1.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
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
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Alzheimer Disease/drug therapy*
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Male
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Female
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Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
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Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People
2.Expert consensus on the diagnosis and treatment of cemental tear.
Ye LIANG ; Hongrui LIU ; Chengjia XIE ; Yang YU ; Jinlong SHAO ; Chunxu LV ; Wenyan KANG ; Fuhua YAN ; Yaping PAN ; Faming CHEN ; Yan XU ; Zuomin WANG ; Yao SUN ; Ang LI ; Lili CHEN ; Qingxian LUAN ; Chuanjiang ZHAO ; Zhengguo CAO ; Yi LIU ; Jiang SUN ; Zhongchen SONG ; Lei ZHAO ; Li LIN ; Peihui DING ; Weilian SUN ; Jun WANG ; Jiang LIN ; Guangxun ZHU ; Qi ZHANG ; Lijun LUO ; Jiayin DENG ; Yihuai PAN ; Jin ZHAO ; Aimei SONG ; Hongmei GUO ; Jin ZHANG ; Pingping CUI ; Song GE ; Rui ZHANG ; Xiuyun REN ; Shengbin HUANG ; Xi WEI ; Lihong QIU ; Jing DENG ; Keqing PAN ; Dandan MA ; Hongyu ZHAO ; Dong CHEN ; Liangjun ZHONG ; Gang DING ; Wu CHEN ; Quanchen XU ; Xiaoyu SUN ; Lingqian DU ; Ling LI ; Yijia WANG ; Xiaoyuan LI ; Qiang CHEN ; Hui WANG ; Zheng ZHANG ; Mengmeng LIU ; Chengfei ZHANG ; Xuedong ZHOU ; Shaohua GE
International Journal of Oral Science 2025;17(1):61-61
Cemental tear is a rare and indetectable condition unless obvious clinical signs present with the involvement of surrounding periodontal and periapical tissues. Due to its clinical manifestations similar to common dental issues, such as vertical root fracture, primary endodontic diseases, and periodontal diseases, as well as the low awareness of cemental tear for clinicians, misdiagnosis often occurs. The critical principle for cemental tear treatment is to remove torn fragments, and overlooking fragments leads to futile therapy, which could deteriorate the conditions of the affected teeth. Therefore, accurate diagnosis and subsequent appropriate interventions are vital for managing cemental tear. Novel diagnostic tools, including cone-beam computed tomography (CBCT), microscopes, and enamel matrix derivatives, have improved early detection and management, enhancing tooth retention. The implementation of standardized diagnostic criteria and treatment protocols, combined with improved clinical awareness among dental professionals, serves to mitigate risks of diagnostic errors and suboptimal therapeutic interventions. This expert consensus reviewed the epidemiology, pathogenesis, potential predisposing factors, clinical manifestations, diagnosis, differential diagnosis, treatment, and prognosis of cemental tear, aiming to provide a clinical guideline and facilitate clinicians to have a better understanding of cemental tear.
Humans
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Dental Cementum/injuries*
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Consensus
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Diagnosis, Differential
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Cone-Beam Computed Tomography
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Tooth Fractures/therapy*
3.Correlation between preoperative coronary angiography and postoperative acute kidney injury in cardiac surgery: A retrospective study in a single center
Changying ZHAO ; Yang YAN ; Tao SHI ; Yongxin LI ; Jing LI ; Wenyan LIU ; Miaomiao LIU ; Xinglong ZHENG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(12):1820-1825
Objective To explore the relationship between preoperative coronary angiography and postoperative acute kidney injury (AKI) in cardiac surgery. Methods The clinical data of patients who underwent coronary angiography within 30 days before cardiac surgery in the First Affiliated Hospital of Xi’an Jiaotong University from January 2015 to April 2019 were retrospectively analyzed. Univariate analysis and multivariate logistic regression analyses were used to explore the relationship between the interval from preoperative coronary angiography to cardiac surgery and postoperative AKI. Results Finally 1 112 patients were collected, including 700 males and 412 females, with a median age of 61 (55, 66) years. The incidence of postoperative AKI was 40.8% (454/1 112), of which grade 2-3 AKI accounted for 11.9%. Multivariate analysis showed that age (OR=1.049, 95%CI 1.022-1.077, P<0.001), body mass index (OR=1.065, 95%CI 1.010-1.123, P=0.020) and time interval between preoperative coronary angiography and cardiac surgery within 24 hours (OR=1.625, 95%CI 1.116-2.364, P=0.011) were independent predictors of postoperative AKI. Patients who underwent coronary angiography within 24 hours before surgery had a 10.6% higher incidence of postoperative AKI compared to those who underwent angiography ≥24 hours before surgery (P=0.004). Patients who underwent valve surgery with or without coronary artery bypass grafting (CABG) had a higher risk of AKI than those who only underwent CABG. The in-hospital stay of patients who developed AKI was 2 days longer than those without AKI. However, undergoing coronary angiography within 24 hours before cardiac surgery did not prolong the length of ICU stay or hospital stay, nor did it increase the risk of death or renal failure after the operation. Conclusion Undergoing coronary angiography within 24 hours before cardiac surgery increases the risk of postoperative AKI.
