INTRODUCTION: Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD. METHODS: In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging. RESULTS: A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline. CONCLUSIONS: Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies. REGISTRATION ClinicalTrials.gov , NCT07034222.
Humans ; Alzheimer Disease/drug therapy* ; Male ; Female ; Aged ; Middle Aged ; Cognitive Dysfunction/drug therapy* ; Aged, 80 and over ; Amyloid beta-Peptides/metabolism* ; Biomarkers ; East Asian People

Objective:To evaluate the effectiveness of an integrated management model involving the Centers for Disease Control and Prevention (CDC), general hospitals, and community health service centers in improving outcomes for community-dwelling patients with chronic obstructive pulmonary disease (COPD), with the aim of optimizing existing COPD management strategies.Methods:This study was a cluster randomized controlled trial. From January to March 2022, a total of 236 patients with COPD were recruited from four communities in Chibi City, Hubei Province. Ultimately, 223 patients completed follow-up and participated in the intervention evaluation. The participants were cluster-randomized into an intervention group ( n=121) and a control group ( n=102). The intervention group received a one-year "trinity" integrated community management model, while the control group received only basic follow-up. Face-to-face questionnaires were administered before and after the intervention to collect data on demographics, disease awareness, risk factors, respiratory symptoms, medication use, and disease management. Quality of life scores and pulmonary function tests were also assessed. Pre-and post-intervention outcomes were compared using t-tests or chi-square tests. Results:The intervention group demonstrated significantly higher rates of COPD awareness and disease-related knowledge compared to the control group (94.12% vs 77.78% and 78.15% vs 49.49%; both P<0.05), along with lower overall smoking rate and current smoking rate (57.14% vs 70.71% and 29.41% vs 47.47%; both P<0.05). The intervention group showed reduced household polluting fuel use for heating (17.65% vs 28.93%; P<0.05), while the control group exhibited no significant change. Significant improvements were observed in the intervention group for inhaler medication usage (14.05% vs 2.94%), exercise training, and respiratory muscle training (22.31% vs 2.94% and 26.45% vs 0.98%)(all P<0.05). Additionally, the intervention group reported lower prevalence of chronic sputum production, wheezing, and dyspnea (12.40%, 0.83%, 27.27% vs 24.51%, 9.80%, 41.18%; all P<0.05) compared to controls. Pulmonary function tests revealed that the percentage of forced expiratory volume in one second (FEV 1%predicted) was significantly higher in the intervention group than in the control group [(69.53±18.01)% vs (54.90±12.39)%; both P<0.05]. Conclusions:The "trinity" integrated management model effectively enhances health literacy, self-management capabilities, and quality of life among COPD patients, while reducing behavioral risk factors. This model aligns with the long-term and individualized management needs of COPD patients.

Turning to critical illness is a common stage of various diseases and injuries before death. Patients usually have complex health conditions, while the treatment process involves a wide range of content, along with high requirements for doctor′s professionalism and multi-specialty teamwork, as well as a great demand for time-sensitive treatments. However, this is not matched with critical care professionals and the current state of medical care in China. Telemedicine, which shortens the distance of medical professionals and the gap of disease diagnosis and treatments in various regions through electronic information, can effectively solve the current problem. Therefore, there is an urgent need to develop a standardized, high-quality visualization telemedicine round system .Therefore, experts have been organized to search domestic and foreign literature on telemedicine round for critically ill patients and to form this consensus based on clinical experiences so as to further improve the level of critical care treatments in regions.

