OBJECTIVE To investigate the clinical characteristics and risk factors for batroxobin-related severe hypofibrinogenemia （HFIB） and construct a risk prediction model. METHODS A retrospective analysis was conducted on inpatients treated with batroxobin in the First Medical Center of a tertiary hospital from January 1， 2020， to December 31， 2024. Patients were categorized into non-severe HFIB group and severe HFIB group based on the severity of HFIB. Univariate and multivariate Logistic regression analyses were performed to identify the independent influencing factors for batroxobin-related severe HFIB. A nomogram was developed using the “rms” package in R 4.5 software. The predictive performance of the model was evaluated using the receiver operating characteristic curve. Calibration was assessed via the Bootstrap resampling method， and goodness-of-fit was evaluated with the Hosmer-Lemeshow test. RESULTS A total of 1 472 patients were included in this study. Of these， 1 445 developed HFIB， yi elding an incidence of 98.17%. Furthermore， 895 were classified as severe HFIB， accounting for 60.80% of the cohort. Multivariate Logistic regression analysis showed that increased age， high initial dose per 10 kg body weight， use of maintenance dose， and concomitant glucocorticoid use were independent risk factors for batroxobin-related severe HFIB， while high baseline fibrinogen （FIB） level was identified as a protective factor. The model demonstrated an area under the curve of 0.760 （95% CI： 0.735-0.785）. The mean absolute error of the calibration curve was 0.006. The P value of the Hosmer-Lemeshow test was 0.609. CONCLUSIONS Batroxobin can rapidly and significantly reduce FIB levels and carries a risk of inducing severe HFIB. Patients with advanced age， high initial dose per 10 kg body weight， use of maintenance dose and concomitant glucocorticoid use had a higher risk of batroxobin-related severe HFIB， while high baseline FIB level had a lower risk of batroxobin-related severe HFIB. The risk prediction model developed based on these factors can be used to predict the likelihood of batroxobin-related severe HFIB.

Objective:To understand the incidence rate of herpes zoster (HZ) and postherpetic neuralgia (PHN) in Beijing, and analyze the incidence trend of HZ and PHN from 2015 to 2022.Methods:Cases of HZ and PHN from 2015 to 2022 were retrieved from the Hospital Information Systems (HIS) of all primary and above hospitals/clinics in three districts representing the urban, inner suburban, and outer suburban areas of Beijing. After duplication screening, the first visit cases were screened, and the incidence characteristics were described. The incidence rate of HZ and PHN in each year by sex and age group and the age-standardized incidence rate were calculated. The annual percentage increase (APC) of incidence rate was calculated using the Joint regression model, and the change trend was analyzed.Results:The age-standardized incidence rate of HZ in Beijing from 2015 to 2022 ranged from 7.44‰ to 10.05‰, with an average annual incidence rate of 8.95 ‰, significantly increasing with age ( P<0.001). The Joinpoint regression model showed that the overall age-standardized incidence of HZ remained relatively stable, with no significant difference (APC=2.28%, t=1.56, P=0.170). However, the incidence rate among the 0-19-year-old group exhibited a trend of decrease (APC=-10.70%, t=-6.29, P<0.001). For PHN, the age-standardized incidence in Beijing ranged from 0.77‰ to 2.67‰, with an average annual incidence rate of 1.59‰ and a proportion of 9.48% to 26.86% among HZ cases. Both the incidence of PHN and its proportion among HZ cases increased with age ( P<0.001). The age-standardized incidence of PHN increased annually (APC=18.56%, t=9.02, P<0.001). Conclusion:The incidence rate of HZ and PHN in Beijing continues to be at a high level, and PHN shows an increasing trend over time.