4.Association and its population heterogeneities between low-density lipoprotein cholesterol and all-cause and cardiovascular mortality: A population-based cohort study
Jiapeng LU ; Haibo ZHANG ; Bowang CHEN ; Yang YANG ; Jianlan CUI ; Wei XU ; Lijuan SONG ; Hao YANG ; Wenyan HE ; Yan ZHANG ; Wenyao PENG ; Xi LI
Chinese Medical Journal 2024;137(17):2075-2083
Background::The association and its population heterogeneities between low-density lipoprotein cholesterol (LDL-C) and all-cause and cardiovascular mortality remain unknown. We aimed to examine the dose-dependent associations of LDL-C levels with specific types of cardiovascular disease (CVD) mortality and heterogeneities in the associations among different population subgroups.Methods::A total of 2,968,462 participants aged 35-75 years from China Health Evaluation And risk Reduction through nationwide Teamwork (ChinaHEART) (2014-2019) were included. Cox proportional hazard models and Fine-Gray subdistribution hazard models were used to estimate associations between LDL-C categories (<70.0, 70.0-99.9, 100.0-129.9 [reference group], 130.0-159.9, 160.0-189.9, and ≥190.0 mg/dL) and all-cause and cause-specific mortality.Results::During a median follow-up of 3.7 years, 57,391 and 23,241 deaths from all-cause and overall CVD were documented. We observed J-shaped associations between LDL-C and death from all-cause, overall CVD, coronary heart disease (CHD), and ischemic stroke, and an L-shaped association between LDL-C and hemorrhagic stroke (HS) mortality ( P for non-linearity <0.001). Compared with the reference group (100.0-129.9 mg/dL), very low LDL-C levels (<70.0 mg/dL) were significantly associated with increased risk of overall CVD (hazard ratio [HR]: 1.10, 95% confidence interval [CI]: 1.06-1.14) and HS mortality (HR: 1.37, 95% CI: 1.29-1.45). Very high LDL-C levels (≥190.0 mg/dL) were associated with increased risk of overall CVD (HR: 1.51, 95% CI: 1.40-1.62) and CHD mortality (HR: 2.08, 95% CI: 1.92-2.24). The stronger associations of very low LDL-C with risk of CVD mortality were observed in individuals with older age, low or normal body mass index, low or moderate 10-year atherosclerotic CVD risk, and those without diagnosed CVD or taking statins. Stronger associations between very high LDL-C levels and all-cause and CVD mortality were observed in younger people. Conclusions::People with very low LDL-C had a higher risk of all-cause, CVD, and HS mortality; those with very high LDL-C had a higher risk of all-cause, CVD, and CHD mortality. On the basis of our findings, comprehensive health assessment is needed to evaluate cardiovascular risk and implement appropriate lipid-lowering therapy for people with very low LDL-C.