OBJECTIVES: To investigate the mechanism mediating the regulatory effect of miR-155-5p on proliferation of human submandibular gland epithelial cells (HSGECs) in primary Sjogren's syndrome (pSS). METHODS: Dual luciferase reporter assay was used to verify the targeting relationship between miR-155-5p and the PI3K/AKT pathway. In a HSGEC model of pSS induced by simulation with TRAIL and INF-γ, the effects of miR-155-inhibitor-NC or miR-155 inhibitor on cell viability, cell cycle, apoptosis and proliferation were evaluated using CKK8 assay, flow cytometry and colony formation assay. ELISA and RT-PCR were used to detect the expressions of inflammatory cytokines and miR-155-5p mRNA in the cells; Western blotting was performed to detect the expressions of proteins in the PI3K/AKT signaling pathway. RESULTS: Dual luciferase assay showed that miR-155-5p targets the PI3K/AKT pathway via PIK3R1 mRNA. The HSGEC model of pSS showed significantly decreased cell viability, cell clone formation ability and expressions IL-10 and IL-4 and increased cell apoptosis, cell percentage in G2 phase, expressions of TNF‑α, IL-6, miR-155-5p and PIK3R1 mRNA, p-PI3K/PI3K ratio, p-Akt/AKT ratio, and PIK3R1 protein expression. Treatment of the cell models with miR-155 inhibitor significantly increased the cell viability, G1 phase cell percentage, colony formation ability, and expressions of IL-10 and IL-4 levels, and obviously reduced cell apoptosis rate, G2 phase cell percentage, expressions of TNF-α, IL-6, miR-155-5p and PIK3R1 mRNA, p-PI3K/PI3K ratio, p-AKT/AKT ratio, and PIK3R1 protein expression. CONCLUSIONS In HSGEC model of pSS, inhibition of miR-155-5p can promote cell proliferation and reduced cell apoptosis by targeting PI3K1 mRNA to negatively regulate the overexpression of PI3K/AKT signaling pathway.
Humans ; MicroRNAs/genetics* ; Cell Proliferation ; Signal Transduction ; Proto-Oncogene Proteins c-akt/metabolism* ; Sjogren's Syndrome/pathology* ; Epithelial Cells/cytology* ; Submandibular Gland/cytology* ; Phosphatidylinositol 3-Kinases/metabolism* ; Apoptosis ; Class Ia Phosphatidylinositol 3-Kinase ; Cells, Cultured

Objective:To evaluate the effectiveness of an integrated management model involving the Centers for Disease Control and Prevention (CDC), general hospitals, and community health service centers in improving outcomes for community-dwelling patients with chronic obstructive pulmonary disease (COPD), with the aim of optimizing existing COPD management strategies.Methods:This study was a cluster randomized controlled trial. From January to March 2022, a total of 236 patients with COPD were recruited from four communities in Chibi City, Hubei Province. Ultimately, 223 patients completed follow-up and participated in the intervention evaluation. The participants were cluster-randomized into an intervention group ( n=121) and a control group ( n=102). The intervention group received a one-year "trinity" integrated community management model, while the control group received only basic follow-up. Face-to-face questionnaires were administered before and after the intervention to collect data on demographics, disease awareness, risk factors, respiratory symptoms, medication use, and disease management. Quality of life scores and pulmonary function tests were also assessed. Pre-and post-intervention outcomes were compared using t-tests or chi-square tests. Results:The intervention group demonstrated significantly higher rates of COPD awareness and disease-related knowledge compared to the control group (94.12% vs 77.78% and 78.15% vs 49.49%; both P<0.05), along with lower overall smoking rate and current smoking rate (57.14% vs 70.71% and 29.41% vs 47.47%; both P<0.05). The intervention group showed reduced household polluting fuel use for heating (17.65% vs 28.93%; P<0.05), while the control group exhibited no significant change. Significant improvements were observed in the intervention group for inhaler medication usage (14.05% vs 2.94%), exercise training, and respiratory muscle training (22.31% vs 2.94% and 26.45% vs 0.98%)(all P<0.05). Additionally, the intervention group reported lower prevalence of chronic sputum production, wheezing, and dyspnea (12.40%, 0.83%, 27.27% vs 24.51%, 9.80%, 41.18%; all P<0.05) compared to controls. Pulmonary function tests revealed that the percentage of forced expiratory volume in one second (FEV 1%predicted) was significantly higher in the intervention group than in the control group [(69.53±18.01)% vs (54.90±12.39)%; both P<0.05]. Conclusions:The "trinity" integrated management model effectively enhances health literacy, self-management capabilities, and quality of life among COPD patients, while reducing behavioral risk factors. This model aligns with the long-term and individualized management needs of COPD patients.

