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 establish a quantifiable quality control index system for infection management in neonatal specialty hospitals for the comprehensive evaluation of neonatal healthcare-associated infection(HAI)management quality,and to promote the continuous enhancement and improvement of neonatal HAI management quality.Methods The framework of the index system was preliminarily established through literature research and focus group discussion,the indexes were repeatedly screened using Delphi expert consultation approach,and the weights of each index were determined using the analytic hierarchy process.The empirical study of the established index sys-tem was conducted using TOPSIS method and rank sum ratio method.Results Three rounds of expert consultation were conducted,and the effective response rate of the questionnaire was 100％.The authoritative coefficient of the third round of expert consultation was 0.89,and the Kendall's coefficient of concordance for expert opinion was 0.322.The established index system included 3 first-level indexes,6 second-level indexes,and 16 third-level inde-xes.Thirteen of third-level indexes could be directly obtained from the hospital information system.Conclusion The quality control index system for neonatal HAI management established in this study is relatively scientific,with rational weights and all quantifiable indexes.It can be used for vertical and horizontal evaluations of neonatal HAI management quality,providing a reference for the continuous improvement of neonatal HAI management work.

Objective To investigate the risk factors and intervention measures for surgical site infec-tion following posterolateral approach lumbar fusion surgery.Methods A total of 1 078 patients who under-went posterolateral approach lumbar fusion surgery in the department of spine surgery from January 1,2022 to December 31,2023 were included.Patient related information was collected through the real-time nosocomi-al infection monitoring system,while medical visit information was obtained via the outpatient electronic med-ical record system.Multivariate logistic regression analysis was performed to identify risk factors for surgical site infection.Results Among the 1 078 patients,34 cases(3.15%)developed surgical site infections,while 1 044 cases did not.Multivariate logistic regression analysis revealed that age,smoking,hypertension,diabetes,concurrent hospital stay,operative time,duration of postoperative antimicrobial use after initial surgery,and total antimicrobial use duration were significant risk factors for surgical site infection(P＜0.05).Among the 34 infected patients,the duration of antimicrobial use varied significantly across different infection sites(P＜0.05),with the longest duration observed in patients with deep space infections.Conclusion Targeted surveil-lance of surgical site infections should be reinforced based on these risk factors.Perioperative infection control measures must be strictly implemented to improve the scientific,precise,and standardized management of sur-gical-related nosocomial infections.

Objective:To analyze the characteristics of Hashimoto thyroiditis(HT)and Graves disease(GD),two autoimmune thyroid diseases aged 10-59 in Qingdao City from 2022 to 2024,and to provide scientific basis for making targeted prevention and treatment measures.Methods:A cross-sectional study design was adopted,based on the data of the Regional Health Information Platform in Qingdao,the con-firmed cases of HT and GD from 2022 to 2024 were included,and combined with the data of the seventh population census,the three-year and annual prevalence rates of HT and GD were calculated,and the time trend of annual prevalence was analyzed by Cochran-Armitage trend test.The distribution characte-ristics of HT and GD prevalence in different age groups and regions were analyzed,and Chi-square test was used to compare the differences between the groups.Results:The total number of HT patients among women aged 10-59 in Qingdao City from 2022 to 2024 was 40 362.The proportion of HT patients in 30-34 years old was the highest(19.83％).The proportion of HT patients in Huangdao District was the highest(17.72％).The three-year prevalence of HT was 1 206.53/100 000.In 2022-2024,the annual prevalence of HT increased significantly(P＜0.001),from 385.32/100 000 in 2022 to 1 206.32/100 000 in 2024.The three-year prevalence of HT was significantly different in age distribution(P＜0.001).The three-year prevalence of HT in 25-29 years(2 354.44/100 000)and 35-39 years(2 022.20/100 000)was higher than that in other age groups,showing a bimodal distribution.There were significant differences in the three-year prevalence of HT in different regions(P＜0.001),among which the three-year prevalence of HT in Shinan District was the highest(2 392.90/100 000),followed by Licang Dis-trict(1 492.41/100 000),and Laixi City was the lowest(659.940/100 000).The total number of GD patients was 2 095,among which the proportion of GD patients in the 35-39 age group was the highest(15.42％),and the proportion of GD patients from Jimo District was the highest(12.27％).From 2022 to 2024,the three-year prevalence rate of GD was 62.63/100 000,and the annual prevalence rate of GD showed an increasing trend(P＜0.001),from 20.33/100 000 in 2022 to 62.63/100 000 in 2024.There were significant differences in the prevalence of GD by age(P＜0.001).The three-year prevalence of GD reached the highest value in the 25-29 age group(98.90/100 000),followed by the 35-39 age group(85.21/100 000),and the lowest in the 10-14 age group(14.43/100 000).In the regional distribution,there were significant differences in the 3-year prevalence of GD(P＜0.001).Laoshan District had the highest three-year prevalence of GD(107.58/100 000),followed by Shinan District(97.83/100 000)and Huangdao District(28.92/100 000).Conclusion:The three-year pre-valence of HT and GD in females aged 10-59 years in Qingdao City from 2022 to 2024 is low,but the annual prevalence is on the rise,and the three-year prevalence of HT and GD in females aged 25-39 years is higher than that in other age groups,so it is necessary to strengthen the screening and monitoring of this population.

