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an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device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.

OBJECTIVE: This study aimed to explore the association between body mass index (BMI) and mortality based on the 10-year population-based multicenter prospective study. METHODS: A general population-based multicenter prospective study was conducted at four sites in rural China between 2013 and 2023. Multivariate Cox proportional hazards models and restricted cubic spline analyses were used to assess the association between BMI and mortality. Stratified analyses were performed based on the individual characteristics of the participants. RESULTS: Overall, 19,107 participants with a sum of 163,095 person-years were included and 1,910 participants died. The underweight (< 18.5 kg/m ²) presented an increase in all-cause mortality (adjusted hazards ratio [ aHR] = 2.00, 95% confidence interval [ CI]: 1.66-2.41), while overweight (≥ 24.0 to < 28.0 kg/m ²) and obesity (≥ 28.0 kg/m ²) presented a decrease with an aHR of 0.61 (95% CI: 0.52-0.73) and 0.51 (95% CI: 0.37-0.70), respectively. Overweight ( aHR = 0.76, 95% CI: 0.67-0.86) and mild obesity ( aHR = 0.72, 95% CI: 0.59-0.87) had a positive impact on mortality in people older than 60 years. All-cause mortality decreased rapidly until reaching a BMI of 25.7 kg/m ² ( aHR = 0.95, 95% CI: 0.92-0.98) and increased slightly above that value, indicating a U-shaped association. The beneficial impact of being overweight on mortality was robust in most subgroups and sensitivity analyses. CONCLUSION This study provides additional evidence that overweight and mild obesity may be inversely related to the risk of death in individuals older than 60 years. Therefore, it is essential to consider age differences when formulating health and weight management strategies.
Humans ; Body Mass Index ; China/epidemiology* ; Male ; Female ; Middle Aged ; Prospective Studies ; Rural Population/statistics & numerical data* ; Aged ; Follow-Up Studies ; Adult ; Mortality ; Cause of Death ; Obesity/mortality* ; Overweight/mortality*

Objective This research was performed to identify rodent-borne pathogens in Hekou Port,Yunnan Province.Methods Rodents were captured using cages and dissected to collect their lungs,liver,spleen,and other viscera.Eight pathogens,including Yersinia pestis,Leptospira,Bartonella,and Anaplasmataceae,were identified using polymerase chain reaction amplification.Amplified pathogen sequences from positive samples were sequenced,and BLAST homology searches were conducted using GenBank to confirm pathogen identities.A phylogenetic tree of the identified pathogens was constructed using the neighbor joining method.Results The total of 31 rodents,identified as Rattus tanezumi,R.norvegicus,and Mus musculus,were captured.Among these,R.tanezumi was the dominant species,accounting for 64.52％of the total.Two pathogens,Leptospira interrogans and Neoehrlichia mikurensis,were detected,with positivity rates of 9.68％and 29.03％,respectively.No other pathogens were detected.The overall positivity rate for rodent-borne pathogens was 35.48％.Conclusions The single 16S rRNA gene fragment is insufficient for the molecular identification of all Neoehrlichia species.Accurate species identification should be based on a combined analysis of multiple genes.The prevalence of rodent-borne pathogens in Hekou Port indicates the necessity for enhanced surveillance of rodent-borne diseases and implementation of additional prevention and control measures in border ports.