Objective:To explore the significance and value of peripheral blood lymphocyte subpopulation characteristics in patients with leukemia recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT).Methods:A retrospective cohort study was conducted on 115 leukemia patients with allo HSCT admitted to Beijing Ludaopei Hospital from April 1, 2021 to December 31, 2023, including 26 relapsed patients and 89 non-relapsed patients, 65 males and 50 females aged 33 (20, 50) years old. Flow cytometry was used for regular monitoring of the post-transplantation peripheral blood lymphocyte subpopulations in the patients, i.e. total lymphocytes, B-lymphocytes, T-lymphocytes, NK-cells, CD4+Treg-cells, CD3+CD4+CD8+T-cells, CD3+CD4-CD8-T-cells, CD28 T-cells. The significance of lymphocyte subpopulation detection in the relapsed group of leukemia patients was further discussed. The χ 2 test was used for comparison between the two groups. Indicators statistically significant in one-way analysis were then analyzed by binary logistic regression analysis. Results:Compared with patients in the non-relapse group, patients in the relapse group had lower total lymphocytes (458.5<1 003/μl, U=1 118.00, P=0.004), B lymphocytes (4<51/μl, U=67.00, P<0.001), T lymphocytes (320.5<721/μl, U=746.00, P=0.006), CD4+T lymphocytes (57<150/μl, U=629.50, P<0.001), CD8+T lymphocytes (240<468/μl, U=1 150.00, P=0.017), CD3+CD4-CD8-T cells (5<32.5/μl, U=259.00, P<0.001), CD8+CD28+T cells (92<298/μl, U=294.00, P=0.002), CD4+CD28+T cell counts (43<141/μl, U=245.50, P<0.001), CD8+CD28+T cells as a percentage of CD8+T cells (63.3<70.9%, U=331.00, P=0.006), and CD4+CD28+T cells as a percentage of CD4+T cells (86.1<97.3%, U=313.50, P=0.003), while the CD4+Treg cell count (2.5>8/μl, U=635.00, P<0.001) was higher. The percentage of CD8+CD28+T cells to CD8+T cells in the peripheral blood of patients after transplantation was a significant independent risk factor for relapse, and the results of the ROC curve showed an AUC of 0.724 ( P<0.01), with a decision value of 66.89, a sensitivity of 0.733, and a specificity of 0.613. Conclusions:The low percentage of CD8+CD28+T cells to CD8+T cells in peripheral blood has a certain value of suggestive warning for post-transplantation leukemia relapse. The application of flow cytometry for regular monitoring of patients′ peripheral blood immune cell subpopulations after transplantation helps to understand patients′ immune reconstitution status and provides a certain reference basis for clinical diagnosis and treatment.

Objective To observe the value of pool sign on T2WI for differentiating solitary brain metastasis(SBM)from solitary mass type high grade glioma(HGG).Methods Totally 120 patients with SBM(SBM group)and 184 patients with solitary mass type HGG(HGG group)confirmed by postoperative pathology or clinical follow-up were retrospectively enrolled.The incidence of pool sign were compared between groups,and the efficacy of pool sign for differentiating SBM from solitary mass type HGG was analyzed.Results Pool sign was noticed in 37 cases(37/120,30.83％)in SBM group and 9 cases(9/184,4.89％)in HGG group,the incidence of pool sign in SBM group was higher than that in HGG group(x2=38.063,P＜0.001).The sensitivity,specificity,positive predictive value and negative predictive value of pool sign for differentiating SBM and solitary mass type HGG was 30.83％(37/120),95.11％(175/184),80.43％(37/46)and 67.83％(175/258),respectively.In SBM group,the incidence of pool sign in cases with primary tumor of adenocarcinoma,squamous cell carcinoma and neuroendocrine carcinoma was 40.79％(31/76),16.67％(3/18)and 12.50％(3/24),respectively,with significant difference(x2=8.911,P=0.012),while compared pairwisely showed significant difference between SBM of adenocarcinoma and neuroendocrine carcinoma(x2=6.505,P=0.011).Conclusion The pool sign on T2WI was helpful for differentiating SBM,especially SBM of adenocarcinoma from solitary mass type HGG.