Objective To establish a quantifiable quality control index system for infection management in neonatal specialty hospitals for the comprehensive evaluation of neonatal healthcare-associated infection(HAI)management quality,and to promote the continuous enhancement and improvement of neonatal HAI management quality.Methods The framework of the index system was preliminarily established through literature research and focus group discussion,the indexes were repeatedly screened using Delphi expert consultation approach,and the weights of each index were determined using the analytic hierarchy process.The empirical study of the established index sys-tem was conducted using TOPSIS method and rank sum ratio method.Results Three rounds of expert consultation were conducted,and the effective response rate of the questionnaire was 100％.The authoritative coefficient of the third round of expert consultation was 0.89,and the Kendall's coefficient of concordance for expert opinion was 0.322.The established index system included 3 first-level indexes,6 second-level indexes,and 16 third-level inde-xes.Thirteen of third-level indexes could be directly obtained from the hospital information system.Conclusion The quality control index system for neonatal HAI management established in this study is relatively scientific,with rational weights and all quantifiable indexes.It can be used for vertical and horizontal evaluations of neonatal HAI management quality,providing a reference for the continuous improvement of neonatal HAI management work.

Objective:To analyze the characteristics of Hashimoto thyroiditis(HT)and Graves disease(GD),two autoimmune thyroid diseases aged 10-59 in Qingdao City from 2022 to 2024,and to provide scientific basis for making targeted prevention and treatment measures.Methods:A cross-sectional study design was adopted,based on the data of the Regional Health Information Platform in Qingdao,the con-firmed cases of HT and GD from 2022 to 2024 were included,and combined with the data of the seventh population census,the three-year and annual prevalence rates of HT and GD were calculated,and the time trend of annual prevalence was analyzed by Cochran-Armitage trend test.The distribution characte-ristics of HT and GD prevalence in different age groups and regions were analyzed,and Chi-square test was used to compare the differences between the groups.Results:The total number of HT patients among women aged 10-59 in Qingdao City from 2022 to 2024 was 40 362.The proportion of HT patients in 30-34 years old was the highest(19.83％).The proportion of HT patients in Huangdao District was the highest(17.72％).The three-year prevalence of HT was 1 206.53/100 000.In 2022-2024,the annual prevalence of HT increased significantly(P＜0.001),from 385.32/100 000 in 2022 to 1 206.32/100 000 in 2024.The three-year prevalence of HT was significantly different in age distribution(P＜0.001).The three-year prevalence of HT in 25-29 years(2 354.44/100 000)and 35-39 years(2 022.20/100 000)was higher than that in other age groups,showing a bimodal distribution.There were significant differences in the three-year prevalence of HT in different regions(P＜0.001),among which the three-year prevalence of HT in Shinan District was the highest(2 392.90/100 000),followed by Licang Dis-trict(1 492.41/100 000),and Laixi City was the lowest(659.940/100 000).The total number of GD patients was 2 095,among which the proportion of GD patients in the 35-39 age group was the highest(15.42％),and the proportion of GD patients from Jimo District was the highest(12.27％).From 2022 to 2024,the three-year prevalence rate of GD was 62.63/100 000,and the annual prevalence rate of GD showed an increasing trend(P＜0.001),from 20.33/100 000 in 2022 to 62.63/100 000 in 2024.There were significant differences in the prevalence of GD by age(P＜0.001).The three-year prevalence of GD reached the highest value in the 25-29 age group(98.90/100 000),followed by the 35-39 age group(85.21/100 000),and the lowest in the 10-14 age group(14.43/100 000).In the regional distribution,there were significant differences in the 3-year prevalence of GD(P＜0.001).Laoshan District had the highest three-year prevalence of GD(107.58/100 000),followed by Shinan District(97.83/100 000)and Huangdao District(28.92/100 000).Conclusion:The three-year pre-valence of HT and GD in females aged 10-59 years in Qingdao City from 2022 to 2024 is low,but the annual prevalence is on the rise,and the three-year prevalence of HT and GD in females aged 25-39 years is higher than that in other age groups,so it is necessary to strengthen the screening and monitoring of this population.