AIM To investigate the effects of Qifu Yixin Granules on cardiac inflammation in a rat model of heart failure.METHODS The rats were induced into chronic heart failure(CHF)models by 6-week intraperitoneal injection of doxorubicin followed by the random assignment of the successful rat models into the model group,the captopril group(22.5 mg/kg),and the low-dose,medium-dose,and high-dose Qifu Yixin Granules groups(2.84,5.67,11.34 g/kg),in contrast to the normal rats of the blank group.The rats had their body weight monitored;their cardiac function assessed by echocardiography;their serum levels of NT-proBNP,TNF-α,IL-6,IL-1 and CRP measured by ELISA;their cardiac morphological alterations observed by HE and Masson staining;their cardiac protein expressions of TLR4,MyD88 and NF-κB detected by immunohistochemistry and Western blot;and their cardiac mRNA expressions of TLR4,MyD88 and NF-κB measured by RT-qPCR.RESULTS Compared to the blank group,the model group exhibited significantly reduced body weight,LVEF and LVFS(P＜0.01),alongside significantly elevated LVEDD,LVESD,and serum concentrations of NT-proBNP,TNF-α,IL-6,IL-1 and CRP(P＜0.01).Additionally,the model group displayed greater myocardial inflammatory cell aggregation,increased collagen deposition(P＜0.01);and upregulated myocardial protein and mRNA expressions of TLR4,MyD88 and NF-κB(P＜0.01).Compared to the model group,the groups intervened with captopril or medium/high dose Qifu Yixin Granules demonstrated significantly increased body weight,LVEF and LVFS(P＜0.05,P＜0.01);significantly reduced LVEDD,LVESD,and serum levels of the aforementioned indicators(P＜0.05,P＜0.01);mitigated inflammation and collagen deposition(P＜0.05,P＜0.01);and downregulated myocardial protein and mRNA expressions of TLR4,MyD88 and NF-κB(P＜0.05,P＜0.01).CONCLUSION Qifu Yixin Granules attenuate cardiac inflammation and improve cardiac function in doxorubicin-induced CHF rats;this therapeutic effect is mediated by inhibiting the activation of the TLR4/MyD88/NF-κB signaling pathway.

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.

AIM To investigate the effects of Qifu Yixin Granules on cardiac inflammation in a rat model of heart failure.METHODS The rats were induced into chronic heart failure(CHF)models by 6-week intraperitoneal injection of doxorubicin followed by the random assignment of the successful rat models into the model group,the captopril group(22.5 mg/kg),and the low-dose,medium-dose,and high-dose Qifu Yixin Granules groups(2.84,5.67,11.34 g/kg),in contrast to the normal rats of the blank group.The rats had their body weight monitored;their cardiac function assessed by echocardiography;their serum levels of NT-proBNP,TNF-α,IL-6,IL-1 and CRP measured by ELISA;their cardiac morphological alterations observed by HE and Masson staining;their cardiac protein expressions of TLR4,MyD88 and NF-κB detected by immunohistochemistry and Western blot;and their cardiac mRNA expressions of TLR4,MyD88 and NF-κB measured by RT-qPCR.RESULTS Compared to the blank group,the model group exhibited significantly reduced body weight,LVEF and LVFS(P＜0.01),alongside significantly elevated LVEDD,LVESD,and serum concentrations of NT-proBNP,TNF-α,IL-6,IL-1 and CRP(P＜0.01).Additionally,the model group displayed greater myocardial inflammatory cell aggregation,increased collagen deposition(P＜0.01);and upregulated myocardial protein and mRNA expressions of TLR4,MyD88 and NF-κB(P＜0.01).Compared to the model group,the groups intervened with captopril or medium/high dose Qifu Yixin Granules demonstrated significantly increased body weight,LVEF and LVFS(P＜0.05,P＜0.01);significantly reduced LVEDD,LVESD,and serum levels of the aforementioned indicators(P＜0.05,P＜0.01);mitigated inflammation and collagen deposition(P＜0.05,P＜0.01);and downregulated myocardial protein and mRNA expressions of TLR4,MyD88 and NF-κB(P＜0.05,P＜0.01).CONCLUSION Qifu Yixin Granules attenuate cardiac inflammation and improve cardiac function in doxorubicin-induced CHF rats;this therapeutic effect is mediated by inhibiting the activation of the TLR4/MyD88/NF-κB signaling pathway.