5.Application of deep learning with multimodal data in glaucoma diagnosis and severity grading
Chaoxu QIAN ; Lingxiang ZHOU ; Xueli FENG ; Xi CHEN ; Wenyan YANG ; Sanli YI ; Hua ZHONG
Chinese Journal of Experimental Ophthalmology 2024;42(12):1149-1154
Objective:To develop a deep learning model based on multimodal data for glaucoma diagnosis and severity assessment.Methods:A diagnostic test was conducted.A total of 145 normal eyes from 86 participants and 507 eyes with primary open-angle glaucoma from 314 participants were collected at the First Affiliated Hospital of Kunming Medical University from June to December in 2023.Fundus photographs and visual field data were obtained, and glaucoma eyes were divided into three groups based on the mean deviation value of the visual field, namely mild group (154 eyes), moderate group (113 eyes), and severe group (240 eyes).Three convolutional neural network (CNN) models, including DenseNet 121, ResNet 50 and VGG 19, were used to build an artificial intelligence (AI) model.The impact of single-modal and multimodal data on the classification results was evaluated, and the most appropriate CNN network architecture for multimodal data was identified.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of The First Affiliated Hospital of Kunming Medical University (No.2023L93).Written informed consent was obtained from each subject.Results:A total of 652 eyes had both fundus photographs and visual field test results.Images were randomly assigned to training and test datasets in a 4∶1 ratio by using computer random number method.AI models built with different CNN models showed high accuracy, with DenseNet 121 outperforming ResNet 50 and VGG 19 on various effectiveness measures.In the single-modal algorithm using fundus photographs, single-modal algorithm using visual field tests, and multimodal algorithm combining fundus photographs and visual field data, the area under the curve for early glaucoma detection was 0.87, 0.93 and 0.95, respectively.Conclusions:The use of multimodal data enables the development of a highly accurate tool for the glaucoma diagnosis and severity grading.
6.Visual analysis of critical care research based on Web of Science core set
Wenyan XI ; Xiaoxu ZHANG ; Pengbo YAN ; Kaili SHU ; Yajing QIN ; Aihong FANG ; Yongsheng LI
Chinese Journal of Practical Nursing 2022;38(14):1115-1121
Objective:To analyze the data of critical care related literatures published in Web of Science core set by knowledge map visualizing technology, and summarize the research status and hotspots of critical care.Methods:The core set database of Web of Science from January 2011 to December 2020 was searched, the extracted information was standardized and analyzed by knowledge map visualizing technology.Results:A total of 783 articles in the field of critical care were included, and the number of literatures increased year by year, among which the number of articles published in the American Journal of Critical Care(305) was the most. The United States (437) was the country with the most published literatures, and Australia was the country with the highest centrality (centrality=0.67). The number and centrality of articles published from China were at the lower middle level. There was cooperation among countries, but not close cooperation. The cooperation among authors was in the state of small aggregation and large dispersion. Cluster analysis and keyword emergence analysis showed that many aspects in the field of intensive care had been the research hotspots, among which "post intensive care syndrome" and "children′s intensive care" were the research hotspots in recent years.Conclusions:The research field of intensive care is still in the rising stage of development, and post intensive care syndrome and children's intensive care are the latest hotspots in intensive care research.
7. Research of TLD calibrated in different standard X-ray RQR radiation field in terms of eye lens dose H p(3)
Wenyan LI ; Guiying ZHANG ; Zhichao WANG ; Zeqin GUO ; Mengxiao KANG ; Chuanye LIU ; Wentao SHENG ; Yue ZENG ; Xi LUO ; Linlin YUE
Chinese Journal of Radiological Medicine and Protection 2020;40(1):42-46
Objective:
To compare the calibration result of standard X-ray RQR radiation field between SSDL (NIRP) and CEA LIST LNHB(France), and to explore the feasibility of calibrating
8.Expressions of programmed death-ligand 1 and 2 and phosphorylated protein kinase B in diffuse large B-cell lymphoma and their clinical significances
Wenyan WANG ; Wenli YAN ; Yirong XU ; Fei CHAI ; Yanfeng XI ; Wei BAI ; Peng BU ; Zhenwen CHEN ; Jinfen WANG
Journal of Leukemia & Lymphoma 2019;28(2):81-87