AIM To investigate the protective effect of Sanfeng Tongqiao Dropping Pills against house dust mite(HDM)-induced allergic asthma in mice.METHODS Compared to the intact BALB/c mice in the blank control group,the BALB/c mice randomly assigned into the model group,the dexamethasone group(0.67 mg/kg),and the low-dose,medium-dose,and high-dose Sanfeng Tongqiao Dropping Pills groups(15,30 and 60 mg/kg),were induced into acute allergic asthma models via weekly intraperitoneal sensitization with 0.1 mL HDM solution(0.5 mg/mL)for three weeks followed by three consecutive daily intranasal challenges with 10 μL HDM solution(2.5 mg/mL)starting in the third week.The drug administered continuously 7 days after the last excitation.The mice had their airway reactive Penh value detected,their pulmonary pathological changes observed by HE staining,their blood eosinophils(EOS)counted,their Th2 cytokines in lung tissue and serum IgE levels detected by ELISA,and their number of peripheral blood mononuclear cells(PBMC)and pulmonary Th2 cells detected by flow cytometry.Chronic allergic asthma was induced in grouped BALB/c mice through repeated intranasal challenges with 10 μL HDM solution(2.5 mg/mL)administered five times weekly for five consecutive weeks.Drug treatment continued for 14 days following the final challenge.After the final treatment,the mice had their pulmonary pathological changes observed by HE staining,and their levels of Th2 cytokines in B ALF and lung tissue and serum IgE detected by ELISA.RESULTS Compared to the blank control group,the acute allergic asthma model group exhibited increases in Penh value,EOS count and IgE level in serum,IL-4 and IL-5 levels in lung tissue(P＜0.01);obvious pulmonary inflammatory cells infiltration,and thickened airway wall;and increase in pulmonary number of Th2 cells(P＜0.01).Compared to the model group,the groups intervened with Sanfeng Tongqiao Dropping Pills demonstrated decreased Penh value,serum EOS count,IgE level and IL-5 level in lung tissue(P＜0.05,P＜0.01);reduced pulmonary inflammatory infiltration and alleviated airway wall thickening;and decreased number of pulmonary Th2 cells.Compared to the blank group,the chronic allergic asthma model group showed obvious pulmonary inflammatory infiltration and airway wall thickening;and increased EOS count and IgE level in serum,IL-4 and IL-13 in lung tissue and IL-14 in BALF(P＜0.05,P＜0.01).Compared to the model group,the groups intervened with either medium-dose or high-dose Sanfeng Tongqiao Dropping Pills demonstrated reduced pulmonary inflammatory infiltration;and decreased serum EOS count,IgE level,IL-13 in lung tissue and IL-14 in BALF(P＜0.05,P＜0.01).CONCLUSION Sanfeng Tongqiao Dropping Pills reduce Th2 cells in peripheral blood and lung tissue,suppress type 2 inflammation,and thereby alleviate allergic asthma.

Objective:To find out about the sentiment about the current physical training among Air Force pilots (cadets), propose methods for optimizing their programs of physical training, and to enhance the effectiveness of training in order to improve flight adaptability.Methods:A total of 1 135 pilots (cadets) were randomly selected as the subjects and divided into 3 groups according to types of aircraft and types of personnel: group A (pilots of fighters, bombers and advanced trainers), group B (pilots of fighter bombers, transporters, helicopters, special aircraft and junior trainers), and group C (flying cadets). A questionnaire survey was conducted to collect data on current physical training among pilots and flying cadets.Results:A total of 1 135 questionnaires were distributed, with 1 086 valid responses collected, yielding an effective response rate of 95.68%. Of the 1 086 participating pilots (cadets), 209 were in Group A, 499 in Group B, and 378 in Group C.There was statistically significant difference in the frequency and duration of weekly physical training between the 3 groups ( χ2=82.23, 61.56, both P<0.001). The proportion of participants engaging in >3 h weekly physical training sessions was significantly higher in group C (71.7%) than in group A (38.8%) and group B (44.9%). Significant differences were observed in weekly training durations between group C and group A (all P<0.05), as well as between group C and group B in the training durations of <3 h and 5-7 h (all P<0.05). The percentage of subjects who trained for 5-7 h per week was the highest in group C (41.5%). In groups A and B, pilots mostly trained for 3-<5 h per week (51.7% and 39.9%, respectively). The survey on the willingness to adjust training programs revealed statistically significant differences between the 3 groups in their willingness to engage in muscle strength training, coordination training, specific ability training, and adjustment of intensities of core training ( H=46.23, 16.12, 22.03, 60.68, all P<0.001). No significant difference was observed in their willingness to have aerobic training programs adjusted ( P>0.05). Group C was significantly different from groups A and B in their preference for adjustment in training programs related to muscle strength, coordination, specific abilities, and in core training programs (all P<0.01). Group C was mostly in favor of "increasing" muscle strength, coordination, and core training while opting for "no change" in aerobic training and specific ability training. Groups A and B preferred "no change". Regarding their willingness to have training intensities revised, statistically significant differences were observed between the 3 groups ( H=15.58, 19.08, 8.17, 58.01, P<0.001, <0.001, =0.017, <0.001), but no significant difference was found in their preference for adjustment of aerobic training intensities ( P>0.05). Group C showed much more preference for intensity adjustment related to muscle strength, coordination, specific abilities, and core training programs than groups A and B (all P<0.05 or 0.01). All the 3 groups predominantly favored "no change" in training intensities. Conclusions:Pilots of different aircraft types generally meet the requirements of the current physical training programs. However, the frequency of physical training for pilots (cadets) requires more rigorous supervision. Flying cadets can adaptively engage in targeted training programs. Pilots of fighters, fighter bombers and advanced trainers should care about the intensity of aerobic training while giving more weight to load resistance physical training. Pilots of other types of aircraft should devote more effort to core training programs.