Objective:To analyze the impact of transcervical resection of adhesion (TCRA) on obstetric complications in patients after frozen-thawed embryo transfer (FET) and its associated factors.Methods:A retrospective cohort study was conducted by collecting clinical data from patients who underwent autologous oocyte FET treatment and gave birth to at least one live newborn at the Reproductive Medicine Center of Nanjing Women and Children's Healthcare Hospital from April 2015 to May 2022. Based on the uterine condition, patients were divided into three groups: control group with normal uterine morphology (712 cases); the intrauterine adhesion (IUA) group consisting of IUA patients who did not undergo TCRA surgery (45 cases); the TCRA group, which included IUA patients who received TCRA treatment (51 cases). The relationship between uterine conditions and obstetric complications among the three groups was investigated using propensity score matching (PSM). Multivariate logistic regression analysis was applied to identify risk factors associated with obstetric complications related to TCRA. The performance of the constructed multivariate logistic regression model was evaluated using calibration curves and receiver operating characteristic (ROC) curves.Results:1) Before PSM, statistically significant differences were observed among the three groups regarding endometrial thickness, the presence of a scarred uterus, numbers of pregnancies, deliveries, miscarriages, induced abortions, and transferred embryos (all P<0.05). After PSM, baseline characteristics were balanced across the groups. The rates of placenta accreta spectrum disorders (PAS) in the TCRA group [48.8% (20/41)] and the IUA group [45.2% (19/42)] were significantly higher than those in control group [24.7% (18/73), P=0.016; 22.8% (18/79), P=0.019]. 2) Multivariable logistic regression analysis revealed that endometrial thickness ( OR=0.79, 95% CI: 0.69-0.90, P<0.001], number of pregnancies (2 times, OR=2.25, 95% CI: 1.33-3.82, P=0.003), endometrial preparation protocol (gonadotropin-releasing hormone agonist plus hormone replacement therapy, OR=2.29, 95% CI: 1.16-4.52, P=0.017), the presence of a scarred uterus ( OR=2.19, 95% CI: 1.39-3.45, P<0.001), and uterine cavity conditions (IUA and TCRA, OR=2.11, 95% CI: 1.07-4.17, P=0.031; OR=2.70, 95% CI: 1.37-5.31, P=0.004) were independent predictors of PAS occurrence. 3) The area under the ROC curve for this model was 0.732 (95% CI: 0.686-0.778). Calibration curve results, after internal validation, showed good consistency between predicted risks and actual outcomes, demonstrating good discriminative ability and calibration ( P=0.540). Conclusion:The incidence of obstetric complications such as placenta previa, postpartum hemorrhage, and premature rupture of membranes in patients who underwent TCRA surgery was comparable to that of patients with a normal uterine morphology. However, TCRA significantly increased the risk of PAS in patients with IUA undergoing FET assisted reproductive treatment.

Objective:To analyze the impact of transcervical resection of adhesion (TCRA) on obstetric complications in patients after frozen-thawed embryo transfer (FET) and its associated factors.Methods:A retrospective cohort study was conducted by collecting clinical data from patients who underwent autologous oocyte FET treatment and gave birth to at least one live newborn at the Reproductive Medicine Center of Nanjing Women and Children's Healthcare Hospital from April 2015 to May 2022. Based on the uterine condition, patients were divided into three groups: control group with normal uterine morphology (712 cases); the intrauterine adhesion (IUA) group consisting of IUA patients who did not undergo TCRA surgery (45 cases); the TCRA group, which included IUA patients who received TCRA treatment (51 cases). The relationship between uterine conditions and obstetric complications among the three groups was investigated using propensity score matching (PSM). Multivariate logistic regression analysis was applied to identify risk factors associated with obstetric complications related to TCRA. The performance of the constructed multivariate logistic regression model was evaluated using calibration curves and receiver operating characteristic (ROC) curves.Results:1) Before PSM, statistically significant differences were observed among the three groups regarding endometrial thickness, the presence of a scarred uterus, numbers of pregnancies, deliveries, miscarriages, induced abortions, and transferred embryos (all P<0.05). After PSM, baseline characteristics were balanced across the groups. The rates of placenta accreta spectrum disorders (PAS) in the TCRA group [48.8% (20/41)] and the IUA group [45.2% (19/42)] were significantly higher than those in control group [24.7% (18/73), P=0.016; 22.8% (18/79), P=0.019]. 2) Multivariable logistic regression analysis revealed that endometrial thickness ( OR=0.79, 95% CI: 0.69-0.90, P<0.001], number of pregnancies (2 times, OR=2.25, 95% CI: 1.33-3.82, P=0.003), endometrial preparation protocol (gonadotropin-releasing hormone agonist plus hormone replacement therapy, OR=2.29, 95% CI: 1.16-4.52, P=0.017), the presence of a scarred uterus ( OR=2.19, 95% CI: 1.39-3.45, P<0.001), and uterine cavity conditions (IUA and TCRA, OR=2.11, 95% CI: 1.07-4.17, P=0.031; OR=2.70, 95% CI: 1.37-5.31, P=0.004) were independent predictors of PAS occurrence. 3) The area under the ROC curve for this model was 0.732 (95% CI: 0.686-0.778). Calibration curve results, after internal validation, showed good consistency between predicted risks and actual outcomes, demonstrating good discriminative ability and calibration ( P=0.540). Conclusion:The incidence of obstetric complications such as placenta previa, postpartum hemorrhage, and premature rupture of membranes in patients who underwent TCRA surgery was comparable to that of patients with a normal uterine morphology. However, TCRA significantly increased the risk of PAS in patients with IUA undergoing FET assisted reproductive treatment.