Objective To investigate the expressions of programmed death-ligand 1 (PD-L1) and PD-L2 and phosphorylated protein kinase B (p-AKT) in diffuse large B-cell lymphoma (DLBCL) patients and their correlations with clinicopathological features and prognosis. Methods A total of 68 paraffin-embedded specimens of DLBCL patients diagnosed in Shanxi Provincial Cancer Hospital with detailed follow-up record from January 2010 to December 2012 were included in the study. The expressions of PD-L1, PD-L2 and p-AKT proteins in DLBCL were detected by using immunohistochemistry (IHC). Results The positive rate of PD-L1 protein in DLBCL patients was 22.1% (15/68), which was related to germinal center B-cell (GCB) subtype or not (χ2= 5.591, P= 0.018), clinical stage (χ2= 3.969, P= 0.046), international prognostic index (IPI) grades (χ2=4.178, P=0.041) and treatment remission rate (χ2=6.587, P=0.010). The positive rate of PD-L2 protein in DLBCL patients was 14.7% (10/68), which was related to extranodal metastasis or not (χ2=6.772, P= 0.009). The positive rate of p-AKT for DLBCL patients was 61.8% (42/68), which was correlated with age (≥60 years old) or not (χ2=6.227, P=0.013), Eastern Cooperative Oncology Group (ECOG) grades (χ2=4.005, P=0.045), B symptoms (χ2=10.187, P=0.001) and treatment remission rate (χ2=4.096, P=0.043). Univariate survival analysis showed that the overall survival (OS) rate and progression free survival (PFS) rate of PD-L1 protein positive expression group were lower than those of PD-L1 protein negative expression group (both P< 0.05). In the patients with non-GCB subtype, OS rate and PFS rate of PD-L1 protein positive expression group were lower than those of PD-L1 protein negative expression group (both P<0.05). p-AKT protein positive expression group had poorer OS rate and PFS rate compared to p-AKT negative expression group (both P< 0.05). Correlation analysis showed that PD-L1 protein expression was correlated with PD-L2 and p-AKT proteins expressions (r= 0.380, P= 0.001;r= 0.273, P= 0.025). The prognosis was worse when p-AKT and PD-L1 proteins was co-expressed (P< 0.05). Multivariate analysis suggested high expressions of PD-L1 and p-AKT proteins were independent prognosis risk factors in DLBCL (both P<0.05). Conclusions The expressions of PD-L1 and p-AKT proteins may be involved in the occurrence and development of DLBCL. Blocking PD-1 and PD-L1 access or combined blocking could provide a promising future for the clinical therapy.
9.Investigation on Medical Students' Ethical Cognition of Assisted Reproductive Technology
Xiaoning LU ; Wenyan XI ; Shengyu FU ; Xianghong LI ; Qiang HAN
Chinese Medical Ethics 2017;30(8):985-988
Objective:To investigate the medical students' cognition of ethical issues in assisted reproductive technology (ART) and discuss the importance of ethical education in medical colleges and universities.Methods:A questionnaire survey about the ethical cognition of assisted reproductive technology was conducted among 632 medical students.The questionnaire included the donation and management of gametes and embryos,and offspring problems.Results:Medical students agreed with most of the current ART-related laws and regulations.however,44.8% of medical students considered that criteria of donating eggs should be relaxed,such as allowing women who do not receive ART treatment be paid for eggs.In addition,a total of 39.0% of medical students supported the legalization of surrogacy technology in china.Conclusion:Medical students exists a certain misunderstanding in egg donation and surrogacy technology.We should give more training to medical students in ethical knowledge.In addition,our country can supplement and perfect the current laws and regulations to a certain extent.
10.Analysis on correlation between biofilm formation and bacterial resistance in Staphylococcus epidermidis
Yangqin YE ; Yujie BAO ; Ke MA ; Wenyan ZHANG ; Ting XI ; Fangying CHEN ; Ming ZONG ; Lieying FAN
International Journal of Laboratory Medicine 2016;37(5):618-620
Objective To investigate the formation of biofilm in clinical isolates of Staphylococcus epidermidis ,and to analyse the correlation between biofilm formation and antibacterial resistance of Staphylococcus epidermidis .Methods A total of 62 strains of Staphylococcus epidermidis isolated from blood specimens of inpatients with bloodstream infection ,from January 2014 to February 2015 ,were collected .The biofilm formation of Staphylococcus epidermidis was detected by using the semi‐quantitative adherence as‐say and polymerase chain reaction(PCR) amplification experiment .The antibacterial susceptibility test was carried out according to K‐B method .Results The positive rate of biofilm formation detected by using the semi‐quantitative adherence assay and PCR for icaA gene were 37 .1% (23 strains) and 43 .5% (27 strains) respectively ,and there was no statistically significant difference(P>0 .05) .There were 14 positive strains detected by both methods .The resistance rates of strains producing biofilm to antibacterial a‐gents were generally higher than those of non‐producing biofilm strains ,and there were statistically significant differences in resist‐ance rates of strains to gentamicin ,penicillin ,oxacillin ,levofloxacin and cefoxitin(P<0 .05) .All bacteria were sensitive to vancomy‐cin ,linezolid and quinupristin/dalfopristin .Conclusion There is no significant difference between the two methods in detecing bio‐film formation .The resistance rates of strains producing biofilm to antibacterial agents were generally higher than those of non‐pro‐ducing biofilm strains .

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