Objective:To analyze the short-term clinical efficacy and safety of arsenic trioxide (ATO) combined with a modified N7 induction regimen in the treatment of children with high-risk neuroblastoma (NB).Methods:This study was a prospective, single-arm, multicenter phase Ⅱ clinical study. Sixty-seven high-risk NB children from eight units of Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Wuhan Children′s Hospital of Tongji Medical College of Huazhong University of Science and Technology, First Affiliated Hospital of Guangxi Medical University, Hainan General Hospital, Affiliated Hospital of Guangdong Medical University, Kunming Children′s Hospital, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, and Guangdong Provincial Agricultural Reclamation Center Hospital were enrolled from January 2019 to August 2023 and were treated with ATO combined with a modified N7 induction regimen. The efficacy and adverse effects at the end of induction chemotherapy were assessed and analyzed, and the differences in the clinical characteristics were further compared between the treatment-responsive and treatment-unresponsive groups by using the Fisher′s exact test.Results:Among 67 high-risk NB children, there were 40 males (60%) and 27 females (40%), with the age of disease onset of 3.5 (2.6, 4.8) years. Primary NB sites were mostly in retroperitoneum (including adrenal gland) (56/67, 84%) and the common metastases sites at initial diagnosis were distant lymph node in 25 cases (37%),bone in 48 cases (72%),bone marrow in 56 cases (84%) and intracalvarium in 3 cases (4%). MYCN gene amplification were detected in 28 cases (42%). At the end of induction, 33 cases (49%) achieved complete remission, 29 cases (43%) achieved partial remission, 1 case (1%) with stable disease, and 4 cases (6%) were assessed as progressive disease (PD). The objective remission rate was 93% (62/67) and the disease control rate was 94% (63/67). The percentage of central system metastases at the initial diagnosis was higher in the treatment-unresponsive group than in the treatment-responsive group (2/5 vs. 2% (1/62), P=0.013), whereas the difference in MYCN gene amplification was not statistically significant between two groups (3/5 vs.40% (25/62), P=0.786). Grade Ⅲ or higher adverse reactions during the induction chemotherapy period were myelosuppression occurred in 60 cases (90%), gastrointestinal symptoms occurred in 33 cases (49%), infections occurred in 20 cases (30%), hepatotoxicity occurred in 4 cases (6%), and cardiovascular toxicity occurred in 1 case (2%). There were no chemotherapy-related deaths. Conclusion:ATO combined with N7-modified induction regimen had a superiority in efficacy and safety, which deserved further promotion in clinical practice.