Objective:To investigate the effect of safflower yellow pigment injection combined with alprostadil on patients after coronary artery bypass grafting(CABG).Methods:A total of 92 patients with coronary heart disease who received CABG in Department of Cardiovascular Surgery,Handan Central Hospital between September 2018 and September 2020 were selected.According to order of admission,they were divided into control group(n=46,from September 2018 to Sep-tember 2019,routine therapy+alprostadil after CABG)and study group(n=46,from October 2019 to September 2020,safflower yellow pigment injection based on control group),both groups were treated for 28d.On 3d after drug withdraw-al,therapeutic effect,cardiac function indexes,four myocardial enzyme spectrum and perioperative indexes were compared between two groups.Results:On 3d after drug withdrawal,compared with control group,patients in study group had sig-nificant higher total effective rate(73.9％vs.91.3％),left ventricular ejection fraction(LVEF)[(55.77±4.48)％vs.(62.18±4.21)％](P=0.028,＜0.001),and significant lower left atrial diameter(LAD)[(36.83±3.45)mm vs.(32.09±3.23)mm],left ventricular end-diastolic diameter(LVEDd)[(49.04±4.65)mm vs.(43.83±5.24)mm],levels of creatine kinase(CK)[(125.13±14.21)U/L vs.(62.56±8.42)U/L],lactate dehydrogenase(LDH)[(203.58±31.63)U/L vs.(156.07±22.26)U/L],aspartate aminotransferase(AST)[(44.25±12.98)U/L vs.(35.41±12.37)U/L]and creatine kinase isoenzyme MB(CK-MB)[(28.11±9.84)U/L vs.(17.59±7.41)U/L](P＜0.001 all).Conclusion:The combination of safflower yellow pigment injection and alprostadil can improve the thera-peutic effect and heart function,and reduce myocardial injury in patients after CABG.

Vascular calcification is a highly regulated process of ectopic calcification in cardiovascular system while no effective intervention can be clinically performed up to date.As vascular calcification undergoes a common regulatory mechanism within bone formation,bone morphogenetic protein 7(BMP-7)main-tains contractile phenotype of vascular smooth muscle cells and further inhibits vascular calcification via promoting the process of osteoblast differentiation,reducing ectopic calcification pressure by increasing bone formation and reducing bone resorption.This work systematically reviews the role of BMP-7 in vascular calcifi-cation and the possible mechanism,and their current clinical application as well.The current proceedings may help develope early diagnostic strategy and therapeutic treatment with BMP-7 as a new molecular marker and potential drug target.The expec-tation could achieve early prevention and intervention of vascular calcification and improve poor prognosis on patients.