Turning to critical illness is a common stage of various diseases and injuries before death. Patients usually have complex health conditions, while the treatment process involves a wide range of content, along with high requirements for doctor′s professionalism and multi-specialty teamwork, as well as a great demand for time-sensitive treatments. However, this is not matched with critical care professionals and the current state of medical care in China. Telemedicine, which shortens the distance of medical professionals and the gap of disease diagnosis and treatments in various regions through electronic information, can effectively solve the current problem. Therefore, there is an urgent need to develop a standardized, high-quality visualization telemedicine round system .Therefore, experts have been organized to search domestic and foreign literature on telemedicine round for critically ill patients and to form this consensus based on clinical experiences so as to further improve the level of critical care treatments in regions.

Background::Breast cancer (BC) risk-stratification tools for Asian women that are highly accurate and can provide improved interpretation ability are lacking. We aimed to develop risk-stratification models to predict long- and short-term BC risk among Chinese women and to simultaneously rank potential non-experimental risk factors.Methods::The Breast Cancer Cohort Study in Chinese Women, a large ongoing prospective dynamic cohort study, includes 122,058 women aged 25-70 years old from the eastern part of China. We developed multiple machine-learning risk prediction models using parametric models (penalized logistic regression, bootstrap, and ensemble learning), which were the short-term ensemble penalized logistic regression (EPLR) risk prediction model and the ensemble penalized long-term (EPLT) risk prediction model to estimate BC risk. The models were assessed based on calibration and discrimination, and following this assessment, they were externally validated in new study participants from 2017 to 2020.Results::The AUC values of the short-term EPLR risk prediction model were 0.800 for the internal validation and 0.751 for the external validation set. For the long-term EPLT risk prediction model, the area under the receiver operating characteristic curve was 0.692 and 0.760 in internal and external validations, respectively. The net reclassification improvement index of the EPLT relative to the Gail and the Han Chinese Breast Cancer Prediction Model (HCBCP) models for external validation was 0.193 and 0.233, respectively, indicating that the EPLT model has higher classification accuracy.Conclusions::We developed the EPLR and EPLT models to screen populations with a high risk of developing BC. These can serve as useful tools to aid in risk-stratified screening and BC prevention.

Objective:To understand the current status of occupational exposure to dust or harmful gases and occupational protection in people aged ≥40 years in China, and provide data support for the prevention and control of occupational dust or harmful gas exposure.Methods:The data were obtained from the surveillance for chronic obstructive pulmonary disease (COPD) in adults aged ≥40 years selected by multi-stage stratified cluster sampling from 125 surveillance points in 31 provinces (autonomous regions and municipalities) during 2014-2015 and 2019-2020, and relevant information about occupational dust or harmful gas exposure and protection measures were collected through face-to-face interviews. Occupational dust or harmful gas exposure rate and occupational protection rate were estimated by using weighting complex sampling methods, and then the results were compared.Results:From 2014 to 2015 and from 2019 to 2020, a total of 71 061 and 71 023 individuals aged ≥40 years were surveyed, respectively. The rate of occupational exposure to dust or hazardous gas was 33.8% (95% CI: 29.9%-37.7%) during 2019-2020. The occupational exposure rate was higher in men than in women and in rural residents than in urban residents. With the increase of education level, the rate of occupational exposure to dust or harmful gas showed a downward trend. The protection rate against occupational dust or hazardous gas exposure was 47.9% (95% CI: 43.2%-52.6%) during 2019-2020. Compared with 2014-2015, the rate of occupational exposure to dust or hazardous gas decreased by 10.7 percentage points in different gender, area and occupational groups and the occupational protection rate increased by 21.9 percentage points during 2019-2020. The decrease in occupational exposure rate was higher in western China than in eastern and central China, and the increase in occupational protection rate was higher in western China than in eastern and central China. Conclusions:The rate of occupational exposure to dust or harmful gas decreased and the rate of occupational protection against dust or harmful gas exposure increased in China during 2019-2020. However, about one-third of the population still suffer from the occupational exposure, and less than half of them take protection measures. It is necessary to pay more attention to the key populations, such as workers with lower cultural level and rural migrant workers, in occupational health practice.