Objective:To comprehensively understand the disease burden of liver cirrhosis and other chronic liver diseases caused by alcohol use in China from 1990 to 2019, as well as to predict the trends in disease burden from 2020 to 2030.Methods:The analysis utilized data from the Global Burden of Disease study in 2019 (GBD2019). Key indicators such as incidence rate, mortality rate, disability-adjusted life years (DALY), years of life lost due to premature mortality, and years lived with disability were selected to describe the disease burden of alcohol-related liver cirrhosis and other chronic liver diseases in China from 1990 to 2019. The estimated annual percentage change (EAPC) was used to depict the temporal trends in disease burden. Furthermore, a Bayesian age-period-cohort (BAPC) model was constructed using R software to predict the age-standardized incidence rate (ASIR) and age-standardized mortality rate (ASMR) of alcohol-related liver cirrhosis and other chronic liver diseases in China from 2020 to 2030.Results:From 1990 to 2019, the incidence of alcohol-related liver cirrhosis and other chronic liver diseases in China showed an upward trend, with an EAPC of 0.31% (95% CI: 0.10%-0.52%). However, the DALY declined, with an EAPC of -2.81% (95% CI: -2.92% - -2.70%). The ASMR showed a downward trend, with an EAPC of -2.55% (95% CI: -2.66% - -2.45%). The highest incidence of cirrhosis of liver caused by alcohol and other chronic liver diseases was reported in the age group of 35-49 years, while the ASMR increased gradually with age, with a significant rise after the age of 30. The age-standardized DALY rate peaked between the ages of 55 and 64. The disease burden indicators for males were consistently higher than those for females during the same period. According to the predictions of the BAPC model, from 2020 to 2030, the ASIR for cirrhosis of liver caused by alcohol and other chronic liver diseases in the entire population of China was projected to increase from 3.45/100 000 in 2020 to 3.78/100 000 in 2030, a growth of 9.57%. Conversely, the ASMR was expected to decrease from 1.45/100 000 in 2020 to 1.24/100 000 in 2030, a reduction of 14.48%. Conclusions:The disease burden of cirrhosis of liver caused by alcohol and other chronic liver diseases remained serious in China, especially in men and the middle-aged to elderly population. There is a pressing need to prioritize attention and resources towards these groups. Despite the projected decrease in ASMR, the ASIR continued to rise and is expected to persist in its upward trend until 2030.

Objective To analyze the risk factors of nosocomial infection among the patients in neuro-surgical ICU,and to construct the risk prediction model to provide reference for the prediction of nosocomial infection in neurosurgical ICU patients.Methods The clinical data of 280 patients admitted and treated in the neurosurgery ICU of this hospital from January 2021 to December 2022 were retrospectively analyzed.The pa-tients were divided into the infection group and non-infection group based on whether or not nosocomial infec-tion occurring,140 cases in each group.A total of 196 patients were extracted as the training set by a ratio of 7︰3 for constructing the model,while the remaining 84 patients served as the validation set for conducting the internal verification.The logistic regression was used to analyze the risk factors of nosocomial infection in the neurosurgery ICU patients,and a predictive model was established.The receiver operating characteristic (ROC) curve was drawn to evaluate the predictive effect of the model.Results The multivariate logistic re-gression analysis indicated that old age,long surgery time,catheter use and glucocorticoids use were screened as the main risk factors of nosocomial infection occurrence in neurosurgery ICU patients.The nomogram mod-el was constructed based on the results of multivariate analysis,the area under the curve of training set and validation set were 0.796 and 0.875,respectively.The correcting model reflected good consistency between actual diagnosis and predictive diagnosis.Conclusion The model constructed in this study has the high predic-tive value for the nosocomial infection occurrence risk in the patients of the neurosurgery ICU.

Endometriosis（EMs） is a common chronic inflammatory gynecological disease，affecting about 5%-10% of women of childbearing age worldwide，and has always been a major challenge in clinical treatment. Huposan， derived from the Experiential Prescriptions for Universal Relief （《普济本事方》）， has the effects of moving qi， activating blood，expelling blood stasis， and relieving pain. It is often used to treat EMs clinically and has achieved good curative effect. The relevant studies on the treatment of EMs by Huposan were retrieved from databases， such as CNKI，PubMed，Wanfang Data， and VIP for summarizing the mechanisms of action and clinical application of Huposan in the treatment of EMs， aiming to provide ideas and references for the basic research and clinical application of Huposan. As revealed by basic experiments，Huposan could exert therapeutic effects on EMs through resisting cell adhesion by reducing intercellular adhesion molecule 1（ICAM-1）content，decreasing concentrations of matrix metalloproteinase（MMP）-2 and MMP-9 against ectopic endometrial invasion，inhibiting vascular endothelial growth factor（VEGF）expression for antiangiogenesis，inhibiting the expression of tumor necrosis factor-α（TNF-α）， interleukin （IL）-6， and IL-1，reversing helper T cell（Th）1/Th2 balance shifts to regulate the body's immune mechanism，and reducing the serum levels of nitric oxide（NO）and nitric oxide synthase（NOS）. In clinic practice，Huposan has the effects of reducing ectopic lesions，relieving pain symptoms，reducing serum carbohydrate antigen 125（CA125）content，improving hormone levels，regulating endocrine and immune factors，and reducing postoperative recurrence rate. Huposan plays a therapeutic role in EMs through multiple targets and mechanisms，which is worthy of further exploration and clinical promotion.