Objective To identify high-risk factors for healthcare-associated infection(HAI)in patients in inten-sive care units(ICUs),and develop a quick response(QR)code-based APP prediction tool.Methods Information of inpatients in general ICUs of three hospitals in Guizhou Province from January to December 2024 were collected.Risk factors were analyzed with a logistic regression model.QR code-based APP was constructed and validated.Results A total of 1 782 patients in general ICUs of three hospitals in Guizhou Province in 2024 were included in the analysis,out of which 410 were HAI cases,and the incidence of HAI was 23.01％.Multivariate logistic regre-ssion analysis results of HAI in ICU inpatients showed that regional gross domestic product(GDP)≥58 685 Yuan,performing pathogen culture during this hospitalization,history of diabetes mellitus,history of cancer,length of hospital stay ≥7 days before infection,and duration of persistent fever＞5 days before infection were independent risk factors for HAI in ICU patients(all P＜0.05).The discrimination of the model(area under the receiver operating characteristic curve[AUC]of 0.841),calibration(Brier score of 0.129),and clinical effectiveness(net benefit of 11.4％when the risk threshold was 5％-74％)all performed well.Conclusion The QR code-based APP prediction tool is of great significance for scientific research transformation and precise HAI control.

Objective:To understand the incidence rate of herpes zoster (HZ) and postherpetic neuralgia (PHN) in Beijing, and analyze the incidence trend of HZ and PHN from 2015 to 2022.Methods:Cases of HZ and PHN from 2015 to 2022 were retrieved from the Hospital Information Systems (HIS) of all primary and above hospitals/clinics in three districts representing the urban, inner suburban, and outer suburban areas of Beijing. After duplication screening, the first visit cases were screened, and the incidence characteristics were described. The incidence rate of HZ and PHN in each year by sex and age group and the age-standardized incidence rate were calculated. The annual percentage increase (APC) of incidence rate was calculated using the Joint regression model, and the change trend was analyzed.Results:The age-standardized incidence rate of HZ in Beijing from 2015 to 2022 ranged from 7.44‰ to 10.05‰, with an average annual incidence rate of 8.95 ‰, significantly increasing with age ( P<0.001). The Joinpoint regression model showed that the overall age-standardized incidence of HZ remained relatively stable, with no significant difference (APC=2.28%, t=1.56, P=0.170). However, the incidence rate among the 0-19-year-old group exhibited a trend of decrease (APC=-10.70%, t=-6.29, P<0.001). For PHN, the age-standardized incidence in Beijing ranged from 0.77‰ to 2.67‰, with an average annual incidence rate of 1.59‰ and a proportion of 9.48% to 26.86% among HZ cases. Both the incidence of PHN and its proportion among HZ cases increased with age ( P<0.001). The age-standardized incidence of PHN increased annually (APC=18.56%, t=9.02, P<0.001). Conclusion:The incidence rate of HZ and PHN in Beijing continues to be at a high level, and PHN shows an increasing trend over time.

Objective To observe the value of pool sign on T2WI for differentiating solitary brain metastasis(SBM)from solitary mass type high grade glioma(HGG).Methods Totally 120 patients with SBM(SBM group)and 184 patients with solitary mass type HGG(HGG group)confirmed by postoperative pathology or clinical follow-up were retrospectively enrolled.The incidence of pool sign were compared between groups,and the efficacy of pool sign for differentiating SBM from solitary mass type HGG was analyzed.Results Pool sign was noticed in 37 cases(37/120,30.83％)in SBM group and 9 cases(9/184,4.89％)in HGG group,the incidence of pool sign in SBM group was higher than that in HGG group(x2=38.063,P＜0.001).The sensitivity,specificity,positive predictive value and negative predictive value of pool sign for differentiating SBM and solitary mass type HGG was 30.83％(37/120),95.11％(175/184),80.43％(37/46)and 67.83％(175/258),respectively.In SBM group,the incidence of pool sign in cases with primary tumor of adenocarcinoma,squamous cell carcinoma and neuroendocrine carcinoma was 40.79％(31/76),16.67％(3/18)and 12.50％(3/24),respectively,with significant difference(x2=8.911,P=0.012),while compared pairwisely showed significant difference between SBM of adenocarcinoma and neuroendocrine carcinoma(x2=6.505,P=0.011).Conclusion The pool sign on T2WI was helpful for differentiating SBM,especially SBM of adenocarcinoma from solitary mass type HGG.

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.