronary artery dilation (CAD) subgroup and no coronary artery dilation (NCAD) subgroup.Then conventional echocardiography,2D STI and laboratory indexes were acquired and compared between IVIG resistant group and IVIG responder group,as well as between CAD and NCAD subgroup.ROC curve analysis was used to determine threshold values of 2D STI measurements associated with IVIG resistance.Results Compared with IVIG responder group,coronary artery dilation,left ventricular mass and left ventricular mass index increased,systolic global longitudinal strain (GLS) and systolic global circumferential strain (GCS) decreased,albumin,erythrocyte sedimentation rate,C-reactive protein and platelet increased in IVIG resistant group (all P＜0.05).Taking absolute GLS 16.8％ as a threshold,the area under curve (AUC) was 0.769 (P=0.021),sensitivity,specificity in diagnosis of IVIG resistant was 79.27％,68.36％.Taking absolute GCS 15.9％ as a threshold,AUC was 0.749 (P=0.038),sensitivity,specificity in diagnosis of IVIG resistant was 71.43％,57.28％.Conclusion IVIG resistant KD patients present significantly greater systolic dysfunction compared with responders in patients with KD,which may be the results of myocardium infection other than coronary artery lesions.2D STI may predict myocardial injury in IVIG resistant KD patients.

Objective To systematically analyze and assess the overall value of transrectal shear wave elastograpy in diagnosis of prostate cancer (PCa) using Meta-analysis.Methods Relevant Chinese and foreign papers diagnosing PCa with transrectal shear wave elastograpy published before December 2016 were searched.The references were evaluated and screened according to the criteria of diagnostic research.The selected references were analyzed by Meta-Disc 1.4 and Stata 12.0 statistical software.Results Eight articles were included in the present Meta-analysis.Five of these literatures were about transrectal shear wave elastograpy in diagnosis of PCa,the summarized sensitivity (SEN) and summarized specificity (SPE) in diagnosis of PCa were 0.80 (95％CI [0.75,0.84]) and 0.75 (95％CI [0.71,0.79]),respectively;the positive likelihood ratios (PLR) and negative likelihood ratios (NLR) were 3.60 (95 ％ CI [2.57,5.05]) and 0.17 (95 ％ CI[0.08,0.37]),respectively;the area under SROC curves was 0.895.Five of these literatures were about transrectal shear wave elastograpy supplemental prostatic biopsy in diagnosis of PCa,the summarized SEN and SPE were 0.86 (95％ CI [0.83,0.88]) and 0.84 (95％CI [0.82,0.85]) respectively;the PLR and NLR were 5.81 (95％CI [3.07,10.99]) and 0.14 (95％CI [0.04,0.49]) respectively;the area under SROC curves were 0.924.Conclusion Transrectal shear wave elastograpy has better clinical value in detection of PCa and can be used to supplemental prostatic biopsy.