Objective:To understand the passive smoking exposure status in adults aged ≥40 years in China.Methods:Local residents aged ≥40 years were enrolled as study subjects from 125 areas of chronic obstructive pulmonary disease (COPD) surveillance during 2014-2015 and 2019-2020 in 31 provinces of China. A total of 74 559 adults aged ≥40 years were selected through multi-stage stratified cluster sampling for a face to face questionnaire survey and the data from 64 142 study subjects were used for the analysis. The passive smoking exposure rate, the proportions of the adults reporting passive smoking exposure at four types of places and the proportion of the adults living with daily smokers were described by using complicated sampling weighting method, the related factors were analyzed and the results were compared with the data of COPD surveillance during 2014-2015.Results:The passive smoking exposure rate in the adults aged ≥40 years was 46.4% (95% CI: 44.1%-48.8%) in China during 2019-2020, and the rate was higher in women (47.2%, 95% CI:44.8%-49.7%) than in men (44.8%, 95% CI:42.0%-47.6%) and lower in the older people. The office workers had the highest passive smoking exposure rate. The proportions of those reporting passive smoking exposure at homes, workplaces, restaurants, and public transports were 24.3% (95% CI:22.2%-26.4%)、23.3% (95% CI:21.1%-25.5%)、6.6% (95% CI:5.3%-7.9%) and 2.2% (95% CI:1.6%-2.7%). The higher education level the adults had, the less passive smoking exposure at home they reported. The proportions of those living with daily smokers before 14 years old and since 14 years old were 56.4% and 59.2%. Compared with the data during 2014-2015, the overall passive smoking exposure rate in the adults aged ≥40 years during 2019-2020 showed an increase, and the difference was not significant ( P=0.356); The passive smoking exposure rate at homes declined, but the exposure rate at workplaces increased, with the biggest increase found in those being engaged in farming, forestry, husbandry, fishery and water conservancy. Multivariate analysis indicated that the factors influencing the passive smoking exposure and the exposure proportions at different places included gender, age, occupation, and education level. Conclusions:The passive smoking exposure rate in China is still high, especially in those being engaged in farming, forestry, husbandry, fishery and water conservancy. It is necessary to strengthen supervision of the enforcement of current smoking bans in public places and promote the legislation of ban smoking in public places. More attention should be paid to smoking ban and protection against passive smoking exposure in women, people with lower education level and people being engaged in in farming, forestry, husbandry, fishery and water conservancy.

Objective:To analyze the exposure level and changes in severe respiratory infection among Chinese residents aged ≥40 years in China and to provide essential data for preventing and controlling chronic respiratory diseases.Methods:The data came from chronic obstructive pulmonary disease surveillance of Chinese residents in 2014-2015 and 2019-2020. The surveillance covers 31 provinces (autonomous regions and municipalities) in China. A multi-stage stratified cluster random sampling method was used to select permanent residents aged ≥40 years. Relevant information about exposure to severe respiratory infections during childhood was collected through investigation. Rigorous complex sampling and weighted analysis were applied to estimate the exposure rate of severe respiratory infections among children with different characteristics among residents aged ≥40 years in China from 2019 to 2020. Additionally, changes in severe respiratory infections during childhood were analyzed over 2014-2015 and 2019-2020.Results:In 2019-2020, the exposure rate of severe respiratory infection before 18 for residents aged ≥40 years in China was 21.58‰ (95% CI: 17.57‰-25.59‰). The exposure rate of severe respiratory infection before the age of 14 was 19.40‰ (95% CI:15.25‰-23.55‰), the difference in the exposure rate between men and women was not statistically significant (both P>0.05), and the exposure rate of urban residents is higher than that of rural residents. The results of multivariate logistic regression analysis showed that in western rural areas, factors including being born by cesarean section, exposure to secondhand smoke before age 14 years old, and a family history of chronic respiratory diseases were associated with severe respiratory infections in childhood. Compared with 2014-2015, the proportion of residents aged 40 and older in China hospitalized for pneumonia or bronchitis before 14 from 2019 to 2020 was slightly lower than five years prior. Conclusions:Among residents in China aged ≥40 years, 21.58‰ experienced severe respiratory infection exposure during childhood, varying exposure levels across different demographic groups. The burden of chronic respiratory diseases in adulthood cannot be ignored. Efforts should be made to expand the coverage of planned immunization and to focus on early-life interventions during childhood to reduce the incidence of severe respiratory infections.